Drug Library

Abilify
Adderall
Adderall XR
Adzenys XR-ODT
Anafranil
Aptensio XR
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Concerta
Cotempla XR-ODT
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Evekeo
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Focalin XR
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Jornay PM
Kapvay
Lexapro
Luvox
Metadate CD
Methylin
Mydayis
Onyda XR
ProCentra
Prozac
Qelbree
QuilliChew ER
Quillivant XR
Relexxii
Risperdal
Ritalin
Ritalin LA
Strattera
Trileptal
Vyvanse
Wellbutrin XL
Xelstrym
Zenzedi
Zoloft

Abilify

(aripiprazole)

Abilify (aripiprazole); not controlled

Summary

Abilify is an atypical antipsychotic approved for irritability associated with autistic disorder, Tourette's disorder, pediatric bipolar I mania, and adolescent schizophrenia. It is a partial agonist at dopamine D2 rather than a full antagonist, which gives it a lower prolactin and extrapyramidal burden than risperidone. In an ADHD practice it is reached for when aggression or severe irritability persists despite optimised stimulant therapy, not as an ADHD treatment. Not controlled; brand and generic.

Forms & Strengths

Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg
Orally disintegrating tablets: 10 mg, 15 mg, 20 mg, 30 mg
Oral solution: 1 mg/mL
Oral soluble film (Opipza): 10 mg
Long-acting injectables (Abilify Maintena, Aristada, Asimtufii): separate products with their own labels

Dosing

Age:
- Irritability with autistic disorder: 6-17 y/o
- Tourette's disorder: 6-18 y/o
- Bipolar I, acute mania or mixed: 10-17 y/o
- Schizophrenia: 13-17 y/o
Onset: 1-2 weeks for behavioural effect; steady state within 14 days
Duration: continuous with once-daily dosing
Initial Dose: 2 mg once daily for every pediatric indication
Titration: increase at intervals of no less than 1 week; target 5-10 mg/day for autism irritability, 10 mg/day for bipolar I and schizophrenia
Max Dose:
- Irritability with autistic disorder: 15 mg/day
- Tourette's, under 50 kg: 10 mg/day
- Tourette's, 50 kg and over: 20 mg/day
- Bipolar I: 30 mg/day
- Schizophrenia: 30 mg/day
Considerations: May be taken with or without food. Halve the usual dose in CYP2D6 poor metabolizers and with strong CYP2D6 or CYP3A4 inhibitors. Tourette's dosing bands by weight, not age.

Pharmacology

Mechanism: Partial agonist at D2 and 5-HT1A, antagonist at 5-HT2A
Class Positioning: D2 partial agonism gives a lower prolactin and EPS burden than risperidone (Risperdal); akathisia is the trade-off and the commonest reason for discontinuation
Metabolism: CYP2D6 and CYP3A4, to the active metabolite dehydro-aripiprazole
Half-life: about 75 hours for aripiprazole, 94 hours for dehydro-aripiprazole, about 146 hours in CYP2D6 poor metabolizers
Pharmacogenomics: CYP2D6 poor metabolizers receive half the usual dose; this is a labeled adjustment, not advisory

Indications

Irritability Associated with Autistic Disorder (ICD-10: F84.0): patients 6-17 y/o
Tourette's Disorder (ICD-10: F95.2): patients 6-18 y/o
Bipolar I Disorder, acute mania or mixed episodes (ICD-10: F31.x): patients 10-17 y/o and adults
Schizophrenia (ICD-10: F20.x): patients 13-17 y/o and adults
Major Depressive Disorder, adjunctive (ICD-10: F32.x, F33.x): adults only

Off-Label Uses

Severe aggression and disruptive behaviour (ICD-10: F90.x, F91.x): second line, after behavioural intervention and optimised treatment of the primary disorder. Evidence for aripiprazole graded insufficient to low; expert consensus. (AACAP 2011; AHRQ 2017)
Anxiety disorders (ICD-10: F41.x): insufficient; no eligible pediatric studies were identified at all. (AHRQ 2017)
Obsessive-compulsive disorder (ICD-10: F42.x): insufficient; the effect of aripiprazole augmentation is not known. (AHRQ 2017)
Depression (ICD-10: F32.x, F33.x): insufficient in youth. The adult adjunctive MDD indication does not extend to children. (AHRQ 2017)

Contraindications & Warnings

Boxed Warning: Increased mortality in elderly patients with dementia-related psychosis; aripiprazole is not approved for that use. Also suicidal thoughts and behaviors when used with antidepressants: screen at every visit.
Contraindicated:
- Known hypersensitivity to aripiprazole or any component of the formulation.
Use with caution:
- Cardiovascular or cerebrovascular disease, or any condition predisposing to hypotension.
- Diabetes, obesity, or a family history of either.
- Seizure history or a lowered seizure threshold.
- Conditions raising core temperature: strenuous exercise, heat exposure, anticholinergic co-medication.
Screen before starting:
- Weight, BMI, and waist circumference.
- Fasting glucose or A1c, and a fasting lipid panel.
- Personal and family history of diabetes, dyslipidemia, and cardiovascular disease.
- Baseline abnormal involuntary movements, using AIMS.

Drug Interactions

Strong CYP2D6 or CYP3A4 inhibitors (fluoxetine, paroxetine, quinidine, ketoconazole, itraconazole, clarithromycin): give half the usual dose.
Both a strong CYP2D6 and a strong CYP3A4 inhibitor: give a quarter of the usual dose.
CYP2D6 poor metabolizer on a strong CYP3A4 inhibitor: give a quarter of the usual dose.
Strong CYP3A4 inducers (carbamazepine, rifampin): double the usual dose over 1 to 2 weeks; reverse when the inducer stops.
Antihypertensives: additive hypotension; check orthostatic vitals after any dose change.
CNS depressants and alcohol: additive sedation; counsel explicitly in adolescents.

Administration

Give once daily, at the same time each day, with or without food.
Tablet: swallow whole.
Orally disintegrating tablet: place on the tongue and let it dissolve; do not chew, crush, or push through the foil.
Oral solution: measure with a dosing syringe or calibrated cup; at 1 mg/mL doses map directly to millilitres.
If a dose is missed, give it unless the next dose is near; do not double up.
Do not stop abruptly. See Discontinuation & Taper.

Side Effects

Common: akathisia and restlessness, sedation and fatigue, weight gain, nausea and vomiting, headache, dizziness, constipation, insomnia
Serious:
- Tardive dyskinesia: assess with AIMS; discontinue where clinically possible if it emerges.
- Neuroleptic malignant syndrome: fever, rigidity, altered mental status, autonomic instability. Treat as an emergency.
- Hyperglycemia and new-onset diabetes, including ketoacidosis: check glucose for polyuria, polydipsia, or unexplained weight loss.
- Orthostatic hypotension and syncope: check lying and standing blood pressure at each dose change.
- Seizures.
- Leukopenia, neutropenia, agranulocytosis: check CBC with fever or infection; discontinue if ANC falls below 1000/mm3.
- Pathological gambling, binge eating, compulsive shopping, hypersexuality: ask directly, since patients rarely volunteer them.
- Dysphagia and laryngeal or dystonic reactions.

Monitoring & Labs

Weight and BMI: at 4, 8, and 12 weeks after starting or changing dose, then quarterly. Consider switching agent on a gain of 5% or more. (ADA 2004)
Fasting glucose or A1c: at baseline and 12 weeks, then annually; sooner with weight gain, family history, or metabolic change. (ADA 2004)
Fasting lipids: at baseline and 12 weeks, then every 5 years if normal; recheck when weight or glucose moves. (ADA 2004)
Blood pressure: at baseline and 12 weeks, annually thereafter, plus orthostatics at every dose change. (ADA 2004)
Movement: AIMS at baseline and every 3 months in children; ask about akathisia at every visit during titration.
Prolactin: only if symptomatic, meaning galactorrhea, gynecomastia, amenorrhea, or delayed puberty. Aripiprazole usually lowers prolactin.
CBC: not routine; check with fever, infection, or a history of leukopenia or neutropenia.

Discontinuation & Taper

Taper gradually rather than stopping abruptly, to minimise withdrawal effects. Guideline recommendation, not a labeled instruction. (AACAP 2011)
Reassess the continued need regularly; document indication, response, and rationale for continuing. (AACAP 2011)
The long half-life means levels fall slowly, so withdrawal or rebound may appear days after the last dose.
Discontinue immediately if neuroleptic malignant syndrome is suspected.
Discontinue for severe neutropenia, an absolute neutrophil count below 1,000/mm3.

Pregnancy & Lactation

Pregnancy: Third-trimester exposure may cause neonatal extrapyramidal or withdrawal symptoms. Weigh continued treatment against relapse of the maternal condition rather than stopping reflexively.
Lactation: Maternal doses up to 15 mg daily give low milk levels; relative infant dose ranges from under 0.7% to 12.7%. Monitor for dehydration and inadequate weight gain. (LactMed 2026)
Milk supply: Aripiprazole lowers prolactin dose-dependently and can suppress lactation outright. Raise this before starting in a patient who intends to breastfeed. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for Atypical Antipsychotics, 1-866-961-2388, womensmentalhealth.org.

Counseling Points

Counsel the family on:
- Restlessness in the first weeks. Name akathisia explicitly; families read it as worsening behaviour and stop the drug.
- Appetite increase and weight gain, and that weight is plotted at every visit.
- Effect on irritability building over 1-2 weeks, so the first week is not a fair trial.
- Rising slowly from lying or sitting during titration.
- Extra caution with heat and strenuous exercise; the drug impairs temperature regulation.
- Never stopping abruptly, even if the medication seems to be doing nothing.
Advise them to call for:
- Fever with muscle stiffness or confusion, which is an emergency.
- Any involuntary movement of the face, tongue, or limbs.
- Fainting, or dizziness on standing that does not settle.
- Marked thirst, frequent urination, or unexplained weight loss.
- New gambling, spending, eating, or sexual urges that feel out of character.
- New or worsening suicidal thoughts, especially alongside an antidepressant.

References

DailyMed. Abilify (aripiprazole) tablet prescribing information. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac
LactMed. Aripiprazole. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501016/
American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004. https://diabetesjournals.org/care/article/27/2/596/28450/
AACAP. Practice parameter for the use of atypical antipsychotic medications in children and adolescents. 2011. https://www.aacap.org/App_Themes/AACAP/docs/practice_parameters/Atypical_antipsychotic_Medications_Web.pdf
AHRQ. First- and second-generation antipsychotics in children and young adults: systematic review update. Comparative Effectiveness Review No. 184. 2017. https://www.ncbi.nlm.nih.gov/books/NBK442344/

Adderall

(dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)

Adderall (mixed amphetamine salts); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Adderall is an immediate-release, short-acting amphetamine tablet approved for ADHD from age 3 and for narcolepsy from age 6. It is a fixed 3:1 ratio of dextroamphetamine to levoamphetamine salts, and unlike methylphenidate it both blocks reuptake and drives presynaptic catecholamine release. Its short duration makes it useful for afternoon coverage or for patients who cannot tolerate a full-day agent, at the cost of multiple daily dosing. Schedule II; brand and generic.

Forms & Strengths

Tablets: 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg

Dosing

Age:
- ADHD: ≥ 3 y/o
- Narcolepsy: ≥ 6 y/o
Onset: 30-60 min
Duration: 4-6 hours
Initial Dose:
- 3-5 y/o: 2.5 mg daily
- ≥ 6 y/o: 5 mg once or twice daily
Titration:
- 3-5 y/o: increase by 2.5 mg at weekly intervals
- ≥ 6 y/o: increase by 5 mg at weekly intervals
Max Dose:
- ADHD: 40 mg/day; the label states only in rare cases will it be necessary to exceed this
- Narcolepsy: usual range 5-60 mg/day
Considerations: Give the first dose on waking, with further doses at 4-6 hour intervals. May be taken with or without food; a high-fat meal may delay absorption. Avoid late-afternoon dosing.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
Formulation: Fixed 3:1 ratio of dextroamphetamine to levoamphetamine salts; the levo isomer contributes more peripheral and noradrenergic effect
Class Positioning: Covers a discrete window rather than a school day; ER siblings of the same salts are Adderall XR and Mydayis
Elimination: Urinary excretion is pH dependent, which is why acidifying and alkalinizing agents change exposure

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 3 y/o
Narcolepsy (ICD-10: G47.419): patients ≥ 6 y/o

Off-Label Uses

Attention problems after TBI (ICD-10: S06.x): limited data, and largely for methylphenidate; insufficient for amphetamine in youth.
Depression augmentation (ICD-10: F32.x, F31.x): adult literature only; insufficient in children.
Cognitive enhancement without ADHD: not an indication; not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction; risk of overdose and death. Assess abuse risk before prescribing and monitor throughout. Educate the family on secure storage and disposal of unused drug.
Contraindicated:
- Known hypersensitivity to amphetamine or any component of the product.
- Current use of an MAOI, or use within the preceding 14 days, because of hypertensive crisis.
Use with caution (Warnings in this label, not contraindications):
- Known structural cardiac abnormality, cardiomyopathy, or serious arrhythmia, because of sudden death reports.
- Pre-existing hypertension, because blood pressure and heart rate rise.
- Pre-existing psychosis or bipolar disorder, because of exacerbation and treatment-emergent mania.
- History of substance use disorder in the patient or household.
- Peripheral vasculopathy including Raynaud phenomenon.
Screen before starting:
- Cardiac history, exertional syncope, family history of sudden cardiac death before 50. ECG only if positive.
- Personal or family history of bipolar disorder, psychosis, and tics.
- Abuse and diversion risk, which the boxed warning requires.
- Baseline height, weight, blood pressure, and heart rate.

Drug Interactions

MAOIs: contraindicated within 14 days; risk of hypertensive crisis.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone, St John's Wort, tryptophan): serotonin syndrome; counsel on symptoms and reassess when adding.
Alkalinizing agents (sodium bicarbonate, some antacids): raise amphetamine blood levels and potentiate its effect.
Acidifying agents (ascorbic acid, fruit juices): lower amphetamine blood levels and reduce efficacy.
Sympathomimetics (decongestants, beta-agonists): additive cardiovascular effect.

Administration

Give the first dose on waking; give any further doses at 4-6 hour intervals.
May be taken with or without food. A high-fat meal may delay absorption.
Avoid late-afternoon and evening doses, which cause insomnia.
If a dose is missed, skip it rather than giving it late in the day; do not double up.
A capsule of mixed amphetamine salts is not this product; confirm IR versus ER before substituting.
Store securely. This is a Schedule II product and household diversion is a real risk.

Side Effects

Common: decreased appetite, insomnia, weight loss, headache, dry mouth, irritability, anxiety, abdominal pain, increased heart rate and blood pressure
Serious:
- Sudden death, myocardial infarction and stroke, reported in patients with structural cardiac abnormalities or other serious cardiac problems.
- Psychosis, mania, and new aggression, including in patients with no prior psychiatric history.
- Serotonin syndrome when combined with serotonergic agents.
- Peripheral vasculopathy including Raynaud phenomenon: reassess at each visit; discontinue if digital ulceration occurs.
- Growth suppression in children.
- Priapism, which may require surgical intervention and can occur after dose reduction or withdrawal.

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI plotted on a growth chart at baseline and every 6 months; evaluate if a child crosses two major percentile lines.
Appetite and Sleep: at every visit. These are the two most common reasons for discontinuation.
Psychiatric: screen for new psychosis, mania, aggression and worsening tics at each visit.
Abuse and Diversion: adherence, pill counts, PDMP check at each refill. Uncontrolled alternatives: Strattera, Qelbree.
Laboratory: no routine laboratory monitoring is required.

Discontinuation & Taper

Immediate-release amphetamine can be stopped abruptly at therapeutic doses; no taper is required.
Expect rebound irritability, hunger and fatigue at offset; this is pharmacodynamic, not withdrawal.
Drug holidays are reasonable where appetite or growth suppression is the limiting problem.

Pregnancy & Lactation

Pregnancy: Use only if benefit justifies fetal risk. No exposure registry in this label.
Lactation: Label advises against nursing. LactMed: milk levels ~1.9-2.1% of maternal dose; therapeutic doses considered compatible if the infant is watched for irritability, insomnia and poor feeding. (LactMed 2025)
Milk supply: Dose-related prolactin suppression of ~25-40%; large doses may impair milk production before lactation is established. (LactMed 2025)

Counseling Points

Counsel the family on:
- The 4-6 hour window; the afternoon drop-off is the drug wearing off, not failing.
- Rebound irritability and hunger at offset; not a reason to increase the dose.
- Appetite suppression peaking midday; move the largest meal to breakfast and to the evening.
- No doses after roughly 4 pm; later dosing costs sleep.
- Secure storage; sharing or selling a Schedule II medication is a felony.
- Bringing a teacher rating scale to the next visit rather than a verbal impression.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness, or colour change in the fingers or toes.
- A new or markedly worse tic.
- Weight loss, or clothes fitting more loosely over a few weeks.
- A painful erection lasting more than a few hours, which is a surgical emergency.

References

DailyMed. Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) tablets prescribing information. Teva Pharmaceuticals USA. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f22635fe-821d-4cde-aa12-419f8b53db81
LactMed. Amphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/

Adderall XR

(dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate, amphetamine aspartate)

Adderall XR (mixed amphetamine salts, extended-release); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Adderall XR is a once-daily extended-release amphetamine capsule approved for ADHD from age 6, using immediate- and delayed-release beads to reproduce immediate-release Adderall taken twice, four hours apart. It is a fixed 3:1 ratio of dextroamphetamine to levoamphetamine salts, and unlike methylphenidate it both blocks reuptake and drives catecholamine release. Its differentiator against Mydayis is the age floor: this is the mixed-salts option for a school-age child, where Mydayis starts at 13. Schedule II; brand and generic.

Forms & Strengths

Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg

Dosing

Age: ≥ 6 y/o; not recommended below 6 years
Onset: 30-60 min, from the immediate-release bead fraction
Duration: 10-12 hours
Release Profile: Biphasic; immediate-release plus delayed-release beads in one capsule, Tmax about 7 hours
Initial Dose:
- 6-12 y/o: 10 mg once daily in the morning; 5 mg where a lower start is judged appropriate
- 13-17 y/o: 10 mg once daily in the morning
- ≥ 18 y/o: 20 mg once daily in the morning
- Severe renal impairment (GFR 15 to < 30): 5 mg, 6-17 y/o; 15 mg, adults. ESRD not recommended
Titration:
- 6-12 y/o: increase by 5 mg or 10 mg at weekly intervals
- 13-17 y/o: a single increase to 20 mg after one week if control is inadequate
Max Dose:
- 6-12 y/o: 30 mg/day; doses above 30 mg/day have not been studied in children. Severe renal impairment: 20 mg/day
- 13-17 y/o: no numeric maximum in the label; no added benefit above 20 mg/day in the adolescent trial
- ≥ 18 y/o: no numeric maximum; same finding above 20 mg/day
Considerations: Give on awakening and avoid afternoon doses; a capsule may not be divided, and the patient must not take less than one whole capsule per day.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
Delivery / Release: Immediate-release plus delayed-release beads, giving a profile comparable to IR Adderall taken twice, 4 hours apart; Tmax about 7 hours
Formulation: Fixed 3:1 dextro- to levoamphetamine; the levo isomer carries more peripheral and noradrenergic effect
Metabolism: CYP2D6 to 4-hydroxyamphetamine. d-amphetamine half-life 9-11 h, l-amphetamine 11-14 h across pediatric ages. Renal excretion is pH dependent
Pharmacogenomics: No genotype-directed dosing in the label; the actionable consequence is the CYP2D6-inhibitor interaction
Class Positioning: One dose instead of two versus Adderall. Mydayis runs to about 16 hours but starts at 13; this is the mixed-salts ER option below that age

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o. The only approved indication.

Off-Label Uses

Narcolepsy (ICD-10: G47.419): off-label at every age; insufficient. Use an approved product: Adderall, Zenzedi, Dexedrine Spansule.
ADHD under 6 years (ICD-10: F90.x): insufficient. AAP names behavioral intervention first-line, and methylphenidate if medication is added (AAP 2019).
Where the evidence does not support use: depression augmentation and post-TBI attention; no pediatric evidence for ER mixed salts (AHRQ 2024).
Cognitive enhancement without ADHD: not an indication; not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction; risk of overdose and death, rising with higher doses and non-oral routes. Assess abuse risk before prescribing and monitor throughout.
Contraindicated:
- Known hypersensitivity or idiosyncrasy to amphetamine or any component
- MAOI use, current or within 14 days
Use with caution (label Warnings, not contraindications):
- Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; the label says avoid
- Hypertension; expect mean rises of 2-4 mmHg and 3-6 bpm
- Psychosis or bipolar disorder; new psychotic or manic symptoms in about 0.1%
- Prior seizure or EEG abnormality
- Peripheral vasculopathy including Raynaud phenomenon
- Tics or Tourette syndrome, personal or family
- Substance use disorder, patient or household
- Severe renal impairment; ESRD not recommended
Screen before starting:
- Cardiac and family history of sudden death; ECG only if positive
- Tics, Tourette syndrome and mania risk factors, including family history
- Abuse and diversion risk
- Baseline height, weight, blood pressure and heart rate
- Renal function where impairment is suspected

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, IV methylene blue): hypertensive crisis; do not give within 14 days.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone, St John's Wort): serotonin syndrome; counsel on symptoms and stop both if it occurs.
CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion, quinidine): raise exposure; start lower.
Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels; the label says avoid.
Acidifying agents (ascorbic acid, fruit juices): lower levels; adjust on response, not assumed failure.
Tricyclics (desipramine, protriptyline): sustained rise in brain d-amphetamine with potentiated cardiovascular effect; monitor and adjust.
Proton pump inhibitors (omeprazole): shorten Tmax, so the dose lands and fades earlier; adjust timing.

Administration

Once daily on awakening; afternoon doses cost sleep.
With or without food; a high-fat meal delays Tmax only.
Swallow whole, or sprinkle the entire contents on applesauce, eaten immediately without chewing. Do not store.
Do not divide a capsule; sprinkling is a swallowing accommodation, not a dose split.
Where neither route works, Adzenys XR-ODT has a published conversion from this product.
Switching from IR Adderall: same total daily dose once daily, then titrate weekly. The only conversion the label supports.
Do not substitute milligram-for-milligram for Mydayis or any other amphetamine.
If a dose is missed, skip it; do not double up.

Side Effects

Common, 6 to 12: loss of appetite 22%, insomnia 17%, abdominal pain 14%, emotional lability 9%, vomiting 7%, nervousness 6%, weight loss 4%
Common, 13 to 17: loss of appetite, insomnia, abdominal pain, weight loss, nervousness each ≥ 5%
Serious:
- Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
- Psychosis, mania and new aggression. Consider discontinuing.
- Serotonin syndrome. Stop both drugs and treat supportively.
- Seizures. Discontinue.
- Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
- Growth suppression; mean 4-week weight change -1.1 lbs at 10 mg, -2.8 lbs at 20 mg. Interrupt if growth falls behind.
- New or worsening motor and verbal tics. Discontinue if clinically appropriate.

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months; act above the age-specific 95th percentile.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if the child crosses two major percentile lines.
Appetite and Sleep: at every visit and every dose change.
Psychiatric and tics: psychosis, mania, aggression, emotional lability and new tics at every visit.
Peripheral vasculopathy: inspect fingers and toes at every visit.
Abuse and Diversion: adherence, pill counts and PDMP check at every refill.
Renal function: at baseline where impairment is suspected, and annually.
Laboratory: none routinely; amphetamines interfere with urinary steroid assays.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; no taper is required.
Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
Late-afternoon rebound irritability and hunger is offset, not withdrawal.
Interrupt treatment where growth falls behind; the label names interruption, not dose reduction.
Drug holidays are reasonable where appetite or growth suppression is limiting.

Pregnancy & Lactation

Pregnancy: No drug-associated risk of major birth defects or miscarriage. Premature delivery and low birth weight reported. Monitor exposed newborns for withdrawal.
Lactation: Label says breastfeeding is not recommended. Relative infant dose 2 to 13.8%, milk/plasma ratio 1.9 to 7.5; no reported infant adverse effects.
Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.

Counseling Points

Counsel the family on:
- Sprinkling is a swallowing accommodation, not a dose split; use a lower strength instead.
- The applesauce must be eaten immediately and completely.
- The 10 to 12 hour window; ask what time the fade starts before changing the dose.
- For adolescents, no added benefit above 20 mg/day in the label's own trial.
- Vitamin C and fruit juice can mimic treatment failure; bicarbonate and antacids raise levels.
- Move the largest meal to breakfast and to the evening.
- Locked storage; sharing or selling a Schedule II medication is a felony.
- Bring a teacher rating scale to the next visit.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness or colour change in the fingers or toes.
- A new or markedly worse tic, or a seizure of any kind.
- Weight loss, or clothes fitting more loosely over a few weeks.
- Agitation, shivering, sweating or confusion after an antidepressant change.

References

DailyMed. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate) extended-release capsules prescribing information. Takeda Pharmaceuticals America. Revised 4/2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aff45863-ffe1-4d4f-8acf-c7081512a6c0
LactMed. Amphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
openFDA. NDC Directory, generic_name "amphetamine aspartate". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis
Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Adzenys XR-ODT

(amphetamine)

Adzenys XR-ODT (amphetamine); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Adzenys XR-ODT is an extended-release amphetamine orally disintegrating tablet approved for ADHD from age 6, taken once daily in the morning. It carries a 3:1 ratio of d- to l-amphetamine, pairing an immediate-release half with a delayed-release half in a tablet that dissolves on the tongue without water. Its differentiator is a full-day amphetamine for a child who will not swallow a capsule; its trap is that strengths are amphetamine base. Schedule II; brand and generic.

Forms & Strengths

Extended-release orally disintegrating tablets (orange; blister packed; amphetamine base): 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg

Dosing

Age: ≥ 6 y/o
Onset: 30 to 60 min
Duration: ~ 12 hours
Release Profile: 50% immediate-release / 50% delayed-release amphetamine in one tablet. Delayed, not extended
Initial Dose:
- 6-17 y/o: 6.3 mg once daily in the morning
- ≥ 18 y/o: 12.5 mg once daily, the recommended adult dose rather than a starting dose
Titration: 3.1 mg or 6.3 mg every 7 days, patients 6-17
Max Dose:
- 6-12 y/o: 18.8 mg/day
- 13-17 y/o: 12.5 mg/day
- ≥ 18 y/o: 12.5 mg/day recommended; no separate adult maximum is stated
Considerations: The adolescent ceiling is LOWER than the child ceiling, and is not a typo: a 13 year old cannot exceed 12.5 mg/day. Strengths are amphetamine base; never convert milligram for milligram.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: 50% immediate-release / 50% delayed-release, from ion-exchange resin particles of which half carry a methacrylic acid coat
Disintegration in saliva is a delivery convenience and does not change absorption
Formulation: 3:1 d- to l-amphetamine, strengths as amphetamine base where the mixed-salt products state salts
Metabolism: CYP2D6 forms active 4-hydroxyamphetamine. d-amphetamine half-life 9-10 h in children 6-12 and 11 h in adults; l-amphetamine 10-11 h and 14 h; excretion is pH dependent
Class Positioning: pharmacokinetically Adderall XR delivered differently, 18.8 mg matching its 30 mg profile; choose it for route, not kinetics
Against Dyanavel XR, the other base-dosed amphetamine: no bottle or measuring device, but fixed steps rather than continuous titration

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o

Off-Label Uses

None established for this formulation by graded pediatric evidence.
Where the evidence does not support use:
- Children under 6: argued against by this label; the 3.1 mg strength makes a small dose look available, but the age floor applies.
- Above 12.5 mg/day at 13 to 17 y/o: the lower ceiling is deliberate. Not supported.
- Non-ADHD indications in youth: AHRQ CER 267 graded none (AHRQ 2024).
- Cognitive enhancement without ADHD: not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High abuse potential leading to substance use disorder; overdose and death, more so at higher doses or by non-oral routes. Assess risk before prescribing; reassess throughout.
Contraindicated:
- Known hypersensitivity to amphetamine or components
- MAOI use, current or within 14 days, including linezolid and IV methylene blue
Use with caution (Warnings, not contraindications):
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
- Pre-existing hypertension, because BP and HR rise
- Pre-existing psychosis; bipolar disorder, for treatment-emergent mania
- Motor or verbal tics, Tourette syndrome, or peripheral vasculopathy including Raynaud phenomenon
- Hereditary fructose intolerance; this tablet lists fructose as an inactive ingredient, unlike the swallowed capsule alternatives
- Substance use disorder in the patient or the household
Screen before starting:
- Cardiac history, family history of sudden death or arrhythmia, and exam
- Personal and family history of tics or Tourette syndrome
- Mania risk: personal or family depression, bipolar disorder, suicide
- Abuse and diversion risk
- Baseline height, weight, BP, HR

Drug Interactions

MAOIs (also linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Confirm a 14 day washout.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone): serotonin syndrome. Start lower; stop both drugs if symptoms appear.
CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
Urinary pH agents: acidifiers (ascorbic acid, fruit juice) lower amphetamine levels; alkalinizers (bicarbonate, acetazolamide, thiazides) raise them. The label directs a dose adjustment either way.
Sympathomimetics (decongestants, beta-agonists): additive cardiovascular effect. Avoid OTC decongestants.
Laboratory assays: amphetamines interfere with urinary steroid determinations; interpret rather than repeat.

Administration

Once daily in the morning, with or without food; food lowers Cmax about 19% and delays Tmax about 2 hours, which the label calls not clinically significant.
Open the blister with dry hands at the moment of dosing; peel the backing, never push the tablet through the foil.
Place the whole tablet on the tongue and let it disintegrate; do not chew or crush, and no water is needed.
Switching from Adderall XR only, at the equivalent once-daily dose; the label permits this for no other amphetamine.
- Adzenys 3.1 mg = Adderall XR 5 mg
- 6.3 = 10
- 9.4 = 15
- 12.5 = 20
- 15.7 = 25
- 18.8 = 30 mg
From any other amphetamine: stop the previous drug and titrate from the beginning.
Avoid late dosing; the delayed-release half puts an afternoon dose near bedtime.
Store securely, preferably locked.

Side Effects

Common, children 6-12 vs placebo: loss of appetite 22% vs 2%, insomnia 17% vs 2%, abdominal pain 14% vs 10%, emotional lability 9% vs 2%, vomiting 7% vs 4%.
Also common, same study: nervousness 6% vs 2%, fever 5% vs 2%, nausea 5% vs 3%, weight loss 4% vs 0%, dizziness, dyspepsia and fatigue each 2%.
Serious:
- Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor through it.
- Increased BP and HR, mean rise 2-4 mm Hg and 3-6 bpm; monitor rather than assume the mean applies.
- Psychosis or mania, roughly 0.1% in pooled stimulant trials; consider discontinuing.
- Serotonin syndrome; stop both drugs and treat supportively.
- Angioedema and anaphylaxis; stop and do not rechallenge.
- Peripheral vasculopathy including Raynaud phenomenon; reduce or stop.
- Growth suppression; interrupt in a child not growing as expected.
- New or worsening tics and Tourette syndrome.

Monitoring & Labs

Cardiovascular: HR and BP at baseline, each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two percentile lines.
Appetite and sleep: every visit; at 22% and 17% these are the two commonest reasons for stopping.
Psychiatric: psychosis, mania, aggression and emotional lability at each visit and 2 weeks after any increase.
Tics and digits: ask about tics and inspect fingers and toes at each visit.
Dose ceiling at the 13th birthday: review the dose at the visit before a patient turns 13; a child stable at 15.7 or 18.8 mg is above the adolescent ceiling on their birthday.
Abuse and diversion: adherence, tablet counts and PDMP check at each refill.
Laboratory: none routinely.

Discontinuation & Taper

Can be stopped abruptly at therapeutic doses; no taper required.
Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
Evening rebound as the second pulse wears off is pharmacodynamic offset, not withdrawal.
Drug holidays suit appetite or growth as the limiting problem.

Pregnancy & Lactation

Pregnancy: Decades of data have not identified a drug-associated risk of major birth defects or miscarriage. Amphetamines vasoconstrict, may reduce placental perfusion, and stimulate uterine contractions.
Pregnancy, clinical: premature delivery and low birth weight reported; background risk 2% to 4% for defects, 15% to 20% for miscarriage. Weigh rather than abstain.
Neonate: monitor for withdrawal: feeding difficulty, irritability, agitation, drowsiness.
Lactation: in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5; no reported adverse infant effects; the label does not recommend breastfeeding.
Lactation, milk supply: prolactin suppressed 25% to 40%; large doses may impair production where lactation is not established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medication, 1-866-961-2388, www.womensmentalhealth.org/pregnancyregistry

Counseling Points

Counsel the family on:
- Peeling the blister backing with dry hands at the moment of dosing; pushing the tablet through the foil crumbles it, and moisture breaks it down.
- Letting it dissolve on the tongue without chewing, and that no water is needed.
- That the strength number will not match a previous amphetamine prescription, and is not a pharmacy error.
- The ceiling dropping at age 13, so nobody is blindsided when the dose is reduced.
- Appetite suppression, 22% of children; largest meal at breakfast and in the evening.
- Storing it locked and away from younger siblings; the orange flavour looks like a sweet, and bringing a teacher rating scale to the next visit.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Swelling of the lips, tongue or face after a dose.
- Numbness, coldness or colour change in the fingers or toes.
- A new or worse tic; weight loss; mood swings new since the last dose change.

References

DailyMed. Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets prescribing information. Neos Therapeutics Brands. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c1179269-00b5-48ea-972d-31e614e99b7e
FDA. openFDA National Drug Code Directory, generic_name "amphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22amphetamine%22&limit=1000
LactMed. Amphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Anafranil

(clomipramine hydrochloride)

Anafranil (clomipramine hydrochloride); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Anafranil is a tricyclic antidepressant, clomipramine, supplied only as an oral capsule and approved for obsessive-compulsive disorder from age 10. Benefit builds over weeks, and the label approves no other pediatric use. Cardiac conduction effects, dose-related seizures and lethality in overdose place it behind the SSRIs, which match it for efficacy. Not controlled; brand and generic.

Forms & Strengths

Capsules: 25 mg, 50 mg, 75 mg

Dosing

Age:
- OCD: 10-17 y/o; not established below age 10.
- OCD: ≥ 18 y/o, at a higher ceiling.
Onset: 2 to 3 weeks for early effect; judge response after several weeks at a therapeutic dose
Duration: continuous with once-daily dosing
Initial Dose: 25 mg daily, divided, with meals
Titration:
- First 2 weeks: to 3 mg/kg or 100 mg daily, whichever is smaller.
- Thereafter: toward the ceiling, allowing 2 to 3 weeks between adjustments.
Max Dose:
- 10-17 y/o: 3 mg/kg or 200 mg daily, whichever is smaller.
- ≥ 18 y/o: 250 mg daily.
- These ceilings limit seizure risk; do not exceed them to chase response.
Considerations: Divide doses with meals during titration, then give the total at bedtime to limit sedation. The mg/kg cap is a seizure limit and moves with weight.

Pharmacology

Mechanism: Tricyclic; inhibits serotonin and, via its active metabolite, norepinephrine reuptake, with muscarinic, histamine H1 and alpha-1 blockade causing most adverse effects
Metabolism: Hepatic, to desmethylclomipramine; half-life 32 hours parent, 69 hours metabolite, so steady state takes 2 to 3 weeks
Nonlinear kinetics, a safety property: exposure is not dose-proportional; above 150 mg/day accumulation can be dramatic, raising dose-dependent seizure risk.
Pharmacogenomics: CYP2D6 poor metabolizers, 7% to 10% of Caucasians, reach 8-fold higher AUC; adding an inhibitor makes a stable patient toxic.
Class Positioning: the only tricyclic with an FDA pediatric indication. Against Zoloft, Prozac and Luvox it adds no efficacy and costs receptor blockade.

Indications

Obsessive-Compulsive Disorder (ICD-10: F42.2, F42.3, F42.8, F42.9): patients 10-17 y/o and adults, where symptoms cause marked distress or impair function

Off-Label Uses

Before anything off-label: in pediatric OCD an SSRI is as effective and better tolerated. Use Zoloft, Prozac or Luvox with exposure and response prevention first. (AHRQ 2024)
Depression in youth (ICD-10: F32.x, F33.x): not supported; no pre-pubertal benefit, marginal in adolescents. (Cochrane 2013)
Looked for, evidence not found:
- Trichotillomania and body-focused repetitive behaviors (ICD-10: F63.3): adult data only; insufficient in youth.
- Repetitive behaviors in autism (ICD-10: F84.0): insufficient; no graded conclusion.
- Cataplexy in narcolepsy (ICD-10: G47.411): adult tricyclic use; insufficient pediatric evidence.

Contraindications & Warnings

Boxed Warning, suicidal thoughts and behaviors: antidepressants increase suicidal thinking and behavior in children, adolescents and young adults. Monitor closely for clinical worsening; families observe daily.
Overdose lethality makes quantity dispensed a prescribing decision. A tricyclic overdose kills where an SSRI overdose generally does not: the lowest reported fatal dose is 750 mg.
Quantity, in practice: the label twice instructs prescribing the smallest quantity consistent with good patient management. Confirm locked storage at every refill.
Dose-related seizure risk, the label's principal risk: cumulative incidence up to 300 mg/day was 0.64% at 90 days, 1.12% at 180 days, 1.45% at 365 days.
Seizure ceilings: dose predicts risk, hence 250 mg daily maximum in adults, 3 mg/kg or 200 mg daily in youth.
Contraindicated:
- Hypersensitivity to clomipramine or other tricyclics.
- An MAOI, linezolid or intravenous methylene blue, or within 14 days of either.
- The acute recovery period after a myocardial infarction.
Use with caution:
- Cardiovascular disease, seizure history, brain injury, or a seizure-threshold-lowering drug.
- Unrecognized bipolar disorder or schizophrenia; mania or psychosis may follow.
- Hyperthyroidism, liver or renal disease, or adrenal medulla tumors.
- Planned electroconvulsive therapy or surgery; stop well before, tell the anesthetist.
Screen before starting:
- Cardiac and family history of sudden death, and a baseline ECG.
- Seizure history, head injury, and family history of bipolar disorder or suicide.
- Baseline weight, height, heart rate, and blood pressure sitting and standing.
- CYP2D6 inhibitors, and who stores the medication at home.

Drug Interactions

MAOIs (phenelzine, tranylcypromine, linezolid, methylene blue): contraindicated. Allow 14 days in either direction.
SSRIs (fluoxetine, sertraline, paroxetine, fluvoxamine): inhibit CYP2D6 and raise clomipramine levels. Use lower doses; allow 5 weeks after stopping fluoxetine.
Other CYP2D6 inhibitors (quinidine, cimetidine, phenothiazines, propafenone, flecainide): a stable patient can turn abruptly toxic. Lower the dose.
Other serotonergic drugs (triptans, fentanyl, lithium, tramadol, buspirone, St John's Wort): serotonin syndrome. Stop both if it occurs.
Methylphenidate and other stimulants: raise tricyclic levels, a live combination in ADHD practice. Titrate slowly, watch cardiac effects.
Level shifters (phenytoin, carbamazepine, haloperidol, warfarin, digoxin, clonidine, alcohol): recheck response, INR or blood pressure after any change.

Administration

Give in divided doses with meals during titration, for gastrointestinal tolerance.
After titration, give the total dose at bedtime; 46% of pediatric trial patients reported somnolence.
Swallow capsules whole; no liquid form exists and they are not opened or divided.
Allow 2 to 3 weeks between dose adjustments; steady state is not reached sooner.
Do not stop abruptly; see Discontinuation & Taper.
Store locked; dispense the smallest quantity consistent with good management, per the label.

Side Effects

Common, pediatric trial rates: dry mouth 63% (placebo 16%), somnolence 46% (11%), dizziness 41% (14%), fatigue 35% (9%), tremor 33% (2%), constipation 22%, anorexia 22%, urinary retention 7%
Serious:
- Suicidal thinking and behavior, per the boxed warning. Ask directly at every dose change.
- Seizure, dose related and the label's most significant identified risk. Stop the drug.
- Cardiac conduction abnormality: 1.5% on treatment against 0.7% on placebo, chiefly ventricular ectopy and conduction delay.
- Serotonin syndrome, particularly with an MAOI. Stop both drugs.
- Angle-closure glaucoma, hepatic injury, agranulocytosis.
- Hyponatremia from SIADH, with reported seizure, coma and death.
- DRESS, drug rash with eosinophilia and systemic symptoms. Stop immediately.
- Psychosis, hallucinations, paranoia, precipitated hypomania or mania.
- Sexual dysfunction, above placebo in males, a common reason adolescents quietly stop.

Monitoring & Labs

ECG: at baseline for unsuspected long QT, at steady state on the target dose, and after every subsequent increase. (AACAP 2012; AHA 1999)
ECG thresholds that stop escalation: heart rate above 130 bpm, PR above 200 ms, QRS above 120 ms, QTc above 460 ms. Hold and refer. (AHA 1999)
Suicidality: every visit for 12 weeks, every dose change, then at least every 3 months. Ask about agitation, hostility and akathisia.
Weight, height, blood pressure and heart rate: baseline, each dose change, every 3 months. Weight sets the 3 mg/kg ceiling.
Seizure surveillance: ask about seizure, aura, staring spell or fall at every visit; reconfirm each new dose stays under the cap.
Quantity dispensed and storage: at every refill, confirm how much is in the home, that it is locked, and who holds it.
On trigger: CY-BOCS every 4 to 6 weeks in titration; sodium for confusion; liver enzymes for jaundice; CBC for fever with sore throat.

Discontinuation & Taper

Do not stop abruptly. The label calls for gradual tapering with careful monitoring.
Withdrawal brings dizziness, nausea, vomiting, headache, malaise, sleep disturbance, hyperthermia, irritability, psychiatric worsening.
Long half-lives mean withdrawal may appear days after a reduction; judge each step over a week.
Discontinue immediately for a seizure, DRESS, symptomatic hyponatremia, or serotonin syndrome.
Drug holidays are not appropriate; interruption risks withdrawal and relapse.
OCD is chronic; continue a responder on the lowest effective dose. Benefit held a year under double-blind conditions.

Pregnancy & Lactation

Pregnancy: No adequate controlled studies. Use only if benefit justifies risk, weighing untreated severe OCD. No exposure registry is named.
Pregnancy, neonatal: jitteriness, tremor and seizures reported in neonates exposed until delivery.
Lactation: acceptable on limited evidence; a fully breastfed infant receives about 1.3% to 2.2% of the maternal weight-adjusted dose. (LactMed 2022)
Lactation, caveats: after pregnancy exposure the milk amount may not prevent neonatal withdrawal; better-studied agents exist for depression.

Counseling Points

Counsel the family on:
- Storing capsules locked, and why the prescription is deliberately small: a tricyclic overdose is dangerous as other medicines are not.
- Dry mouth, in nearly two thirds of children. Offer sugar-free gum, water and a dental check.
- Daytime sleepiness early; moving the dose to bedtime is the planned fix.
- A realistic timeline: little change in the first fortnight; 2 to 3 weeks between changes.
- Reporting any staring spell, fall or convulsion, since seizure is the dose-limiting risk.
- Never stopping suddenly, and telling you before planned surgery.
Advise them to call for:
- New or worsening thoughts of self-harm, or new agitation or hostility.
- Any seizure, staring spell, or unexplained fall.
- Fainting, near-fainting, or a racing heartbeat.
- Fever with sore throat, or rash with fever or facial swelling.
- Inability to pass urine, or eye pain with blurred vision or halos.

References

DailyMed. Anafranil (clomipramine hydrochloride) capsules prescribing information. 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4074b555-7635-41a9-809d-fae3b3610059
AHRQ. Obsessive Compulsive Disorders in Children. Effectiveness Review 276. 2024. https://www.ncbi.nlm.nih.gov/books/NBK611136/
AACAP. Practice Parameter, Obsessive-Compulsive Disorder. 2012. https://www.jaacap.org/article/S0890-8567(11)00882-3/fulltext
Cochrane. Tricyclic drugs for depression in children. CD002317. 2013. https://www.cochrane.org/evidence/CD002317_tricyclic-drugs-depressed-children-and-adolescents
LactMed. Clomipramine. Drugs and Lactation Database. 2022. https://www.ncbi.nlm.nih.gov/books/NBK501175/
American Heart Association. Cardiovascular monitoring of children on psychotropics. 1999. https://www.ahajournals.org/doi/10.1161/01.cir.99.7.979

Aptensio XR

(methylphenidate hydrochloride)

Aptensio XR (methylphenidate hydrochloride); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Aptensio XR is a long-acting methylphenidate CNS stimulant supplied as a multilayer-bead extended-release capsule, approved for ADHD from age 6 with no upper age limit. Each bead carries an immediate-release layer over a controlled-release layer, producing two plasma peaks from one morning dose. The capsule may be opened and sprinkled on applesauce, which is its practical advantage over a swallow-whole osmotic tablet. Schedule II; brand and generic.

Forms & Strengths

Extended-release capsules (multilayer beads, may be opened onto applesauce): 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Dosing

Age: >= 6y; no upper limit
Onset: ~ 1 hour
Duration: up to 12 hours
Release Profile: 40% IR / 60% ER via multilayer beads
Initial Dose: 10 mg once daily in the morning
Titration: 10 mg every 7 days
Max Dose: 60 mg/day
Considerations: May be swallowed whole or opened onto applesauce, but never divided, so the ladder moves in whole capsules only.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 40% IR / 60% ER via multilayer beads. Initial peak at about 2 hours, a dip over 4 to 6 hours, then a second peak at about 8 hours.
Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Terminal half-life about 5.1 hours; ~90% recovered in urine, so renal impairment has little effect.
Class Positioning: Racemic, unlike dexmethylphenidate products. Against Concerta it trades an ascending profile for two peaks and can be opened; not interchangeable with Metadate CD or Ritalin LA.
Alcohol: at 40% alcohol, 96% of the dose released within two hours in vitro. Dose dumping is a real risk in an adolescent who drinks.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o

Off-Label Uses

Narcolepsy (ICD-10: G47.411, G47.419): IR methylphenidate carries this indication, Aptensio XR does not. Extrapolates from the moiety, not the product; limited data.
ADHD in children 4 to under 6 years (ICD-10: F90.x): the label records evidence against. 50% (20 of 39) dropped 10 or more weight percentiles, on exposure 2 to 3 fold higher. Benefits do not outweigh risks.
Treatment-resistant depression augmentation (ICD-10: F32.x, F33.x): adult literature only; insufficient in children.
Cognitive enhancement in youth without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death; risk rises with dose and non-oral routes. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
- MAOI use, current or within 14 days: hypertensive crisis
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: mean rises 2 to 4 mmHg and 3 to 6 bpm, individually larger
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Personal or family history of tics or Tourette's syndrome
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Substance use disorder in patient or household
Screen before starting:
- Cardiac history and exam, plus family history of sudden death; mandatory in section 2.1
- Tics or Tourette's, personal and family, with clinical evaluation; also mandatory
- Risk factors for a manic episode: depressive symptoms, family history of bipolar disorder or suicide
- Abuse and diversion risk in patient and household
- Baseline height, weight, blood pressure and heart rate

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only. Counsel on symptoms rather than avoiding.
Alcohol: a formulation interaction, not a pharmacologic one; 96% released within two hours at 40% alcohol. Counsel adolescents explicitly.

Administration

Once daily in the morning. The label asks for a consistent routine with meals rather than fed or fasted.
Swallow whole, or sprinkle the entire contents onto applesauce and eat at once without chewing. Never store a sprinkled dose.
Never divide a capsule. Sprinkling is a swallowing accommodation, not a way to split a dose.
A high-fat meal blunts or removes the second peak and raises Cmax ~28%. An erratic breakfast makes the afternoon erratic.
Missed dose: give the next as scheduled. Never double up or give a first dose late in the day.
Store locked; dispose of unused capsules through a take-back program.

Side Effects

Common, pediatric 6 to 17 y (vs placebo): headache 10.9% vs 8.5%, insomnia 9.8% vs 2.1%, upper abdominal pain 8.2% vs 0%, decreased appetite 4.9% vs 0%, nausea 3.8%, vomiting 3.8%.
Serious:
- Sudden death with structural cardiac disease: avoid the drug rather than monitor through it
- New psychosis or mania, ~0.1% pooled, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Growth suppression: about 2 cm and 2.7 kg less over 3 years
- Acute angle closure glaucoma; new or worsening tics and Tourette's: discontinue if appropriate
- Hypersensitivity including angioedema and anaphylaxis
- Postmarketing: severe hepatic injury, serotonin syndrome, seizures including grand mal, rhabdomyolysis, pancytopenia

Monitoring & Labs

Cardiovascular: BP and HR at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI at baseline and every 6 months. Crossing two percentile lines is a labeled trigger to interrupt.
Appetite and sleep: at every visit; both are dose-timing problems before they are drug problems.
Psychiatric and tics: screen for psychosis, mania, aggression and tics at every visit and after each dose increase.
Digital perfusion: inspect fingers and toes at each visit for colour change or ulceration.
Ocular: no routine schedule; refer before starting in significant hyperopia, and at any new eye pain or halos.
Abuse and diversion: at every refill, capsule count, ask about sharing and selling, check the PDMP. A boxed-warning obligation.
Laboratory: none required. Check LFTs only for jaundice, dark urine or unexplained fatigue.
Efficacy stopping rule: discontinue if no improvement after appropriate dose adjustment over one month. A labeled instruction.

Discontinuation & Taper

Can be stopped abruptly at therapeutic doses; the label gives no taper schedule.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite. Do not read it as relapse.
Reduce or discontinue for paradoxical worsening or adverse reactions.
Drug holidays are reasonable where growth limits treatment. Priapism has been reported during holidays and on discontinuation.

Pregnancy & Lactation

Pregnancy: human data are limited and insufficient to inform a drug-associated risk. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant plasma in every reported case. Monitor for agitation, poor feeding and reduced weight gain. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.

Counseling Points

Counsel the family on:
- The two-peak profile: a mid-morning dip, then coverage to about 12 hours. Unwarned families read the dip as too low a dose.
- Sprinkling onto applesauce, eaten straight away without chewing, never saved for later.
- Never splitting a capsule; the ladder moves in whole capsules only.
- Keeping breakfast consistent; a fatty breakfast on some days and none on others changes the afternoon.
- Moving the largest meal to breakfast and the evening, since appetite suppression peaks midday.
- Locked storage; sharing or selling a Schedule II medication is a felony.
- For adolescents, that alcohol can release almost the whole capsule at once. Specific to this formulation.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness, or colour change in the fingers or toes.
- A new or markedly worse tic, or a new vocal tic.
- Weight loss, or clothes fitting more loosely over a few weeks.
- A painful erection lasting more than a few hours, which is a surgical emergency.
- Yellowing of the eyes or skin, dark urine, or new eye pain with halos around lights.

References

DailyMed. Aptensio XR (methylphenidate hydrochloride) extended-release capsules prescribing information. Rhodes Pharmaceuticals LLC. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5adedc01-ebf0-11e3-ac10-0800200c9a66
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling

Azstarys

(serdexmethylphenidate and dexmethylphenidate)

Azstarys (serdexmethylphenidate and dexmethylphenidate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Azstarys is a once-daily, long-acting capsule containing dexmethylphenidate together with serdexmethylphenidate, a prodrug converted to dexmethylphenidate mainly in the lower gastrointestinal tract, approved for ADHD from age 6. The duration comes from delayed prodrug conversion rather than from a bead or osmotic delivery system, so nothing in the capsule can be damaged by chewing or sprinkling. Its milligram numbers do not compare with any other methylphenidate product. Schedule II; brand only.

Forms & Strengths

Capsules (serdexmethylphenidate / dexmethylphenidate): 26.1 mg / 5.2 mg, 39.2 mg / 7.8 mg, 52.3 mg / 10.4 mg

Dosing

Age:
- 6-12 y/o: established by a controlled trial and a 12-month open-label safety study
- 13-17 y/o and adults: established by pharmacokinetic bridging
- Under 6 y/o: not recommended; higher plasma exposure and more adverse reactions, including weight loss
Onset: ~ 2 hours fasted, later with food
Duration: up to 13 hours
Release Profile: fixed molar ratio, 30% dexmethylphenidate to 70% serdexmethylphenidate. This is capsule composition, not a bead-release split: the long tail comes from prodrug conversion in the lower gut
Initial Dose: 39.2 mg / 7.8 mg once daily in the morning, in every age band
Titration:
- 6-12 y/o: after 7 days, increase to 52.3 mg / 10.4 mg or decrease to 26.1 mg / 5.2 mg
- 13-17 y/o and adults: after 7 days, increase to 52.3 mg / 10.4 mg; no labelled down-titration step
Max Dose: 52.3 mg / 10.4 mg once daily, in every age band
Considerations: Once daily in the morning; food delays the peak about 2 hours without changing exposure. Never substitute for another methylphenidate milligram for milligram; stop it and titrate from the standard start.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses. Serdexmethylphenidate is inactive until converted.
Delivery / Release: Fixed molar ratio, 30% dexmethylphenidate to 70% serdexmethylphenidate. The free drug peaks at ~2 hours fasted; the prodrug converts in the lower gut and alone peaks at about 8 hours.
Metabolism: The converting enzymes are unidentified; prodrug bioavailability is under 3%, and neither component is a CYP or transporter substrate. Half-life ~5.7 h (prodrug) and ~11.7 h (dexmethylphenidate, absorption-limited). Steady state by the third dose.
Class Positioning: Duration comes from a prodrug rather than beads (Focalin XR) or an osmotic pump (Concerta), so there is no release mechanism to destroy by opening or chewing.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older, including adults

Off-Label Uses

Narcolepsy (ICD-10: G47.419): racemic methylphenidate carries the indication; this product does not. Insufficient.
ADHD in a child aged 4 to 5 (ICD-10: F90.x): behavioral parent training first (AAP 2019). Use below 6 is not recommended, and the lowest strength already equals 20 mg. Not the preschool option.
Where the evidence does not support use. AHRQ 2024 grades stimulant head-to-head comparisons as low strength of evidence, so nothing supports the prodrug design outperforming a conventional long-acting methylphenidate, or any use outside ADHD in youth.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction, which can lead to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
- Hypersensitivity to serdexmethylphenidate, methylphenidate or any component; bronchospasm, rash and pruritus reported.
- Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid.
- Pre-existing hypertension, because blood pressure and heart rate rise on stimulants.
- Pre-existing psychosis or bipolar disorder; motor or verbal tics and Tourette's syndrome.
- Open-angle glaucoma, raised intraocular pressure, or significant hyperopia.
- Peripheral vasculopathy including Raynaud's; substance use disorder in patient or household.
Screen before starting:
- Cardiac disease by history, family history of sudden death, and exam. No routine ECG.
- Personal and family history of tics or Tourette's syndrome.
- Risk factors for mania; abuse and diversion risk; baseline height, weight, blood pressure and heart rate.

Drug Interactions

Other methylphenidate products: not an interaction but a substitution hazard the label calls out. Never switch milligram for milligram in either direction; discontinue the other product and titrate from the standard starting dose.
MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Do not co-prescribe; allow 14 days after stopping.
Antihypertensives (any class): effectiveness may fall. Monitor blood pressure and adjust their dose.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): sudden intraoperative pressure and rate rise. Avoid on the day of surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.

Administration

Once daily in the morning, with or without food. A meal does not change exposure but pushes the peak to 4 or 4.5 hours.
Swallow whole, or empty the contents into 50 mL of water or 2 tablespoons of applesauce and consume it all within 10 minutes of mixing.
There is no release mechanism to destroy; the delay is in the prodrug chemistry.
Switching from another methylphenidate: stop that product and start at 39.2 mg / 7.8 mg. Never convert by milligrams.
Stop the drug if a month of dose adjustment brings no improvement. Store securely, preferably locked.

Side Effects

Common (pooled methylphenidate class rates; no product-specific table exists): decreased appetite, decreased weight, nausea, abdominal pain, vomiting, insomnia, anxiety, affect lability, irritability, increased blood pressure, tachycardia.
Serious:
- Sudden death with structural cardiac disease; avoid use, and evaluate exertional syncope promptly.
- New psychosis or mania, including with no psychiatric history; consider discontinuing.
- Priapism, sometimes requiring surgery, including during drug holidays. Immediate care.
- Peripheral vasculopathy including Raynaud's; reduce dose or stop.
- Growth suppression: over 12 months in children 6-12, mean z-score change was minus 0.20 for weight and minus 0.21 for height, most in the first 4 months.
- Acute angle closure glaucoma and raised intraocular pressure.
- Hypersensitivity: bronchospasm, rash and pruritus reported with this product.

Monitoring & Labs

Substitution errors: at every refill and transition of care, confirm no milligram conversion to or from another methylphenidate. The label warns this risks overdose.
Growth: height, weight and BMI at baseline, monthly for the first 4 months, then every 6 months. Most weight z-score loss occurs in those 4 months.
Cardiovascular: blood pressure and heart rate at baseline, at every dose change, and at least every 6 months; a sustained or symptomatic rise triggers dose reduction.
Appetite and sleep: at every visit and dose change. Coverage runs to about 13 hours, so confirm the dosing time before treating insomnia as a dose problem.
Psychiatric, tics and digits: screen for new psychosis, mania, aggression and emergent tics at every visit; inspect fingers and toes.
Abuse and diversion: at every refill reassess risk, reconcile the pill count, and check the state PDMP per state requirement.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; this label gives no taper instruction.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, agitation.
Priapism has occurred during withdrawal and planned holidays; mention it before a holiday in an adolescent male.
Drug holidays are reasonable where appetite or growth limits treatment; the growth data make that a first-year conversation. No partial dose exists below 26.1 mg / 5.2 mg.

Pregnancy & Lactation

Pregnancy: No data on Azstarys itself; methylphenidate studies have not identified a drug-associated risk. Stimulants reduce placental perfusion. Delayed fetal ossification in rats at 3 times the maximum human dose.
Lactation: No data on serdexmethylphenidate in milk. For the dexmethylphenidate component, infant doses were 0.16% to 0.7% of the maternal dose. Monitor for agitation, poor feeding and low weight gain.
Dexmethylphenidate specifically: a maternal requirement is not a reason to stop breastfeeding; large doses may interfere before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388

Counseling Points

Counsel the family on:
- Why the milligram numbers look large: most of the capsule is prodrug, inactive until the gut converts it. The 39.2/7.8 mg capsule equals about 30 mg of dexmethylphenidate.
- That no other ADHD medication converts to this one by milligrams, so any substitution must be checked with the prescriber first.
- Coverage running to roughly 13 hours, so a late-morning dose still works at bedtime. Keep the dose time fixed and early.
- That opening the capsule into water or applesauce is a labelled option, but the mixture must be finished within 10 minutes.
- Appetite suppression, largest in the first 4 months: move the largest meal to breakfast and to the evening.
- Locked storage, and that sharing a Schedule II medication is a felony.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious, fearful or grandiose thinking.
- Wheeze, rash or itching after a dose, reported with this product specifically.
- Numbness or colour change in the fingers or toes; eye pain or blurred vision.
- A new tic, or a marked worsening of an existing one.
- Weight loss, or clothes fitting more loosely, particularly in the first 4 months.
- A painful erection lasting more than a few hours, including during a planned break.

References

DailyMed. Azstarys (serdexmethylphenidate and dexmethylphenidate) capsules prescribing information. Commave Sub, LLC. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00b5e716-5564-4bbd-acaf-df2bc45a5663
LactMed. Dexmethylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK500764/
FDA. National Drug Code Directory, openFDA. Queried by generic names serdexmethylphenidate and dexmethylphenidate. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Clonidine

(clonidine hydrochloride, immediate release)

Clonidine (clonidine hydrochloride, immediate release); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Clonidine immediate-release tablets are a central alpha-2 adrenergic agonist approved for hypertension only, in adults; safety and effectiveness in pediatric patients have not been established. It is short acting and given in divided daily doses. It is not the ADHD product: only extended-release clonidine carries the ADHD indication, and any ADHD use of this tablet is off label, most often a bedtime dose for sleep onset. Not controlled; generic only.

Forms & Strengths

Tablets, immediate release: 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg
Separate labels, not covered here and not interchangeable:
- Clonidine ER tablets 0.1 mg (Kapvay generics): ADHD indicated
- Onyda XR, ER oral suspension 0.1 mg/mL: ADHD indicated
- Nexiclon XR 0.17 mg: hypertension
- Clonidine transdermal system: 0.1, 0.2, 0.3 mg/24 h; hypertension
- Javadin oral solution 0.02 mg/mL: adult hypertension
- Clonidine injection (Duraclon): epidural analgesia

Dosing

Age: adults; pediatric safety and effectiveness not established
Onset: blood pressure falls in 30 to 60 min, maximum at 2 to 4 hours; ADHD benefit is not an effect of this product
Duration: dosed twice daily; half-life 12 to 16 hours
Initial Dose: 0.1 mg twice daily, morning and bedtime; lower in elderly or renal impairment
Titration: 0.1 mg/day every 7 days to response
Max Dose: usual range 0.2 to 0.6 mg/day divided; label maximum effective dose 2.4 mg/day
Considerations: This is the hypertension product, not the ADHD product; give the larger share of the daily dose at bedtime to limit dry mouth and drowsiness, and never substitute it milligram-for-milligram for an extended-release clonidine.

Off-label pediatric ADHD dosing: [VERIFY] No FDA-approved pediatric ADHD dosing exists for immediate-release clonidine. Weight-band values published previously are withheld pending a graded pediatric source. For labeled pediatric ADHD dosing use extended-release clonidine or Onyda XR.

Pharmacology

Mechanism: Central alpha-2 adrenergic agonist; reduces sympathetic outflow from the locus coeruleus and enhances prefrontal noradrenergic signalling. Not a CNS stimulant; mechanism in ADHD unknown.
Delivery / Release: Immediate-release tablet; bioavailability 70% to 80%, peak plasma 1 to 3 hours.
Metabolism: About 50% hepatic, 40% to 60% renal unchanged. Half-life 12 to 16 hours, up to 41 in severe renal impairment; haemodialysis removes minimal drug.
Class Positioning: Non-selective alpha-2 agonist, more sedating than guanfacine, which is alpha-2A selective. Against Kapvay and Onyda XR the difference is kinetic, not pharmacodynamic: same moiety, different release, different indication, no mg-for-mg equivalence.

Indications

Hypertension (ICD-10: I10): adults, alone or with other antihypertensives. The only approved indication on this label.
ADHD is not an approved indication for this product. Extended-release clonidine (Kapvay) and Onyda XR are the ADHD-approved clonidine products, ages 6 to 17.

Off-Label Uses

ADHD (ICD-10: F90.0-F90.9): the studied agents are ER guanfacine and ER clonidine, effect size about 0.7 versus 1.0 for stimulants; the IR tablet is expert consensus at best. (AAP 2019)
Tic disorders and Tourette syndrome (ICD-10: F95.1, F95.2): class option, most useful with comorbid ADHD. Supported by controlled trials for the class; limited data for IR clonidine. (AACAP 2013)
Sleep-onset insomnia in ADHD (ICD-10: G47.00): commonest real-world use. Limited data; sedation is a labeled adverse effect, not a demonstrated benefit.
Where the evidence does not support use: oppositional defiant disorder and aggression (ICD-10: F91.3); insufficient for IR clonidine.

Contraindications & Warnings

Contraindicated: known hypersensitivity to clonidine
Warning, withdrawal: abrupt cessation causes a rapid rise in blood pressure; rare hypertensive encephalopathy, stroke and death reported
Use with caution:
- Sinus node dysfunction or AV block; severe bradycardia needing atropine and pacing reported
- Concurrent sympatholytics, especially digitalis, calcium channel blockers, beta-blockers
- Renal impairment; half-life up to 41 hours, so start lower and monitor
- Any child prone to vomiting illness; missed doses are de facto abrupt discontinuation
- Contact lens wearers, because of dry eyes
- Pheochromocytoma; no therapeutic effect expected
Screen before starting:
- Blood pressure and heart rate, supine and standing
- History of syncope, bradycardia, heart block or conduction disease
- Renal function
- Sympatholytic and sedating co-medication, including any beta-blocker

Drug Interactions

Beta-blockers: additive bradycardia and worse withdrawal hypertension; if both stop, withdraw the beta-blocker several days first
AV nodal agents (digitalis, calcium channel blockers): monitor heart rate; bradycardia needing pacing reported with diltiazem and verapamil
Sedatives and alcohol (barbiturates, benzodiazepines, antihistamines): potentiated CNS depression; ask at every visit
Tricyclic antidepressants: reduce the hypotensive effect; recheck blood pressure when either is started or stopped
Neuroleptics: worsen orthostatic hypotension; check orthostatic vitals after adding either agent
Other antihypertensives: additive lowering; adjust and recheck

Administration

Same times daily, with or without food; food does not affect kinetics
Give the larger share of the daily dose at bedtime
The 0.1, 0.2 and 0.3 mg tablets are scored and may be bisected
The 0.05 mg tablet is listed by a single labeler; confirm stock with the pharmacy
Do not substitute mg-for-mg for Kapvay, Onyda XR or the transdermal system
Do not stop abruptly; see Discontinuation & Taper
Continue to within 4 hours of surgery, resume promptly, monitor blood pressure perioperatively
Store locked; as little as 0.1 mg has produced toxicity in a small child

Side Effects

Common (adult label rates, dose related, diminish over time): dry mouth 40%, drowsiness 33%, dizziness 16%, constipation 10%, sedation 10%
Serious:
- Withdrawal with rebound hypertension, rarely hypertensive encephalopathy, stroke, death; never stop abruptly
- Bradycardia, sinus arrest, high-degree AV block; stop and obtain an ECG for syncope or slow, irregular pulse
- Orthostatic hypotension and syncope; recheck standing vitals, reduce or hold
- Hallucinations, delirium, depression; discontinue and reassess
- Raynaud phenomenon, hepatitis, thrombocytopenia, colonic pseudo-obstruction
- Angioedema, urticaria, generalised rash, especially after prior transdermal sensitisation

Monitoring & Labs

Heart rate and blood pressure: baseline, after each increase, then every 3 months
Orthostatics: lying and standing at baseline, at every dose change, and at any dizziness visit
Sedation: ask at every titration visit and every visit for 3 months; commonest reason for stopping
Rebound risk: at every refill confirm no missed doses and restate that the drug is never stopped abruptly
ECG: not routine; baseline if conduction disease, syncope history or concurrent sympatholytics, and promptly for new syncope or bradycardia
Renal function: baseline, annually, and after any illness that could impair it
Mood and perception: ask about depression and hallucinations each visit; neither is volunteered
Laboratory: no other routine monitoring required

Discontinuation & Taper

Never stop abruptly. Reduce the dose gradually over 2 to 4 days
Abrupt cessation: nervousness, agitation, headache, tremor, then rapid blood pressure rise; rarely hypertensive encephalopathy, stroke, death
Risk rises with higher doses and continued beta-blockade; withdraw the beta-blocker several days first, then taper clonidine
An excessive post-discontinuation rise reverses with oral clonidine or IV phentolamine
A vomiting illness in a child is de facto abrupt discontinuation; families should call rather than let doses lapse
Drug holidays are not appropriate for this class

Pregnancy & Lactation

Pregnancy: no adequate controlled human studies; clonidine crosses the placenta. Rats showed increased resorptions, rabbits no teratogenicity. Use only if clearly needed; ER labels note decades of human use without an identified defect risk.
Lactation: milk levels about double maternal serum; relative infant dose 4.1% to 8.4%. One infant had drowsiness, hypotonia, suspected seizures and apnoea. Monitor for sedation, lethargy, tachypnoea, poor feeding. (LactMed 2024)
Lactation, milk supply: dose-related oxytocin and prolactin effects; postpartum galactorrhea and hyperprolactinaemia with gynecomastia reported. Other antihypertensives preferred while nursing a newborn. (LactMed 2024)

Counseling Points

Counsel the family on:
- Why this tablet is not the ADHD-approved product, and why the box says hypertension
- Never stopping on their own, even for a few days; name rebound high blood pressure as the reason
- Calling if the child cannot keep the medicine down, because missed doses and withdrawal are the same thing
- Dry mouth and drowsiness peaking early, dose related, easing with time
- Standing up slowly, and calling rather than pushing through dizziness
- Keeping the bottle locked; one 0.1 mg tablet can seriously harm a small child
- Avoiding alcohol and sedating medicines, including over-the-counter antihistamines
Advise them to call for:
- Fainting, or dizziness on standing that does not settle in a minute or two
- A pulse that feels very slow or irregular
- Drowsiness so heavy the child is hard to wake
- Severe headache with blurred vision or confusion, especially after missed doses
- Seeing or hearing things that are not there, or a marked mood change
- Numbness or colour change in the fingers or toes
- Any vomiting illness that stops the medicine going down

References

DailyMed. Clonidine hydrochloride tablets, USP prescribing information. Actavis Pharma, Inc. 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a842ab83-3531-44dd-a8a8-64dd89e87026
DailyMed. Clonidine hydrochloride extended-release tablets prescribing information. Actavis Pharma, Inc. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0100c70d-7fde-46a1-8374-940550a27e43
DailyMed. Catapres-TTS (clonidine transdermal system) prescribing information. Boehringer Ingelheim. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa
LactMed. Clonidine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2024. https://www.ncbi.nlm.nih.gov/books/NBK501628/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AACAP. Practice parameter for the assessment and treatment of children and adolescents with tic disorders. Journal of the American Academy of Child and Adolescent Psychiatry. 2013. https://www.jaacap.org/article/S0890-8567(13)00695-3/fulltext
FDA. openFDA National Drug Code Directory, clonidine, queried by generic name across all labelers. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22clonidine%22&limit=1000

Concerta

(methylphenidate hydrochloride extended-release, OROS)

Concerta (methylphenidate hydrochloride extended-release, OROS); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Concerta is a long-acting methylphenidate tablet using an OROS osmotic pump to deliver an immediate overcoat dose followed by ascending release from the core, approved for ADHD from age 6 through 65. It is the reference long-acting methylphenidate and the one with a labeled conversion table from immediate-release dosing. Its differentiator is that ascending profile: levels rise across the day rather than plateauing. Schedule II; brand and generic.

Forms & Strengths

Extended-release tablets (OROS, swallow whole): 18 mg, 27 mg, 36 mg, 54 mg, 72 mg

Dosing

Age: 6 to 65 y/o
Onset: ~ 1 hour
Duration: up to 12 hours
Release Profile: 22% IR / 78% ER via OROS osmotic delivery
Initial Dose:
- 6 to 17 y/o, new to methylphenidate: 18 mg once daily in the morning
- 18 to 65 y/o, new to methylphenidate: 18 mg or 36 mg once daily
- From IR methylphenidate, per dose given 2-3 times daily: 5 mg to 18 mg; 10 mg to 36 mg; 15 mg to 54 mg; 20 mg to 72 mg (13 y/o and older only)
Titration: 18 mg every 7 days; use 27 mg for a smaller step
Max Dose:
- 6 to 12 y/o: 54 mg/day
- 13 to 17 y/o: 72 mg/day, not to exceed 2 mg/kg/day
- 18 to 65 y/o: 72 mg/day
Considerations: Swallow whole; splitting or chewing destroys the extended release. The nondeformable tablet is unsuitable in severe GI narrowing, and the empty shell passing in stool is not a failed dose.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 22% IR / 78% ER via OROS osmotic delivery. An overcoat dissolves within an hour, then a push layer forces drug through a laser-drilled orifice; two core layers make release ascending.
Metabolism: De-esterified to PPAA (ritalinic acid), inactive. Not a CYP substrate. Half-life ~3.5 hours, ~90% recovered in urine, no accumulation.
Class Positioning: Ascending, not two-peaked, so no interpeak trough unlike Ritalin LA or Metadate CD. Relexxii is a different OROS product (18% IR overcoat, Tmax 5.5 h), not interchangeable.
Alcohol: no increased release in vitro up to 40%, unlike Metadate CD, which dose-dumps.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 65 y/o

Off-Label Uses

ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral parent training first line; if medication is needed use IR methylphenidate, not OROS. Expert consensus. (AAP 2019)
Narcolepsy (ICD-10: G47.419): IR methylphenidate carries this indication, Concerta does not. Insufficient.
Where the evidence does not support use: treatment-resistant depression, binge eating disorder, cancer-related and chronic fatigue. Adult literature only; insufficient in children. (AHRQ 2024)
Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death; risk rises with dose and with non-oral routes. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
- MAOI use, current or within 14 days: hypertensive crisis
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: mean rises 2 to 4 mm Hg and 3 to 6 bpm
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Severe GI narrowing: obstruction reported with nondeformable tablets
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Personal or family history of tics or Tourette's syndrome
- Substance use disorder in the patient or the household
Screen before starting:
- Cardiac history and exam including family sudden death; the label requires no routine ECG
- Tics, and mania risk factors: depressive symptoms, family history of bipolar disorder
- Abuse and diversion risk in patient and household
- Ability to swallow a tablet whole; any GI stricture or bowel surgery
- Baseline height, weight, blood pressure and heart rate

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only, not in the interaction table. Counsel on symptoms rather than avoiding.

Administration

Once daily in the morning, with or without food; a high-fat breakfast changes nothing.
Swallow whole. Splitting, crushing or chewing destroys the extended release.
No sprinkle option. If the child cannot swallow a tablet, use a bead capsule or a liquid (Quillivant XR).
The intact shell is often visible in stool; it is the spent pump, not a lost dose.
Never substitute milligram-for-milligram; use the labeled conversion table.
Missed dose: skip it; a mid-afternoon OROS dose costs that night's sleep.
Store locked; household diversion of a Schedule II product is a real risk.

Side Effects

Common, pediatric 6 to 17 y (>= 2%): upper abdominal pain 6%, insomnia 3%, nasopharyngitis 3%, vomiting 3%, pyrexia 2%.
Common, adults: decreased appetite 25%, headache 22%, dry mouth 14%, nausea 13%, insomnia 12%, anxiety 8%, weight loss 7%, dizziness 7%, irritability 6%, tachycardia 5%.
Serious:
- Sudden death with structural cardiac disease: avoid the drug rather than monitor through it
- New psychosis or mania, ~0.1% in pooled trials versus 0% on placebo: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits at each visit
- Growth suppression: about 2 cm and 2.7 kg less over 3 years; GI obstruction in pre-existing narrowing
- Acute angle closure glaucoma; new or worsening tics and Tourette's: discontinue if appropriate
- Postmarketing: convulsion, hepatocellular injury, rhabdomyolysis, pancytopenia, angioedema, anaphylaxis

Monitoring & Labs

Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months. Investigate a sustained rise beyond 2 to 4 mm Hg or 3 to 6 bpm.
Growth: height, weight and BMI at baseline and every 6 months, every visit if losing weight. Crossing two percentile channels triggers interruption.
Appetite and sleep: at every visit and dose change; appetite suppression is worst at midday.
Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at baseline and every visit.
Abuse and diversion: at every refill, pill count, ask about sharing and selling, check the PDMP. A boxed-warning obligation.
Where diversion risk decides, neither non-stimulant (Strattera, Qelbree) is a controlled substance.
Gastrointestinal: ask about obstructive symptoms each visit where there is a stricture history. No routine labs; CBC and chemistry are not label-directed.

Discontinuation & Taper

No taper required; the label gives no tapering schedule.
Discontinue if no improvement after appropriate dose adjustment over one month.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
Priapism has occurred during drug holidays; mention it when planning one.
Drug holidays are reasonable where growth or appetite limits treatment; an interrupted day is fully unmedicated.

Pregnancy & Lactation

Pregnancy: human data are inconsistent on major birth defects and miscarriage. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant serum in every reported case, including Concerta 36 mg. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, insomnia and poor weight gain. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

Counsel the family on:
- Seeing the intact shell in the stool. Say it before the first dose, or families stop the drug.
- Half an 18 mg tablet is not 9 mg, it is a broken pump. The 27 mg strength exists to avoid cutting.
- The ascending release: effect builds through the day; the hardest hours are the first and the last.
- Moving the largest meal to breakfast and the evening. Upper abdominal pain, the only pediatric reaction above 5%, usually settles.
- Locked storage; sharing or selling a Schedule II medication is a felony, and adolescents are the ones being asked.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or suspicious or fearful thinking; eye pain with halos around lights.
- Numbness, coldness or colour change in fingers or toes, or a sore that will not heal.
- A new or markedly worse tic, including throat clearing and blinking.
- A painful erection lasting more than a few hours, including during a planned break.
- Severe abdominal pain, vomiting or constipation, especially with bowel narrowing.
- Clothes fitting more loosely, or no weight gain across a few months.

References

DailyMed. Concerta (methylphenidate hydrochloride) extended-release tablets prescribing information. Janssen Pharmaceuticals. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a88218c-5b18-4220-8f56-526de1a276cd
FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Cotempla XR-ODT

(methylphenidate)

Cotempla XR-ODT (methylphenidate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Cotempla XR-ODT is a long-acting methylphenidate CNS stimulant supplied as a grape-flavoured extended-release tablet that disintegrates on the tongue, approved for ADHD in patients 6 to 17 years only. Drug is ion-bound to a resin, giving one morning dose a full school-day profile with no water and no swallowing. Its strengths are stated in methylphenidate base, so they do not match the hydrochloride numbers on any other product. Schedule II; brand and generic.

Forms & Strengths

Extended-release orally disintegrating tablets (grape): 8.6 mg, 17.3 mg, 25.9 mg

Dosing

Age: 6-17 y/o; pediatric only
Onset: ~ 1 hour
Duration: up to 12 hours
Release Profile: 25% IR / 75% ER, methylphenidate ion-bound to polystyrene sulfonate resin
Initial Dose: 17.3 mg once daily in the morning
Titration: 8.6 mg to 17.3 mg every 7 days
Max Dose: 51.8 mg/day
Considerations: Strengths are methylphenidate base, so 17.3 mg equals 20 mg of a hydrochloride product. Do not co-prescribe an H2-blocker or PPI; they alter the release profile.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 25% IR / 75% ER; drug exchanges off a coated ion-exchange resin. Monophasic, no second peak. Tmax ~5 h adults, 4.6 h children.
Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Half-life ~4 h adults, 4.4 h children; 90% urinary.
Pediatric exposure: at 51.8 mg, children 6-12 reach roughly twice adult plasma levels; adolescents match adults. Start everyone at 17.3 mg.
Class Positioning: The resin buys a water-free dose, unlike the sprinkle capsule Aptensio XR or the liquid Quillivant XR, and is why gastric pH matters here alone.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6-17 y/o. No adult indication.

Off-Label Uses

ADHD in adults (ICD-10: F90.x): reasonable where swallowing is the obstacle; the indication stops at 17. Limited data.
Narcolepsy (ICD-10: G47.411, G47.419): on-label for IR methylphenidate, not this product; limited data.
Where the evidence does not support use.
- ADHD under 6 y/o (ICD-10: F90.x): the label records evidence against, with higher exposure and more adverse reactions including weight loss; insufficient. (AHRQ 2024)
- Dissolving the tablet in water or juice: not studied, not supported. Prescribe a liquid product if a liquid is needed.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High potential for abuse and misuse, leading to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
- Known hypersensitivity to methylphenidate or any component; angioedema and anaphylaxis reported.
- Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
- Established acid suppression. A child already on a PPI or H2-blocker is a poor candidate; switch formulation rather than stop the acid suppression.
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid, because of sudden death reports.
- Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm.
- Psychotic or bipolar disorder; exacerbation and treatment-emergent mania.
- Tics or Tourette's syndrome, personal or family.
- Significant hyperopia, open-angle glaucoma, or raised intraocular pressure.
- Substance use disorder in the patient or household.
Screen before starting:
- Cardiac history, family history of sudden death or arrhythmia, and exam.
- Personal and family history of tics or Tourette's syndrome.
- Current acid-suppression therapy, prescribed or over the counter.
- Risk factors for mania: past depression, family history of suicide or bipolar disorder.
- Abuse and diversion risk; baseline height, weight, blood pressure and heart rate.

Drug Interactions

Gastric pH modulators (famotidine, omeprazole, pantoprazole): alter the release profile. Concomitant use is not recommended. Switch formulation if acid suppression must continue.
MAOIs: hypertensive crisis, with reported death, stroke and MI. Do not co-prescribe, and allow 14 days after stopping.
Antihypertensives: effectiveness may fall. Recheck blood pressure and adjust their dose.
Halogenated anesthetics: sudden intraoperative pressure and rate rise. Hold on the day of surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.
Serotonergic agents: serotonin syndrome is postmarketing only here; counsel on symptoms rather than avoid.

Administration

Once daily in the morning, consistently either with food or without food.
With dry hands, peel the foil back at the moment of dosing. Never push the tablet through the foil, which crushes the extended-release coating.
Place the whole tablet on the tongue and let it disintegrate. Do not chew, crush, split or add liquid.
Missed dose: resume as scheduled; do not double up or dose late in the day.
Switching from another methylphenidate: re-titrate from 17.3 mg; strengths are in base, not hydrochloride.
Store securely, preferably locked; dispose through a take-back program.

Side Effects

Common (pooled methylphenidate trials; no Cotempla-specific table exists): decreased appetite, insomnia, decreased weight, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, anxiety, irritability, affect lability, dizziness, raised blood pressure and heart rate.
Serious:
- Sudden death with structural cardiac disease; avoid the drug in that group.
- New psychosis or mania, ~0.1% pooled, including with no psychiatric history; consider discontinuing.
- Priapism, which may require surgery; also during drug holidays. Seek immediate care.
- Peripheral vasculopathy including Raynaud's, with digital ulceration; reduce dose or stop.
- Growth suppression: ~2 cm and 2.7 kg less over 3 years. Interrupt if growth stalls.
- Acute angle closure glaucoma and raised intraocular pressure.
- New or worsening tics; discontinue if clinically appropriate.
- Angioedema and anaphylaxis; postmarketing seizures, rhabdomyolysis, pancytopenia, raised hepatic enzymes.

Monitoring & Labs

Acid-suppression therapy: ask at every visit, including over-the-counter use. A new PPI is the likeliest hidden cause of a regimen that stops working.
Administration technique: at first follow-up and at any loss of effect, have the caregiver demonstrate how the tablet is given.
Cardiovascular: blood pressure and heart rate at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months. Interrupt if the child crosses two major percentile lines.
Appetite, sleep, mood and tics: at every visit and after every dose increase; screen for new psychosis, mania and aggression.
Digital perfusion: inspect fingers and toes at each visit.
Abuse and diversion: tablet counts and PDMP check at each refill, per state requirement. Blister cards make counting easy.
Laboratory: none routine. LFTs only for jaundice, dark urine or unexplained fatigue.
Efficacy stopping rule: discontinue if no improvement after one month of dose adjustment.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; the label gives no taper schedule.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, psychomotor slowing or agitation. Do not read it as relapse.
Drug holidays are reasonable where appetite or growth limits treatment; priapism has been reported during them.
If the reason for stopping is a newly required PPI or H2-blocker, switch formulation rather than abandoning methylphenidate.

Pregnancy & Lactation

Pregnancy: Human data insufficient to inform risk. No teratogenicity in rats or rabbits at 4 and 18 times the 51.8 mg maximum; spina bifida in rabbits at 60 times. Stimulants reduce placental perfusion.
Lactation: Present in milk; infant receives 0.16% to 0.7% of the maternal weight-adjusted dose. Monitor for agitation, insomnia, poor feeding and low weight gain. (LactMed 2025)
Lactation, milk supply: Methylphenidate lowers prolactin; large doses may interfere before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.

Counseling Points

Counsel the family on:
- The handling sequence, demonstrated once: dry hands, peel the foil, tablet on the tongue, let it melt.
- Never pushing the tablet through the foil, which turns a 12-hour product into a short one.
- No water, no chewing, no crushing, no dissolving in a drink.
- Keeping breakfast consistent, fed every morning or fasted every morning.
- Telling you before starting any heartburn medicine, including over-the-counter omeprazole or famotidine. Families will not volunteer this.
- The numbers looking smaller than on other methylphenidates without being smaller doses.
- Appetite suppression: move the largest meal to breakfast and to the evening.
- Locked storage, and that sharing a Schedule II medication is a felony.
- For adolescents, that spirits can release the whole tablet at once.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness, or colour change in the fingers or toes.
- A new or markedly worse tic, or a new vocal tic.
- Weight loss, or clothes fitting more loosely over a few weeks.
- A painful erection lasting more than a few hours, which is a surgical emergency.
- New eye pain, blurred vision, or haloes around lights.
- Swelling of the lips, tongue or face, or a spreading rash.

References

DailyMed. Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets prescribing information. Neos Therapeutics Brands LLC. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33f70f58-c871-42c8-8adb-345caeafefcd
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling

Cymbalta

(duloxetine)

Cymbalta (duloxetine); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Cymbalta is a serotonin and norepinephrine reuptake inhibitor supplied as a delayed-release capsule, approved in children for generalized anxiety disorder from 7 years and for juvenile fibromyalgia from 13 years, with further indications in adults only. It has no ADHD indication at any age, and appears in this library because anxiety so often accompanies ADHD. Its distinguishing feature in youth is dual action on mood and pain. Not controlled; brand and generic.

Forms & Strengths

Delayed-release capsules: 20 mg, 30 mg, 40 mg, 60 mg
Delayed-release capsules, separate NDA: 80 mg, 90 mg, 120 mg
Delayed-release sprinkle capsules (Drizalma Sprinkle, separate NDA): 20 mg, 30 mg, 40 mg, 60 mg

Dosing

Age:
- Generalized anxiety disorder: 7 y/o and older, and adults
- Juvenile fibromyalgia: 13 y/o and older
- Major depressive disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain: adults only
Onset: 2 weeks for early effect; 10 to 13 weeks for full response
Duration: continuous with once-daily dosing; steady state at about 3 days
Initial Dose:
- GAD, 7 to 17 y/o: 30 mg once daily, held for 2 weeks before any increase
- Juvenile fibromyalgia, 13 to 17 y/o: 30 mg once daily
- Adults: 60 mg once daily; geriatric adults 30 mg once daily
Titration:
- GAD, 7 to 17 y/o: 30 mg increments, first no sooner than 14 days, usual range 30 to 60 mg daily
- Juvenile fibromyalgia, 13 to 17 y/o: single increase to 60 mg once daily on response and tolerability
Max Dose:
- GAD and MDD, any age: 120 mg/day
- Fibromyalgia and chronic musculoskeletal pain: 60 mg/day, with no added benefit above 60 mg
Considerations: Avoid in chronic liver disease, cirrhosis, substantial alcohol use, and GFR under 30 mL/min. Never stop abruptly; discontinuation syndrome follows tapered as well as abrupt cessation.

Pharmacology

Mechanism: serotonin and norepinephrine reuptake inhibitor; the full serotonergic action drives both serotonin syndrome and bleeding risk
Delivery / Release: enteric-coated pellets protect an acid-labile drug, so the capsule cannot be crushed, chewed or sprinkled
Metabolism: hepatic via CYP1A2 and CYP2D6; half-life about 12 hours, range 8 to 17. Duloxetine is itself a moderate CYP2D6 inhibitor
Class Positioning: steady state at ages 7 to 17 runs about 30% below adults. Against atomoxetine (Strattera) it adds serotonergic action, analgesia and a discontinuation syndrome

Indications

Generalized Anxiety Disorder (ICD-10: F41.1): patients 7 y/o and older, and adults
Juvenile Fibromyalgia Syndrome (ICD-10: M79.7): patients 13 to 17 y/o
Fibromyalgia (ICD-10: M79.7): adults only
Major Depressive Disorder (ICD-10: F32.x, F33.x): adults only. Not approved at any pediatric age
Diabetic Peripheral Neuropathic Pain (ICD-10: E11.42 with G63): adults only
Chronic Musculoskeletal Pain (ICD-10: M79.1, G89.29): adults only

Off-Label Uses

Pediatric major depressive disorder (ICD-10: F32.x, F33.x): specifically negative. Efficacy was not demonstrated in two 10-week trials, 800 patients aged 7 to 17.
ADHD (ICD-10: F90.x): insufficient. No ADHD indication or trial at any age; use an approved non-stimulant (Strattera, Qelbree).
Pediatric neuropathic and musculoskeletal pain (ICD-10: G63, M79.1): insufficient; not established below adulthood.
Other pediatric anxiety disorders (ICD-10: F40.x, F93.0, F41.0): insufficient; the evidence is confined to GAD.

Contraindications & Warnings

Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS. Antidepressants increased suicidal thinking and behaviour in children, adolescents and young adults. Monitor closely for worsening and emergent suicidality, particularly in the first months and at every dose change.
Contraindicated:
- Concomitant MAOI antidepressant, or use within 14 days of stopping one.
- Initiation in a patient taking linezolid or intravenous methylene blue.
Use with caution, or avoid (Warnings in this label, not contraindications):
- Chronic liver disease, cirrhosis or substantial alcohol use: avoid, because of fatal hepatic failure.
- Severe renal impairment with GFR under 30 mL/min: avoid.
- Untreated anatomically narrow angles: angle-closure glaucoma.
- Other serotonergic drugs; serotonin syndrome occurs with duloxetine alone.
- Antiplatelets, anticoagulants and NSAIDs: increased bleeding.
- History of seizure disorder; such patients were excluded from the trials.
- Pre-existing hypertension, and any risk of orthostatic hypotension, falls or syncope.
- Bipolar disorder or risk factors for it: activation of mania.
- Diabetes, and conditions that slow gastric emptying.
Screen before starting:
- Personal and family history of bipolar disorder, mania or hypomania.
- Blood pressure, measured before initiation.
- Liver history including alcohol use, and renal function.
- Medication list for MAOIs, serotonergic agents, CYP1A2 inhibitors, antiplatelets.
- Baseline height and weight, plotted on a growth chart.

Drug Interactions

MAOIs (phenelzine, tranylcypromine, linezolid, intravenous methylene blue): serotonin syndrome. Contraindicated; allow 14 days in either direction.
Potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin, enoxacin) and thioridazine: avoid. Qelbree is a strong CYP1A2 inhibitor.
Potent CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, bupropion): duloxetine levels rise. Reduce the dose or choose another agent.
CYP2D6 substrates (antidepressants, antipsychotics, atomoxetine, metoprolol): exposure rises. Reduce the substrate dose.
Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, lithium, buspirone, St John's Wort): serotonin syndrome. Reassess within 1 week of any change.
NSAIDs, aspirin, warfarin, antiplatelets: increased bleeding. Reconsider routine NSAID use.
Drugs causing hyponatremia (thiazides, carbamazepine): additive SIADH risk. Check sodium for lethargy or confusion.

Administration

Give once daily, with or without food; food blunts early nausea.
Swallow the capsule whole. Do not crush, chew, open or sprinkle it onto food.
If the patient cannot swallow capsules, prescribe the separate sprinkle product.
The adult MDD label permits 20 mg twice daily; every pediatric step is once daily.
Missed dose: take when remembered unless the next is near; do not double up.
Never stop abruptly. See Discontinuation & Taper.

Side Effects

Common (pediatric, at least 5% and twice placebo): decreased weight and appetite, nausea, vomiting, diarrhea, dizziness, fatigue
Serious:
- Suicidal thoughts and behaviour: the boxed warning.
- Hepatotoxicity including fatal hepatic failure: discontinue for jaundice or liver dysfunction.
- Serotonin syndrome: stop all serotonergic agents and treat as an emergency.
- Erythema multiforme and Stevens-Johnson syndrome: stop at first blistering or mucosal erosion.
- Increased bleeding; mania or hypomania; seizures.
- Angle-closure glaucoma: sudden eye pain or visual change needs same-day ophthalmology.
- Hyponatremia with SIADH; orthostatic hypotension, falls and syncope; raised blood pressure.
- Discontinuation syndrome: dizziness, headache, nausea, electric-shock paresthesia, irritability, insomnia, anxiety.
- Growth effect: mean 0.1 kg loss at 10 weeks against 0.9 kg gain on placebo; mean height percentile fell 1% over 9 months.

Monitoring & Labs

Suicidality: weekly for 4 weeks, every visit through 3 months, every dose change, then each routine visit.
Blood pressure: baseline, 4 weeks, every dose change, then every 3 months. Include a standing reading.
Growth: height and weight on a growth chart at baseline, then every 3 months. Investigate a 3.5% weight loss.
Liver: no routine schedule. Check ALT, AST and bilirubin for jaundice or right upper quadrant pain; ask about alcohol each visit.
Sodium: not routine. Check for headache, confusion or unsteadiness; at 2 to 4 weeks if on a thiazide or carbamazepine.
Bleeding and psychiatric: ask about bruising, nosebleeds and mania each visit during titration, then every 3 months.
Glucose: in diabetes, check A1c 3 months after starting; not routine otherwise.

Discontinuation & Taper

Do not stop abruptly; the label directs gradual dose reduction.
Symptoms follow tapered as well as abrupt cessation: dizziness, headache, nausea, paresthesia, irritability, insomnia, anxiety.
If intolerable symptoms follow a reduction, resume the previous dose and decrease more gradually.
Drug holidays are not appropriate; a missed weekend causes discontinuation symptoms.
Discontinue immediately for jaundice, serotonin syndrome, or a serious skin reaction.

Pregnancy & Lactation

Pregnancy: no clear risk of major birth defects. Use in the month before delivery may increase postpartum haemorrhage.
- Third-trimester SNRI exposure may cause neonatal poor adaptation: respiratory distress, feeding difficulty, hypotonia, tremor, irritability.
- Background risk is 2 to 4% for birth defects, 15 to 20% for miscarriage; weigh continuation against relapse.
Lactation: milk and infant serum levels are low; not a reason to stop breastfeeding. Prefer a better-studied agent for a newborn or preterm infant. Galactorrhea reported in mothers. (LactMed 2024)
Exposure Registry: National Pregnancy Registry for Antidepressants, 1-866-961-2388, womensmentalhealth.org

Counseling Points

Counsel the family on:
- Never running out; missed doses cause dizziness and electric-shock sensations.
- Holding the starting dose a full 2 weeks in anxiety before any increase.
- Nausea in the first week or two, usually settled by food.
- Swallowing the capsule whole, never opening it onto food.
- Avoiding alcohol as a liver instruction, and asking before any NSAID.
- Daily observation for new agitation or talk of self-harm through the first months.
Advise them to call for:
- New or worsening talk of self-harm, or a sudden change in mood.
- Yellowing of the skin or eyes, dark urine, or pain under the right ribs.
- Shivering with twitching, agitation, fever and a racing heart.
- A rash with blisters, peeling skin, or sores in the mouth or eyes.
- Unusual bruising, persistent nosebleeds, or bleeding gums.
- Headache with confusion, unsteadiness or unusual sleepiness.
- Sudden eye pain, redness or blurred vision, or fainting on standing.

References

DailyMed. Cymbalta (duloxetine delayed-release capsules) prescribing information. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba
LactMed. Duloxetine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2024. https://www.ncbi.nlm.nih.gov/books/NBK501470/
FDA. National Drug Code Directory, openFDA. Queried by generic name duloxetine. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22duloxetine%22&limit=1000

Daytrana

(methylphenidate)

Daytrana (methylphenidate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Daytrana is a long-acting methylphenidate CNS stimulant delivered as an adhesive transdermal patch worn on the hip, approved for ADHD in patients 6 to 17 years only. Dose is set by patch size and by wear time, so a parent can shorten the day by removing it early, which no oral product allows. It is also the only methylphenidate carrying a risk of permanent skin depigmentation. Schedule II; brand and generic.

Forms & Strengths

Transdermal system (patch, hip): 10 mg/9 h, 15 mg/9 h, 20 mg/9 h, 30 mg/9 h

Dosing

Age: 6-17 y/o; pediatric only
Onset: ~ 2 hours after application
Duration: through 12 hours after application, on a 9-hour wear time
Release Profile: continuous transdermal delivery from an adhesive matrix; no IR fraction and no bead or coat split
Initial Dose: 10 mg/9 h patch (12.5 cm2) once daily, including when converting from an oral methylphenidate
Titration: one patch size every 7 days, in the order 10, 15, 20, 30 mg/9 h
Max Dose: 30 mg/9 h
Considerations: Wear time is a second dosing variable: remove at 9 hours, or earlier for a shorter day. Never cut a patch. Heat or inflamed skin under the patch can double or triple absorption.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: Three-layer adhesive matrix; peak plasma ~10 h single dose, ~8 h on repeat. No food effect. Absorption rises with repeat dosing over the first four weeks.
Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Half-life after removal 4 to 5 hours.
Class Positioning: Bypassing first pass leaves l-methylphenidate at 40% to 46% of the d-isomer instead of near zero, so conversion from an oral product restarts at the smallest patch.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6-17 y/o. No adult indication.

Off-Label Uses

Where the evidence does not support use.
- ADHD under 6 y/o (ICD-10: F90.x): the label records evidence against, with higher exposure and more weight loss; insufficient. (AHRQ 2024)
- Sites other than the hip: absorption differs and is not adequately studied; insufficient.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction, which can lead to substance use disorder, overdose and death.
Chemical leukoderma, specific to this product: persistent depigmentation at, around and sometimes distant from the site. It may be permanent. Discontinue for good.
Contraindicated:
- Hypersensitivity to methylphenidate or any system component, adhesives included; the reaction may be to the system, not the drug.
- Concomitant MAOI, or within 14 days of stopping one.
Contact sensitization (0.3% of 305 children): a sensitized patient may react systemically to oral methylphenidate, and some cannot take it.
Use with caution:
- Personal or family history of vitiligo, because of chemical leukoderma.
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; avoid.
- Prior seizures or EEG abnormality; this label carries a Seizures warning the oral labels do not.
- Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm.
- Psychotic or bipolar disorder; tics or Tourette's (tic ran 7.1% versus 0%).
- Hyperopia, open-angle glaucoma, or raised intraocular pressure; substance use disorder in patient or household.
Screen before starting:
- Cardiac history, family history of sudden death or arrhythmia, and exam.
- History of tics, vitiligo, eczema or adhesive reactions; inspect the hip sites. Seizure or EEG history; risk factors for mania.
- Whether the household can manage a timed daily application and removal; abuse risk; baseline growth, vitals and CBC.

Drug Interactions

Coumarins, anticonvulsants, TCAs and SSRIs (warfarin; phenobarbital, phenytoin, primidone): metabolism may be inhibited. Reduce their dose and monitor levels, or INR.
MAOIs: hypertensive crisis. Do not co-prescribe; allow 14 days after stopping.
External heat, which behaves like an interaction: hair dryers, heating pads, electric blankets, hot tubs and prolonged sun raise absorption more than 2-fold; inflamed skin about 3-fold.
Antihypertensives: effectiveness may fall; recheck blood pressure and adjust.
Halogenated anesthetics: sudden intraoperative pressure and rate rise. Apply no patch on the day of surgery.
Risperidone: a dose change either way may raise EPS risk; monitor across any change. Serotonergic agents: serotonin syndrome is postmarketing only here, so counsel on symptoms rather than avoid.

Administration

Timing: apply to the hip 2 hours before an effect is needed; remove 9 hours later. Record both times on the carton chart.
Wear time is a dose control: remove earlier for a shorter day or late-day effects.
Site: clean, dry hip skin, not oily or irritated; avoid the waistline, alternate hips daily.
Press firmly with the palm for 30 seconds at the edges. Never cut a patch. Discard one whose liner tore or took adhesive with it.
If a patch falls off, apply a new one at a fresh site; the day still ends at 9 hours. Do not tape or re-stick a patch.
Removal: peel slowly; work mineral oil under a stubborn edge. Never use acetone or nail polish remover.
Disposal: used patches retain drug. Take-back site, or fold adhesive-to-adhesive and flush. A caregiver applies and removes it for children.
Switching from an oral methylphenidate (Concerta or any other): start at 10 mg/9 h. Xelstrym is a dextroamphetamine patch, not interchangeable. Do not refrigerate; store securely, preferably locked.

Side Effects

Common in children 6-12 (n=98 vs 85, 7 weeks): decreased appetite 25.5% vs 4.7%, insomnia 13.3% vs 4.7%, nausea 12.2% vs 2.4%, weight decreased 9.2% vs 0%, tic 7.1% vs 0%. Adolescent rates similar. Site erythema is near-universal and minor.
Serious:
- Chemical leukoderma, possibly permanent, including at sites distant from the patch; and contact sensitization. Discontinue permanently for either.
- Sudden death with structural cardiac disease; avoid the drug in that group.
- Seizures; discontinue if one occurs. New psychosis or mania, ~0.1% pooled; consider discontinuing.
- Priapism, which may require surgery, also during drug holidays. Peripheral vasculopathy including Raynaud's; reduce dose or stop.
- Growth suppression: ~2 cm and 2.7 kg less over 3 years. Interrupt if growth stalls.
- Acute angle closure glaucoma; new or worsening tics; angioedema and anaphylaxis; rare NMS; abnormal liver function.

Monitoring & Labs

Skin, for depigmentation: examine the hips at every visit, minimum every 3 months, and ask about a pale patch anywhere on the body. Stop at the first sign.
Skin, for sensitization: at every visit; escalate if erythema carries edema or vesicles past 48 hours.
Hematologic: CBC, differential and platelets at baseline and at least annually. Labeled on Daytrana alone.
Application and removal times: review the chart at every visit; drift in the removal hour explains most lost effect.
Weeks 2 to 4: reassess tolerability at 4 weeks even without a size change; absorption rises with repeat dosing.
Cardiovascular and growth: blood pressure, heart rate, height, weight and BMI at baseline, each size change, and every 6 months.
Psychiatric, tics, seizures and digits: at every visit and size change; stop if a seizure occurs.
Abuse and diversion: count patches against days at each refill and check the state PDMP per state requirement.

Discontinuation & Taper

May be stopped abruptly; the label gives no taper schedule.
The offset is delayed. Absorption continues from the skin depot for hours, so a patch off at 4 p.m. does not stop working at 4 p.m.
Shortening wear time is a legitimate step-down, and the right lever for evening insomnia rather than a smaller patch.
Discontinue permanently for chemical leukoderma, and stop for suspected sensitization or a seizure.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite. Drug holidays are simply a day without a patch.

Pregnancy & Lactation

Pregnancy: Human data insufficient to identify a risk. No reproduction studies with the transdermal system; oral data showed spina bifida in rabbits at 200 mg/kg/day. Stimulants reduce placental perfusion.
Lactation: Present in milk; infant receives 0.16% to 0.7% of the maternal weight-adjusted dose. Monitor for agitation, insomnia, poor feeding and low weight gain. (LactMed 2025)
Milk supply: Methylphenidate lowers prolactin; large doses may interfere before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

Counsel the family on:
- Watching for any pale or white patch of skin anywhere on the body, not only where the patch was. It can be permanent and must be reported the day it is noticed.
- Applying two hours before it is needed, and writing the removal time down.
- Taking it off early being a legitimate adjustment, and that the effect does not stop when it comes off.
- Redness being normal; swelling, blisters or spreading redness being a reason to call.
- Alternating hips daily, off the waistline, and keeping heat off the site: no hair dryers, heating pads or long sun, which can double the dose absorbed.
- Never cutting a patch; if one falls off, a fresh site, and the day still ends at 9 hours.
- Removing adhesive with olive oil, never nail polish remover, and folding a used patch sticky sides together to dispose of it.
Advise them to call for:
- Any white or pale patch of skin, at the site or anywhere else.
- Swelling, blisters, or redness spreading beyond the patch edge.
- Chest pain, fainting, or a racing heart that does not settle.
- A seizure, new hallucinations, or new fearful thinking.
- Numbness or colour change in the fingers or toes; a new or worse tic.
- Weight loss over a few weeks, or a patch that has gone missing.
- A painful erection lasting more than a few hours, a surgical emergency.

References

DailyMed. Daytrana (methylphenidate transdermal system) prescribing information. Noven Therapeutics LLC. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c312c31-3198-4775-91ab-294e0b4b9e7f
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling

Desoxyn

(methamphetamine hydrochloride)

Desoxyn (methamphetamine hydrochloride); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Desoxyn is methamphetamine hydrochloride, a short-acting immediate-release amphetamine tablet approved for ADHD in patients 6 years of age and older. It is pharmacologically an amphetamine and offers no labeled advantage over conventional amphetamine products, while carrying the same boxed warning and a far larger diversion problem. The brand no longer exists. Schedule II; generic only, from three labelers.

Forms & Strengths

Tablets: 5 mg

Dosing

Age: ADHD: ≥ 6 y/o; no adult and no other pediatric indication is carried
Onset: 30 to 60 min
Duration: 4 to 6 hours
Initial Dose: 5 mg once or twice daily
Titration: 5 mg every 7 days
Max Dose: 25 mg/day; the label gives a recommended range of 20 to 25 mg daily rather than an absolute ceiling
Considerations: Avoid dosing late in the evening because of insomnia. Acidifying agents lower and alkalinizing agents raise blood levels; the label directs dose adjustment by clinical response.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: Immediate-release tablet
Metabolism: Hepatic hydroxylation, N-dealkylation and deamination, with at least seven urinary metabolites including active amphetamine. Half-life 4 to 5 hours; excretion is pH dependent and alkaline urine lengthens it
Pharmacogenomics: no genotype-based adjustment labeled; CYP2D6 inhibitors raise exposure, so start lower
Class Positioning: an amphetamine with an added N-methyl group, raising lipophilicity and central penetration, which is also what makes it more reinforcing
Against Adderall, a lower ceiling (20-25 against 40 mg/day) and no claimed advantage; against Vyvanse, built to blunt a rapid rise, it sits at the opposite end of that axis

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o
No obesity indication. Methamphetamine historically carried a short-term exogenous obesity indication. No currently marketed label carries it, and it should not be prescribed for weight management

Off-Label Uses

None established. No off-label pediatric use is supported by graded evidence.
Where the evidence was looked for and not found: AHRQ CER 267 contains no methamphetamine result, so nothing grades it against methylphenidate, the amphetamine salts or a non-stimulant. (AHRQ 2024)
Narcolepsy (ICD-10: G47.4x): other amphetamines carry it; this one does not. Insufficient. Use a labeled agent.

Contraindications & Warnings

Boxed Warning: ABUSE, MISUSE, AND ADDICTION. High potential for abuse and misuse, which can lead to substance use disorder including addiction; overdose and death, with risk increased at higher doses or by snorting or injection. Assess each patient's risk before prescribing, educate patient and family on the risks and on proper storage and disposal, and reassess risk and monitor throughout treatment.
Contraindicated:
- Known hypersensitivity to amphetamine or tablet components
- MAOI use, current or within 14 days, including linezolid and IV methylene blue
Use with caution (Warnings, not contraindications):
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
- Hypertension; BP rises about 2 to 4 mm Hg and HR about 3 to 6 bpm
- Psychotic or bipolar disorder; new psychosis or mania in 0.1% against 0% on placebo
- Prior seizure or EEG abnormality; the convulsive threshold may fall, and discontinue if a seizure occurs
- Tics or Tourette's syndrome; peripheral vasculopathy including Raynaud phenomenon
- Serotonergic drugs or CYP2D6 inhibitors; diabetes, where insulin needs may change
Substance use history in the patient or household is a strong reason to choose a non-controlled agent such as Strattera or Qelbree.
Screen before starting (label section 2.1 plus the boxed-warning duty):
- Cardiac history, family history of sudden death or arrhythmia, and exam; ECG only if positive
- Tic history; mania risk from past depression or family suicide, bipolar disorder or depression
- Abuse risk in the patient, diversion risk in the household, and who else has access
- Whether it can be stored locked; baseline height, weight, BP, HR

Drug Interactions

MAOIs (phenelzine, tranylcypromine, linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Do not prescribe within 14 days.
Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol): serotonin syndrome. Start lower; stop both drugs if it occurs.
CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, quinidine): raise exposure and serotonin syndrome risk. Start lower or choose an alternative.
Urinary pH agents: alkalinizers (bicarbonate, antacids) raise exposure and the label says avoid; acidifiers (ascorbic acid, fruit juice) lower efficacy. Adjust by response.
Tricyclic antidepressants: sustained rise in brain d-amphetamine with potentiated cardiovascular effects. Monitor; adjust or switch.
Laboratory interference: amphetamines interfere with urinary steroid assays and produce positive amphetamine urine drug screens. Document that for the family in advance.

Administration

Give orally once daily, or in two divided doses daily.
Avoid administration late in the evening because of insomnia.
No food restriction; doses are whole multiples of 5 mg, so splitting is unnecessary.
If a dose is missed, skip it rather than giving it late; do not double up.
Store in a safe place, preferably locked; never give it to anyone else, and dispose of unused drug.
No conversion ratio is published against any other amphetamine. Switching means restarting titration at the new drug's own starting dose.

Side Effects

Common: palpitation, dizziness, insomnia, tremor, headache, bowel change, dry mouth, unpleasant taste, restlessness, overstimulation, dysphoria or euphoria, elevated blood pressure, tachycardia.
Serious:
- Abuse, misuse and addiction, per the boxed warning; reassess at every visit and refill.
- Sudden death, myocardial infarction and stroke with serious cardiac disease; avoid use. Fatal cardiorespiratory arrest, mostly with abuse.
- New psychosis or mania, including with no prior history; consider discontinuing.
- Growth suppression; interrupt if a child is not growing as expected.
- Peripheral vasculopathy, rarely with digital ulceration; reduce or stop.
- Seizure; discontinue. Serotonin syndrome; stop both drugs and treat supportively.
- New or worsening tics; rhabdomyolysis; intestinal ischemia; Stevens-Johnson syndrome; angioedema; prolonged erections.
- Overdose: tachyarrhythmias, blood pressure extremes, vasospasm, agitation, hallucinations, seizures, stroke, coma, hyperthermia. Not dialyzable.

Monitoring & Labs

Abuse, misuse and diversion: at every visit and refill: adherence, pill count, who has access at home, locked storage confirmed, and a PDMP check per state requirement.
Why: a boxed-warning obligation, and four or five 5 mg tablets a day is the easiest supply here to divert unnoticed.
Cardiovascular: BP and HR at baseline, each dose change, and every 6 months; investigate exertional chest pain or syncope promptly.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt in a child not growing or gaining as expected.
Appetite and sleep: every visit; the label warns against evening dosing.
Psychiatric, tics and digits: psychosis, mania, aggression and hostility at every visit and each dose increase; ask about tics and examine the digits.
Laboratory: none routinely; recheck glucose control in diabetes after starting or changing dose.

Discontinuation & Taper

No taper is specified in the label, and an immediate-release stimulant at therapeutic doses can be stopped without one.
Physical dependence is labelled, with withdrawal after abrupt stop or reduction: dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
That statement is more explicit than the amphetamine-salts labels carry; step down over a week or two after prolonged higher-dose use.
Tolerance is also labelled; escalating dose requirements call for reassessment of diagnosis, adherence and misuse, not an automatic increase.
Discontinue for a seizure, suspected serotonin syndrome, unresolving psychosis or mania, or digital ulceration.
Drug holidays suit appetite or growth as the limiting problem; dispose of unused drug.

Pregnancy & Lactation

Pregnancy: Decades of data have not identified a drug-associated risk of major birth defects or miscarriage; background risk is 2% to 4% and 15% to 20%.
Pregnancy, clinical: amphetamines vasoconstrict and reduce placental perfusion; premature delivery, low birth weight and neonatal withdrawal are reported.
Neonate: monitor for feeding difficulty, irritability, agitation and drowsiness.
Lactation: the label does not recommend breastfeeding, and no published experience exists with therapeutic methamphetamine while nursing, so prefer an alternate drug. (LactMed 2026)
Lactation, illicit use: peak milk levels of 160 and 610 mcg/L in two women; withhold breastfeeding 48 hours after use, or 24 hours after a negative urine screen. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org. Named in this label.

Counseling Points

Counsel the family on:
- What this medicine is, plainly and first: the same molecule as the street drug, at a small fraction of the non-medical dose, taken orally rather than smoked or injected.
- That route is most of the difference in what a drug does, and why you chose it over a conventional amphetamine.
- Locked storage in the label's terms: a safe place, preferably locked, never given to anyone else, unused tablets disposed of properly.
- Counting tablets at each refill, yours as well as theirs; routine for this drug, not suspicion of the child.
- No dose late in the evening; largest meal at breakfast and in the evening for midday appetite suppression.
- Positive urine amphetamine screens at sports physicals or employment testing. Give them something in writing first.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or suspicious, fearful or grandiose thinking.
- Any seizure; agitation with sweating, shivering, twitching or fever, which can be serotonin syndrome.
- Numbness or colour change in the fingers or toes; a rash with fever or blistering; a new tic; weight loss; a painful erection lasting hours.
- Tablets going missing, running out early, or anyone in the household asking for them. Say explicitly that this is a phone call.

References

DailyMed. Methamphetamine hydrochloride tablets, for oral use, CII, prescribing information. Hikma Pharmaceuticals USA Inc. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90c02ac6-e5e2-4c97-8c68-81e4e389a195
DailyMed. Methamphetamine hydrochloride tablet. Dr. Reddy's Laboratories Inc. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d0905e2c-a02f-ec4f-59a3-6f7ad0acbbf6
DailyMed. Methamphetamine hydrochloride tablet. Mayne Pharma Commercial LLC. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f31f580f-1f08-4a0f-b078-0b9e3308f712
openFDA. NDC Directory, generic_name methamphetamine, all labelers. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methamphetamine%22&limit=1000
AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
LactMed. Methamphetamine. Drugs and Lactation Database, NICHD. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501612/

Dexedrine Spansule

(dextroamphetamine sulfate)

Dexedrine Spansule (dextroamphetamine sulfate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Dexedrine Spansule is a sustained-release dextroamphetamine capsule approved for narcolepsy and for ADHD in patients aged 6 to 16. It is single-isomer dextroamphetamine, so it carries no levoamphetamine and less peripheral noradrenergic load than Adderall XR at an equivalent dose. Its role is once-daily dextroamphetamine where the immediate-release tablet would need two or three doses; the label is candid that the pellet is only more convenient, not more effective. Schedule II; brand and generic.

Forms & Strengths

Sustained-release capsules (Spansule): 5 mg, 10 mg, 15 mg

Dosing

Age:
- ADHD: 6-16 y/o, the label's own upper bound. Not recommended below 6 years
- Narcolepsy: no age bound stated; the label gives a dose ladder from age 6
Onset: 30-60 min, from the promptly released initial fraction
Duration: 6 to 8 hours
Release Profile: Sustained-release pellets; an initial dose released promptly, the remainder gradually. Tmax about 8 hours against about 3 hours for the tablet
Initial Dose:
- ADHD, 6-16 y/o: 5 mg once or twice daily
- Narcolepsy, 6-11 y/o: 5 mg daily
- Narcolepsy, ≥ 12 y/o: 10 mg daily
Titration:
- ADHD, 6-16 y/o: 5 mg at weekly intervals
- Narcolepsy, 6-11 y/o: 5 mg at weekly intervals
- Narcolepsy, ≥ 12 y/o: 10 mg at weekly intervals
Max Dose:
- ADHD: 40 mg/day; only in rare cases will it be necessary to exceed this
- Narcolepsy: usual range 5-60 mg/day in divided doses
Considerations: Use once daily where appropriate; the same total dose of immediate release in divided doses is equally effective by this label. Avoid late evening doses.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
Delivery / Release: Lower peak than the tablet (Cmax 23.5 vs 36.6 ng/mL at 15 mg), same bioavailability
Formulation: Single-isomer dextroamphetamine sulfate; no levoamphetamine, the difference from the 3:1 mixed-salt products
Metabolism: CYP2D6 to 4-hydroxyamphetamine, with minor CYP2D6 inhibition. Half-life about 12 hours. Renal excretion is pH dependent
Pharmacogenomics: No genotype-directed dosing in the label; the actionable consequence is the CYP2D6-inhibitor interaction
Class Positioning: Buys once-daily dosing and a lower peak over Zenzedi, and gives up the 3 to 5 year band. Single-isomer and later-peaking than Adderall XR

Indications

Narcolepsy (ICD-10: G47.419): no age bound stated; dosing from age 6
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 16 y/o, within a total treatment program

Off-Label Uses

ADHD at 17 and older (ICD-10: F90.x): this label stops at 16. Supported by the broader amphetamine literature; switch to a product with an adult indication.
ADHD under 6 years (ICD-10: F90.x): insufficient. Zenzedi, the same moiety, is approved from age 3, so the floor is formulation-specific. AAP: behavioral intervention first-line (AAP 2019).
Binge eating disorder (ICD-10: F50.81): lisdexamfetamine holds it, adults only; insufficient here.
Where the evidence does not support use: depression augmentation; no pediatric evidence for sustained-release dextroamphetamine (AHRQ 2024).
Cognitive enhancement without ADHD: not an indication; not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction; risk of overdose and death, rising with higher doses and non-oral routes. Assess abuse risk and monitor throughout.
Contraindicated:
- Known hypersensitivity to amphetamine or any component
- MAOI use, current or within 14 days
Use with caution (label Warnings, not contraindications):
- Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; the label says avoid
- Pre-existing hypertension; expect mean rises of 2-4 mmHg and 3-6 bpm
- Psychosis or bipolar disorder; in psychotic children, worsened behaviour disturbance and thought disorder
- Prior seizure or EEG abnormality
- Peripheral vasculopathy including Raynaud phenomenon
- Tics or Tourette syndrome, personal or family
- Substance use disorder, patient or household
- Symptoms secondary to environmental factors or another psychiatric disorder
Screen before starting:
- Cardiac and family history of sudden death or ventricular arrhythmia; ECG only if positive
- Tics and Tourette syndrome, in child and family; this label makes that a precondition
- Mania risk factors, including family history of suicide or bipolar disorder
- Abuse and diversion risk
- Baseline height, weight, blood pressure and heart rate

Drug Interactions

MAOIs (selegiline, tranylcypromine, phenelzine, linezolid, methylene blue): hypertensive crisis; do not give within 14 days.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone): serotonin syndrome; counsel on symptoms and stop both if it occurs.
CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure; start lower.
Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels; the label says avoid.
Acidifying agents (ascorbic acid, methenamine salts): lower levels; adjust on response.
Tricyclics (desipramine, protriptyline): sustained rise in brain d-amphetamine; monitor and adjust.
Antiepileptics (phenytoin, phenobarbital, ethosuximide): delayed absorption; separate dosing and check levels after any stimulant change.
Antihypertensives: hypotensive effect antagonised; recheck blood pressure after starting the stimulant.
Antihistamines: sedative effect counteracted; do not rely on one for sleep.

Administration

Give the first dose on waking; may be used once daily wherever appropriate.
For narcolepsy the label's usual dose is divided; the Spansule may replace those divisions.
Avoid late evening doses.
Swallow whole. This label carries no instruction to open, sprinkle, crush or chew, and no data for doing so, unlike its mixed-salt siblings.
If the child cannot swallow a capsule, switch to an IR tablet or ProCentra oral solution.
Food does not matter; absorption is similar fed and fasted.
The label directs prescribing the least quantity feasible at one time.
If a dose is missed, skip it; do not double up.
Store securely, preferably locked.

Side Effects

Common: loss of appetite, weight loss, insomnia, overstimulation, restlessness, dry mouth, headache, dizziness, tremor, dysphoria, diarrhoea, constipation, palpitations, raised blood pressure
Serious:
- Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
- Psychotic episodes at recommended doses (rare), mania and new aggression. Consider discontinuing.
- Serotonin syndrome. Stop both drugs and treat supportively.
- Seizures. Discontinue.
- Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
- Growth suppression. Interrupt if height or weight gain falls behind.
- New or worsening motor and verbal tics. Discontinue if clinically appropriate.
- Cardiomyopathy with chronic use, rhabdomyolysis, intestinal ischaemia.
- Prolonged erections; painful erection beyond a few hours is a surgical emergency.

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if two major percentile lines are crossed.
Appetite and Sleep: at every visit and dose change; ask what time the child eats and falls asleep.
Psychiatric and tics: psychosis, mania, aggression, dysphoria and new tics at every visit.
Peripheral vasculopathy: inspect fingers and toes at every visit.
Abuse and Diversion: adherence, pill counts and PDMP check at every refill; set quantity limits per this label's least-quantity instruction.
Age boundary: review the indication at the 17th birthday.
Laboratory: none routinely.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; no taper is required.
Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
Rebound irritability and hunger arrive later than with the IR tablet; families describe a difficult evening.
Interrupt treatment where growth or weight gain falls behind.
Drug holidays are reasonable where appetite or growth suppression is limiting; unlike Zenzedi, this label does not itself recommend periodic interruption.

Pregnancy & Lactation

Pregnancy: No adequate controlled studies; animal teratogenicity only far above human doses. Amphetamine-dependent mothers have more premature delivery and low birth weight. Use only if benefit justifies fetal risk.
Lactation: Label advises against nursing. LactMed: infant dose about 5.7% of the maternal weight-adjusted dose, infant plasma 6 to 14% of maternal, all four infants studied growing normally. (LactMed 2025)
Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2025)
Exposure Registry: None on this label; the National Pregnancy Registry for Psychostimulants (1-866-961-2388) accepts amphetamine exposures.

Counseling Points

Counsel the family on:
- Swallowing the capsule whole; unlike the mixed-salt capsules there is no sprinkle instruction.
- Telling you if the child cannot swallow it, so the product changes rather than being improvised.
- The capsule being a convenience, not an upgrade; divided immediate release works as well.
- The later peak, around eight hours, so the hard stretch is often evening rather than mid-afternoon.
- Vitamin C mimicking treatment failure; bicarbonate and antacids raising levels.
- On phenytoin, phenobarbital or ethosuximide, a level check after a stimulant change is expected.
- Moving the largest meal to breakfast and evening, with a weight check each visit.
- The ADHD approval running to age 16; plan before the 17th birthday.
- Locked storage; the prescription is deliberately written in the smallest workable quantity.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness or colour change in the fingers or toes.
- A new or markedly worse tic, or a seizure of any kind.
- Severe muscle pain with dark urine after exertion.
- Weight loss, or clothes fitting more loosely over a few weeks.
- A painful erection lasting more than a few hours, which is a surgical emergency.
- Agitation, shivering, sweating or confusion after an antidepressant change.

References

DailyMed. DEXEDRINE SPANSULE (dextroamphetamine sulfate) sustained-release capsules prescribing information. Amneal Pharmaceuticals LLC. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cc717b9b-22ea-4c60-a1d4-ee38a40bce78
LactMed. Dextroamphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/
openFDA. NDC Directory, generic_name "dextroamphetamine". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis
Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Dyanavel XR

(amphetamine)

Dyanavel XR (amphetamine); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Dyanavel XR is an extended-release amphetamine supplied as an oral suspension and as an extended-release tablet under one label, approved for ADHD from age 6. The moiety is amphetamine in a 3.2:1 d- to l- ratio, dosed in amphetamine base rather than salt, with immediate- and extended-release components for once-daily morning dosing. Its differentiator is being the only full-day amphetamine available as a true liquid. Schedule II; brand only.

Forms & Strengths

Extended-release oral suspension (bubblegum; 60 mL and 464 mL bottles): 2.5 mg/mL
Extended-release tablets (5 mg scored; may be chewed): 5 mg, 10 mg, 15 mg, 20 mg

Dosing

Age: ≥ 6 y/o
Onset: ~ 1 hour
Duration: up to 13 hours
Release Profile: combined immediate-release and extended-release components; this label publishes no percentage split
Initial Dose: 2.5 mg or 5 mg once daily in the morning, all patients ≥ 6
Titration: 2.5 mg to 10 mg per day every 4 to 7 days
Max Dose: 20 mg once daily
Considerations: Suspension and tablet substitute milligram for milligram; no other amphetamine does, because these strengths are base rather than salt. Titrate from scratch when switching in.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: Ion-exchange resin supplies the extended fraction, amphetamine aspartate and dextroamphetamine sulfate the immediate. Median Tmax ~4 h (suspension), ~5 h (tablet)
Formulation: 3.2:1 d- to l-amphetamine, all strengths as amphetamine base; the critical fact when converting in
Metabolism: CYP2D6 forms active 4-hydroxyamphetamine; norephedrine also active. Half-life 12.4 h d- and 15.1 h l- in adults, 10.4 h and 12.1 h in children 6-12; urinary recovery is pH dependent
Pharmacogenomics: CYP2D6 is polymorphic; no genotype-based adjustment specified, so titrate slowly rather than genotype
Class Positioning: Against Adderall XR, a 3.2:1 rather than 3:1 ratio, base rather than salt dosing, 13 hour ceiling; against Adzenys XR-ODT, also base-dosed, it is the option when nothing solid is accepted
Impairment: renal and hepatic impairment unstudied for this product; both may prolong exposure

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o

Off-Label Uses

None established. One indication, and no off-label use of this formulation is supported by graded pediatric evidence.
Where the evidence does not support use:
- Children under 6: argued against by this label; the liquid makes small doses easy to give, which is why this needs saying.
- Non-ADHD indications in youth: AHRQ CER 267 graded none; insufficient (AHRQ 2024).
- Cognitive enhancement without ADHD: not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High potential for abuse, leading to substance use disorder; overdose and death, more so at higher doses or by non-oral routes. Assess risk before prescribing; reassess throughout.
Contraindicated:
- Known hypersensitivity to amphetamine or components; angioedema and anaphylaxis reported
- MAOI use, current or within 14 days, including linezolid and IV methylene blue
Use with caution (Warnings in this label, not contraindications):
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
- Pre-existing hypertension, because BP and HR rise
- Pre-existing psychosis; bipolar disorder, for treatment-emergent mania
- Motor or verbal tics, or Tourette syndrome
- Peripheral vasculopathy including Raynaud phenomenon
- Renal or hepatic impairment; unstudied for this product, and both may prolong exposure
- Substance use disorder in the patient or the household
Screen before starting:
- Cardiac history, family history of sudden death or arrhythmia, and exam
- Personal and family history of tics or Tourette syndrome
- Mania risk: personal or family depression, bipolar disorder, suicide
- Abuse and diversion risk; baseline height, weight, BP and HR

Drug Interactions

MAOIs (also linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Do not co-prescribe; confirm a 14 day washout.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone, St John's Wort): serotonin syndrome. Start lower; stop both drugs if symptoms appear.
CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
Urinary pH agents: acidifiers (ascorbic acid, fruit juice) lower amphetamine levels; alkalinizers (bicarbonate, acetazolamide, thiazides) raise them. The label directs an explicit dose adjustment either way.
Sympathomimetics (decongestants, beta-agonists): additive cardiovascular effect. Avoid OTC decongestants.
Laboratory assays: amphetamines elevate plasma corticosteroids and interfere with urinary steroid determinations; interpret rather than repeat.

Administration

Once daily in the morning, with or without food; a high-fat meal changes exposure only a few percent.
Suspension: shake hard before every dose; keep the bottle adapter inserted and measure with the pharmacy dispenser.
Tablet: may be chewed or swallowed whole, with no significant change in exposure or Tmax; only the 5 mg is scored.
Between the two Dyanavel XR forms: substitute milligram for milligram, the only such substitution the label permits.
From any other amphetamine: stop the previous drug and titrate from the beginning.
Avoid late dosing; with a 13 hour ceiling an afternoon dose reaches bedtime.
Store securely, preferably locked.

Side Effects

Common (extended-release amphetamine class list, per this label): decreased appetite and weight loss, insomnia, irritability, abdominal pain, dry mouth, headache, tremor, restlessness, bowel change, palpitations, tachycardia, elevated blood pressure.
Serious:
- Sudden death, myocardial infarction and stroke with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor through it.
- Psychosis or mania at recommended doses, roughly 0.1% in pooled stimulant trials; consider discontinuing.
- Serotonin syndrome; stop both drugs and treat supportively.
- Angioedema, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis; stop and do not rechallenge.
- Peripheral vasculopathy including Raynaud phenomenon, with digital ulceration reported; reduce or stop, refer if persistent.
- Growth suppression; interrupt in a child not growing or gaining as expected.
- New or worsening tics and Tourette syndrome.
- Rhabdomyolysis, intestinal ischemia; priapism, a surgical emergency.

Monitoring & Labs

Cardiovascular: HR and BP at baseline, each dose change, and every 6 months; mean rise 2-4 mm Hg and 3-6 bpm.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two major percentile lines.
Appetite and sleep: every visit; with a 13 hour ceiling, sleep is what most often forces a timing change here.
Psychiatric: psychosis, mania, aggression, dysphoria at each visit and 2 weeks after any increase.
Tics and digits: ask about tics and inspect fingers and toes for colour change, coolness or unexplained wounds at each visit.
Dosing technique: watch the caregiver shake and draw a dose at first follow-up and whenever response turns erratic; an unshaken bottle looks like tolerance.
Abuse and diversion: adherence, bottle or pill counts and PDMP check at each refill.
Laboratory: none routinely required.

Discontinuation & Taper

Can be stopped abruptly at therapeutic doses; no taper required.
Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
Late-evening rebound irritability and hunger is pharmacodynamic offset, not withdrawal.
Drug holidays suit appetite or growth as the limiting problem, less so a child who struggles outside school hours.

Pregnancy & Lactation

Pregnancy: Published data are insufficient to determine a drug-associated risk of major malformations or miscarriage. Amphetamines vasoconstrict placental vessels, may increase growth restriction, and stimulate uterine contractions.
Pregnancy, clinical: premature delivery and low birth weight in dependent mothers; background risk is 2% to 4% for major defects and 15% to 20% for miscarriage. Weigh rather than abstain.
Neonate: monitor for feeding difficulty, irritability, agitation and drowsiness.
Lactation: present in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5. No reported adverse infant effects; long-term neurodevelopment unknown; the label does not recommend breastfeeding.
Lactation, practical: some experts accept therapeutic doses, monitoring the infant for irritability, insomnia and feeding difficulty; prolactin is suppressed 25% to 40%. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388, https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/

Counseling Points

Counsel the family on:
- Shaking the suspension hard before every dose; an unshaken bottle is the commonest cause of a Dyanavel XR that works some days and not others.
- That the tablet may be chewed, which often solves swallowing without moving to the liquid.
- The roughly 13 hour window, so a dose after mid-morning still works at bedtime.
- Appetite suppression peaking midday; largest meal at breakfast and in the evening.
- Never converting from a previous amphetamine milligram for milligram.
- Storing the bottle locked, not with the other syrups; the bubblegum flavour is a formulation property.
- Bringing a teacher rating scale to the next visit rather than a verbal impression.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Swelling of the lips, tongue or face, or any spreading rash or blistering.
- Numbness, coldness or colour change in the fingers or toes.
- A new or markedly worse tic; weight loss or clothes fitting more loosely.
- A painful erection lasting more than a few hours.

References

DailyMed. Dyanavel XR (amphetamine) extended-release oral suspension and extended-release tablets prescribing information. NextWave Pharmaceuticals. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae304b29-0b40-40ec-ad0d-76b742d4a9b9
FDA. openFDA National Drug Code Directory, generic_name "amphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22amphetamine%22&limit=1000
LactMed. Amphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Evekeo

(amphetamine sulfate)

Evekeo (amphetamine sulfate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Evekeo is an immediate-release, short-acting tablet of racemic amphetamine sulfate, approved for ADHD from age 3, narcolepsy from age 6, and short-term use in exogenous obesity from age 12. Unlike Adderall it is a single-entity salt rather than a mixed-salt blend, and unlike Zenzedi it carries the l-isomer too; that racemic composition is why you would reach for it. Schedule II; brand and generic.

Forms & Strengths

Tablets (5 mg single-scored, 10 mg double-scored): 5 mg, 10 mg

Dosing

Age:
- ADHD: ≥ 3 y/o
- Narcolepsy: ≥ 6 y/o
- Exogenous obesity: ≥ 12 y/o
Onset: 30 to 60 min
Duration: 4 to 6 hours
Initial Dose:
- ADHD, 3-5 y/o: 2.5 mg daily
- ADHD, ≥ 6 y/o: 5 mg once or twice daily
- Narcolepsy, 6-11 y/o: 5 mg daily
- Narcolepsy, ≥ 12 y/o: 10 mg daily
- Exogenous obesity, ≥ 12 y/o: 5-10 mg per dose, 30-60 min before meals
Titration:
- ADHD, 3-5 y/o: 2.5 mg every 7 days
- ADHD, ≥ 6 y/o: 5 mg every 7 days
- Narcolepsy, 6-11 y/o: 5 mg every 7 days
- Narcolepsy, ≥ 12 y/o: 10 mg every 7 days
Max Dose:
- ADHD: 40 mg/day, at any age
- Narcolepsy: usual range 5-60 mg/day in divided doses
- Exogenous obesity: up to 30 mg/day in divided doses of 5-10 mg
Considerations: First dose on awakening, then one or two further doses at 4-6 hour intervals; the maximum is set by indication, not by weight, and late evening doses cause insomnia.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: Plain immediate-release tablet; single early peak, one block of coverage per dose
Formulation: Racemic amphetamine sulfate, equal d- and l-isomer. Per the label the l-isomer is more potent in cardiovascular activity and much less potent in CNS excitatory effects
Metabolism: CYP2D6 forms active 4-hydroxyamphetamine; urinary excretion is pH dependent; this label publishes no half-life
Class Positioning: A single salt, not the 3:1 d:l blend of Adderall, so relatively more peripheral effect per unit of CNS effect; unlike pure-dextroamphetamine Zenzedi and ProCentra it adds the l-isomer back
Interchange: not milligram-for-milligram equivalent to any other amphetamine moiety

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 3 y/o, within a total treatment program
Narcolepsy (ICD-10: G47.419): patients ≥ 6 y/o
Exogenous obesity (ICD-10: E66.9): patients ≥ 12 y/o, short-term adjunct of a few weeks, second-line only; the label puts the gain over placebo at a fraction of a pound per week

Off-Label Uses

None established for this moiety outside its labelled indications.
Where the evidence does not support use:
- Non-ADHD indications in youth: AHRQ CER 267 graded none; insufficient (AHRQ 2024).
- Weight management under 12, first-line, or beyond a few weeks: not supported.
- Cognitive enhancement without ADHD: not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High potential for abuse, leading to substance use disorder; overdose and death, more so at higher doses or by snorting or injection. Assess risk before prescribing; reassess throughout.
Contraindicated:
- Known hypersensitivity to amphetamine products
- MAOI use, current or within 14 days; hypertensive crisis
Use with caution (Warnings in this label, not contraindications):
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
- Hypertension, including mild, which the label names explicitly
- Pre-existing psychosis; bipolar disorder, for treatment-emergent mania
- Prior seizure or prior EEG abnormality; this label carries an explicit Seizures warning and directs discontinuation if a seizure occurs
- Motor or verbal tics, or Tourette syndrome
- Peripheral vasculopathy including Raynaud phenomenon
- Substance use disorder in the patient or the household
Screen before starting:
- Cardiac history, family history of sudden death or arrhythmia, and exam
- Personal and family history of tics or Tourette syndrome
- Mania risk: personal or family depression, bipolar disorder, suicide
- Abuse and diversion risk; baseline height, weight, BP and HR

Drug Interactions

MAOIs (also linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Do not co-prescribe; confirm a 14 day washout.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone, St John's Wort): serotonin syndrome. Start lower; stop both drugs if symptoms appear.
CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
Urinary pH agents: acidifiers (ascorbic acid, fruit juice, ammonium chloride, methenamine) lower levels and efficacy; alkalinizers (bicarbonate, antacids, acetazolamide, thiazides) raise them. Check both before changing the dose.
Tricyclic antidepressants (desipramine, protriptyline): sustained rise in brain d-amphetamine, potentiated cardiovascular effect. Monitor BP and HR; titrate slowly.
Sympathomimetics and antihypertensives: additive cardiovascular effect; hypotensive effect antagonized. Avoid OTC decongestants; recheck blood pressure.

Administration

First dose on awakening; one or two further doses at 4-6 hour intervals.
Split the scored 5 mg tablet for the 2.5 mg preschool starting dose.
Exogenous obesity only: dose 30 to 60 minutes before a meal; that timing does not apply to ADHD or narcolepsy.
Avoid late evening doses; the label names resulting insomnia.
No suspension, chewable or sprinkle form exists; any instruction to shake or open belongs to another product.
Interrupt occasionally to see whether symptoms recur at a level requiring continued therapy; this is a label instruction.
Store securely, preferably locked.

Side Effects

Common: decreased appetite and weight loss, insomnia, overstimulation, irritability and dysphoria, headache, dizziness, dry mouth, unpleasant taste, bowel change, palpitations, tachycardia, elevated blood pressure.
Serious:
- Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor through it.
- Psychosis or mania at recommended doses, roughly 0.1% in pooled stimulant trials; consider discontinuing.
- Serotonin syndrome; stop both drugs and treat supportively.
- Seizure; discontinue.
- Peripheral vasculopathy including Raynaud phenomenon, rarely digital ulceration; reduce or stop, refer if persistent.
- Growth suppression; interrupt in a child not growing or gaining as expected.
- New or worsening tics and Tourette syndrome; discontinue if clinically appropriate.
- Rhabdomyolysis, intestinal ischemia; priapism, a surgical emergency.

Monitoring & Labs

Cardiovascular: HR and BP at baseline, each dose change, and every 6 months; mean rise 2-4 mm Hg and 3-6 bpm, investigate beyond that.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two major percentile lines.
Appetite and sleep: every visit; usually fixed by timing rather than dose.
Psychiatric: psychosis, mania, aggression, dysphoria at each visit and 2 weeks after any increase.
Tics and digits: ask about tics and inspect fingers and toes for colour change, coolness or unexplained wounds at each visit.
Abuse and diversion: adherence, pill counts and PDMP check at each refill; reassess need for therapy at least annually.
Laboratory: none routinely; amphetamines interfere with urinary steroid determinations.

Discontinuation & Taper

Can be stopped abruptly at therapeutic doses; no taper required.
Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite. Warn the family in advance.
End-of-dose rebound irritability and hunger is pharmacodynamic offset, not withdrawal.
Planned interruptions are asked for by this label; drug holidays suit appetite or growth as the limiting problem.

Pregnancy & Lactation

Pregnancy: No adequate controlled studies. Embryotoxic and teratogenic in two mouse strains at about 41 times the maximum human dose; not in rabbits at 7 or rats at 12.5 times.
Pregnancy, clinical: increased premature delivery and low birth weight in dependent mothers; infants may withdraw. Weigh rather than abstain.
Lactation: the label says amphetamines enter milk and mothers should not nurse. LactMed: one narcolepsy case gave 1.9% to 2.1% of the maternal weight-adjusted dose. (LactMed 2025)
Lactation, practical: some experts accept therapeutic doses, monitoring the infant for irritability, insomnia and feeding difficulty.
Lactation, milk supply: prolactin suppressed 25% to 40% dose-dependently; large doses may impair milk production where lactation is not yet established. (LactMed 2025)

Counseling Points

Counsel the family on:
- The 4-6 hour window, and that a second or third dose usually covers the afternoon.
- End-of-dose rebound irritability and hunger; not a signal to increase the dose.
- Moving the last dose earlier rather than adding a sleep aid.
- Appetite suppression peaking midday; largest meal at breakfast and in the evening.
- Avoiding vitamin C loading and fruit juice around dosing, and asking before any antacid.
- Secure, preferably locked storage; sharing a Schedule II medication is a felony.
- Bringing a teacher rating scale to the next visit, and expecting a planned trial off medication.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- Any seizure, or a new staring spell.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness or colour change in the fingers or toes, or an unexplained sore on a digit.
- A new or markedly worse tic; new throat clearing or blinking.
- Weight loss, or clothes fitting more loosely over a few weeks.
- A painful erection lasting more than a few hours.

References

DailyMed. Evekeo (amphetamine sulfate) tablets, USP prescribing information. Azurity Pharmaceuticals. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f469fb38-0380-4621-9db3-a4f429126156
FDA. openFDA National Drug Code Directory, generic_name "amphetamine sulfate". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22amphetamine%22&limit=1000
LactMed. Amphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Focalin

(dexmethylphenidate)

Focalin (dexmethylphenidate hydrochloride); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Focalin is a short-acting, immediate-release tablet of dexmethylphenidate, the d-threo enantiomer of racemic methylphenidate and the more pharmacologically active one, approved for ADHD from age 6. Because the active enantiomer is given alone, the labelled conversion from racemic methylphenidate is half the total daily dose, which is the number most often got wrong when switching. It is the methylphenidate to reach for when a discrete window of coverage is wanted. Schedule II; brand and generic.

Forms & Strengths

Tablets: 2.5 mg, 5 mg, 10 mg

Dosing

Age:
- 6-17 y/o: established in two controlled trials
- Under 6 y/o: not established
- 18 y/o and older: no adult dose ladder on this label; adult data sit on the Focalin XR label
Onset: ~ 30 min
Duration: 5 to 6 hours
Initial Dose:
- New to methylphenidate: 5 mg daily, given as 2.5 mg twice daily
- Currently on racemic methylphenidate: half the current total daily dose
Titration: 2.5 mg to 5 mg every 7 days
Max Dose: 20 mg/day, given as 10 mg twice daily
Considerations: Give twice daily at least 4 hours apart, with or without food. Converting from racemic methylphenidate is half the total daily dose, never milligram for milligram.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: Plain immediate-release tablet; peak at 1 to 1.5 hours fasted, no accumulation on BID dosing. A high-fat breakfast leaves exposure unchanged but delays the peak to 2.9 hours.
Metabolism: De-esterified to d-ritalinic acid, little or no activity. Not a clinically relevant CYP substrate. Bioavailability 22% to 25%; half-life ~2.2 hours; ~90% urinary.
Class Positioning: The isolated d-threo enantiomer, the more active one, with little interconversion back to the l-isomer. Racemic methylphenidate at twice the milligram amount gives comparable plasma levels, which is the conversion rule.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older

Off-Label Uses

Narcolepsy (ICD-10: G47.419): racemic methylphenidate carries the indication; this enantiomer does not. Insufficient.
ADHD in a child aged 4 to 5 (ICD-10: F90.x): behavioral parent training first, methylphenidate only if impairment stays moderate to severe (AAP 2019). That covers racemic methylphenidate; this product is unstudied below 6. Insufficient.
Where the evidence does not support use. AHRQ 2024 grades head-to-head comparisons between stimulants as low strength of evidence, so nothing supports choosing dexmethylphenidate over another agent in an individual child, and nothing supports use outside ADHD in youth.
Cognitive enhancement without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High potential for abuse and misuse, leading to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
- Hypersensitivity to methylphenidate or any component; angioedema and anaphylaxis reported.
- Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid, because of sudden death reports.
- Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm, and some patients rise further.
- Pre-existing psychosis or bipolar disorder; new psychotic or manic symptoms in ~0.1% of stimulant-treated patients.
- Motor or verbal tics, and Tourette's syndrome.
- Open-angle glaucoma, raised intraocular pressure, or significant hyperopia.
- Peripheral vasculopathy including Raynaud's phenomenon.
- Substance use disorder in patient or household.
Screen before starting:
- Cardiac disease by history, family history of sudden death or arrhythmia, and exam. No routine ECG.
- Personal and family history of tics or Tourette's syndrome.
- Risk factors for mania: past depression, family history of suicide or bipolar disorder.
- Abuse and diversion risk; baseline height, weight, blood pressure and heart rate.

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Do not co-prescribe; allow 14 days after stopping.
Antihypertensives (any class): effectiveness may fall. Monitor blood pressure and adjust their dose.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): sudden intraoperative pressure and rate rise. Avoid on the day of surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans): serotonin syndrome appears postmarketing, not in the interaction table. Counsel and reassess when adding one.

Administration

Twice daily, at least 4 hours apart; the first dose usually on waking.
With or without food. A high-fat breakfast does not change exposure but delays the peak by about 1.4 hours.
Avoid late-afternoon dosing, which costs sleep.
Switching from racemic methylphenidate: half the current total daily dose. To Focalin XR: the same total daily dose.
Stop the drug if a month of dose adjustment brings no improvement.
Store securely, preferably locked. No liquid, chewable or transdermal dexmethylphenidate exists; a child who cannot swallow needs Focalin XR sprinkled or another molecule.

Side Effects

Common (two pediatric placebo-controlled trials): abdominal pain 15% vs 6%, nausea 9% vs 1%, anorexia 6% vs 1%, fever 5% vs 1%. The label adds decreased appetite, insomnia, anxiety, headache, dizziness and tachycardia. 7.3% discontinued for an adverse reaction.
Serious:
- Sudden death with structural cardiac disease; avoid use, and evaluate exertional syncope promptly.
- New psychosis or mania, including with no psychiatric history; consider discontinuing.
- Priapism, sometimes requiring surgery, including during drug holidays. Immediate care.
- Peripheral vasculopathy including Raynaud's, with digital ulceration; reduce dose or stop.
- Long-term growth suppression; interrupt if a child is not growing or gaining as expected.
- Acute angle closure glaucoma and raised intraocular pressure.
- Angioedema and anaphylaxis; rare rhabdomyolysis and severe hepatic injury postmarketing.

Monitoring & Labs

Cardiovascular: blood pressure and heart rate at baseline, at every dose change, and at least every 6 months. A rise beyond the expected 2 to 4 mmHg, or any symptomatic rise, triggers dose reduction.
Growth: height, weight and BMI at baseline and every 6 months. Crossing two major percentile lines triggers a treatment interruption.
Appetite and sleep: at every visit and dose change. The fix is usually the timing of the second dose, not a dose reduction.
Psychiatric and tics: screen for new psychosis, mania, aggression and emergent tics at every visit.
Digits: inspect fingers and toes for colour change, coldness or ulceration at every visit.
Abuse and diversion: at every refill reassess risk, reconcile the pill count, and check the state PDMP per state requirement. A twice-daily IR product is the easiest methylphenidate to divert.
Laboratory: no routine laboratory monitoring is required.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; this label gives no taper instruction.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, agitation. Strongest in the first days.
Priapism has occurred during withdrawal and planned holidays; mention it before a holiday in an adolescent male.
Drug holidays are easy on a twice-daily IR product and reasonable where appetite or growth limits treatment.

Pregnancy & Lactation

Pregnancy: Published studies and postmarketing reports have not identified a drug-associated risk. Stimulants reduce placental perfusion. Delayed fetal ossification in rats at 5 times the maximum human dose; spina bifida in rabbits at 200 mg/kg/day.
Lactation: Present in milk; infant doses were 0.16% to 0.7% of the maternal weight-adjusted dose, with no reported infant effects. Monitor for agitation, insomnia, poor feeding and low weight gain.
Dexmethylphenidate specifically: no clinical use data in lactation; a maternal requirement is not a reason to stop breastfeeding. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, https://womensmentalhealth.org/adhd-medications/

Counseling Points

Counsel the family on:
- The two-dose structure: the school-day plan must name who gives the midday dose and where it is stored. If none can be arranged, switch to a once-daily product.
- That the milligram number is deliberately half what a racemic methylphenidate bottle showed, and is not a dose reduction. Pharmacies have read the halving as an error.
- Rebound irritability and hunger as a dose wears off, which is the drug leaving, not a reason to increase it.
- Appetite suppression peaking mid-day: move the largest meal to breakfast and to the evening, when appetite returns.
- Locked storage, and that sharing a Schedule II medication is a felony.
- Bringing a teacher rating scale to the next visit rather than a verbal impression.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious, fearful or grandiose thinking.
- Numbness or colour change in the fingers or toes, or a sore that will not heal on a fingertip.
- A new tic, or a marked worsening of an existing one.
- Weight loss, or clothes fitting more loosely over a few weeks.
- A painful erection lasting more than a few hours, including during a planned break.
- Eye pain, blurred vision, or haloes around lights.

References

DailyMed. Focalin (dexmethylphenidate hydrochloride) tablets prescribing information. Novartis. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7c552f11-e24a-4d9b-bb8d-be10c928eca8
DailyMed. Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules prescribing information. Novartis. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a1da905-42a0-4748-9c39-67eca45deccc
LactMed. Dexmethylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK500764/
FDA. National Drug Code Directory, openFDA. Queried by generic name dexmethylphenidate. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Focalin XR

(dexmethylphenidate XR)

Focalin XR (dexmethylphenidate hydrochloride); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Focalin XR is a once-daily, long-acting bead capsule of dexmethylphenidate, the more pharmacologically active d-threo enantiomer of racemic methylphenidate, approved for ADHD in children from age 6 and in adults. Half of each capsule is immediate-release beads and half enteric-coated delayed-release beads, producing two distinct plasma peaks rather than a flat curve. The capsule can be sprinkled on applesauce, making it the only dexmethylphenidate option for a patient who cannot swallow. Schedule II; brand and generic.

Forms & Strengths

Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg

Dosing

Age:
- 6-17 y/o: safety and effectiveness established
- 18 y/o and older: efficacy established at 20, 30 and 40 mg/day
- Under 6 y/o: not recommended; higher plasma exposure and more adverse reactions, including weight loss, at the same dosage
Onset: ~ 30 min
Duration: up to 12 hours
Release Profile: 50% IR / 50% delayed-release via enteric-coated beads, giving two plasma peaks about 4 hours apart, the second at about 6.5 hours
Initial Dose:
- New to methylphenidate, 6-17 y/o: 5 mg once daily in the morning
- New to methylphenidate, 18 y/o and older: 10 mg once daily in the morning
- Currently on racemic methylphenidate: half the current total daily dose
- Currently on Focalin immediate-release tablets: the same total daily dose
Titration: 5 mg every 7 days (6-17 y/o); 10 mg every 7 days (18 y/o and older)
Max Dose: 30 mg/day (6-17 y/o); 40 mg/day (18 y/o and older)
Considerations: Once daily in the morning, with or without food. Swallow whole or open onto applesauce and take immediately without chewing. A capsule must never be divided.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 50% IR / 50% delayed-release enteric-coated beads; two peaks roughly 4 hours apart. Against IR tablets at the same total dose, a lower second peak, higher trough, equivalent AUC.
Metabolism: De-esterified to d-ritalinic acid, little activity. Not a clinically relevant CYP substrate. Bioavailability 22% to 25%; half-life 2 to 3 hours; ~90% urinary.
Class Positioning: Duration comes from a second discrete release, not continuous delivery like the osmotic Concerta or the prodrug Azstarys, so some patients have a real interpeak dip in the early afternoon.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older, including adults

Off-Label Uses

Narcolepsy (ICD-10: G47.419): racemic methylphenidate carries the indication; this enantiomer does not. Insufficient.
ADHD in a child aged 4 to 5 (ICD-10: F90.x): behavioral parent training first (AAP 2019). This label goes further than lacking data: it states use below 6 is not recommended. Not the preschool methylphenidate.
Where the evidence does not support use. AHRQ 2024 grades stimulant head-to-head comparisons as low strength of evidence, so nothing supports choosing this over another long-acting methylphenidate, or any use outside ADHD in youth.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction, which can lead to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
- Hypersensitivity to methylphenidate or any component; angioedema and anaphylaxis reported.
- Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid.
- Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm.
- Pre-existing psychosis or bipolar disorder; new psychotic or manic symptoms in ~0.1% of stimulant-treated patients.
- Motor or verbal tics, and Tourette's syndrome.
- Open-angle glaucoma, raised intraocular pressure, or significant hyperopia.
- Peripheral vasculopathy including Raynaud's; substance use disorder in patient or household.
Screen before starting:
- Cardiac disease by history, family history of sudden death, and exam. No routine ECG.
- Personal and family history of tics or Tourette's syndrome.
- Risk factors for mania; abuse and diversion risk; baseline height, weight, blood pressure and heart rate.

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Do not co-prescribe; allow 14 days after stopping.
Antihypertensives (any class): effectiveness may fall. Monitor blood pressure and adjust their dose.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): sudden intraoperative pressure and rate rise. Avoid on the day of surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans): serotonin syndrome appears postmarketing, not in the interaction table. Counsel and reassess when adding one.

Administration

Once daily in the morning, with or without food.
Swallow whole, or sprinkle the entire contents onto applesauce and eat it all immediately without chewing. Do not store a mixed dose.
Never divide a capsule. Adjust by strength, not by splitting.
Switching from racemic methylphenidate: half the total daily dose. From Focalin tablets: the same total daily dose. The two rules differ; this is the commonest conversion error here.
Stop the drug if a month of dose adjustment brings no improvement. Store securely, preferably locked.

Side Effects

Common (pediatric controlled trial): decreased appetite 30% vs 9%, headache 25% vs 11%, dyspepsia 8% vs 4%, anxiety 6% vs 0%. Dose related: insomnia rose from 5% at 10 mg/day to 17% at 30 mg/day, vomiting from 2% to 9%.
Serious:
- Sudden death with structural cardiac disease; avoid use, and evaluate exertional syncope promptly.
- New psychosis or mania, including with no psychiatric history; consider discontinuing.
- Priapism, sometimes requiring surgery, including during drug holidays. Immediate care.
- Peripheral vasculopathy including Raynaud's, with digital ulceration; reduce dose or stop.
- Growth suppression: mean weight change minus 0.5 kg on drug against plus 0.4 kg on placebo over 7 weeks. Interrupt if a child is not gaining.
- Acute angle closure glaucoma and raised intraocular pressure.
- Angioedema and anaphylaxis.

Monitoring & Labs

Cardiovascular: blood pressure and heart rate at baseline, at every dose change, and at least every 6 months. A rise beyond the expected 2 to 4 mmHg triggers dose reduction.
Growth: height, weight and BMI at baseline and every 6 months, more often in the first year; this label documents net weight loss over 7 weeks.
Appetite and sleep: at every visit and dose change. Insomnia triples between 10 mg and 30 mg here, so treat it as a dose signal first.
Afternoon coverage: ask about the early to mid afternoon at each visit; a dip there is a formulation problem, not necessarily a dose problem.
Psychiatric and tics: screen for new psychosis, mania, aggression and emergent tics at every visit. Inspect fingers and toes for colour change or ulceration.
Abuse and diversion: at every refill reassess risk, reconcile the pill count, and check the state PDMP per state requirement.
Laboratory: no routine laboratory monitoring is required.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; this label gives no taper instruction.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, agitation.
Priapism has occurred during withdrawal and planned holidays; mention it before a holiday in an adolescent male.
A drug holiday is a skipped morning dose. There is no partial-dose option, since capsules must not be divided.

Pregnancy & Lactation

Pregnancy: Published studies and postmarketing reports have not identified a drug-associated risk. Stimulants reduce placental perfusion. Delayed fetal ossification in rats at 5 times the maximum human dose; spina bifida in rabbits at 200 mg/kg/day.
Lactation: Present in milk; infant doses were 0.16% to 0.7% of the maternal weight-adjusted dose, with no reported infant effects. Monitor for agitation, insomnia, poor feeding and low weight gain.
Dexmethylphenidate specifically: no clinical use data in lactation; a maternal requirement is not a reason to stop breastfeeding. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, https://womensmentalhealth.org/adhd-medications/

Counseling Points

Counsel the family on:
- The two-peak shape of the day: some children dip in the early afternoon. Ask them to note when in the day the trouble happens.
- Coverage running about 12 hours, so a child dosed at 7 a.m. does homework and dinner off medication.
- The sprinkle method: onto applesauce, eaten at once, never chewed, never saved. Chewing destroys the delayed-release half.
- That the milligram number is deliberately half what a racemic methylphenidate bottle showed, and is not a dose reduction.
- Appetite suppression: move the largest meal to breakfast and to the evening.
- Locked storage, and that sharing a Schedule II medication is a felony.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious, fearful or grandiose thinking.
- Numbness or colour change in the fingers or toes; eye pain or blurred vision.
- A new tic, or a marked worsening of an existing one.
- Weight loss, or clothes fitting more loosely over a few weeks.
- Insomnia appearing or worsening after a dose increase.
- A painful erection lasting more than a few hours, including during a planned break.

References

DailyMed. Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules prescribing information. Novartis. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a1da905-42a0-4748-9c39-67eca45deccc
LactMed. Dexmethylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK500764/
FDA. National Drug Code Directory, openFDA. Queried by generic name dexmethylphenidate. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Intuniv

(guanfacine ER)

Intuniv (guanfacine); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Intuniv is extended-release guanfacine, a central alpha-2A adrenergic agonist approved for ADHD in patients 6 to 17 years, as monotherapy or added to a stimulant. It is a once-daily tablet dosed by body weight rather than by age, and its selectivity for the alpha-2A subtype makes it less sedating than clonidine. It is the alpha-2 agonist to reach for when a stimulant is insufficient or poorly tolerated and daytime sedation is the limiting concern. Not controlled; brand and generic.

Forms & Strengths

Tablets, extended release: 1 mg, 2 mg, 3 mg, 4 mg; unscored
These are tablets, not capsules. No guanfacine capsule exists in any form
Separate label: immediate-release guanfacine tablets 1 mg and 2 mg (formerly Tenex), not interchangeable mg-for-mg

Dosing

Age: 6-17 y/o; not established below 6 years
Onset: sedation same day; ADHD benefit over weeks, trial endpoints at 5 to 8 weeks
Duration: once daily, morning or evening, same time each day; half-life about 18 hours
Release Profile: extended release from a matrix tablet; Cmax about 60% lower and AUC about 43% lower than immediate-release guanfacine, Tmax about 3 hours later, relative bioavailability 58%
Initial Dose: 1 mg once daily
Titration: no more than 1 mg every 7 days
Max Dose: target 0.05 to 0.12 mg/kg/day, total 1 mg to 7 mg/day. Two age ceilings sit above the weight bands and both apply:
- 6-12 y/o: do not exceed 4 mg/day
- 13-17 y/o: do not exceed 7 mg/day
- As adjunct to a stimulant: do not exceed 4 mg/day at any age
- Under 25 kg: no weight band; dose from 0.05 to 0.12 mg/kg/day, starting at 1 mg
- 25 to 33.9 kg: 2 to 3 mg/day
- 34 to 41.4 kg: 2 to 4 mg/day
- 41.5 to 49.4 kg: 3 to 5 mg/day
- 49.5 to 58.4 kg: 3 to 6 mg/day
- 58.5 to 91 kg: 4 to 7 mg/day
- Over 91 kg: 5 to 7 mg/day
Considerations: Swallow whole and do not give with a high-fat meal, which raises Cmax about 75%. Halve the dose with strong or moderate CYP3A4 inhibitors, and re-check the weight band as the child grows.

Pharmacology

Mechanism: Central alpha-2 adrenergic agonist; reduces sympathetic outflow from the locus coeruleus and enhances prefrontal noradrenergic signalling. Alpha-2A selective, 15 to 20 fold. Mechanism in ADHD unknown.
Delivery / Release: Matrix tablet; a high-fat breakfast raises Cmax about 75% and AUC about 40%.
Metabolism: Primarily CYP3A4; neither inhibits nor induces major P450s. About 70% protein bound. Inhibits MATE1 and OCT1, which may raise OCT1 substrate exposure.
Pediatric exposure: higher in 6-12 year olds than in adolescents at the same dose (4 mg: Cmax 10 vs 7 ng/mL, AUC 162 vs 116 ng.h/mL). Plasma level falls as weight rises, hence weight banding.
Cardiac: a thorough QT study at 2 to 4 times maximum Intuniv concentrations showed no clinical QTc prolongation.
Class Positioning: Less sedating than non-selective clonidine; once daily against twice-daily Kapvay, weight-banded, with a CYP3A4 profile clonidine lacks. Alpha-2 effect size about 0.7 against 1.0 for stimulants. (AAP 2019)

Indications

ADHD, as monotherapy (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6-17 y/o
ADHD, as adjunctive therapy to stimulants (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6-17 y/o

Off-Label Uses

Tic disorders and Tourette syndrome (ICD-10: F95.1, F95.2): a positive double-blind trial for tic severity, the better tic evidence of the two alpha-2 agonists. (AACAP 2013)
Oppositional defiant disorder, irritability and aggression (ICD-10: F91.3): no eligible controlled pediatric evidence identified; insufficient
Irritability in autism spectrum disorder (ICD-10: F84.0): limited data
Where the evidence does not support use:
- Anxiety disorders (ICD-10: F41.x): insufficient; no graded pediatric evidence identified
- Children under 6 (ICD-10: F90.x): insufficient (AHRQ 2018), and exposure rises as weight falls

Contraindications & Warnings

Warning, rebound hypertension: abrupt discontinuation has caused persistent rebound hypertension above baseline, with hypertensive encephalopathy reported
Contraindicated: hypersensitivity to Intuniv, its excipients, or other guanfacine products; rash and pruritus reported
Use with caution:
- Hypotension, heart block, bradycardia, cardiovascular or cerebrovascular disease; titrate slowly
- Syncope, orthostatic hypotension, or a tendency to dehydration; avoid overheating
- Conduction abnormality, concurrent sympatholytics or CNS depressants; risk of AV block and additive sedation
- Significant renal or hepatic impairment; reduce the dose
- Any child prone to vomiting illness; missed doses are a labeled rebound risk
Screen before starting:
- Heart rate and blood pressure, supine and standing; the label makes this mandatory
- Accurate weight, since the dose ladder is banded by it; renal and hepatic function
- Medication list, screened for CYP3A4 inhibitors and inducers, sedating and sympatholytic agents, and any syncope or conduction history

Drug Interactions

Strong and moderate CYP3A4 inhibitors (ketoconazole, fluconazole, itraconazole, clarithromycin, erythromycin, grapefruit juice): exposure rises. Halve the dose; restore it when the inhibitor stops
Strong and moderate CYP3A4 inducers (rifampin, efavirenz, carbamazepine): exposure falls. Consider up to double the dose over 1 to 2 weeks, and reverse when the inducer stops
CNS depressants and alcohol (benzodiazepines, antihistamines, opioids): additive sedation; advise avoiding alcohol
Antihypertensives and rate-lowering drugs: additive hypotension and syncope; check orthostatic vitals after any dose change
Sympatholytics (beta-blockers, calcium channel blockers, digitalis): may worsen sinus node dysfunction and AV block; titrate slowly
Stimulants: the labeled combination, but featured in the rebound hypertension cases; taper the guanfacine even when the stimulant continues

Administration

Once daily, morning or evening, at about the same time each day
Swallow whole. Do not crush, chew or break; the tablet is unscored, so 1 mg is the smallest deliverable dose
Do not give with a high-fat meal. A prohibition, not a consistency instruction
Missed doses: after two or more in a row, consider re-titrating rather than resuming maintenance
Switching from immediate-release guanfacine: stop it and titrate from 1 mg; relative bioavailability is 58%, so never convert mg-for-mg
Re-check the weight band at every visit in a growing child
No liquid guanfacine exists; Onyda XR is the only liquid alpha-2 agonist, and it is clonidine
Do not stop abruptly; see Discontinuation & Taper

Side Effects

Common (fixed-dose monotherapy trials, all doses and the 4 mg column against placebo):
- Somnolence 38%, 51% at 4 mg, vs 11% placebo; fatigue 14 / 15 vs 3%
- Hypotension 7 / 8 vs 3%; dizziness 6 / 10 vs 4%; dry mouth 4 / 7 vs 1%; lethargy 6 vs 3%; nausea 6 vs 2%
- Stopped for adverse effects: 3% at 1 mg, 7% at 2 mg, 10% at 3 mg, 18% at 4 mg, vs 3% placebo
Serious:
- Persistent rebound hypertension on abrupt discontinuation, with hypertensive encephalopathy reported; taper
- Dose-dependent hypotension, bradycardia and syncope; hold or reduce, and any syncope stops titration
- Conduction abnormality including first-degree AV block; obtain an ECG and stop
- Convulsion; discontinue and evaluate
- Rash, pruritus, dermatitis and exfoliative dermatitis; discontinue
- Hallucinations and confusion; discontinue and reassess
- Raised ALT; check liver enzymes if hepatic injury is suspected

Monitoring & Labs

Heart rate and blood pressure, supine and standing: baseline, 1 to 2 weeks after each 1 mg increment, then every 3 months; hold titration for bradycardia by age or any syncope
Blood pressure and pulse during any dose reduction: at each step down and after the last dose
Sedation: ask about school-day sleepiness at each titration visit and every visit for 3 months
Weight: at every visit, to keep the dose in the right band
ADHD response: rated scale at 5 to 8 weeks, matching the trial endpoints
CYP3A4 co-medication: review at every visit and refill; starting or stopping one requires a dose change
ECG: not routine; baseline if conduction disease, syncope history or sympatholytics, and promptly for new syncope
Renal and hepatic function: baseline and annually
Laboratory: none routine; check ALT if hepatic injury is suspected

Discontinuation & Taper

Never stop abruptly. Reduce by no more than 1 mg every 3 to 7 days; from 7 mg/day that is 3 to 6 weeks
Abrupt cessation has caused persistent rebound hypertension with raised heart rate, and hypertensive encephalopathy has been reported
Cases involved higher doses and concomitant stimulants; taper even when the stimulant continues
Monitor blood pressure and pulse at every taper step and after the final dose
A vomiting illness is de facto abrupt discontinuation; families should call, not let doses lapse
After two or more consecutive missed doses, consider re-titrating
Drug holidays are not appropriate for this class; weekend and summer breaks are a rebound hypertension risk here

Pregnancy & Lactation

Pregnancy: no drug-associated risk identified, but pregnancy use has been infrequent. No fetal harm in rabbits and rats at 3 to 4 times the maximum human dose; reduced fetal survival at 13.5 times.
Lactation: no human data; guanfacine has not been measured in human milk. Present in rat milk at blood-comparable levels. Monitor an exposed infant for sedation, lethargy and poor feeding. (LactMed 2024)
Lactation, milk supply: no published information; guanfacine lowers basal prolactin in men and non-nursing women. Other agents may be preferred while nursing a newborn. (LactMed 2024)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388

Counseling Points

Counsel the family on:
- Sleepiness early and dose related, half the children on 4 mg, while the ADHD benefit takes 5 to 8 weeks
- Not taking it with a high-fat breakfast, and swallowing the unscored tablet whole
- The dose being set by weight, so it is revisited as the child grows
- Never stopping on their own: stopping suddenly can push blood pressure above where it started
- Telling other prescribers before an antifungal, clarithromycin, or a seizure medicine
- Calling if a stomach bug stops the medicine going down, or after two days of missed doses
Advise them to call for:
- Fainting, dizziness on standing that does not settle, or any seizure
- A pulse that feels very slow or irregular, or heavy daytime sleepiness
- Severe headache with blurred vision, especially after missed doses
- A widespread rash, peeling skin, facial swelling, or new confusion or hallucinations
- Any vomiting illness that stops the medicine going down

References

DailyMed. Intuniv (guanfacine) extended-release tablets prescribing information. Takeda Pharmaceuticals America, Inc. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b972af81-3a37-40be-9fe1-3ddf59852528
LactMed. Guanfacine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2024. https://www.ncbi.nlm.nih.gov/books/NBK501522/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AACAP. Practice parameter for the assessment and treatment of children and adolescents with tic disorders. Journal of the American Academy of Child and Adolescent Psychiatry. 2013. https://www.jaacap.org/article/S0890-8567(13)00695-3/fulltext
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 203. 2018. https://www.ncbi.nlm.nih.gov/books/NBK487764/
FDA. openFDA National Drug Code Directory, guanfacine, queried by generic name across all labelers. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22guanfacine%22&limit=1000

Jornay PM

(methylphenidate hydrochloride)

Jornay PM (methylphenidate hydrochloride); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Jornay PM is a long-acting methylphenidate CNS stimulant in a capsule taken in the evening, not the morning, and approved for ADHD from age 6 with no upper age limit. A delayed-release outer coat holds absorption overnight and an inner extended-release coat meters the drug across the following day. It is the only methylphenidate that treats the before-school hour, which is why it is chosen over a morning agent. Schedule II; brand only.

Forms & Strengths

Delayed-release and extended-release capsules: 20 mg, 40 mg, 60 mg, 80 mg, 100 mg

Dosing

Age: 6 y/o and older
Onset: delayed until the following morning (~10 hours after an evening dose)
Duration: through the day after dosing
Release Profile: delayed-release outer coat holds absorption overnight; an extended-release inner coat meters release next day
Initial Dose: 20 mg once daily in the evening, started at 8:00 p.m.
Titration: 20 mg every 7 days
Max Dose: 100 mg/day
Considerations: Dose in the evening only, never in the morning. Start at 8:00 p.m., shift within 6:30 to 9:30 p.m. to tune next-morning onset, then hold that time.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: Two functional coats over a drug-coated core; a single peak at median Tmax 14 hours. Dose-proportional from 20 mg to 100 mg.
Metabolism: De-esterified to ritalinic acid, little activity. No CYP pathway. Apparent half-life ~5.9 hours; 90% urinary.
Bioavailability: 73.9% of the same daily dose of immediate-release methylphenidate given TID.
Pediatric exposure: children reach roughly twice adult Cmax and AUC. Titrate from 20 mg regardless of prior therapy.
Class Positioning: The only methylphenidate engineered to reach onset before the patient wakes. Every other long-acting product, Concerta included, leaves the pre-school hour untreated.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older

Off-Label Uses

Narcolepsy (ICD-10: G47.411, G47.419): on-label for IR methylphenidate (Ritalin), not here, and a delayed onset suits it poorly; limited data.
Where the evidence does not support use.
- ADHD under 6 y/o (ICD-10: F90.x): the label records evidence against, with higher exposure and more adverse reactions including weight loss; insufficient. (AHRQ 2024)
- Evening dosing as a sedative: the reverse of what happens. Any insomnia ran 33% versus 9% on placebo; insufficient.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High potential for abuse and misuse, leading to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
- Hypersensitivity to methylphenidate or any component; angioedema and anaphylaxis reported.
- Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid, because of sudden death reports.
- Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm. Diastolic rise was reported in 7% of treated children.
- Psychotic or bipolar disorder; exacerbation and treatment-emergent mania.
- Tics or Tourette's syndrome, personal or family.
- Significant hyperopia, open-angle glaucoma, or raised intraocular pressure.
- Substance use disorder in the patient or household.
Screen before starting:
- Cardiac history, family history of sudden death or arrhythmia, and exam.
- Personal and family history of tics or Tourette's syndrome.
- Risk factors for mania: past depression, family history of suicide or bipolar disorder.
- Baseline sleep pattern. This drug is taken at bedtime and causes insomnia.
- Abuse and diversion risk; baseline height, weight, blood pressure and heart rate.

Drug Interactions

MAOIs: hypertensive crisis, with reported death, stroke and MI. Do not co-prescribe, and allow 14 days after stopping.
Antihypertensives: effectiveness may fall. Recheck blood pressure and adjust their dose.
Halogenated anesthetics: sudden intraoperative pressure and rate rise. Hold the capsule the night before surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.
Serotonergic agents: serotonin syndrome is postmarketing only here; counsel on symptoms rather than avoid.
Alcohol: ~97% released within 2 hours at 40% alcohol in vitro, during the hours the capsule sits in the stomach. Counsel adolescents explicitly.

Administration

Evening only. Initiate at 8:00 p.m.
Adjust between 6:30 p.m. and 9:30 p.m.; earlier dosing moves onset earlier. Hold the time once optimal.
Take consistently either with food or without food.
Swallow whole, or sprinkle the entire contents onto applesauce and eat immediately without chewing. Never divide a capsule.
Missed dose: take it the same evening; if remembered next morning, skip it.
Switching from another methylphenidate: stop the other product and re-titrate from 20 mg. Never substitute mg-per-mg.
Store securely, preferably locked; dispose through a take-back program.

Side Effects

Common (Study 2, versus placebo): any insomnia 33% vs 9% (initial 14%, middle 11%, terminal 11%), decreased appetite 19% vs 4%, headache 10% vs 5%, vomiting 9% vs 0%, nausea 6% vs 0%, affect lability 6% vs 1%.
Serious:
- Sudden death with structural cardiac disease; avoid the drug in that group.
- New psychosis or mania, ~0.1% pooled, including with no psychiatric history; consider discontinuing.
- Priapism, which may require surgery; also during drug holidays. Seek immediate care.
- Peripheral vasculopathy including Raynaud's, with digital ulceration; reduce dose or stop.
- Growth suppression: ~2 cm and 2.7 kg less over 3 years. Interrupt if growth stalls.
- Acute angle closure glaucoma and raised intraocular pressure.
- New or worsening tics; discontinue if clinically appropriate.
- Angioedema and anaphylaxis; postmarketing hepatic injury, seizures, rhabdomyolysis, pancytopenia.

Monitoring & Labs

Sleep, in three parts: at every visit and dose change, ask separately about falling asleep, night waking and early waking. Move the dosing time before cutting the dose.
Dosing time: confirm the clock time at every visit; drift in it is the commonest reason this product fails.
Morning function: ask about the before-school hour at each visit; it decides whether to continue.
Cardiovascular: blood pressure and heart rate at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months. Interrupt if the child crosses two major percentile lines.
Mood, psychiatric and tics: at every visit and dose increase. Affect lability ran 22% open-label and drove most discontinuations.
Digital perfusion: inspect fingers and toes at each visit.
Abuse and diversion: pill counts and PDMP check at each refill, per state requirement. An evening dose is unobserved by school.
Laboratory: none routine; LFTs only for jaundice or dark urine.
Efficacy stopping rule: discontinue if a month of dose adjustment brings no improvement.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; the label gives no taper schedule.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, agitation.
The offset is displaced like the onset. The first medication-free day is the day after the last capsule, not the evening it is skipped.
Drug holidays work, but the capsule to omit is the night before the free day. Priapism has been reported during them.

Pregnancy & Lactation

Pregnancy: Human data insufficient to inform risk. No teratogenicity in rats or rabbits at 2 and 9 times the 100 mg/day maximum; spina bifida in rabbits at 31 times. Stimulants reduce placental perfusion.
Lactation: Present in milk; infant receives 0.16% to 0.7% of the maternal weight-adjusted dose. Monitor for agitation, insomnia, poor feeding and low weight gain. (LactMed 2025)
Lactation, milk supply: Methylphenidate lowers prolactin; large doses may interfere before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.

Counseling Points

Counsel the family on:
- That the capsule does nothing that evening; nothing happens for about 10 hours, by design.
- Treating the clock as part of the prescription: a fixed time, adjusted only within 6:30 to 9:30 p.m.
- Never taking a forgotten dose in the morning, which would put the peak in the middle of the night.
- Keeping the evening meal consistent; a fatty dinner delays next morning's onset by about 2.5 hours.
- Watching the before-school hour and reporting on it at the next visit.
- Insomnia taking three forms, all reportable, and usually fixed by moving the dosing time rather than stopping.
- Appetite suppression: move the largest meal to breakfast and to the evening.
- Locked storage, and that sharing a Schedule II medication is a felony.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Sudden emotional swings, panic attacks, or new aggression.
- Numbness, coldness, or colour change in the fingers or toes.
- A new or markedly worse tic, or a new vocal tic.
- Weight loss, or clothes fitting more loosely over a few weeks.
- A painful erection lasting more than a few hours, which is a surgical emergency.
- New eye pain, blurred vision, or haloes around lights.
- Yellowing of the eyes or skin, or dark urine.

References

DailyMed. Jornay PM (methylphenidate hydrochloride) extended-release capsules prescribing information. Ironshore Pharmaceuticals Inc. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d95dede0-b1ff-4489-8f91-3bbe122852bf
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling

Kapvay

(clonidine hydrochloride, extended release)

Kapvay (clonidine hydrochloride extended-release tablets); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Kapvay is extended-release clonidine, a central alpha-2 adrenergic agonist and the first clonidine product approved for ADHD, in patients 6 to 17 years, as monotherapy or added to a stimulant. The tablet flattens the peak of immediate-release clonidine and is given twice daily, with the equal or larger share at bedtime. It is the choice when hyperactivity, impulsivity, tics or sleep onset dominate and a stimulant alone is not enough. Not controlled; the brand is no longer marketed, and generic supplies the product.

Forms & Strengths

Tablets, extended release: 0.1 mg only, unscored
No 0.2 mg or 0.3 mg extended-release tablet exists. Those are immediate-release strengths

Dosing

Age: 6-17 y/o; not established below 6 years
Onset: sedation within hours; ADHD benefit over weeks, trial endpoint at 5 weeks
Duration: dosed twice daily, about 12 hours apart; half-life about 12.6 hours
Release Profile: extended release; peak about 50% of immediate release, about 5 hours later, bioavailability about 89%
Initial Dose: 0.1 mg at bedtime for one week
Titration: 0.1 mg/day every 7 days, split twice daily with the equal or larger dose at bedtime:
- 0.1 mg/day: 0.1 mg bedtime
- 0.2 mg/day: 0.1 mg morning, 0.1 mg bedtime
- 0.3 mg/day: 0.1 mg morning, 0.2 mg bedtime
- 0.4 mg/day: 0.2 mg morning, 0.2 mg bedtime
Max Dose: 0.4 mg/day as 0.2 mg twice daily; higher doses were not evaluated
Considerations: Swallow whole, since the 0.1 mg tablet is unscored and crushing speeds release, so a 0.2 mg dose is two tablets and 0.4 mg/day is four. Never substitute mg-for-mg for another clonidine product, and never stop abruptly.

Pharmacology

Mechanism: Central alpha-2 adrenergic agonist; reduces sympathetic outflow from the locus coeruleus and enhances prefrontal noradrenergic signalling. Mechanism in ADHD unknown.
Delivery / Release: Peak about 50% of immediate release, about 5 hours later; bioavailability about 89%. Food has no effect.
Metabolism: About 50% hepatic, 40% to 60% renal unchanged. Half-life about 12.6 hours in adults, up to 41 hours in severe renal impairment.
Pediatric exposure: Weight-normalised clearance is higher than in adults, 23% lower in females, 11% higher with methylphenidate and 44% lower with amphetamine.
Class Positioning: Non-selective and more sedating than guanfacine (Intuniv), which is alpha-2A selective. Onyda XR shares the moiety once daily as a suspension; immediate-release clonidine is not ADHD approved.

Indications

ADHD, as monotherapy (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6-17 y/o
ADHD, as adjunctive therapy to stimulants (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6-17 y/o

Off-Label Uses

Tic disorders and Tourette syndrome (ICD-10: F95.1, F95.2): most useful with comorbid ADHD; supported by controlled trials for the class. (AACAP 2013)
Sleep-onset insomnia in ADHD (ICD-10: G47.00): limited data; somnolence is a labeled adverse effect, not a demonstrated benefit
Where the evidence does not support use:
- Children under 6 (ICD-10: F90.x): insufficient (AHRQ 2018)
- Oppositional defiant disorder and aggression (ICD-10: F91.3): insufficient
- Anxiety and PTSD (ICD-10: F41.x, F43.1): insufficient

Contraindications & Warnings

Contraindicated: history of hypersensitivity to clonidine, including generalised rash, urticaria or angioedema
Use with caution:
- Hypotension, heart block, bradycardia, cardiovascular or cerebrovascular disease, chronic renal failure; titrate slowly
- Syncope, orthostatic hypotension, or a tendency to dehydration; avoid dehydration and overheating
- Conduction abnormality or concurrent sympatholytics; severe bradycardia needing pacing reported
- Concurrent CNS depressants, because of additive sedation
- Renal impairment; set the initial dose by degree of impairment. Haemodialysis needs no supplemental dose
- Prior sensitisation to the clonidine patch; oral use may cause generalised rash
Screen before starting:
- Heart rate and blood pressure, supine and standing; the label makes this mandatory
- Syncope, palpitations, conduction disease, family history of sudden cardiac death
- Renal function
- Sedating and sympatholytic co-medication, including beta-blockers and digitalis

Drug Interactions

Sinus node and AV nodal agents (digitalis, calcium channel blockers, beta-blockers): additive bradycardia and AV block; label says avoid use. If unavoidable, check vitals each visit
CNS depressants (alcohol, barbiturates, benzodiazepines, phenothiazines, sedating antihistamines): potentiated sedation; the label says avoid use
Antihypertensives: potentiated hypotension; monitor blood pressure and adjust
Tricyclic antidepressants: may counteract the hypotensive effect; monitor blood pressure and adjust
Amphetamine: clonidine clearance 44% lower, so exposure is higher than with methylphenidate; titrate more cautiously and watch for sedation and bradycardia

Administration

Twice daily, about 12 hours apart, larger or equal share at bedtime; week 1 bedtime only
Swallow whole. Do not crush, chew or break; the 0.1 mg tablet is unscored and cannot be halved
A 0.2 mg dose is two 0.1 mg tablets, and 0.4 mg/day is four tablets a day. Write the quantity accordingly
For a child who cannot swallow tablets, Onyda XR is extended-release clonidine as a suspension
Missed dose: skip it; never exceed the prescribed daily total. Food does not matter
Switching: no mg-for-mg substitution with immediate-release clonidine, Nexiclon XR or the patch; stop it and titrate from 0.1 mg
Do not stop abruptly; see Discontinuation & Taper

Side Effects

Common (monotherapy, 0.2 / 0.4 mg/day vs placebo):
- Somnolence 38 / 31 vs 4%; fatigue 16 / 13 vs 1%; headache 20 / 13 vs 16%
- Upper abdominal pain 15 / 10 vs 12%; irritability 9 / 5 vs 4%; nightmare 4 / 9 vs 0%
- As adjunct: somnolence 19 vs 7%, fatigue 14 vs 4%
- Stopped for adverse effects: 7% at 0.2 mg/day, 20% at 0.4 mg/day, vs 1% placebo
Serious:
- Rebound hypertension on abrupt discontinuation; taper
- Dose-related hypotension and bradycardia; at 0.4 mg/day systolic fell 8.8, diastolic 7.3 mmHg, heart rate 7.7 bpm
- Syncope; stop and check orthostatic vitals before further titration
- Conduction abnormality or AV block; severe bradycardia has needed pacing. Obtain an ECG and stop
- Allergic reactions including angioedema; discontinue
- Hallucinations and QT prolongation, post-marketing; discontinue and reassess

Monitoring & Labs

Heart rate and blood pressure: baseline, 1 to 2 weeks after each increment, then every 3 months; hold titration for bradycardia by age
Orthostatics: lying and standing at baseline, every dose change, and any dizziness visit
Sedation: ask about school-day sleepiness at every titration visit and every visit for 3 months
Rebound hypertension risk: at every refill confirm no missed doses; recheck blood pressure at each taper step
ADHD response: rated scale at 5 to 8 weeks, matching the trial endpoint
ECG: not routine; baseline if conduction disease, syncope history or concurrent sympatholytics, and promptly for new syncope or bradycardia
Renal function: baseline and annually
Mood and perception: ask about hallucinations and mood change each visit
Laboratory: no routine laboratory monitoring required

Discontinuation & Taper

Never stop abruptly. Reduce the total daily dose by no more than 0.1 mg every 3 to 7 days; from 0.4 mg/day that is 12 days to 4 weeks
Abrupt cessation in adults: headache, tachycardia, nausea, flushing, chest tightness, anxiety
With immediate-release clonidine: nervousness, agitation, tremor, and a rapid rise in blood pressure
Even trial tapers caused events: abdominal pain 6% and raised heart rate 3% at 0.4 mg/day
Measure blood pressure and heart rate at each taper step and after the last dose
A vomiting illness that prevents dosing is de facto abrupt discontinuation; tell families to call
Drug holidays are not appropriate for this class. Weekend and summer breaks are a rebound hypertension risk here

Pregnancy & Lactation

Pregnancy: decades of human use show no identified risk of major birth defects or miscarriage. Animal resorptions at 10x (rat) and 5x (mouse); no rabbit effect to 3x.
Lactation: relative infant dose 4.1% to 8.4%; milk levels about double maternal serum. Most infants unaffected; one case of sedation, hypotonia and apnoea. Monitor for lethargy, tachypnoea and poor feeding. (LactMed 2024)
Lactation, milk supply: dose-related oxytocin and prolactin effects, with postpartum galactorrhea reported. Other agents are preferred while nursing a newborn or preterm infant. (LactMed 2024)
Fertility: animal studies suggest impaired fertility in both sexes
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org

Counseling Points

Counsel the family on:
- Sleepiness in the first weeks: expected, dose related, commonest reason for stopping
- The ADHD benefit taking weeks while sleepiness arrives on night one
- The twice-daily schedule, larger dose at bedtime; this is not the once-daily clonidine
- Swallowing the tablet whole, and that a 0.2 mg dose is two tablets since there is no half tablet
- Never stopping on their own; name rebound high blood pressure in those words, and never doubling a missed dose
- Calling if a stomach bug stops the medicine going down
- Avoiding alcohol and sedating medicines, including antihistamines
Advise them to call for:
- Fainting, or dizziness on standing that does not settle
- A pulse that feels very slow or irregular
- Daytime sleepiness affecting school, or a child hard to wake
- Severe headache with blurred vision, especially after missed doses
- New hives, facial or lip swelling, a widespread rash, or hallucinations
- Any vomiting illness that stops the medicine going down

References

DailyMed. Clonidine hydrochloride extended-release tablets prescribing information. Actavis Pharma, Inc. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0100c70d-7fde-46a1-8374-940550a27e43
DailyMed. Clonidine hydrochloride extended-release tablets, USP prescribing information. Ajanta Pharma USA Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df80255e-f942-4d9f-8edd-cc95795772cb
LactMed. Clonidine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2024. https://www.ncbi.nlm.nih.gov/books/NBK501628/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AACAP. Practice parameter for the assessment and treatment of children and adolescents with tic disorders. Journal of the American Academy of Child and Adolescent Psychiatry. 2013. https://www.jaacap.org/article/S0890-8567(13)00695-3/fulltext
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 203. 2018. https://www.ncbi.nlm.nih.gov/books/NBK487764/
FDA. openFDA National Drug Code Directory, clonidine, queried by generic name across all labelers. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22clonidine%22&limit=1000

Lexapro

(escitalopram)

Lexapro (escitalopram); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Lexapro is a selective serotonin reuptake inhibitor approved for major depressive disorder from 12 years of age and for generalized anxiety disorder from 7 years of age. It is not an ADHD medication, and appears here because depression and anxiety so often accompany ADHD. Its advantage over its SSRI siblings is a flat ladder: a single 10 mg start and a 20 mg ceiling at every approved age. Not controlled; brand and generic.

Forms & Strengths

Tablets, film-coated: 5 mg, 10 mg, 20 mg
Oral solution: 5 mg/5 mL
Capsules: 15 mg

Dosing

Age:
- Major depressive disorder: 12 y/o and older, and adults
- Generalized anxiety disorder: 7 y/o and older, and adults
- Not approved below 7 y/o for any indication
Onset: 1 to 2 weeks for early effect; 8 weeks at target dose for full response
Duration: continuous with once-daily dosing; steady state in about one week
Initial Dose: 10 mg once daily at every approved age and for both indications
Titration:
- MDD, 12 to 17 y/o: to 20 mg once daily, interval no less than 3 weeks
- GAD, 7 to 17 y/o: to 20 mg once daily, interval no less than 2 weeks
- Adults, either indication: to 20 mg once daily, interval no less than 1 week
Max Dose: 20 mg/day at every approved age
Considerations: Cap at 10 mg daily in hepatic impairment and in elderly patients. Screen for personal and family history of bipolar disorder before the first dose. Taper on stopping; do not stop abruptly.

Pharmacology

Mechanism: inhibits neuronal 5-HT reuptake; the S-enantiomer of citalopram, over 100-fold more potent than the R-enantiomer
Delivery / Release: immediate-release tablet, bioequivalent oral solution; half-life 27 to 32 hours, hepatic via CYP3A4 and 2C19
Class Positioning: the only SSRI whose label quantifies a dose-related QTcF rise: 4.5 msec at 10 mg, 6.6 msec predicted at 20 mg, 10.7 msec at 30 mg
Versus siblings: citalopram carries an explicit QT dose cap, escitalopram does not. Weaker CYP inhibitor than fluvoxamine; shorter half-life than fluoxetine. Alternative: Cymbalta.

Indications

Major depressive disorder (ICD-10: F32.x, F33.x): 12 y/o and older, and adults; not established below 12 y/o
Generalized anxiety disorder (ICD-10: F41.1): 7 y/o and older, and adults. This pediatric floor is on the brand label only; generic labels present GAD as adult-only.

Off-Label Uses

Anxiety other than GAD (ICD-10: F93.0, F40.1, F41.0): supported at CLASS level only; AHRQ graded SSRIs and SNRIs moderate to high. (AHRQ 2017)
MDD below 12 y/o (ICD-10: F32.x): insufficient; efficacy not established, and the boxed warning applies fully
Pediatric OCD (ICD-10: F42.x): limited data; no OCD indication at any age, and better-studied agents exist
Adjunctive Abilify (ICD-10: F32.x, F33.x): approved augmentation in adult MDD only; insufficient in youth
ADHD itself (ICD-10: F90.x): insufficient; no indication and no efficacy claim at any age

Contraindications & Warnings

Boxed Warning: Suicidal thoughts and behaviors. Antidepressants increased this risk in children, adolescents and young adults. Monitor closely for clinical worsening and emergent suicidality during the initial few months and at every dose change; counsel caregivers to watch for behaviour change and alert the prescriber; consider stopping if suicidality emerges. Not approved below 7 y/o.
Contraindicated:
- MAOI use, current or within 14 days in either direction, including linezolid and intravenous methylene blue.
- Concurrent pimozide, which risks QT prolongation and ventricular arrhythmia.
- Known hypersensitivity to escitalopram, citalopram, or any inactive ingredient.
Use with caution:
- Known or suspected bipolar disorder; an antidepressant alone can precipitate a manic or mixed episode.
- Seizure disorder; convulsions are reported on treatment.
- Hyponatremia risk, notably diuretics or volume depletion; sodium below 110 mmol/L reported as SIADH.
- Aspirin, NSAIDs, antiplatelets or anticoagulants: added bleeding risk.
- Untreated narrow anterior chamber angles.
- Hepatic impairment, elderly patients and CYP2C19 poor metabolizers: cap at 10 mg daily.
Screen before starting:
- Personal and family history of bipolar disorder, mania or hypomania, plus a baseline suicidality assessment.
- Medication list checked for MAOIs, pimozide, serotonergic agents and drugs affecting hemostasis.
- Baseline height, weight, hepatic function, and sexual function history in adolescents.

Drug Interactions

MAOIs (phenelzine, tranylcypromine, linezolid, methylene blue): contraindicated; allow 14 days in each direction.
Pimozide: contraindicated; QT prolongation and ventricular arrhythmia.
Other serotonergic drugs (SNRIs, triptans, tricyclics, opioids, lithium, buspirone, amphetamines, St John's Wort): additive serotonin syndrome risk, live in an ADHD clinic.
Drugs affecting hemostasis (aspirin, NSAIDs, antiplatelets, warfarin): added bleeding risk; monitor INR closely.
Carbamazepine: may increase escitalopram clearance; suspect it before concluding the drug failed.
CYP2D6 substrates (desipramine, metoprolol): escitalopram 20 mg doubled desipramine AUC; reduce the substrate if toxicity appears.

Administration

Give once daily at a fixed time, with or without food; morning for insomnia, evening for somnolence.
The 10 mg and 20 mg tablets are scored; the 5 mg is not. Step down with the 5 mg tablet or the solution.
If the child cannot swallow tablets, use the bioequivalent 5 mg/5 mL oral solution.
The 15 mg capsule is single-strength; its label bars initiation, titration and discontinuation.
Missed dose: give it when remembered the same day; do not double up.
Do not stop abruptly; see Discontinuation & Taper.

Side Effects

Common: headache, nausea, insomnia, somnolence, fatigue, dry mouth, diarrhea, dizziness, sweating; in children also irritability and anger, the activation signal
Serious:
- Suicidal thoughts and behaviors: the boxed warning. Reassess early and after any dose change.
- Serotonin syndrome: stop escitalopram and every serotonergic drug immediately; treat supportively.
- Activation of mania or a mixed episode: reconsider the diagnosis and stop rather than titrating through.
- Hyponatremia, often SIADH; seizures; bleeding from bruising to life-threatening haemorrhage.
- Angle closure glaucoma in untreated narrow angles: an ophthalmological emergency.
- Sexual dysfunction, decreased appetite and weight loss: ask directly and plot growth.

Monitoring & Labs

Suicidality: assess ideation, agitation and behaviour change at every contact for the first 3 months and at every dose change, then each visit.
Activation and mania: ask during titration and at least every 3 months once stable about reduced sleep need, pressured speech and new anger.
Growth: height and weight charted at baseline, every 3 months for the first year, then every 6 months; investigate a fall over one percentile line.
Serum sodium: check within days of new headache, confusion or unsteadiness; baseline and 4 weeks on a diuretic.
QT: no routine ECG at 10 or 20 mg in a normal heart. Baseline ECG, repeated 1 to 2 weeks after the target dose, if long QT, sudden cardiac death history, electrolyte disturbance or a QT-prolonging co-drug.
Bleeding and sexual function: ask about bruising, epistaxis and new NSAIDs each visit; sexual function every 6 months.
Response: reassess with the same rating instrument at 4 and 8 weeks.

Discontinuation & Taper

Do not stop abruptly; reduce gradually and monitor for discontinuation symptoms.
Discontinuation syndrome: dysphoric mood, irritability, agitation, dizziness, electric shock sensations, headache, insomnia, hypomania. Usually self-limiting.
Matters more than for fluoxetine, whose metabolite self-tapers; this half-life clears in days.
If intolerable symptoms follow a decrease, resume the previous dose and go slower.
Drug holidays are not appropriate; a weekend off buys a discontinuation syndrome.

Pregnancy & Lactation

Pregnancy: no established increase in major birth defects or miscarriage. Risks: persistent pulmonary hypertension of the newborn, poor neonatal adaptation, and a less than 2-fold increase in postpartum hemorrhage.
Weighing it: set these against the relapse risk of untreated illness.
Lactation: relative infant dose roughly 2.6% to 3.9%; maternal doses up to 20 mg daily are not expected to cause adverse effects, and are not a reason to stop breastfeeding. (LactMed 2026)
Infant monitoring: watch for excess sedation, restlessness, agitation, poor feeding and poor weight gain. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for Antidepressants, 1-844-405-6185, womensmentalhealth.org.

Counseling Points

Counsel the family on:
- Little happening for two to four weeks; the decision point is 8 weeks.
- The pediatric ladder being deliberately slow: 3 weeks before 20 mg in MDD at 12 to 17, 2 weeks in GAD at 7 to 17.
- 20 mg being the ceiling at every age; more is not better, and the QT signal is dose-related.
- Watching daily early and after dose changes for agitation, anger or self-harm talk.
- Never stopping abruptly, including when a prescription lapses over a holiday.
- Ibuprofen and aspirin adding to bleeding risk; tell the adolescent directly.
Advise them to call for:
- Any new or worsening talk of self-harm, or sudden change in mood or behaviour.
- Agitation with fever, shivering, twitching or stiffness; a same-day call.
- Several nights of almost no sleep, pressured speech, or grandiose plans.
- Headache with confusion, memory trouble or unsteadiness, which can be low sodium.
- Nosebleeds that will not stop, unusual bruising, or blood in vomit or stool.
- A seizure of any kind.

References

DailyMed. Lexapro (escitalopram) tablets and oral solution, Allergan, Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a
DailyMed. Escitalopram capsules, Almatica Pharma (NDA219130). 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c0401570-a3b0-bef2-7365-c23dc952b8b6
LactMed. Escitalopram. Drugs and Lactation Database, NICHD. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501275/
AHRQ. Anxiety in Children. Comparative Effectiveness Review 192. 2017. https://www.ncbi.nlm.nih.gov/books/NBK476277/
FDA. National Drug Code Directory, openFDA; generic name escitalopram. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22escitalopram%22&limit=1000

Luvox

(fluvoxamine)

Luvox (fluvoxamine); not controlled; brand discontinued, generic only

Full Prescribing Information

DailyMed Drug Information

Summary

Luvox is a selective serotonin reuptake inhibitor whose only approved use is obsessive-compulsive disorder, indicated down to 8 years of age. The brand is discontinued, and the two generic forms are not interchangeable: the immediate-release tablet holds the pediatric indication, while the extended-release capsule has never been evaluated in children. Potent CYP1A2 inhibition gives it the largest interaction burden of any SSRI here. Not controlled; generic only.

Forms & Strengths

Immediate-release tablets (pediatric-indicated, from 8 years): 25 mg, 50 mg, 100 mg
Extended-release capsules (never evaluated in children, adults only): 100 mg, 150 mg
No oral liquid or chewable form

Dosing

Age:
- Immediate-release tablets, OCD: 8 y/o and older, and adults
- Extended-release capsules: adults only; never evaluated in pediatric patients
- Not approved below 8 y/o, or for any indication other than OCD
Onset: 1 to 2 weeks for early effect; 10 weeks for full response
Duration: continuous with daily dosing; half-life 15.6 hours
Initial Dose:
- 8 to 17 y/o: 25 mg once daily at bedtime
- Adults: 50 mg once daily at bedtime
Titration:
- 8 to 17 y/o: 25 mg every 4 to 7 days as tolerated
- Adults: 50 mg every 4 to 7 days as tolerated
Max Dose:
- 8 to 11 y/o: 200 mg/day
- 12 to 17 y/o: 300 mg/day, the adult maximum
- Adults: 300 mg/day
Considerations: These are immediate-release tablet doses; the extended-release capsule is not pediatric and starts at 100 mg. Split pediatric totals above 50 mg, adult totals above 100 mg, larger dose at bedtime. Titrate a girl more slowly than a boy.

Pharmacology

Mechanism: potent serotonin reuptake inhibitor with no significant histaminergic, adrenergic, muscarinic or dopaminergic affinity
Delivery / Release: immediate-release tablet; bioavailability 53%, unaffected by food; half-life 15.6 hours, shortest of the youth SSRIs
Metabolism: hepatic to inactive metabolites; NONLINEAR kinetics over 100 to 300 mg/day. Clearance falls 30% in hepatic dysfunction, rises 25% in smokers.
Class Positioning: enzyme inhibition, not receptor pharmacology, separates it from every other SSRI. A POTENT CYP1A2 inhibitor, it also inhibits CYP2C9, CYP3A4 and CYP2C19.
Versus siblings: four outright drug contraindications no other SSRI carries

Indications

Obsessive-compulsive disorder (ICD-10: F42.x): immediate-release tablets, 8 y/o and older, plus adults
Obsessive-compulsive disorder, adults only (ICD-10: F42.x): extended-release capsules, never evaluated in children
No other approved indication at any age; not approved for depression in the United States

Off-Label Uses

Pediatric anxiety disorders (ICD-10: F93.0, F40.1, F41.1): CLASS-level support only; AHRQ graded SSRIs moderate to high. (AHRQ 2017)
Depression in youth (ICD-10: F32.x, F33.x), autism repetitive behaviours (F84.0), ADHD (F90.x), and pediatric use of the extended-release capsule: all insufficient
Choosing among pediatric OCD agents: AACAP makes CBT first line, adding medication for moderate to severe illness, with little evidence separating SSRIs. (AACAP 2011)

Contraindications & Warnings

Boxed Warning: Suicidal thoughts and behaviors. Antidepressants increased this risk in children, adolescents and young adults. Observe closely for clinical worsening and suicidality, especially early and at dose changes; the label's stated interval is DAILY family observation with communication to the prescriber. Write the smallest quantity of tablets consistent with good patient management.
Contraindicated:
- Tizanidine: AUC rose about 33-fold, dropping systolic pressure a mean 35 mm Hg.
- Thioridazine: concentrations triple, causing QTc prolongation, torsades and sudden death.
- Alosetron: AUC rose 6-fold. Pimozide: QT prolongation and fatal torsades.
- MAOIs, including linezolid and methylene blue: current use or within 14 days, either direction.
Use with caution:
- Known or suspected bipolar disorder; manic reactions hit 4% in the pediatric OCD trial.
- Any seizure disorder; avoid in unstable epilepsy, stop if seizures increase.
- Hyponatremia risk with diuretics; bleeding risk with aspirin, NSAIDs or anticoagulants; untreated narrow angles.
- Hepatic impairment: lower the start, lengthen the interval.
- Any narrow-window substrate: warfarin, theophylline, omeprazole, phenytoin.
Screen before starting:
- The medication list against CYP1A2, CYP3A4, CYP2C9 and CYP2C19 substrates; four agents are contraindicated.
- Bipolar and seizure history, baseline suicidality, height and weight, and smoking status.
- Confirmation the prescription reads immediate-release TABLETS, not capsules.

Drug Interactions

Contraindicated: tizanidine, thioridazine, alosetron, pimozide, and MAOIs within 14 days. Choose another agent.
Potent CYP1A2 inhibition is the defining hazard. Review the medication list for substrates before writing it and at every visit.
Viloxazine (Qelbree): the likeliest collision in an ADHD practice; itself a strong CYP1A2 inhibitor, so combining stacks two potent inhibitors.
Ramelteon AUC rose 190-fold; do not combine. Theophylline: cut to one third, monitor levels.
Warfarin rose 98%; tricyclics, carbamazepine, clozapine, propranolol and methadone rise. Monitor levels; adjust methadone when fluvoxamine starts AND stops.
Benzodiazepines: halve the alprazolam start, avoid diazepam; lorazepam and oxazepam are unaffected.
Other serotonergic drugs (SNRIs, triptans, opioids, lithium, amphetamines): additive serotonin syndrome risk. Quitting smoking raises levels.

Administration

Give at bedtime as one dose while the total is 50 mg or less in a child, 100 mg or less in an adult.
Above those thresholds divide into two doses, the larger at bedtime. Give with or without food.
Tablets must be swallowed; the 25 mg is unscored, thinly stocked.
Never substitute extended-release capsules under 18: never evaluated in children, and its lowest strength, 100 mg, is four times the pediatric start.
Titrate a girl more slowly than a boy the same age; girls reach benefit at lower doses.
Missed dose: same day only, never doubled. Never stop abruptly.

Side Effects

Common: nausea at about 40%, the commonest reason a child stops early, plus headache, somnolence, insomnia, dry mouth, nervousness, diarrhea and tremor; in children also emotional lability, hyperkinesia, ecchymosis and epistaxis
Serious:
- Suicidal thoughts and behavior: the boxed warning. Reassess early and at each dose change.
- Serotonin syndrome: stop fluvoxamine and every serotonergic drug immediately.
- Manic or hypomanic switch, 4% in the pediatric OCD trial: stop rather than titrating through.
- Seizures, hyponatremia as SIADH, bleeding up to life-threatening haemorrhage.
- Angle closure glaucoma, priapism, sexual dysfunction, weight loss. Ask directly and plot growth.

Monitoring & Labs

Suicidality: daily family observation, plus clinician assessment of ideation and behaviour at every contact for 3 months and at every dose change.
Medication reconciliation: recheck the full list at EVERY visit against CYP1A2, CYP3A4, CYP2C9 and CYP2C19 substrates. The highest-yield task.
Activation and mania: ask during titration and every 3 months once stable about reduced sleep need, pressured speech and hyperactivity.
Growth: height and weight charted at baseline, quarterly for a year, then twice yearly.
Sodium, bleeding, seizures: check sodium for new headache or confusion; ask about bruising, nosebleeds and convulsions.
Interacting-drug levels: check any narrow-window co-drug at baseline and 1 week post-change.
Response: reassess with the same instrument at 10 weeks.

Discontinuation & Taper

Do not stop abruptly; reduce gradually and monitor for discontinuation symptoms.
Discontinuation syndrome: dysphoric mood, irritability, agitation, dizziness, electric shock sensations, headache, insomnia.
Taper matters more here than for most SSRIs. Slow it as the dose gets small.
If intolerable symptoms follow a decrease, resume the previous dose and go slower. Exception: emergent suicidality, where the label directs tapering as fast as feasible.
Adjust methadone when fluvoxamine comes off. No drug holidays.

Pregnancy & Lactation

Pregnancy: observational data show no clear risk of major birth defects or miscarriage. Risks: persistent pulmonary hypertension of the newborn, poor neonatal adaptation, a less than 2-fold rise in postpartum hemorrhage.
Fertility: animal findings suggest impaired fertility on treatment. Weigh risk against relapse.
Lactation: relative infant dose roughly 1%; maternal doses up to 300 mg daily are not expected to cause adverse effects, and not a reason to stop nursing. (LactMed 2026)
Infant monitoring: watch for diarrhea, vomiting, poor sleep and agitation. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for Antidepressants, 1-844-405-6185, womensmentalhealth.org

Counseling Points

Counsel the family on:
- The tablet and the capsule not being the same medicine. If the pharmacy hands over capsules, call first.
- Nausea being the commonest problem, worst in the first two weeks; food and slower titration, not stopping.
- Bedtime dosing at 50 mg or less, splitting above that with the larger half at bedtime.
- Bringing every new medicine to you first, over-the-counter included; this one changes how the body handles others.
- Watching daily, early and after dose changes, for agitation, emotional swings or self-harm talk; never stopping abruptly; 10 weeks being the decision point.
Advise them to call for:
- New or worsening self-harm talk, or a sudden mood or behaviour change.
- Several nights of almost no sleep, or pressured speech.
- Agitation with fever, shivering, twitching or stiffness; same-day call.
- Nosebleeds that will not stop, unusual bruising, or blood in vomit or stool.
- Headache with confusion or unsteadiness, which can be low sodium.
- A seizure, an erection over 4 hours, or sudden eye pain.

References

DailyMed. Fluvoxamine maleate tablets, ANI Pharmaceuticals; the pediatric-indicated IR product. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ecd83ec-88f5-4f85-9cc2-9068375d8820
DailyMed. Fluvoxamine maleate extended-release capsules, Actavis Pharma; source of the never-evaluated-in-children statement. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bbd7e39-b9ab-4716-9522-aa8c4b92210e
LactMed. Fluvoxamine. Drugs and Lactation Database, NICHD. https://www.ncbi.nlm.nih.gov/books/NBK501187/
AHRQ. Anxiety in Children. Comparative Effectiveness Review 192. https://www.ncbi.nlm.nih.gov/books/NBK476277/
AACAP. Practice Parameter for Obsessive-Compulsive Disorder in Youth. https://psychiatryonline.org/doi/10.1176/appi.focus.10.3.360
FDA. National Drug Code Directory, openFDA; generic name fluvoxamine. https://api.fda.gov/drug/ndc.json?search=generic_name:%22fluvoxamine%22&limit=1000

Metadate CD

(methylphenidate hydrochloride extended-release, biphasic beads)

Metadate CD (methylphenidate hydrochloride extended-release, biphasic beads); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Metadate CD is a bead-filled methylphenidate capsule delivering 30% of the dose immediately and holding 70% in extended-release beads, approved for ADHD in children 6 to 15 years. Weighting the dose toward the afternoon is its differentiator: less morning spike and more late coverage than the 50 / 50 bead capsules. The capsule can be opened and sprinkled without changing exposure. Schedule II; brand and generic.

Forms & Strengths

Extended-release capsules (biphasic beads, may be opened onto applesauce): 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Dosing

Age: 6 to 15 y/o only; no indication at 16, 17 or in adults
Onset: ~ 1 hour
Duration: about 8 hours
Release Profile: 30% IR / 70% ER via biphasic beads
Initial Dose: 20 mg once daily in the morning, before breakfast
Titration: 10 - 20 mg every 7 days
Max Dose: 60 mg/day
Considerations: Give before breakfast; a high-fat meal raises Cmax ~30% and delays the peak an hour. Alcohol releases 84% of the dose in the first hour, so counsel adolescents. May be opened onto applesauce.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 30% IR / 70% ER via biphasic beads. First peak at a median 1.5 h, second at ~4.5 h; a quarter to a third of children show only one peak.
Metabolism: De-esterified to ritalinic acid, inactive. Not a CYP substrate. Mean terminal half-life 6.8 hours, against 2.9 h for IR tablets and 3.4 h for OROS.
Class Positioning: The most afternoon-weighted bead capsule: 30/70 against the 50/50 of Ritalin LA. Against Concerta it is two-peaked and can be sprinkled. Its liability is alcohol.
Alcohol: at 40% alcohol, 84% of the dose is released within the first hour; Concerta shows no such release. The label instructs counseling to avoid alcohol.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 15 y/o

Off-Label Uses

ADHD at 16 and older, including adults (ICD-10: F90.x): easy to do inadvertently, since a stable 15 year old becomes off-label on a birthday. Insufficient. (AHRQ 2024)
ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral parent training first line; if medication is needed use IR methylphenidate. Expert consensus. (AAP 2019)
Narcolepsy (ICD-10: G47.419): IR methylphenidate carries this indication, Metadate CD does not. Insufficient.
Where the evidence does not support use: treatment-resistant depression, binge eating disorder, cancer-related and chronic fatigue. Adult literature only; insufficient in children. (AHRQ 2024)
Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate or any component
- MAOI use, current or within 14 days: hypertensive crisis
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: monitor blood pressure and pulse
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Personal or family history of tics or Tourette's syndrome
- Any adolescent drinking alcohol or at risk of it
- Substance use disorder in patient or household; a bead capsule is not abuse-deterrent
Screen before starting:
- Cardiac history and exam including family sudden death; the label requires no routine ECG
- Tics, and risk factors for a manic episode
- Alcohol use in an adolescent, asked directly and separately from other substance use
- Abuse and diversion risk in patient and household
- Baseline height, weight, blood pressure and heart rate; age against the 6 to 15 indication

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Alcohol: 84% released in the first hour at 40% alcohol. Advise every adolescent to avoid it; pick another agent where drinking is likely.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only, not in the interaction table. Counsel on symptoms.

Administration

Once daily in the morning, before breakfast, which is a labeled instruction.
Swallow whole, or sprinkle onto about a tablespoon of applesauce and give immediately with fluids.
Sprinkling does not change Cmax or AUC. Never store the mixture.
Do not crush or chew; chewing turns the extended fraction into an immediate one.
Avoid alcohol: at 40% alcohol, 84% of the dose is released in the first hour.
Missed dose: skip it; a late dose peaks in the evening.
Store locked; a bead capsule is easily opened.

Side Effects

Common, pediatric 6 to 15 y (>= 5% and above placebo): headache 12% vs 8%, anorexia 9% vs 2%, abdominal pain 7% vs 4%, insomnia 5% vs 2%. Anorexia and insomnia show the widest gap over placebo.
Serious:
- Cardiac arrest and sudden death with structural cardiac disease: avoid in that population
- New psychosis or mania, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Long-term growth suppression; acute angle closure glaucoma; new or worsening tics and Tourette's
- Postmarketing: suicidal behavior including completed suicide, aggression, OCD, thrombocytopenia, angioedema, rhabdomyolysis, convulsions, cerebral hemorrhage

Monitoring & Labs

Alcohol use: ask at every visit from about age 12. This product releases 84% of the dose within an hour with alcohol.
Appetite and weight: at every visit; ask whether breakfast is actually eaten.
Growth: height, weight and BMI at baseline and every 6 months; failure to gain triggers interruption.
Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months.
Sleep: at every visit and dose change; with 70% extended, an evening problem is likelier the drug than the child.
Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at every visit; ask about suicidal thoughts where depression is comorbid.
Age against indication: check at every annual visit. The indication ends at 15; plan the switch before 16. Concerta is labeled to 65, Aptensio XR has no upper limit.
Abuse and diversion: at every refill, capsule count, ask about sharing and selling, check the PDMP. A boxed-warning obligation.
Laboratory: none is required by this label.

Discontinuation & Taper

No taper required; the label gives no tapering schedule.
Discontinue if no improvement after appropriate dose adjustment over one month.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
Priapism has occurred during drug holidays and on discontinuation.
Drug holidays are reasonable where growth limits treatment; a capsule cannot be part-dosed, and the gap is felt most in the afternoon.

Pregnancy & Lactation

Pregnancy: no drug-associated risk of major birth defects or miscarriage identified. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant serum in every reported case. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, insomnia and poor weight gain. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

Counsel the family on:
- Alcohol releasing most of the day's dose in an hour. Say it to the adolescent directly, before the first prescription.
- Giving the capsule before breakfast, not with it; a fatty breakfast raises the peak by a third.
- About a tablespoon of applesauce, taken at once, never chewed or made up in advance. Exposure matches the intact capsule.
- The dose being weighted to the afternoon, 30% now and 70% later, so the morning effect is smaller.
- The approval ending at 15, so the plan changes in mid-adolescence.
- Locked storage; a capsule of loose beads is easily emptied.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Any talk of self-harm or suicide, or a marked drop in mood.
- Numbness, coldness or colour change in fingers or toes, or a sore that will not heal.
- A new or markedly worse tic, including throat clearing and blinking.
- A painful erection lasting more than a few hours, including during a planned break.
- Unusual bruising or bleeding; eye pain with halos around lights.
- Clothes fitting more loosely, or no weight gain across a few months.

References

DailyMed. Metadate CD (methylphenidate hydrochloride) extended-release capsules prescribing information. Aytu BioPharma. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=be59f8b4-7842-42cc-9559-bfa747f0baa5
FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Methylin

(methylphenidate hydrochloride, immediate-release)

Methylin (methylphenidate hydrochloride, immediate-release); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Methylin is immediate-release methylphenidate supplied as a grape-flavoured oral solution, approved for ADHD in patients 6 years and older and for narcolepsy, with generic chewable tablets at 2.5 mg, 5 mg and 10 mg. Its differentiator is dose granularity for a child who cannot swallow: the solution measures to fractions of a milligram, which no tablet in the class can do. Schedule II; oral solution brand and generic, chewable tablet generic only.

Forms & Strengths

Oral solution (grape, colorless): 5 mg/5 mL and 10 mg/5 mL
Chewable tablets (grape): 2.5 mg, 5 mg, 10 mg

Dosing

Age:
- ADHD: >= 6y
- Narcolepsy: no age floor
Onset: ~ 1 hour
Duration: 3 to 4 hours
Initial Dose:
- >= 6 y/o and older: 5 mg twice daily, before breakfast and before lunch
- Adults: 20 to 30 mg daily in 2 or 3 divided doses, 30 to 45 minutes before meals.
Titration: 5 - 10 mg every 7 days
Max Dose: 60 mg/day
Considerations: The chewable tablet must be taken with at least 8 ounces of fluid because it swells and can cause choking, and it contains phenylalanine.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: Immediate release, no modified-release component in either form. Solution and IR tablet are near-bioequivalent at 20 mg.
Metabolism: De-esterified to ritalinic acid, essentially inactive. Protein binding 10% to 33%. Mean terminal half-life 2.7 hours, the shortest methylphenidate in this library.
Food effect: a high-fat meal raises solution Cmax ~13% and AUC ~25% and delays Tmax by about an hour, a smaller effect than on Metadate CD.
Class Positioning: The only methylphenidate titratable in fractions of a milligram, and the most reversible. Compare Ritalin (IR tablet) and QuilliChew ER, an extended-release chewable not to be confused with this one.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older, and adults
Narcolepsy (ICD-10: G47.419): no age floor

Off-Label Uses

ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral therapy first line; IR methylphenidate from a low dose where it fails. Expert consensus. (AAP 2019)
Afternoon top-up alongside a long-acting methylphenidate (ICD-10: F90.x): coherent given the 3 to 4 hour window; 60 mg/day ceiling applies to the sum. Limited data. (AHRQ 2024)
Where the evidence does not support use: binge eating disorder (F50.2), treatment-resistant depression (F33.9), cancer-related and other fatigue (R53.0, R53.83). Adult literature only; insufficient in children. (AHRQ 2024)
Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death; risk rises with dose and non-oral routes. Assess abuse risk before prescribing and reassess throughout.
Contraindicated:
- Hypersensitivity to methylphenidate or any component
- MAOI use, current or within 14 days: hypertensive crisis
- Chewable tablet only: difficulty swallowing. Use the oral solution.
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease: avoid
- Pre-existing hypertension: monitor blood pressure and pulse
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Personal or family history of tics or Tourette's syndrome
- Phenylketonuria, chewable only: 0.42 / 0.84 / 1.68 mg phenylalanine per 2.5 / 5 / 10 mg tablet
- Substance use disorder in patient or household; a 500 mL CII bottle is hard to audit
Screen before starting:
- Cardiac history and exam including family sudden death; the label requires the screen, not an ECG
- Tics, mania risk factors, and abuse or diversion risk in patient and household
- Swallowing ability, which decides the form; PKU if a chewable is considered
- Baseline height, weight, BP and HR

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold all doses on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only. Counsel on symptoms rather than avoiding.
Venlafaxine: one pediatric NMS-like report after a first dose. Watch the first days of any new serotonergic agent.

Administration

Give 30 to 45 minutes before meals, which is a labeled instruction.
Before breakfast and before lunch; add a third dose for afternoon coverage. Last dose before 6 p.m. if sleep is affected.
Oral solution: measure with an oral syringe or calibrated cup, never a kitchen spoon. The two strengths look identical; state the concentration on every prescription.
Chewable tablet: chew well, swallow with at least 8 ounces of fluid; it swells and can obstruct the throat.
Missed dose: give only if the next is several hours away and it is not late. Never double up.
Store locked. A flavoured CII liquid is the form a younger sibling is likeliest to drink.

Side Effects

Common: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, decreased appetite, weight loss, dry mouth, nausea, abdominal pain. No pediatric percentages published.
Serious:
- Choking or esophageal obstruction from a chewable taken dry: emergency, unique to that form
- Sudden death with structural cardiac disease: avoid in that population
- New psychosis or mania, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, including during drug holidays and withdrawal
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Long-term growth suppression; angle-closure glaucoma; new or worsening tics
- Postmarketing: seizures, dyskinesia, cerebral arteritis, hepatic injury, leukopenia, thrombocytopenic purpura, erythema multiforme, rhabdomyolysis, NMS

Monitoring & Labs

Concentration and measuring device: confirm at every visit and refill; the twofold strength difference is this page's likeliest dosing error.
Adherence: confirm at every visit that the midday dose is given; a missed school dose mimics loss of efficacy.
Growth: height, weight and BMI at baseline and every 6 months; every visit if losing weight.
Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months.
Appetite and sleep: at every visit and dose change; ask the time of the last dose.
Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at baseline and every visit.
Abuse and diversion: at every refill, ask about sharing and selling and check the PDMP. Reconcile volume remaining against days elapsed; a bottle cannot be pill-counted.
Laboratory: none required. Check liver enzymes only for jaundice, dark urine or unexplained abdominal pain.

Discontinuation & Taper

No taper required; neither label gives a tapering schedule.
Discontinue if no improvement after appropriate dose adjustment over one month.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
Priapism has occurred during drug holidays and on discontinuation.
Drug holidays are easiest here: the solution can be part-dosed as well as part-scheduled.

Pregnancy & Lactation

Pregnancy: no drug-associated risk of major birth defects or miscarriage identified. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant plasma in every reported case. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, insomnia and poor weight gain. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.

Counseling Points

Counsel the family on:
- The two concentrations: the same 5 mL is 5 mg or 10 mg depending on the bottle. Check every refill, and measure only with the supplied syringe.
- The chewable needing a full 8 ounce glass every time; chewed dry it swells and can block the throat.
- The 3 to 4 hour window: the lunchtime dose is part of the plan, not a sign the first failed.
- Rebound irritability and hunger several times a day: expected, not a reason to raise the dose.
- Locking up the bottle; a flavoured CII liquid is the easiest form to lose unnoticed.
- Bringing a teacher rating scale, morning and afternoon rated separately.
Advise them to call for:
- Chest pain, vomiting or trouble swallowing after a chewable: emergency
- Chest pain, fainting, or a racing heart that does not settle
- New hallucinations, or new suspicious or fearful thinking
- Numbness, coldness or colour change in fingers or toes, or a sore that will not heal
- A new or markedly worse tic, including throat clearing and blinking
- A painful erection lasting more than a few hours, including during a break
- Any amount of the solution swallowed by another child in the house

References

DailyMed. Methylin (methylphenidate hydrochloride) oral solution prescribing information. Shionogi Inc. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e3c22d9-71d9-46a7-b315-8021c94c4bec
DailyMed. Methylphenidate hydrochloride chewable tablets prescribing information. Lupin Pharmaceuticals. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5bfe50ed-171f-4c40-bc0b-20c68e8e2025
FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Mydayis

(dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate)

Mydayis (mixed salts of a single-entity amphetamine product); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Mydayis is a triple-bead extended-release amphetamine capsule approved for ADHD from age 13, carrying the same four salts and 3:1 dextro to levo ratio as Adderall XR. An immediate-release bead plus two delayed-release beads unlocking at pH 5.5 and pH 7.0 give the longest coverage of any oral amphetamine here. Choose it when an adolescent needs late-evening rather than school-day coverage; it is ruled out below 13, where no safe and effective dose could be established. Schedule II; brand and generic.

Forms & Strengths

Extended-release capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg

Dosing

Age: ≥ 13 y/o; not established at 12 years and younger
Onset: 2-4 hours to measurable effect
Duration: up to 16 hours
Release Profile: Triple bead; one immediate-release plus two delayed-release beads releasing at pH 5.5 and pH 7.0. Tmax 7-10 hours pediatric, about 8 hours adult
Initial Dose:
- 13-17 y/o: 12.5 mg once daily on awakening
- 18-55 y/o: 12.5 mg once daily on awakening; 25 mg may be considered
- Severe renal impairment (GFR 15 to < 30), adults: 12.5 mg once daily. ESRD not recommended at any age
Titration: 12.5 mg no sooner than weekly, at any age
Max Dose:
- 13-17 y/o: 25 mg/day; above 25 mg not evaluated in pediatric trials. Severe renal impairment: 12.5 mg/day
- 18-55 y/o: 50 mg/day; no additional benefit above 50 mg. Severe renal impairment: 25 mg/day
- No dosing recommendation above age 55
Considerations: Give on awakening; effect may last 16 hours. Take consistently with or without food, since a high-fat meal delays Tmax 4.5 to 5 hours. A missed dose is skipped.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
Delivery / Release: Two pH triggers rather than a timed matrix stage the second and third releases down the gut
Formulation: Four salts in equal weight, 3:1 dextro to levo. Linear over 12.5 to 50 mg, steady state days 7 to 8
Metabolism: CYP2D6 to 4-hydroxyamphetamine. Half-life 10-11 h d-amphetamine, 10-13 h l-amphetamine. Renal excretion is pH dependent
Pharmacogenomics: No genotype-directed dosing in the label; the actionable consequence is the CYP2D6-inhibitor interaction
Class Positioning: Same salts as Adderall XR plus a third pH 7.0 bead, extending 12 hours to 16, at the cost of the age-13 floor. Uniquely pH-dependent, so alkalinizers and PPIs matter more

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 13 y/o. The only approved indication.

Off-Label Uses

ADHD in children 6 to 12 (ICD-10: F90.x): studied in two trials and rejected; negative on dose-finding. Use Adderall XR instead.
Narcolepsy (ICD-10: G47.419): off-label at every age; insufficient. Use an approved product: Adderall, Zenzedi, Dexedrine Spansule.
Binge eating disorder (ICD-10: F50.81): lisdexamfetamine holds this indication, adults only; insufficient here.
Where the evidence does not support use: depression augmentation; no pediatric evidence for triple-bead mixed salts (AHRQ 2024).
Cognitive enhancement without ADHD: not an indication; not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction; misuse can cause overdose and death. Assess abuse risk before prescribing and monitor frequently throughout.
Contraindicated:
- Known hypersensitivity to amphetamine products or any ingredient in Mydayis
- MAOI use, current or within 14 days
Use with caution (label Warnings, not contraindications):
- Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; the label says avoid
- Pre-existing hypertension; blood pressure and heart rate rise
- Psychosis or bipolar disorder
- Prior seizure or EEG abnormality
- Peripheral vasculopathy including Raynaud phenomenon
- Tics or Tourette syndrome, personal or family
- Substance use disorder, patient or household
- Severe renal impairment; start and maximum both halve, ESRD not recommended
- Settings where substitution error is likely; the label carries a dedicated overdose warning
Screen before starting:
- Cardiac and family history of sudden death or ventricular arrhythmia; ECG only if positive
- Tics, Tourette syndrome and mania risk factors, including family history
- Abuse and diversion risk
- Baseline height, weight, blood pressure and heart rate
- Baseline sleep pattern, before adding a 16-hour agent

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, IV methylene blue): hypertensive crisis; do not give within 14 days.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone, St John's Wort): serotonin syndrome; counsel on symptoms and stop both if it occurs.
CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion, quinidine): raise exposure; start lower and monitor at each increase.
Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels and can unlock the beads early; avoid.
Acidifying agents (ascorbic acid, fruit juices): lower levels; adjust on response, not assumed failure.
Proton pump inhibitors (omeprazole): raise gastric pH and shift Tmax earlier; adjust timing.
Alcohol: in vitro, 20% and especially 40% alcohol increased release from the capsule; counsel on dose dumping.

Administration

Once daily on awakening; up to 16 hours of effect means later dosing costs sleep.
Take consistently with food or without, never alternating.
Swallow whole, or sprinkle the entire contents on applesauce, eaten immediately without chewing. Do not store.
Do not divide a capsule; sprinkling is a swallowing accommodation, not a dose split.
If a dose is missed, skip it and resume the next morning; never make it up.
Switching from another amphetamine: stop it and titrate from 12.5 mg weekly. No milligram-for-milligram conversion exists.
Store securely, preferably locked.

Side Effects

Common, 13 to 17: decreased appetite 22%, insomnia 8%, nausea 8%, irritability 6%, decreased weight 5%, dizziness 4%, upper abdominal pain 4%
Common, adults: insomnia 31%, decreased appetite 30%, weight decreased 9%, anxiety 7%, depression 3%, bruxism 2%
Serious:
- Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
- Psychosis, mania and new aggression. Consider discontinuing.
- Serotonin syndrome. Stop both drugs and treat supportively.
- Seizures. Discontinue.
- Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
- Growth suppression. Interrupt if height or weight gain falls behind.
- New or worsening motor and verbal tics. Discontinue if clinically appropriate.
- Overdose from substitution error between amphetamine products.

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months; act above the age-specific 95th percentile.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if the adolescent crosses two major percentile lines.
Sleep: at every visit and dose change, asking specifically about sleep-onset latency.
Appetite and weight: at every visit and every dose change.
Psychiatric and tics: psychosis, mania, aggression, irritability and new tics at every visit.
Peripheral vasculopathy: inspect fingers and toes at every visit.
Abuse and Diversion: adherence, pill counts and PDMP check at every refill.
Renal function: at baseline where impairment is suspected, and annually.
Laboratory: none routinely.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; no taper is required.
Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
Rebound irritability and hunger land late in the evening with a 16-hour agent, not after school.
Interrupt treatment where growth or weight gain falls behind.
Drug holidays fit poorly here; where appetite or growth is limiting, switch to a shorter product instead.

Pregnancy & Lactation

Pregnancy: Data insufficient to inform a risk of major birth defects or miscarriage. Premature delivery and low birth weight reported. Monitor exposed newborns for withdrawal.
Lactation: Label says breastfeeding is not recommended. Relative infant dose 2 to 13.8%, milk/plasma ratio 1.9 to 7.5; no reported infant adverse effects.
Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychiatric Medications, 1-866-961-2388.

Counseling Points

Counsel the family on:
- The 16-hour duration is both the reason for choosing it and the reason to watch sleep in week one.
- Dosing on waking every day and never taking a missed dose later; a noon dose is a sleepless night.
- Taking it the same way daily, with or without food, because switching moves the peak by about five hours.
- Alcohol releases amphetamine faster from this capsule in laboratory testing.
- Antacids and reflux medicines change when the later beads open, because they unlock on gut pH.
- Never swapping this for another amphetamine capsule at the same milligrams; Mydayis 37.5 mg is not Adderall XR 37.5 mg.
- Sprinkling being a swallowing accommodation, not a dose split.
- Locked storage; sharing or selling a Schedule II medication is a felony.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness or colour change in the fingers or toes.
- A new or markedly worse tic, or a seizure of any kind.
- Falling asleep after 1 am on more than a night or two.
- Weight loss, or clothes fitting more loosely over a few weeks.
- Agitation, shivering, sweating or confusion after an antidepressant change.

References

DailyMed. MYDAYIS (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate) extended-release capsules prescribing information. Takeda Pharmaceuticals America. Revised 4/2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=141a7970-3f06-44ea-9ab7-aeece2c085fc
LactMed. Amphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
openFDA. NDC Directory, generic_name "amphetamine aspartate". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Onyda XR

(clonidine hydrochloride extended-release oral suspension, 0.1 mg/mL)

Onyda XR (clonidine hydrochloride); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Onyda XR is extended-release clonidine as an orange-flavoured oral suspension, a central alpha-2 adrenergic agonist approved for ADHD in patients 6 years and older, as monotherapy or added to a stimulant. It is the only clonidine product dosed once daily at bedtime, and the only liquid alpha-2 agonist, which is what recommends it for a child who cannot swallow tablets or who needs a dose the tablet cannot make. Not controlled; brand only, from a single manufacturer.

Forms & Strengths

Extended-release oral suspension (orange, light beige to tan, viscous): 0.1 mg/mL
Dose maps to volume: 0.1 mg is 1 mL, 0.2 mg is 2 mL, 0.3 mg is 3 mL, 0.4 mg is 4 mL

Dosing

Age: 6 y/o and older; not established below 6 years
Onset: sedation within hours; ADHD benefit over weeks, trial endpoint at 5 weeks
Duration: once daily; clonidine half-life 12 to 16 hours, up to 41 in severe renal impairment
Release Profile: clonidine complexed with sodium polystyrene sulfonate; 0.095 mg/mL resin-bound plus 0.005 mg free. Steady-state exposure close to ER tablets twice daily, trough about 26% lower
Initial Dose: 0.1 mg (1 mL) once daily at bedtime, with or without food
Titration: 0.1 mg/day every 7 days
Max Dose: 0.4 mg (4 mL) once daily at bedtime; higher doses were not evaluated
Considerations: Shake gently at least 10 seconds before every dose and measure only with the supplied dispenser. Do not substitute for any other clonidine product mg-for-mg, and never stop abruptly.

For patients switching from another clonidine product, discontinue that treatment and titrate Onyda XR from 0.1 mg. Do not substitute milligram for milligram; the pharmacokinetic profiles differ.

Pharmacology

Mechanism: Central alpha-2 adrenergic agonist; reduces sympathetic outflow from the locus coeruleus and enhances prefrontal noradrenergic signalling. Not a CNS stimulant; mechanism in ADHD unknown.
Delivery / Release: Resin-complexed extended release; median Tmax 7.5 hours (range 4 to 17) against 3 to 5 for immediate release. Steady-state peak 107.9% and exposure 97.7% of ER tablets. Food has no effect.
Metabolism: About 50% hepatic, 40% to 60% renal unchanged. Half-life 12 to 16 hours, up to 41 hours in severe renal impairment.
Alcohol and dose dumping: in vitro, 20% alcohol produced faster and more variable release; 5% and 10% did not.
Class Positioning: Non-selective, more sedating than guanfacine (Intuniv). Same pharmacology as clonidine ER tablets but once daily and measurable to any dose; IR clonidine is not ADHD approved.

Indications

ADHD, as monotherapy (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older
ADHD, as adjunctive therapy to CNS stimulants (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older

Off-Label Uses

Tic disorders and Tourette syndrome (ICD-10: F95.1, F95.2): supported by controlled trials for the class, limited data for this product. (AACAP 2013)
Sleep-onset insomnia in ADHD (ICD-10: G47.00): limited data. Somnolence is a labeled adverse effect, but this is the only clonidine whose labeled schedule is a single bedtime dose.
Where the evidence does not support use:
- Children under 6 (ICD-10: F90.x): insufficient (AHRQ 2018), though the liquid makes dosing a preschooler easy
- Oppositional defiant disorder and aggression (ICD-10: F91.3): insufficient
- Anxiety and PTSD (ICD-10: F41.x, F43.1): insufficient

Contraindications & Warnings

Contraindicated: history of hypersensitivity to clonidine, including generalised rash, urticaria or angioedema
Use with caution:
- Hypotension, heart block, bradycardia, cardiovascular or cerebrovascular disease, renal failure; titrate slowly
- Syncope, orthostatic hypotension, or a tendency to dehydration; avoid dehydration and overheating
- Conduction abnormality or concurrent sympatholytics; severe bradycardia needing pacing reported
- Concurrent CNS depressants, because of additive sedation
- Renal impairment; set the initial dose by degree of impairment
- Recurrent vomiting illness, named in this label: missed doses raise the rebound hypertension risk
- Prior sensitisation to the clonidine patch; oral use may cause generalised rash
Screen before starting:
- Heart rate and blood pressure, supine and standing; the label makes this mandatory
- Syncope, palpitations, conduction disease, family history of sudden cardiac death, and all sedating or sympatholytic co-medication
- Renal function
- Whether the family can measure a liquid dose reliably and track the discard window

Drug Interactions

Sinus node and AV nodal agents (digitalis, calcium channel blockers, beta-blockers): additive bradycardia and AV block; label says avoid use. If unavoidable, check vitals each visit
CNS depressants (alcohol, barbiturates, benzodiazepines, phenothiazines, sedating antihistamines): potentiated sedation; reduce or avoid, and counsel adolescents on alcohol
Antihypertensives: potentiated hypotension; monitor blood pressure and adjust
Tricyclic antidepressants: may reduce the hypotensive effect; recheck blood pressure when either is started or stopped
Amphetamine: clonidine clearance 44% lower, and 11% higher with methylphenidate; titrate more cautiously and watch for sedation and bradycardia

Administration

Once daily at bedtime, with or without food
Insert the press-in bottle adapter before first use and leave it in place
Shake gently up and down at least 10 seconds before every dose; vigorous shaking foams it and spoils the draw
Measure only with the supplied oral dispenser, never a spoon
Supplied in 30 mL, 60 mL and 120 mL bottles
Discard 30 days after opening a 30 mL or 60 mL bottle, 60 days after opening a 120 mL bottle. Store at room temperature, protected from light
Missed dose: skip it; never exceed the prescribed daily total
Switching: stop the other product and titrate from 0.1 mg; never convert mg-for-mg from ER tablets or IR clonidine
Do not stop abruptly; see Discontinuation & Taper

Side Effects

Common (at least 5% and twice placebo, from the ER tablet trials this label cites):
- Somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth
- Somnolence 38% at 0.2 mg/day and 31% at 0.4 mg/day, vs 4% placebo
- As adjunct: somnolence 19% vs 7%, plus fatigue, decreased appetite, dizziness
Serious:
- Rebound hypertension on abrupt discontinuation; this label adds that a vomiting illness causing missed doses raises that risk
- Dose-related hypotension and bradycardia; hold or reduce and recheck
- Syncope; stop and check orthostatic vitals before further titration
- Conduction abnormality or AV block; severe bradycardia has needed pacing. Obtain an ECG and stop
- Allergic reactions including generalised rash, urticaria and angioedema; discontinue

Monitoring & Labs

Heart rate and blood pressure: baseline, 1 to 2 weeks after each increment, then every 3 months; hold titration for bradycardia by age
Orthostatics: lying and standing at baseline, every dose change, and any dizziness visit
Sedation: ask about morning grogginess at every titration visit and every visit for 3 months
Rebound hypertension risk: at every refill confirm no missed doses or supply gap, and ask about recent gastroenteritis
Dosing technique: at first follow-up have the caregiver demonstrate shaking and drawing the dose
ADHD response: rated scale at 5 to 8 weeks, matching the bridged trial endpoint
ECG: not routine; baseline if conduction disease, syncope history or concurrent sympatholytics, and promptly for new syncope or bradycardia
Renal function: baseline and annually
Laboratory: no routine laboratory monitoring required

Discontinuation & Taper

Never stop abruptly. Reduce by no more than 0.1 mg (1 mL) every 3 to 7 days; from 0.4 mg that is 12 days to 4 weeks
Abrupt cessation in adults: headache, tachycardia, nausea, flushing, chest tightness, anxiety
With immediate-release clonidine: nervousness, agitation, tremor and a rapid rise in blood pressure
A vomiting illness is de facto abrupt discontinuation, named in this label for children; families should call, and recheck blood pressure afterwards
Measure blood pressure and heart rate at each taper step and after the last dose
Drug holidays are not appropriate for this class. Weekend and summer breaks are a rebound hypertension risk here

Pregnancy & Lactation

Pregnancy: decades of human use show no identified risk of major birth defects, miscarriage or adverse outcomes. Animal resorptions at 10x (rat) and 5x (mouse) the maximum human dose; no rabbit effect to 3x.
Lactation: relative infant dose 4.1% to 8.4%; milk levels about double maternal serum. Most infants unaffected; one case of sedation, hypotonia and apnoea. Monitor for lethargy, tachypnoea and poor feeding. (LactMed 2024)
Lactation, milk supply: dose-related oxytocin and prolactin effects, with postpartum galactorrhea reported. Other agents are preferred while nursing a newborn or preterm infant. (LactMed 2024)
Fertility: animal findings suggest impaired fertility in both sexes
Exposure Registry: National Pregnancy Registry for Psychiatric Medications, 1-866-961-2388, womensmentalhealth.org

Counseling Points

Counsel the family on:
- Shaking gently 10 seconds before every dose, and using only the supplied dispenser; an unshaken bottle underdoses early and overdoses late
- Writing the opening date on the bottle, because it is discarded at 30 or 60 days whether or not it is empty
- The bedtime-only schedule; this is not the twice-daily tablet and the dose does not carry across
- Sleepiness early being expected while the ADHD benefit takes weeks; watch for morning grogginess
- Never stopping on their own; name rebound high blood pressure in those words, and never doubling a missed dose
- Calling during any stomach bug that stops the medicine going down
- Avoiding alcohol in adolescents, for sedation and because alcohol can speed release
Advise them to call for:
- Fainting, or dizziness on standing that does not settle
- A pulse that feels very slow or irregular
- Morning sleepiness affecting school, or a child hard to wake
- Severe headache with blurred vision, especially after missed doses
- New hives, facial or lip swelling, or a widespread rash
- Any vomiting illness that stops the medicine going down

References

DailyMed. Onyda XR (clonidine hydrochloride) extended-release oral suspension prescribing information. NextWave Pharmaceuticals. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a15c850-9da5-4bdc-a34d-7f740a6149b7
DailyMed. Clonidine hydrochloride extended-release tablets prescribing information. Actavis Pharma, Inc. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0100c70d-7fde-46a1-8374-940550a27e43
LactMed. Clonidine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2024. https://www.ncbi.nlm.nih.gov/books/NBK501628/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AACAP. Practice parameter for the assessment and treatment of children and adolescents with tic disorders. Journal of the American Academy of Child and Adolescent Psychiatry. 2013. https://www.jaacap.org/article/S0890-8567(13)00695-3/fulltext
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 203. 2018. https://www.ncbi.nlm.nih.gov/books/NBK487764/
FDA. openFDA National Drug Code Directory, clonidine, queried by generic name across all labelers. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22clonidine%22&limit=1000

ProCentra

(dextroamphetamine sulfate)

ProCentra (dextroamphetamine sulfate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

ProCentra is an immediate-release, short-acting oral solution of single-entity dextroamphetamine sulfate, approved for ADHD from age 3 through 16 and for narcolepsy. It contains only the d-isomer and gives a short block of coverage per dose rather than a school day. Its differentiator is the liquid: the only immediate-release amphetamine titratable in fractions of a milligram for a preschooler or a child who cannot swallow. Schedule II; brand and generic.

Forms & Strengths

Oral solution (bubblegum, colorless; 16 fl oz bottle): 5 mg/5 mL, that is 1 mg/mL

Dosing

Age:
- ADHD: 3-16 y/o, the range this label's indication is written for
- Narcolepsy: ≥ 6 y/o, no upper bound
Onset: 30 to 60 min
Duration: 4 to 6 hours
Initial Dose:
- ADHD, 3-5 y/o: 2.5 mg daily, that is 2.5 mL
- ADHD, 6-16 y/o: 5 mg once or twice daily
- Narcolepsy, 6-11 y/o: 5 mg daily
- Narcolepsy, ≥ 12 y/o: 10 mg daily
Titration:
- ADHD, 3-5 y/o: 2.5 mg every 7 days
- ADHD, 6-16 y/o: 5 mg every 7 days
- Narcolepsy, 6-11 y/o: 5 mg every 7 days
- Narcolepsy, ≥ 12 y/o: 10 mg every 7 days
Max Dose:
- ADHD: 40 mg/day at any age; the label says only in rare cases will it be necessary to exceed this
- Narcolepsy: usual range 5-60 mg/day in divided doses
Considerations: The maximum is set by indication, not by age or weight. First dose on awakening, then one or two more at 4-6 hour intervals. This is a solution, not a suspension; it does not need shaking.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: A true solution, already dissolved; no disintegration step, no modified-release component
Formulation: d-isomer only; at the same milligram dose as a mixed-salt or racemic amphetamine, more CNS effect and less of the peripheral contribution the l-isomer carries
Metabolism: 10 mg gave a mean peak of 33.2 ng/mL, half-life 11.75 hours, 38% urinary recovery over 48 hours; excretion is pH dependent
Half-life is not duration: the dosing interval is 4 to 6 hours despite an 11.75 hour half-life
Class Positioning: the moiety and release profile of Zenzedi in a form a 3 year old can take and that titrates continuously; Dexedrine Spansule is the extended-release sibling
Against Dyanavel XR, the other liquid amphetamine: pure d-isomer, immediate-release, several doses daily

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 3-16 y/o, within a total treatment program
Narcolepsy (ICD-10: G47.419): patients ≥ 6 y/o; the label notes it seldom occurs under 12

Off-Label Uses

ADHD over age 16 (ICD-10: F90.x): outside this label's range, though the tablets carry an adult indication elsewhere. Use in a 17 year old who cannot swallow tablets is expert consensus.
Where the evidence does not support use:
- Non-ADHD, non-narcolepsy indications in youth: AHRQ CER 267 graded none (AHRQ 2024).
- Weight management: unlike Evekeo, this label carries no obesity indication. Not supported.
- Cognitive enhancement without ADHD: not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High abuse potential leading to substance use disorder; overdose and death, more so at higher doses or by snorting or injection. Assess risk before prescribing; reassess throughout.
Contraindicated:
- Known hypersensitivity to amphetamine products
- MAOI use, current or within 14 days; hypertensive crisis
Use with caution (Warnings, not contraindications):
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
- Pre-existing hypertension; pre-existing psychosis; bipolar disorder, for treatment-emergent mania
- Motor or phonic tics or Tourette syndrome; peripheral vasculopathy including Raynaud phenomenon
- Substance use disorder in the household; a palatable liquid in a 16 ounce bottle is a different risk from a blister pack
Screen before starting:
- Cardiac history, family history of sudden death or arrhythmia, and exam
- Personal and family history of tics; mania risk from personal or family depression, bipolar disorder or suicide
- Abuse and diversion risk; baseline height, weight, BP, HR

Drug Interactions

MAOIs (including furazolidone): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Confirm a 14 day washout.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone): serotonin syndrome. Start lower; stop both drugs if symptoms appear.
CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
Acidifying agents (ascorbic acid, fruit juices, ammonium chloride): lower absorption and efficacy. A caregiver mixing a dose into orange juice is creating this interaction; instruct that the dose is given straight.
Alkalinizing agents (bicarbonate, antacids, acetazolamide): raise levels. Reduce the dose rather than assuming lost tolerance.
Tricyclic antidepressants (desipramine, protriptyline): sustained rise in brain d-amphetamine. Monitor BP and HR; titrate slowly.
Sympathomimetics and antihypertensives: additive cardiovascular effect; hypotensive effect antagonized. Avoid OTC decongestants; recheck BP.

Administration

First dose on awakening, one or two more at 4-6 hour intervals, with or without food.
This is a solution, not a suspension. It does not need shaking. Any instruction to shake the bottle was carried over from a different product.
Measure with a calibrated oral syringe, never a spoon: at 1 mg/mL a 2.5 mg dose is 2.5 mL. Confirm the pharmacy supplied one; this label names no dosing device.
Give the dose straight, not in juice. Fruit juice acidifies and lowers absorption, and is a common invisible cause of apparent treatment failure.
Avoid late evening doses; the label names resulting insomnia.
Interrupt occasionally to see whether symptoms recur at a level requiring continued therapy; a label instruction.
Store at room temperature in a tight, light-resistant container, securely and preferably locked.

Side Effects

Common: decreased appetite and weight loss, insomnia, overstimulation, irritability and dysphoria, headache, dizziness, tremor, dry mouth, unpleasant taste, bowel change, palpitations, tachycardia, elevated blood pressure.
Serious:
- Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor.
- Psychosis or mania, roughly 0.1% in pooled stimulant trials; consider discontinuing.
- Serotonin syndrome; stop both drugs and treat supportively.
- Peripheral vasculopathy including Raynaud phenomenon; reduce or stop.
- Growth suppression; interrupt in a child not growing as expected.
- New or worsening tics; rhabdomyolysis; intestinal ischemia.
- Impotence and changes in libido, which an adolescent may not volunteer.

Monitoring & Labs

Cardiovascular: HR and BP at baseline, each dose change, and every 6 months; mean rise 2-4 mm Hg and 3-6 bpm.
Growth: height, weight and BMI charted at baseline and every 6 months; this matters most in the 3 to 5 year olds the formulation exists to serve.
Appetite and sleep: every visit; usually fixed by timing rather than dose.
Psychiatric, tics and digits: psychosis, mania, aggression and dysphoria at each visit and 2 weeks after any increase; ask about motor and phonic tics and inspect the digits.
Dosing technique: watch the caregiver draw a dose at first follow-up and whenever response turns erratic; ask whether it is being mixed into juice, which looks like tolerance.
Volume accounting: at each refill reconcile volume dispensed against daily dose and days elapsed; a liquid cannot be pill-counted.
Abuse and diversion: adherence and PDMP check at each refill; reassess need for therapy at least annually.
Laboratory: none routinely; amphetamines interfere with urinary steroid assays.

Discontinuation & Taper

Can be stopped abruptly at therapeutic doses; no taper required.
Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
End-of-dose rebound irritability and hunger is pharmacodynamic offset, not withdrawal.
Planned interruptions are asked for by this label; drug holidays suit appetite or growth as the limiting problem.

Pregnancy & Lactation

Pregnancy: No adequate controlled studies. Embryotoxic and teratogenic in two mouse strains at about 41 times the maximum human dose; not in rabbits at 7 or rats at 12.5 times.
Pregnancy, human data: one VATER-association case report, bony deformity with tracheoesophageal fistula and anal atresia, after first-trimester use with lovastatin. One confounded case is not a causal finding.
Pregnancy, clinical: increased premature delivery and low birth weight in dependent mothers; infants may withdraw. Weigh rather than abstain.
Lactation: the label says amphetamines enter milk and mothers should not nurse.
Lactation, dextroamphetamine: four mothers on a mean 18 mg daily gave a median milk level of 219 mcg/L, 5.7% of the maternal dose, with all four infants normal. (LactMed 2025)
Lactation, milk supply: a 20 mg dose suppressed prolactin about 40% postpartum; large doses may impair production where lactation is not established. (LactMed 2025)

Counseling Points

Counsel the family on:
- That this bottle does not need shaking, unlike ADHD liquids they may have used before. Say it explicitly.
- Giving the dose straight rather than in orange juice, because acid turns a working dose into a failing one.
- Measuring with the oral syringe, and that 1 mL equals 1 mg so a small volume error is a large dose error.
- The 4-6 hour window, and that a second or third dose usually covers the afternoon.
- End-of-dose rebound irritability and hunger; not a signal to increase the dose.
- Appetite suppression peaking midday; largest meal at breakfast and in the evening.
- Storing the bottle locked; bringing a teacher rating scale to the next visit.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness or colour change in the fingers or toes.
- A new or worse tic, new throat clearing or blinking; weight loss.
- Any accidental swallow by another child; for a 16 ounce bottle of a Schedule II liquid that is an emergency call.

References

DailyMed. ProCentra (dextroamphetamine sulfate) oral solution prescribing information. Independence Pharmaceuticals. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1548cce2-fb6b-4f17-8a3b-868933f6c9d6
FDA. openFDA National Drug Code Directory, generic_name "dextroamphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22dextroamphetamine%22&limit=1000
LactMed. Dextroamphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/
AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Prozac

(fluoxetine)

Prozac (fluoxetine); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Prozac is a selective serotonin reuptake inhibitor approved for major depressive disorder from 8 years of age and for obsessive-compulsive disorder from 7 years. Response is judged over weeks of continuous dosing. Its half-life is the longest in the class, so it is effectively self-tapering and forgiving of a missed dose. Not controlled; brand and generic.

Forms & Strengths

Capsules, immediate release: 10 mg, 20 mg, 40 mg
Tablets: 10 mg, 20 mg, 60 mg
Oral solution: 20 mg/5 mL (4 mg/mL)
Capsule, delayed release, once weekly: 90 mg. A separate label; NEVER studied in children
Olanzapine and fluoxetine capsules: fluoxetine 25 mg or 50 mg with olanzapine 3, 6 or 12 mg

Dosing

Age:
- MDD: 8 y/o and older
- OCD: 7 y/o and older
- Bipolar I depression, with olanzapine: 10 y/o and older
Onset: 4 weeks or longer in MDD; 5 weeks or longer in OCD
Duration: continuous with once-daily dosing
Initial Dose:
- Pediatric MDD: 10 or 20 mg/day; 10 mg/day if lower weight
- Pediatric OCD: 10 mg/day at any weight
- Adults: 20 mg/day
Titration:
- Pediatric MDD: to 20 mg/day after 1 week; OCD: to 20 mg/day after 2 weeks
- Further increases only after several more weeks, never weekly
Max Dose:
- Ceiling at any age or indication: 80 mg/day
- Pediatric OCD: 60 mg/day, or 30 mg/day if lower weight
- Pediatric MDD: no separate maximum; trials used 10 to 20 mg/day
Considerations: Give in the morning; a dose above 20 mg/day may be split between morning and noon. Use a lower or less frequent dose in cirrhosis.

Pharmacology

Mechanism: Blocks presynaptic serotonin reuptake at SERT, without the tricyclics' anticholinergic and sedative burden
Delivery / Release: immediate release; food does not affect bioavailability
Metabolism: hepatic via CYP2D6 to active norfluoxetine. Half-life 4 to 6 days on chronic dosing, norfluoxetine 4 to 16 days, steady state at 4 to 5 weeks
Class Positioning: a POTENT CYP2D6 inhibitor persisting up to 5 weeks after the last dose, unlike Zoloft. The only SSRI with a pediatric MDD indication

Indications

Major Depressive Disorder (ICD-10: F32.x, F33.x): 8 y/o and older
Obsessive-Compulsive Disorder (ICD-10: F42.x): 7 y/o and older
Bulimia Nervosa (ICD-10: F50.2): adults only, at 60 mg/day
Panic Disorder (ICD-10: F41.0): adults only
Bipolar I depression, with olanzapine only (ICD-10: F31.x): 10 y/o and older
Treatment-resistant depression, with olanzapine only: adults

Off-Label Uses

Pediatric anxiety disorders (ICD-10: F41.1, F40.10, F93.0): supported; AHRQ graded SSRIs moderate to high, with CBT outperforming fluoxetine (AHRQ 2017). On-label alternative: Cymbalta from 7 y/o
MDD in CHILDREN rather than adolescents (ICD-10: F32.x): graded low in adolescents, INSUFFICIENT in children (AACAP 2023)
Bulimia nervosa in adolescents (ICD-10: F50.2): insufficient at any dose

Contraindications & Warnings

Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS in children, adolescents and young adults.
- Monitor closely for worsening and emergent suicidality in the initial few months and at every dose change, up or down.
- Observation must include DAILY observation at home. Dispense the smallest quantity consistent with good management.
Contraindicated:
- An MAOI concurrently, within 5 WEEKS of stopping Prozac, or Prozac within 14 days of an MAOI. That 5-week exit washout is longer than the rest of the class, set by norfluoxetine's half-life.
- Linezolid or intravenous methylene blue.
- Pimozide and thioridazine; fluoxetine raises both via CYP2D6 and all three prolong QT.
Use with caution:
- Seizure history; long QT, hypokalemia, hypomagnesemia, recent myocardial infarction, heart failure, bradyarrhythmias.
- Narrow angles without a patent iridectomy; diabetes; cirrhosis, needing a lower dose.
- Underweight patients; NSAIDs, aspirin, anticoagulants, diuretics; prior rash on fluoxetine.
Screen before starting:
- Personal and family history of bipolar disorder, mania or hypomania; baseline height, weight and sexual function.
- QT risk factors, and a medication list for CYP2D6 substrates, MAOIs and anticoagulants.

Drug Interactions

MAOIs (phenelzine, selegiline, linezolid, methylene blue): contraindicated. 14 days before starting Prozac, 5 WEEKS after stopping it
CYP2D6 substrates including atomoxetine (Strattera, TCAs, antipsychotics): start low, and treat anyone dosed within the previous 5 weeks as still on fluoxetine.
- For atomoxetine, lengthen the titration interval to 4 weeks rather than lowering the target dose.
- This pair, and Qelbree, stack two pediatric suicidality boxed warnings.
Bupropion (Wellbutrin XL): doubles 2D6 inhibition and stacks seizure cautions
Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, lithium, AMPHETAMINES): serotonin syndrome. Stop all for agitation, hyperthermia, rigidity or myoclonus
Tricyclics, phenytoin, carbamazepine: levels rise for weeks; check when fluoxetine starts and stops
NSAIDs, aspirin, warfarin: bleeding; check the INR at both ends
QT-prolonging drugs (ziprasidone, erythromycin, amiodarone, methadone): avoid, or obtain an ECG before each increase

Administration

Give once daily in the morning; split a dose above 20 mg for daytime nausea rather than reducing it.
With or without food. Swallow capsules and tablets whole; the oral solution is the only form delivering below 10 mg.
Missed dose: resume at the next dose; do not double up.
Never use the 90 mg once-weekly capsule in a pediatric patient or in place of daily dosing.
Switching to an MAOI: allow 5 weeks off fluoxetine. From an MAOI: allow 14 days.

Side Effects

Common: nausea, insomnia, nervousness, somnolence, anxiety, diarrhea, anorexia, dry mouth, tremor, asthenia.
- Pediatric trials add thirst, hyperkinesia, agitation, epistaxis, urinary frequency and menorrhagia.
Serious:
- Suicidal thoughts and behavior: the boxed warning. Change the regimen, including stopping, if suicidality emerges.
- Serotonin syndrome: stop every serotonergic agent immediately and treat supportively.
- Mania or hypomania, in 2.6% of pediatric patients. Stop and reassess for bipolar disorder.
- Rash and systemic hypersensitivity. Discontinue on any unexplained rash.
- Hyponatremia and SIADH; QT prolongation and torsades; seizures.
- Growth lag: 1.1 cm and 1.1 kg below placebo at 19 weeks.
- Bleeding; angle-closure glaucoma; sexual dysfunction.

Monitoring & Labs

Suicidality: every visit for 3 months, at every dose change in either direction, then every 3 months. Instruct the family in DAILY home observation for the first month
Activation and mania: screen for bipolar history before the first dose, then ask about reduced sleep need, pressured speech and elevated mood every 3 months
Growth: plot height and weight at baseline, every 3 months for the first year, then every 6 months
Hyponatremia: check sodium for new headache, confusion or unsteadiness, or when a diuretic is started
Bleeding: ask about bruising and nosebleeds every 3 months; check the INR on warfarin
Response: do not judge efficacy before 4 weeks in MDD or 5 weeks in OCD; reassess every 6 months, with sexual function

Discontinuation & Taper

Effectively self-tapering: both fluoxetine and norfluoxetine fall gradually at the end of therapy, minimizing discontinuation symptoms.
The contrast that drives drug choice: Zoloft has a 26-hour half-life and must be reduced gradually. Where adherence is unreliable, fluoxetine is safer.
A gradual reduction is still preferred; reactions include dysphoric mood, irritability, dizziness, electric shock sensations and insomnia. If they follow a decrease, resume the previous dose.
Drug holidays are not appropriate; steady state takes 4 to 5 weeks, so a break resets the clock.
Interactions outlast the drug: for 5 weeks an MAOI and thioridazine stay contraindicated.

Pregnancy & Lactation

Pregnancy: decades of data have not established increased risk of major birth defects or miscarriage.
- Later exposure may raise the risk of persistent pulmonary hypertension of the newborn; third-trimester exposure has produced respiratory distress, feeding difficulty, hypotonia and irritability.
- Weigh rather than abstain: women who stopped antidepressants in pregnancy relapsed more often.
Lactation: present in human milk; agitation, irritability, poor feeding and poor weight gain reported.
- Milk levels run HIGHER than most other SSRIs, relative infant dose roughly 2.4% to 7%, with no adverse developmental effects to 5 years (LactMed 2026).
- Zoloft is the lower-exposure choice when starting an SSRI while nursing.
Exposure Registry: National Pregnancy Registry for Antidepressants, 1-844-405-6185, womensmentalhealth.org

Counseling Points

Counsel the family on:
- Nothing much happening for two weeks. Name the review point aloud: 4 weeks for depression, 5 for OCD.
- Taking it in the morning, and splitting a dose above 20 mg if nausea is the problem.
- A missed dose being forgiving here, and a dose increase taking weeks to show for the same reason.
- Never accepting a 90 mg once-weekly capsule; it has never been studied in children.
- Telling every future prescriber about fluoxetine taken within the last 5 weeks.
- Daily home observation for the first month for out-of-character behaviour.
Advise them to call for:
- New or worsening talk of self-harm, or any abrupt mood change after a dose change.
- Days without needing sleep, much faster speech, or a jump in energy.
- Any rash or hives, particularly with fever or joint swelling.
- Shivering, twitching, stiffness, racing heart, sweating and confusion together.
- Nosebleeds that will not stop, unexplained bruising, or black stools.
- Fainting, irregular heartbeat, or a seizure.

References

DailyMed. Prozac (fluoxetine) capsule. Dista Products Company. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299
DailyMed. Fluoxetine delayed release capsule, 90 mg weekly. Dr. Reddy's. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=887fc670-db67-4cfe-967b-46b38375dae5
LactMed. Fluoxetine. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501186/
AHRQ. Anxiety in children. CER No. 192, 17-EHC023-EF. 2017. https://www.ncbi.nlm.nih.gov/books/NBK476277/
AACAP. Depressive disorders practice guideline. 2023. PMID 36273673. https://www.jaacap.org/article/S0890-8567(22)01852-4/fulltext
FDA. NDC Directory, openFDA, generic name fluoxetine. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22fluoxetine%22&limit=1000

Qelbree

(viloxazine)

Qelbree (viloxazine); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Qelbree is a selective norepinephrine reuptake inhibitor supplied as an extended-release capsule taken once daily, approved for ADHD in adults and in children from 6 years of age. It is the second non-stimulant of its class to reach the market and is titrated by fixed milligram steps rather than by weight, which makes the dose ladder simpler than atomoxetine's. Its defining prescribing constraint is that it is a strong CYP1A2 inhibitor, so sensitive CYP1A2 substrates are contraindicated outright rather than merely cautioned. Not controlled; brand only, with no generic marketed.

Forms & Strengths

Extended-release capsules: 100 mg, 150 mg, 200 mg
No oral liquid exists. The label's answer for a child who cannot swallow is to sprinkle the capsule contents

Dosing

Age: 6 y/o and older, and adults; not established below 6 y/o
Onset: weeks to clinical effect; not a rescue or as-needed medication
Duration: continuous with once-daily dosing; steady state in 2 days, no accumulation
Release Profile: extended-release beaded capsule, about 88% relative bioavailability against an immediate-release reference, median Tmax 5 hours (range 3 to 9)
Initial Dose:
- 6 to 11 y/o: 100 mg once daily
- 12 to 17 y/o: 200 mg once daily
- 18 y/o and over: 200 mg once daily
Titration:
- 6 to 11 y/o: 100 mg every 7 days
- 12 to 17 y/o: a single 200 mg increment after 1 week
- 18 y/o and over: 200 mg every 7 days
Max Dose:
- 6 to 11 y/o: 400 mg/day
- 12 to 17 y/o: 400 mg/day
- 18 y/o and over: 600 mg/day
Considerations: In severe renal impairment (eGFR under 30 mL/min/1.73 m2) start at 100 mg once daily, titrate by 50 to 100 mg weekly, and cap at 200 mg/day at any age. No adjustment for mild or moderate impairment.

Pharmacology

Mechanism: Selective norepinephrine reuptake inhibitor; raises synaptic NE and, indirectly, prefrontal dopamine. The label adds 5-HT2C binding with partial agonist activity. [VERIFY: house rule says 5-HT2C antagonism plus 5-HT2B agonism; this label says 5-HT2C partial agonism only]
Delivery / Release: Extended-release beaded capsule, about 88% relative bioavailability, median Tmax 5 hours. Food effects are not clinically meaningful, whether taken with a meal or sprinkled.
Metabolism: Primarily CYP2D6, UGT1A9 and UGT2B15, to 5-hydroxy-viloxazine glucuronide. Half-life 7.0 hours (SD 4.7), protein binding 76 to 82%. Elimination is renal: 90% recovered in urine within 24 hours, under 1% in feces.
Pharmacogenomics: no CYP2D6-based dose adjustment, unlike atomoxetine. Do not extrapolate atomoxetine's poor-metabolizer guidance to this drug.
Class Positioning: Same noradrenergic mechanism as atomoxetine (Strattera), but titrated in fixed milligram steps and carrying a strong CYP1A2 inhibition liability atomoxetine lacks.

Indications

Attention-Deficit/Hyperactivity Disorder (ICD-10: F90.x): patients 6 y/o and older, and adults

Off-Label Uses

None established. No off-label pediatric use meets even the "limited data" descriptor
Where the evidence does not support use:
- Depressive disorders (ICD-10: F32.x, F33.x): insufficient in youth. European antidepressant use decades ago is not evidence for this product at ADHD doses, and the drug can activate mania
- ADHD in autism spectrum disorder (ICD-10: F84.0 with F90.x): insufficient; no viloxazine-specific grade in this population. (AHRQ 2024)
- Comorbid tic disorders and anxiety (ICD-10: F95.2, F41.x): insufficient. Unlike atomoxetine, this label carries no non-worsening trials; absence of a reassuring trial is not a reassuring result

Contraindications & Warnings

Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS
- Pediatric: 9 of 1,019 (0.9%) reported ideation, behaviour or both, against 2 of 463 (0.4%) on placebo
- Adults: 3 of 189 (1.6%) against 0 of 183 on placebo; no attempted or completed suicides
- Monitor closely for clinical worsening, especially in the first months and at every dose change
Contraindicated:
- MAOI use, or within 14 days of stopping one; risk of life-threatening hypertensive crisis
- Any sensitive CYP1A2 substrate, or any CYP1A2 substrate with a narrow therapeutic range. Viloxazine is a strong CYP1A2 inhibitor; this is absolute, not a caution
Use with caution:
- Pre-existing hypertension or tachycardia; dose-related rise in rate and diastolic pressure
- Bipolar disorder or risk factors; can induce a manic or mixed episode
- Any situation requiring alertness; somnolence 16% against 4% on placebo
- Severe renal impairment (eGFR under 30 mL/min/1.73 m2), where the ceiling falls to 200 mg/day
- Moderate sensitive CYP1A2 substrates, not recommended; if unavoidable, reduce the substrate dose
Screen before starting:
- Heart rate and blood pressure; an explicit labeled pre-treatment step
- Psychiatric history including family history of suicide, bipolar disorder and depression
- Full medication list checked for CYP1A2 substrates, which are contraindicated
- Renal function where impairment is suspected; height and weight on a growth chart

Drug Interactions

MAOIs (phenelzine, tranylcypromine, linezolid, IV methylene blue): hypertensive crisis. Do not co-prescribe; allow 14 days in either direction
Sensitive and narrow-therapeutic-range CYP1A2 substrates: strong inhibition raises exposure substantially. Do not co-prescribe
Moderate sensitive CYP1A2 substrates: same mechanism, lesser magnitude. Not recommended; if unavoidable, reduce the substrate dose and watch for toxicity
CYP2D6 substrates (many antidepressants, antipsychotics, beta-blockers, class 1C antiarrhythmics): weak inhibition raises exposure. Monitor and adjust the substrate dose
CYP3A4 substrates: weak inhibition raises exposure. Monitor and adjust the substrate dose

Administration

Once daily, at the same time each day, with or without food
Swallow whole, or open and sprinkle the entire contents over a teaspoonful or tablespoonful of pudding or applesauce
If sprinkled, eat the mixture whole without chewing: within 15 minutes for pudding, 2 hours for applesauce. Never store a prepared mixture
Do not cut, crush or chew the capsule or its contents
Move the dose to the evening if daytime somnolence limits treatment
Missed dose: the label gives no instruction; resume the usual schedule and do not double up
For a child who needs a true liquid non-stimulant, atomoxetine is available as a 4 mg/mL oral solution

Side Effects

Common (pooled pediatric trials, all doses vs placebo):
- Somnolence including sedation and lethargy 16 vs 4%, headache 11 vs 7%, decreased appetite 7 vs 0.4%
- Upper respiratory infection 7 vs 6%, fatigue 6 vs 2%, abdominal pain 5 vs 4%, nausea 5 vs 3%
- Vomiting 4 vs 2%, insomnia 4 vs 1%, irritability 3 vs 1%. Somnolence, fatigue and insomnia are dose related
Serious:
- Suicidal thoughts and behaviour, the boxed warning; consider stopping if they emerge, or on new insomnia, agitation or akathisia
- Blood pressure and heart rate rise: at 400 mg/day, 28% to 34% rose at least 20 bpm and 25% of adolescents at least 15 mm Hg diastolic
- Activation of mania or hypomania; stop and reassess the diagnosis
- Somnolence and fatigue impairing driving in adolescents; move or reduce the dose
- Weight: over 6 to 8 weeks, ages 6-11 gained 0.2 vs 1 kg placebo; ages 12-17 lost 0.2 vs a 1.5 kg gain. Weight-for-age z-score -0.2 at 12 months

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, after every increase, then every 3 months; act on a sustained rise of 20 bpm or 15 mm Hg diastolic
Suicidality: screen at every visit for 3 months and at every dose change; ask about new insomnia and irritability, named as precursors
Growth: height and weight at baseline, every 3 months for a year, then every 6 months; the adolescent weight signal is the larger one
Psychiatric: ask about manic and hypomanic symptoms at each titration visit and every 3 months once stable
Daytime alertness: ask the school as well as the family, at each titration visit and every 6 months; the commonest reason for stopping
Medication reconciliation: recheck the full list at every visit for newly added CYP1A2 substrates, which are contraindicated
Renal function: no routine schedule; recheck eGFR when circumstances change

Discontinuation & Taper

The label gives no tapering instruction and describes no withdrawal syndrome. [VERIFY: absence of a taper instruction is not a positive statement that abrupt cessation is safe]
Discontinue and reassess if suicidal thoughts or behaviours emerge, or if mania or hypomania is activated
Discontinue or reduce the dose for a sustained rise in heart rate or diastolic blood pressure
Drug holidays are not appropriate. The effect depends on continuous daily exposure over weeks
Reevaluate long-term use periodically, adjusting the dose as needed

Pregnancy & Lactation

Pregnancy: discontinue Qelbree when pregnancy is recognized unless benefit outweighs maternal risk, on animal findings of maternal harm and malformations. Human data insufficient. Raise before starting in an adolescent who could conceive.
Lactation: present in breastmilk; at 600 mg daily the estimated infant dose was 0.085 mg/kg, a relative infant dose about 1%. No data on infant effects or milk production. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychiatric Medications, 1-866-961-2388, womensmentalhealth.org/preg

Counseling Points

Counsel the family on:
- Judging the medication over 6 to 8 weeks, not over a day; name the review date at the first visit
- Daytime sleepiness in about one child in six; moving the dose to the evening is the normal fix
- Sprinkling onto pudding or applesauce if needed, eaten whole without chewing
- Telling every prescriber and pharmacist about Qelbree; it raises the level of several other medicines and a few cannot be given at all
- Giving it every day including weekends and holidays
- Watching daily in the first month for new agitation, irritability or trouble sleeping
Advise them to call for:
- New or worsening talk of self-harm, or any sudden mood or behaviour change
- New difficulty falling asleep, or new irritability, in the first weeks
- A racing or pounding heartbeat, or recurring headaches
- Sleepiness stopping a child staying awake at school, or an adolescent unsafe to drive
- A sudden burst of unusually high energy, reduced need for sleep, or racing speech
- Any new prescription from another clinician, before its first dose

References

DailyMed. Qelbree (viloxazine extended-release capsules) prescribing information. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aedf408d-0f84-418d-9416-7c39ddb0d29a
LactMed. Viloxazine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK588747/
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
FDA. National Drug Code Directory, openFDA. Queried by generic name viloxazine. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22viloxazine%22&limit=1000

QuilliChew ER

(methylphenidate hydrochloride)

QuilliChew ER (methylphenidate hydrochloride); CII

Full Prescribing Information

DailyMed Drug Information

Summary

QuilliChew ER is a medium-acting methylphenidate supplied as a cherry-flavoured extended-release chewable tablet, dosed from age 6 with no upper age limit. Drug is ion-bound to resin, and the 20 mg and 30 mg tablets are functionally scored, making it the only long-acting methylphenidate here that can be halved. It contains aspartame and therefore phenylalanine. Schedule II; brand only.

Forms & Strengths

Extended-release chewable tablets (cherry; 20 mg and 30 mg functionally scored, 40 mg not): 20 mg, 30 mg, 40 mg

Dosing

Age: >= 6y; no upper limit
Onset: ~ 45 minutes
Duration: up to 8 hours
Release Profile: 30% IR / 70% ER via drug ion-bound to resin
Initial Dose: 20 mg once daily in the morning
Titration: 10, 15 or 20 mg every 7 days, up or down
Max Dose: 60 mg/day
Considerations: The 20 mg and 30 mg tablets are halved to give the 10 mg and 15 mg steps; the 40 mg is not scored. It contains aspartame, giving 3 to 6 mg of phenylalanine per tablet.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 30% IR / 70% ER. Drug exchanges off resin along the gut; plasma declines monophasically, with no second peak. Median Tmax ~5 hours.
Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Terminal half-life ~5.2 hours; ~90% recovered in urine.
Class Positioning: The shortest-acting product here; the deciding factor is the 8-hour ceiling, not the chewable format. For afternoon homework use Aptensio XR, Cotempla XR-ODT or Quillivant XR.
Alcohol: at 40% alcohol, about 90% of the tablet released within half an hour, the fastest dose dumping of any product here. The Medication Guide says do not drink.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older

Off-Label Uses

Narcolepsy (ICD-10: G47.411, G47.419): IR methylphenidate carries this indication, QuilliChew ER does not. Limited data.
ADHD in children under 6 years (ICD-10: F90.x): the label records evidence against. Higher exposure than older children at the same dose, and more adverse reactions including weight loss. (AHRQ 2024)
Coverage past 8 hours: this product's own trial measured 10, 12 and 13 hours and found no separation. Insufficient.
Adolescents and adults: the efficacy study enrolled 90 children aged 6 to 12. Limited data.
Splitting the 40 mg tablet: it is not scored and there is no basis for a half 40 mg dose. Insufficient.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
- MAOI use, current or within 14 days: hypertensive crisis
Phenylketonuria, specific to this product: contains aspartame, giving 3, 4.5 and 6 mg of phenylalanine in the 20, 30 and 40 mg tablets. Add it to the daily total.
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: mean rises 2 to 4 mmHg and 3 to 6 bpm
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Personal or family history of tics or Tourette's syndrome
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Substance use disorder in patient or household; a cherry chewable raises the storage stakes
Screen before starting:
- Cardiac history and exam plus family history of sudden death; mandatory in section 2.1
- Tics or Tourette's, personal and family, with clinical evaluation; also mandatory
- Phenylketonuria status, and if present the current daily phenylalanine allowance
- Mania risk factors; abuse and diversion risk in patient and household
- Baseline height, weight, blood pressure and heart rate

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only. Counsel on symptoms rather than avoiding.
Alcohol: about 90% released within half an hour at 40% alcohol, the fastest dose dumping here. The label says avoid; counsel adolescents explicitly.
Gastric pH modulators (H2-blockers, PPIs): not on this label, though the sibling resin product restricts them. Uncharacterised here.

Administration

Once daily in the morning, with or without food. A high-fat meal does not delay it; Cmax rises about 20%.
Halving: the 20 mg and 30 mg tablets break to give 10 mg and 15 mg. The 40 mg is not scored and must not be broken.
Chewing: the extended-release fraction sits on resin rather than in a coating, so chewing does not destroy it.
Missed dose: skip one that would land in the afternoon and never double up.
Avoid late-day dosing; a late-morning dose is not clear of bedtime.
Switching from another methylphenidate: re-titrate from 20 mg weekly, never mg-per-mg.
Store locked; treat it as a candy-shaped controlled substance. Dispose through a take-back program.

Side Effects

Common, pooled methylphenidate: decreased appetite and weight, nausea, abdominal pain, insomnia, anxiety, restlessness, irritability, dizziness, tremor, raised BP and heart rate. Appetite and insomnia dominate in practice.
Serious:
- Sudden death with structural cardiac disease: avoid the drug rather than monitor through it
- New psychosis or mania, ~0.1% pooled, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Growth suppression: about 2 cm and 2.7 kg less over 3 years
- Acute angle closure glaucoma; new or worsening tics and Tourette's: discontinue if appropriate
- Hypersensitivity including angioedema and anaphylaxis
- Postmarketing: severe hepatocellular injury, serotonin syndrome, seizures, rhabdomyolysis, pancytopenia

Monitoring & Labs

Afternoon coverage: ask at every visit what happens after school. No benefit past 8 hours was demonstrated, so an afternoon collapse is not a reason to raise the dose.
Phenylalanine load, in PKU only: recount the daily total at every dose change; 20 mg to 40 mg doubles it from 3 mg to 6 mg.
Half-tablet technique: at the first follow-up after any 10 or 15 mg step, confirm they halve a scored 20 or 30 mg tablet, not a 40 mg one.
Cardiovascular: BP and HR at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI at baseline and every 6 months; interrupting for failure to gain is a labeled instruction.
Appetite, sleep, psychiatric and tics: at every visit and after each dose increase; inspect digits for colour change or ulceration.
Abuse and diversion: at every refill, tablet count, check the PDMP, and ask where it is kept. A flavoured chewable is the easiest form to take by accident.
Laboratory: none required. Check LFTs only for jaundice, dark urine or unexplained fatigue. Discontinue if no improvement after one month of appropriate adjustment.

Discontinuation & Taper

Can be stopped abruptly at therapeutic doses; the label gives no taper schedule.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite. Do not read it as relapse.
Down-titration is easier than on other long-acting methylphenidates: 10 and 15 mg steps down as well as up.
Expect a daily offset at around 8 hours; that is the drug wearing off, not withdrawal. Reduce or discontinue for paradoxical worsening.
Drug holidays are reasonable where growth limits treatment; priapism has been reported during them.

Pregnancy & Lactation

Pregnancy: human data are insufficient to inform a drug-associated risk. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant plasma in every reported case. Monitor for agitation, poor feeding and reduced weight gain. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388, womensmentalhealth.org.

Counseling Points

Counsel the family on:
- The 8-hour window: the afternoon drop-off is designed in, not a sign the dose is too low.
- Which tablet may be halved: the 20 mg and 30 mg are scored, the 40 mg is not and must be given whole.
- It tasting like cherry and being chewed, so a sibling will eat it. Locked storage, not a high shelf. No food timing needed.
- For adolescents, that spirits release about 90% of the tablet within half an hour. For PKU families, the phenylalanine per tablet and that it changes with the dose.
- Moving the largest meal to breakfast and the evening. Sharing or selling a Schedule II medication is a felony.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or suspicious or fearful thinking.
- Numbness, coldness or colour change in fingers or toes, or an unexplained sore.
- A new or markedly worse tic.
- Weight loss, or clothes fitting more loosely.
- A painful erection lasting more than a few hours.
- Yellowing of the eyes or skin, dark urine, or new eye pain or vision change.
- Any tablet taken by a child it was not prescribed for.

References

DailyMed. QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablets prescribing information. NextWave Pharmaceuticals Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=defc1205-8e90-4b1e-b862-05e4c35c7364
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling

Quillivant XR

(methylphenidate hydrochloride)

Quillivant XR (methylphenidate hydrochloride); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Quillivant XR is a long-acting methylphenidate supplied as a banana-flavoured powder the pharmacist reconstitutes into an extended-release oral suspension, dosed from age 6 with no upper limit. Drug is ion-bound to resin held in suspension, giving a full school-day profile as a liquid. It is the only long-acting methylphenidate dosed by the millilitre. Schedule II; brand only.

Forms & Strengths

Extended-release oral suspension (banana, contains sucrose; reconstituted from powder): 25 mg/5 mL, that is 5 mg/mL

Dosing

Age: >= 6y; no upper limit
Onset: ~ 45 minutes
Duration: up to 12 hours
Release Profile: 20% IR / 80% ER via drug ion-bound to suspended resin
Initial Dose: 20 mg, which is 4 mL, once daily in the morning
Titration: 10 - 20 mg every 7 days
Max Dose: 60 mg/day, which is 12 mL
Considerations: Shake vigorously at least 10 seconds before every dose or the dose drawn will be wrong. The reconstituted suspension is stable 4 months at room temperature.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 20% IR / 80% ER. Drug is complexed to resin particles that settle, which is why the bottle must be shaken before every dose. Median Tmax about 4 hours.
Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Terminal half-life ~5.2 h in children, ~5.6 h in adults; ~90% recovered in urine.
Class Positioning: The only full-day methylphenidate that is a true liquid with a continuous dose. Same 12 hours as Cotempla XR-ODT but with millilitre granularity; QuilliChew ER covers 8 hours.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older

Off-Label Uses

Narcolepsy (ICD-10: G47.411, G47.419): IR methylphenidate carries this indication, Quillivant XR does not. Limited data.
ADHD in children under 6 years (ICD-10: F90.x): the label records evidence against. Higher exposure than older children at the same dose, and more adverse reactions including weight loss. (AHRQ 2024)
Weight-based or mg/kg dosing: the ladder is fixed at 20 mg for everyone 6 and above. Insufficient.
Enteral feeding tube: not studied; a resin suspension is a plausible tube-blocking hazard. Insufficient.
Adolescents and adults: the efficacy study enrolled 45 children aged 6 to 12. Limited data.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death; risk rises with dose and non-oral routes. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
- MAOI use, current or within 14 days: hypertensive crisis
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: mean rises 2 to 4 mmHg and 3 to 6 bpm
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Personal or family history of tics or Tourette's; tic ran 2% against 0% on placebo
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Substance use disorder in patient or household; a sweet liquid is the most accessible presentation here
Screen before starting:
- Cardiac history and exam, plus family history of sudden death; mandatory in section 2.1
- Tics or Tourette's, personal and family, with clinical evaluation; also mandatory
- Whether the caregiver can shake the bottle and draw an accurate volume daily
- Mania risk factors; abuse and diversion risk in patient and household
- Baseline height, weight, blood pressure and heart rate

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only. Counsel on symptoms rather than avoiding.
Alcohol: the label says avoid it; exposure rose about 20% at 20% alcohol, smaller than the bead and chewable products.
Gastric pH modulators (H2-blockers, PPIs): not on this label, though the sibling resin product Cotempla XR-ODT restricts them. Uncharacterised here.

Administration

Reconstitution is a pharmacist step: add the specified water volume, insert the adapter, shake 10 seconds, dispense in the original carton with the dispenser.
Shake vigorously at least 10 seconds before every dose; an unshaken bottle runs weak early and strong late.
Beyond-use date 4 months. Have the pharmacy date the bottle. Store at room temperature, not refrigerated.
Once daily in the morning. Food does not delay it; a high-fat meal shortens Tmax by about an hour.
Measure with the supplied dispenser, never a kitchen spoon; milligrams divided by five gives millilitres.
Missed dose: give the next as scheduled; never double up or dose late in the day.
Switching from another methylphenidate: re-titrate from 20 mg weekly, never mg-per-mg.
Store locked; a palatable liquid is the easiest form for an unintended child to swallow.

Side Effects

Common, this product (45 patients, 6 to 12 y): affect lability 9% vs 2%, excoriation 4% vs 0%, and insomnia, tic, decreased appetite, vomiting, rash each 2% vs 0%.
Common, pooled methylphenidate: decreased appetite and weight, nausea, abdominal pain, insomnia, anxiety, irritability, dizziness, tremor, raised BP and heart rate.
Serious:
- Sudden death with structural cardiac disease: avoid the drug rather than monitor through it
- New psychosis or mania, ~0.1% pooled, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Growth suppression: about 2 cm and 2.7 kg less over 3 years
- Acute angle closure glaucoma; new or worsening tics and Tourette's: discontinue if appropriate
- Hypersensitivity including angioedema and anaphylaxis
- Postmarketing: severe hepatocellular injury, serotonin syndrome, seizures, rhabdomyolysis, pancytopenia

Monitoring & Labs

Shaking technique: at the first follow-up and any unexplained change in effect, have the caregiver show how they shake. Effect drifting across the month is the signature failure.
Beyond-use date and dose volume: check the reconstitution date and the millilitres drawn at every refill and dose change. A misread dispenser is a silent halving or doubling.
Affect lability: ask at every visit. The highest signal in this product's own trial, 9% against 2%.
Cardiovascular: BP and HR at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI at baseline and every 6 months. Crossing two percentile lines is a labeled trigger to interrupt.
Appetite, sleep, psychiatric and tics: at every visit and after each dose increase; inspect fingers and toes for colour change or ulceration.
Abuse and diversion: reconcile volume remaining against days elapsed at each refill and check the PDMP. A boxed-warning obligation.
Laboratory: none required. Check LFTs only for jaundice, dark urine or unexplained fatigue. Discontinue if no improvement after one month of appropriate adjustment.

Discontinuation & Taper

Can be stopped abruptly at therapeutic doses; the label gives no taper schedule.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
Down-titration is smoother than on any solid: 1 mL, that is 5 mg, steps.
Reduce or discontinue for paradoxical worsening or adverse reactions.
Drug holidays are reasonable where growth limits treatment, but a long one outlasts the bottle.
Priapism has been reported during drug holidays and on discontinuation.

Pregnancy & Lactation

Pregnancy: human data are insufficient to inform a drug-associated risk. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant plasma in every reported case. Monitor for agitation, poor feeding and reduced weight gain. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388, womensmentalhealth.org.

Counseling Points

Counsel the family on:
- Shaking hard for a full 10 seconds before every dose. Count it out loud with them once; a poorly shaken bottle runs weak then strong across the month.
- The 4-month limit from the reconstitution date, room-temperature storage, and using only the supplied dispenser: 1 mL is 5 mg.
- The flavour being banana, so a child who has refused banana medicines will refuse this.
- Emotional swings being a recognised effect of this product, manageable by dose. Move the largest meal to breakfast and the evening.
- Locked storage; a toddler can drink a large amount of a sweet liquid quickly.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or suspicious or fearful thinking.
- Numbness, coldness or colour change in fingers or toes.
- A new or markedly worse tic, or a new vocal tic.
- Weight loss, clothes fitting more loosely, or a marked change in emotional control.
- A painful erection lasting more than a few hours.
- Yellowing of the eyes or skin, dark urine, or new eye pain with halos around lights.
- Any amount swallowed by a child it was not prescribed for.

References

DailyMed. Quillivant XR (methylphenidate hydrochloride) for extended-release oral suspension prescribing information. NextWave Pharmaceuticals Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c2dc2109-44a6-4797-b04e-18761dd9d45a
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling

Relexxii

(methylphenidate hydrochloride extended-release, OROS)

Relexxii (methylphenidate hydrochloride extended-release, OROS); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Relexxii is a long-acting methylphenidate tablet using the same class of OROS osmotic delivery as Concerta, approved for ADHD from age 6 through 65. Its differentiator is the strength ladder: 45 mg, 63 mg and 72 mg exist as single tablets, so a patient needing more than 54 mg takes one tablet rather than two. It is not labeled as bioequivalent to Concerta. Schedule II; brand and authorized generic.

Forms & Strengths

Extended-release tablets (OROS, swallow whole): 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg

Dosing

Age: 6 to 65 y/o
Onset: ~ 1 hour
Duration: up to 12 hours
Release Profile: 18% IR / 82% ER via OROS osmotic delivery
Initial Dose:
- 6 to 17 y/o, new to methylphenidate: 18 mg once daily in the morning
- 18 to 65 y/o, new to methylphenidate: 18 mg or 36 mg once daily in the morning
- From methylphenidate 2-3 times daily, per dose: 5 mg to 18 mg; 10 mg to 36 mg; 15 mg to 54 mg; 20 mg to 72 mg
Titration: 18 mg every 7 days; 27, 45 and 63 mg give intermediate steps
Max Dose:
- 6 to 12 y/o: 54 mg/day
- 13 to 17 y/o: 72 mg/day, not to exceed 2 mg/kg/day
- 18 to 65 y/o: 72 mg/day
Considerations: Swallow whole; chewing or dividing destroys the osmotic pump. The 45, 63 and 72 mg strengths avoid two-tablet regimens above 54 mg. Do not substitute milligram-for-milligram with another methylphenidate.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 18% IR / 82% ER via OROS osmotic delivery. The overcoat dissolves within an hour, then a push layer forces drug through a laser-drilled orifice; two core layers make release rise over 6 to 7 hours.
Metabolism: De-esterified to PPAA (ritalinic acid), inactive. Half-life ~3.5 hours, ~90% recovered in urine. Renal impairment has little effect.
Class Positioning: Same osmotic principle as Concerta, not the same product: 18% against 22% immediate fraction, Tmax 5.5 h against 6 to 10 h, no bioequivalence study. Advantage: single-tablet dosing at 45, 63 and 72 mg.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 65 y/o

Off-Label Uses

ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral parent training first line; if medication is needed use IR methylphenidate, not OROS. Expert consensus. (AAP 2019)
Narcolepsy (ICD-10: G47.419): IR methylphenidate carries this indication, Relexxii does not. Insufficient.
Substituting for Concerta at the same strength: common at 18 to 54 mg but unsupported by any bioequivalence study. Recheck response after a switch. Insufficient.
Where the evidence does not support use: treatment-resistant depression, binge eating disorder, cancer-related and chronic fatigue. Adult literature only; insufficient in children. (AHRQ 2024)
Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
- MAOI use, current or within 14 days: hypertensive crisis
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: monitor blood pressure and pulse
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- GI narrowing: the tablet is nondeformable
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Personal or family history of tics or Tourette's syndrome
- Substance use disorder in the patient or the household
Screen before starting:
- Cardiac history and exam including family sudden death; the label requires no routine ECG
- Tics, and risk factors for a manic episode
- Abuse and diversion risk in patient and household
- Ability to swallow a tablet whole; any GI stricture or bowel surgery
- Baseline height, weight, blood pressure and heart rate

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only, not in the interaction table. Counsel on symptoms.

Administration

Once daily in the morning, with or without food.
Swallow whole. Do not chew, divide or crush; there is no sprinkle option.
If the child cannot swallow a tablet, use a bead capsule (Ritalin LA) or a liquid (Quillivant XR).
The intact shell passes in the stool; warn the family before the first dose.
Never substitute milligram-for-milligram; use the labeled conversion table and recheck response after any switch.
Missed dose: skip it rather than giving it late in the day.
Store locked; the 63 and 72 mg strengths are high-value diversion targets.

Side Effects

Common, pediatric 6 to 17 y: upper abdominal pain, the only reaction above 5%; insomnia, nasopharyngitis, vomiting, pyrexia 2% to 3%.
Common, adults (all above 5%): decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, hyperhidrosis.
Serious:
- Sudden death with structural cardiac disease: avoid the drug in that population
- New psychosis or mania, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Long-term growth suppression; GI obstruction from the nondeformable tablet in pre-existing narrowing
- Acute angle closure glaucoma; new or worsening tics and Tourette's
- Postmarketing: convulsion, dyskinesia, serotonin syndrome, hypersensitivity reactions

Monitoring & Labs

Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months.
Growth: height, weight and BMI at baseline and every 6 months; failure to gain triggers interruption.
Appetite and sleep: at every visit and dose change; the usual reasons titration stalls short of 72 mg.
Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at baseline and every visit.
Abuse and diversion: at every refill, pill count, ask about sharing and selling, check the PDMP. A boxed-warning obligation.
Dose ceiling: at every titration step in a 13 to 17 year old, recalculate 2 mg/kg/day. Under 36 kg the weight cap bites before the 72 mg cap.
Laboratory: none is required by this label.

Discontinuation & Taper

No taper required; the label gives no tapering schedule.
Discontinue if no improvement after appropriate dose adjustment over one month.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
Priapism has occurred during drug holidays and on discontinuation.
Drug holidays are reasonable where growth or appetite limits treatment; an interrupted day is fully unmedicated.

Pregnancy & Lactation

Pregnancy: no drug-associated risk of major birth defects or miscarriage identified. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant serum in every reported case, including 72 mg daily. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, anorexia and poor weight gain. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388.

Counseling Points

Counsel the family on:
- Relexxii and Concerta not being the same tablet even where milligrams match; watch the first week after a substitution.
- The 45, 63 and 72 mg strengths being the reason for this product: one tablet replaces two.
- Seeing the intact shell in the stool; it is the spent pump, not a wasted dose.
- Half a 45 mg tablet being a broken osmotic pump, not 22.5 mg.
- Dosing at the same early hour daily; a late dose pushes the ascending peak into the evening.
- Moving the largest meal to breakfast and the evening, when appetite returns.
- Locked storage; the high strengths are the ones peers ask for.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness or colour change in fingers or toes.
- A new or markedly worse tic.
- A painful erection lasting more than a few hours; a surgical emergency.
- Severe abdominal pain or vomiting, especially with any history of bowel narrowing.
- Eye pain with blurred vision or halos around lights.
- Clothes fitting more loosely, or no weight gain across a few months.

References

DailyMed. Relexxii (methylphenidate hydrochloride) extended-release tablets prescribing information. Vertical Pharmaceuticals. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d
DailyMed. Concerta (methylphenidate hydrochloride) extended-release tablets prescribing information. Janssen Pharmaceuticals. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a88218c-5b18-4220-8f56-526de1a276cd
FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Risperdal

(risperidone)

Risperdal (risperidone); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Risperdal is an atypical antipsychotic approved for irritability associated with autistic disorder from 5 years, bipolar I mania from 10 years, and schizophrenia from 13 years. Full D2 antagonism buys the strongest evidence in this library for reducing aggression and, in the same breath, the largest prolactin burden of any agent here. It follows optimised ADHD treatment, never replaces it. Not controlled; brand and generic.

Forms & Strengths

Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
Orally disintegrating tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
Oral solution: 1 mg/mL
Long-acting injectables (Risperdal Consta, Perseris, Uzedy, Rykindo): separate labels

Dosing

Age:
- Autism irritability: 5 to 17 y/o; no dosing data under 15 kg
- Bipolar I mania: 10 to 17 y/o and adults
- Schizophrenia: 13 to 17 y/o and adults
Onset: weeks to clinical effect; the pediatric ladder holds 14 days before further increase
Duration: continuous with once-daily dosing; combined half-life 20 hours
Initial Dose:
- Autism irritability: 0.25 mg/day under 20 kg, 0.5 mg/day at 20 kg and over
- Bipolar mania or schizophrenia, 10 to 17 y/o: 0.5 mg once daily
- Adults: 2 mg/day schizophrenia, 2 to 3 mg/day bipolar mania
Titration:
- Autism irritability: after 4 days minimum, to 0.5 mg/day under 20 kg or 1 mg/day at 20 kg and over
- Hold 14 days minimum, then increase every 2 weeks or more by 0.25 mg/day under 20 kg or 0.5 mg/day at 20 kg and over
- Adolescents: 0.5 mg or 1 mg per day, at intervals of 24 hours or greater
- Adults: 1 to 2 mg/day schizophrenia, 1 mg/day bipolar mania
Max Dose:
- Autism irritability: 0.5 to 3 mg/day
- Bipolar mania, 10 to 17 y/o: 1 to 6 mg/day; above that not studied
- Schizophrenia, 13 to 17 y/o: 1 to 6 mg/day, no added benefit above 3 mg/day; above 6 mg/day not studied
- Adults, schizophrenia: above 6 mg/day no more effective and more EPS; 16 mg/day highest studied
- With fluoxetine or paroxetine: do not exceed 8 mg/day in adults
Considerations: Give once daily, or split if somnolence persists; a bedtime dose is the usual answer to daytime sedation. Start 0.5 mg twice daily in severe renal or hepatic impairment.

Pharmacology

Mechanism: D2 and 5-HT2A antagonist with alpha-1 and H1 blockade; alpha-1 drives orthostasis, H1 the sedation
Delivery / Release: immediate-release; peak about 1 hour, unaffected by food
Metabolism: CYP2D6 to paliperidone, similarly active; combined half-life about 20 hours
Pharmacogenomics: no genotype-based dose adjustment; do not extrapolate the aripiprazole halving rule here
Class Positioning: the label states risperidone gives higher prolactin elevations than other antipsychotics, persisting on chronic dosing; aripiprazole (Abilify) usually lowers prolactin
That difference drives the choice between the two in a growing child

Indications

Irritability Associated with Autistic Disorder (ICD-10: F84.0): 5 to 17 y/o. Labeled targets: aggression, self-injury, tantrums, quickly changing moods.
Bipolar I Disorder, acute manic or mixed episodes (ICD-10: F31.x): 10 to 17 y/o and adults; adjunctive with lithium or valproate.
Schizophrenia (ICD-10: F20.x): 13 to 17 y/o and adults

Off-Label Uses

Aggression and conduct problems in ADHD and disruptive behaviour disorders (ICD-10: F90.x, F91.x): moderate strength of evidence; second line, after the primary disorder is treated. (AHRQ 2017; AACAP 2011)
Tic disorders and Tourette's disorder (ICD-10: F95.2): low strength of evidence; aripiprazole holds the FDA indication here. (AHRQ 2017)
Behavioural disturbance with intellectual disability (ICD-10: F70-F79): low strength of evidence. (AHRQ 2017)
Obsessive-compulsive disorder augmentation (ICD-10: F42.x): insufficient. (AHRQ 2017)
Core ADHD symptoms, anxiety, depression (ICD-10: F90.x, F41.x, F32.x): insufficient. Use Concerta, Strattera or Qelbree. (AHRQ 2017)

Contraindications & Warnings

Boxed Warning: Increased mortality in elderly patients with dementia-related psychosis. Risperidone is not approved for that use.
Contraindicated:
- Known hypersensitivity to risperidone, to paliperidone (its active metabolite), or to any excipient.
Use with caution:
- Any condition predisposing to hypotension, or a concurrent antihypertensive.
- Diabetes, obesity, dyslipidemia, or a family history of them.
- A child or adolescent in puberty; persistent hyperprolactinemia with hypogonadism reduces bone density.
- History of low white cell count, leukopenia, or neutropenia.
- Seizure history, dysphagia, aspiration risk, and falls risk.
- Severe renal impairment (CrCl under 30 mL/min) or Child-Pugh 10 to 15.
- Conditions raising core temperature: exercise, heat, dehydration, anticholinergics.
Screen before starting:
- Weight, height, BMI percentile, waist circumference, standing blood pressure.
- Fasting glucose or A1c, and a fasting lipid panel.
- Family history of diabetes, dyslipidemia, obesity, cardiovascular disease.
- AIMS, pubertal staging, menstrual history in an adolescent girl.

Drug Interactions

Enzyme inducers (carbamazepine, phenytoin, rifampin, phenobarbital): levels fall. Increase up to double; reverse when the inducer stops.
CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion, quinidine): levels rise. Reduce the initial dose; do not exceed 8 mg/day in adults.
Antihypertensives and hypotensive agents: additive orthostatic hypotension; check lying and standing blood pressure.
CNS depressants, alcohol, sedating antihistamines: additive sedation; counsel adolescents explicitly.
Anticholinergics: additive impairment of temperature regulation.
Other prolactin-raising drugs (metoclopramide, antipsychotics): additive hyperprolactinemia.

Administration

Give the total daily dose once daily or split; food does not affect absorption.
Tablet: swallow whole. ODT: dissolve on the tongue; do not chew, crush, or push through the foil.
Oral solution: use a dosing syringe; at 1 mg/mL a 0.25 mg dose is 0.25 mL.
After an interruption, restart on the initial titration schedule.
Do not stop abruptly; see Discontinuation & Taper.

Side Effects

Common: sedation (63% in the pediatric autism trials), increased appetite, fatigue, vomiting, constipation, enuresis, drooling, headache, weight gain, tremor, parkinsonism
Serious:
- Neuroleptic malignant syndrome: fever, rigidity, altered mental status, autonomic instability.
- Tardive dyskinesia: assess with AIMS; consider discontinuing.
- Metabolic change: 32.6% of pediatric patients gained 7% or more of body weight, against 6.9% on placebo.
- Hyperglycemia and diabetes: check glucose for polydipsia, polyuria or polyphagia.
- Hyperprolactinemia, higher than other antipsychotics and persisting: galactorrhea, amenorrhea, gynecomastia, reduced bone density.
- Orthostatic hypotension, syncope, falls.
- Leukopenia, neutropenia, agranulocytosis: discontinue for an unexplained fall.
- Seizures, dysphagia, priapism, impaired temperature regulation, cognitive and motor impairment.

Monitoring & Labs

Weight and BMI: baseline, 4, 8 and 12 weeks after any start or dose change, then quarterly. Consider switching on a gain of 5% or more. (ADA 2004)
Waist circumference: baseline, then annually. (ADA 2004)
Fasting glucose or A1c: baseline, 12 weeks, then annually; sooner with weight gain or family history. (ADA 2004)
Fasting lipid panel: baseline and 12 weeks, then every 5 years if normal. (ADA 2004)
Blood pressure: baseline, 12 weeks, then annually, plus a standing reading at every dose change. (ADA 2004)
AIMS: baseline, then every 3 months in children; ask about akathisia and stiffness during titration.
Prolactin: baseline in an adolescent, and if symptomatic. Ask about galactorrhea, gynecomastia, amenorrhea and delayed puberty every 3 months.
Growth and puberty: height and pubertal staging every 6 months; menstrual history every visit in an adolescent girl.
Complete blood count: not routine; check with a low white cell history, fever or infection.

Discontinuation & Taper

Taper gradually rather than stopping abruptly, to limit withdrawal dyskinesia and rebound. Guideline, not label. (AACAP 2011)
Once response is maintained, the label directs a gradual dose reduction. Reassess the indication every 6 months. (AACAP 2011)
Discontinue immediately for suspected neuroleptic malignant syndrome; consider it for tardive dyskinesia or an unexplained white cell fall.
Prolactin normalises a median 4 to 6 weeks after stopping or switching. (LactMed 2026)

Pregnancy & Lactation

Pregnancy: Third-trimester exposure risks neonatal extrapyramidal or withdrawal symptoms. No established risk of major birth defects; weigh continuation against maternal relapse.
Lactation: Maternal doses up to 6 mg daily give low milk levels, but sedation, failure to thrive, tremor and respiratory depression are reported. (LactMed 2026)
Lactation, agent choice: Reviews place risperidone second line while breastfeeding; monitor the infant for drowsiness, weight gain, tremor. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for Atypical Antipsychotics, 1-866-961-2388, womensmentalhealth.org

Counseling Points

Counsel the family on:
- Sleepiness in the first weeks, in two thirds of children; the fix is a bedtime dose.
- Appetite increase and weight gain expected, with weight plotted every visit.
- Breast tenderness or enlargement, milk production, or periods stopping; name these early.
- The dose ladder being deliberately slow, so pauses are not read as inaction.
- Caution with heat and sport; rise slowly from lying or sitting.
Advise them to call for:
- Fever with muscle stiffness or confusion, an emergency.
- Involuntary movement of the face, tongue or limbs, or inability to sit still.
- Milk from the breasts, breast swelling, or periods stopping.
- Fainting, or dizziness on standing that does not settle.
- Marked thirst, frequent urination, or unexplained weight loss.
- Difficulty swallowing or choking.
- An erection lasting more than 4 hours, an emergency.

References

DailyMed. Risperdal (risperidone) prescribing information. Janssen. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0
American Diabetes Association and others. Consensus conference on antipsychotic drugs, obesity and diabetes. Diabetes Care. 2004. https://diabetesjournals.org/care/article/27/2/596/28450/
AACAP. Practice parameter for atypical antipsychotics in children and adolescents. 2011. https://www.aacap.org/App_Themes/AACAP/docs/practice_parameters/Atypical_antipsychotic_Medications_Web.pdf
AHRQ. Antipsychotics in children and young adults. Comparative Effectiveness Review No. 184. 2017. https://www.ncbi.nlm.nih.gov/books/NBK442344/
LactMed. Risperidone. Drugs and Lactation Database, NICHD. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501095/
FDA. National Drug Code Directory, openFDA. 2026. https://open.fda.gov/apis/drug/ndc/

Ritalin

(methylphenidate hydrochloride, immediate-release)

Ritalin (methylphenidate hydrochloride, immediate-release); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Ritalin is the immediate-release methylphenidate tablet, approved for ADHD in patients 6 years and older and for narcolepsy, and it is the reference product from which every long-acting methylphenidate is converted. Its short, sharply defined window is both its use and its cost: reversible within an afternoon and easy to schedule around, at the price of multiple daily dosing and a visible offset. Schedule II; brand and generic.

Forms & Strengths

Tablets (10 mg and 20 mg partially bisected, 5 mg not scored): 5 mg, 10 mg, 20 mg

Dosing

Age:
- ADHD: >= 6y, and adults
- Narcolepsy: no age floor
Onset: ~ 1 hour
Duration: 3 to 4 hours
Initial Dose:
- >= 6 y/o and older: 5 mg twice daily, before breakfast and before lunch
- Adults: 20 to 30 mg daily in 2 or 3 divided doses, 30 to 45 minutes before meals.
Titration: 5 - 10 mg every 7 days
Max Dose: 60 mg/day
Considerations: Give 30 to 45 minutes before meals, and the last dose before 6 p.m. The offset is abrupt and visible, which is the trade-off against every long-acting product.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: Immediate release. Absolute bioavailability 22% d-enantiomer, 5% l-enantiomer; first-pass loss is large and stereoselective. No relevant food effect.
Metabolism: Esterase de-esterification to ritalinic acid, inactive. Not a CYP substrate. Protein binding 10% to 33%. Half-life 2.5 h in children, 3.5 h in adults; under 1% excreted unchanged.
Class Positioning: The reference immediate-release methylphenidate, and the product every long-acting conversion table is written from. Esterase clearance means renal and hepatic impairment barely change exposure, and elimination is not pH-dependent.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older, and adults
Narcolepsy (ICD-10: G47.419): no age floor is stated in this label

Off-Label Uses

ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral parent training first line; IR methylphenidate where it fails and disturbance stays moderate to severe. Expert consensus. (AAP 2019)
Afternoon top-up alongside a long-acting methylphenidate (ICD-10: F90.x): coherent given the 3 to 4 hour window; the 60 mg/day ceiling applies to the sum. Limited data. (AHRQ 2024)
Where the evidence does not support use: treatment-resistant depression (F33.9), binge eating disorder (F50.2), cancer-related and chronic fatigue (R53.0, R53.83). Adult literature only; insufficient in children. (AHRQ 2024)
Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate or any component
- MAOI use, current or within 14 days: hypertensive crisis
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: monitor blood pressure and pulse
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Personal or family history of tics or Tourette's syndrome
- Substance use disorder in patient or household; an IR tablet is the most divertible methylphenidate form
Screen before starting:
- Cardiac history and exam including family sudden death; the label requires no routine ECG
- Tics, and risk factors for a manic episode
- Abuse and diversion risk in patient and household
- Baseline height, weight, blood pressure and heart rate

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold every dose on the day of surgery, not just the morning one.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only, not in the interaction table. Counsel on symptoms.

Administration

Give 30 to 45 minutes before meals, which is a labeled instruction.
Before breakfast and before lunch; add a third dose for afternoon coverage.
Last dose before 6 p.m. for anyone whose sleep is affected.
Food has no relevant effect on absorption; a missed meal is not a reason to hold a dose.
The 5 mg tablet is not scored; a sub-5 mg step needs the 2.5 mg chewable or the oral solution (Methylin).
Missed dose: give only if the next is several hours away and it is not late. Never double up.
Converting to a long-acting product (Ritalin LA, Metadate CD, Concerta): never match milligrams; use that product's conversion table.
Store locked; an IR tablet is the methylphenidate form most often diverted.

Side Effects

Common: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, abdominal pain. No pediatric percentages published.
Serious:
- Sudden death with structural cardiac disease: avoid the drug in that population
- New psychosis or mania, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Long-term growth suppression; acute angle closure glaucoma; new or worsening tics and Tourette's
- Postmarketing: convulsions, choreoathetoid dyskinesia, cerebral vasculitis and hemorrhage, serotonin syndrome
- Rebound irritability, hunger and tearfulness at each offset, two or three times a day: an offset effect, not an adverse reaction

Monitoring & Labs

Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months. Tachycardia and palpitations head this label's reaction list.
Growth: height, weight and BMI at baseline and every 6 months; failure to gain triggers interruption.
Appetite and sleep: at every visit and dose change; ask what time the last dose is given.
Adherence: confirm at every visit that the midday dose is given; a missed school dose mimics loss of efficacy.
Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at baseline and every visit.
Abuse and diversion: at every refill, count the tablets rather than accepting a report, ask about sharing and selling, check the PDMP. A boxed-warning obligation.
Laboratory: none is required by this label.

Discontinuation & Taper

No taper required; the label gives no tapering schedule.
Discontinue if no improvement after appropriate dose adjustment over one month.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
Priapism has occurred during drug holidays and on discontinuation.
Partial drug holidays are possible here: school days only, or a morning dose only at weekends. That granularity is the IR tablet's main advantage where growth limits treatment.

Pregnancy & Lactation

Pregnancy: no drug-associated risk of major birth defects or miscarriage identified. Stimulant vasoconstriction may reduce placental perfusion. Weigh against untreated maternal ADHD or narcolepsy.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant plasma in every reported case, including 40 mg twice daily. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, insomnia and poor weight gain. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

Counsel the family on:
- The 3 to 4 hour window: the lunchtime dose is part of the plan, not a sign the first failed.
- Dosing 30 to 45 minutes before a meal, keeping the appetite trough between meals.
- The last dose being before 6 p.m.; a 7 p.m. dose costs that night's sleep.
- Rebound irritability and hunger two or three times a day: expected, not a reason to raise the dose.
- Arranging the school dose before the first prescription is filled: nurse-administered, self-carry, or switch to a long-acting product.
- The 5 mg tablet not being scored; a smaller step means a chewable or the solution, not a cut tablet.
- Locked storage; sharing or selling a Schedule II medication is a felony, and the IR tablet is what peers ask for.
- Bringing a teacher rating scale that separates morning from afternoon.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness or colour change in fingers or toes, or a sore that will not heal.
- A new or markedly worse tic, including throat clearing and blinking.
- A painful erection lasting more than a few hours, including during a planned break.
- Any seizure, or a jerking movement the child cannot stop.
- Eye pain with blurred vision or halos around lights.
- Clothes fitting more loosely, or no weight gain across a few months.

References

DailyMed. Ritalin (methylphenidate hydrochloride) tablets prescribing information. Novartis Pharmaceuticals Corporation. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c0bf0835-6a2f-4067-a158-8b86c4b0668a
FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Ritalin LA

(methylphenidate hydrochloride extended-release, bimodal beads)

Ritalin LA (methylphenidate hydrochloride extended-release, bimodal beads); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Ritalin LA is a bead-filled methylphenidate capsule carrying half its dose as immediate-release beads and half as enteric-coated delayed-release beads, reproducing a twice-daily Ritalin regimen in one morning capsule. Its approval is narrower than any other long-acting methylphenidate here: ADHD in children 6 to 12 years only. The capsule can be opened onto applesauce, so it suits a child who cannot swallow. Schedule II; brand and generic.

Forms & Strengths

Extended-release capsules (bimodal beads, may be opened onto applesauce): 10 mg, 20 mg, 30 mg, 40 mg, 60 mg

Dosing

Age: 6 to 12 y/o only; no adolescent and no adult indication
Onset: ~ 1 hour
Duration: about 8 hours
Release Profile: 50% IR / 50% DR via bimodal beads
Initial Dose:
- New to methylphenidate: 20 mg once daily in the morning; 10 mg where a lower start is appropriate
- From Ritalin twice daily, per dose: 5 mg to 10 mg; 10 mg to 20 mg; 15 mg to 30 mg; 20 mg to 40 mg; 30 mg to 60 mg once daily
Titration: 10 mg every 7 days
Max Dose: 60 mg/day
Considerations: Switching from any methylphenidate other than Ritalin means titrating from the start, not converting milligram-for-milligram. Capsules may be opened onto cool applesauce.

Pharmacology

Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 50% IR / 50% DR via bimodal beads. Enteric-coated beads release past gastric pH, giving two peaks about 4 hours apart with less fluctuation than two separate tablets.
Metabolism: De-esterified to ritalinic acid, inactive. Not a CYP substrate. Half-life 2.5 h in children, 3.5 h in adults. No accumulation once daily.
Class Positioning: Two discrete peaks, not an ascending ramp, and a shallower dip than two separate Ritalin tablets. Against Metadate CD the split is 50/50 not 30/70; against Concerta it can be sprinkled but stops at 12.
Cardiac electrophysiology: no QT study on this product; the dexmethylphenidate study cited found mean QTcF under 5 ms.

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 12 y/o

Off-Label Uses

ADHD in adolescents 13 to 17 and in adults (ICD-10: F90.x): the commonest off-label use; no adolescent efficacy data. Insufficient for this product. (AHRQ 2024)
ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral parent training first line; if medication is needed use IR methylphenidate. Expert consensus. (AAP 2019)
Narcolepsy (ICD-10: G47.419): IR methylphenidate carries this indication, Ritalin LA does not. Insufficient.
Where the evidence does not support use: treatment-resistant depression, binge eating disorder, cancer-related and chronic fatigue. Adult literature only; insufficient in children. (AHRQ 2024)
Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

Boxed Warning: Abuse, misuse and addiction, with overdose and death. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
- Hypersensitivity to methylphenidate or any component
- MAOI use, current or within 14 days: hypertensive crisis
Use with caution:
- Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
- Pre-existing hypertension: monitor blood pressure and pulse
- Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
- Significant hyperopia or angle-closure risk: refer to ophthalmology
- Personal or family history of tics or Tourette's syndrome
- Substance use disorder in patient or household; beads can be crushed, so this is not abuse-deterrent
Screen before starting:
- Cardiac history and exam including family sudden death; the label requires no routine ECG
- Tics, and risk factors for a manic episode
- Abuse and diversion risk in patient and household
- Baseline height, weight, blood pressure and heart rate
- Age against the 6 to 12 indication; near 13, pick an agent labeled for adolescents

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration; a common pairing in ADHD with aggression.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only, not in the interaction table. Counsel on symptoms.

Administration

Once daily in the morning; no food timing needed, and no dose dumping.
Swallow whole, or open onto a spoonful of applesauce that is cool, never warm; heat damages the coating on the delayed beads.
Swallow the applesauce mixture at once and entirely, without chewing; never prepare it in advance.
Do not crush, chew or divide the beads; chewing converts the whole dose to immediate release.
Switching from any methylphenidate other than Ritalin: titrate from the beginning, never milligram-for-milligram.
Missed dose: skip it; a late dose puts the delayed bead peak in the evening.
Store locked; an openable bead capsule is straightforward to misuse.

Side Effects

Common: headache, insomnia, upper abdominal pain, decreased appetite, anorexia. No pediatric percentages published.
Serious:
- Sudden death with structural cardiac disease: avoid the drug in that population
- New psychosis or mania, including with no psychiatric history: consider discontinuing
- Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
- Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
- Long-term growth suppression; the whole indicated population is prepubertal
- Acute angle closure glaucoma; new or worsening tics and Tourette's
- Postmarketing: convulsions, choreoathetoid dyskinesia, cerebral vasculitis and hemorrhage, serotonin syndrome

Monitoring & Labs

Growth: height, weight and BMI at baseline and every 6 months, every visit if losing weight.
Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months.
Appetite and sleep: at every visit and dose change; suppression is heaviest at the morning peak.
Afternoon coverage: ask at every visit about the hours after the second peak. Late-afternoon return is expected; change product rather than raise the dose.
Age against indication: check at every annual visit. At 13 this becomes off-label with no adolescent efficacy data; plan the switch first. Concerta is labeled to 65, Aptensio XR has no upper limit.
Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at baseline and every visit.
Abuse and diversion: at every refill, capsule count, ask about sharing and selling, check the PDMP. A capsule made to be opened is not abuse-deterrent.
Laboratory: none is required by this label.

Discontinuation & Taper

No taper required; the label gives no tapering schedule.
Discontinue if no improvement after appropriate dose adjustment over one month.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
Priapism has occurred during drug holidays and on discontinuation.
Drug holidays are reasonable where growth limits treatment; a capsule cannot be part-dosed.
Switching to another methylphenidate: titrate the new product from its own starting dose.

Pregnancy & Lactation

Pregnancy: no drug-associated risk of major birth defects or miscarriage identified. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant serum in every reported case. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, insomnia and poor weight gain. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

Counsel the family on:
- The applesauce rule: cool never warm, swallowed at once, never chewed, never made up in advance.
- The two-peak pattern: a mid-morning lull is not a failed dose.
- Coverage reaching early afternoon, not evening; if homework is the problem, this is the wrong product.
- Giving breakfast before the capsule; the morning half is what flattens appetite.
- Never chewing the beads; chewed beads turn a full-day dose into one immediate-release hit.
- The 6 to 12 approval, so the plan will change in adolescence. Say it early, or the switch reads as failure.
- Locked storage; a capsule of loose beads is easily emptied.
Advise them to call for:
- Chest pain, fainting, or a racing heart that does not settle.
- New hallucinations or suspicious thinking; eye pain with halos around lights.
- Numbness, coldness or colour change in fingers or toes, or a sore that will not heal.
- A new or markedly worse tic, including throat clearing and blinking.
- A painful erection lasting more than a few hours, including during a planned break.
- Any seizure, or a jerking movement the child cannot stop.
- Clothes fitting more loosely, or no weight gain across a few months.

References

DailyMed. Ritalin LA (methylphenidate hydrochloride) extended-release capsules prescribing information. Novartis Pharmaceuticals Corporation. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=effd952d-ac94-47bb-b107-589a4934dcca
FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Strattera

(atomoxetine)

Strattera (atomoxetine); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Strattera is a selective norepinephrine reuptake inhibitor supplied as an oral capsule, approved for ADHD in adults and in children from 6 years of age. It is dosed on a milligram-per-kilogram basis and gives continuous, all-day coverage rather than a timed stimulant effect, so it is judged over weeks and not over a school day. It is the option to reach for when a stimulant is not tolerated, when tics or anxiety coexist, or when diversion risk makes a controlled substance unattractive. Not controlled; brand and generic.

Forms & Strengths

Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg
Oral solution (separate NDA, Atoncy): 4 mg/mL

Dosing

Age: 6 y/o and older, and adults; not established below 6 y/o
Onset: weeks to clinical effect, not minutes; not a rescue or as-needed medication
Duration: continuous with daily dosing; no afternoon wear-off
Initial Dose:
- Under 70 kg: 0.5 mg/kg/day
- 70 kg and over, and adults: 40 mg/day
Titration:
- Under 70 kg: after at least 3 days, to a target of 1.2 mg/kg/day; no added benefit above that
- 70 kg and over, and adults: after at least 3 days, to 80 mg/day; if response is not optimal after 2 to 4 further weeks, may increase to 100 mg/day
- CYP2D6 poor metabolizers and patients on a strong CYP2D6 inhibitor: titration interval of 4 weeks, not 3 days. Starting, target and maximum doses unchanged
Max Dose:
- Under 70 kg: the lesser of 1.4 mg/kg/day or 100 mg/day
- 70 kg and over, and adults: 100 mg/day
Considerations: Give once daily in the morning, or as two evenly divided doses morning and late afternoon; never more. Reduce to 50% of the usual dose in moderate hepatic impairment and 25% in severe.

Pharmacology

Mechanism: Selective norepinephrine reuptake inhibitor; raises synaptic NE and, indirectly, prefrontal dopamine
Delivery / Release: Immediate-release capsule, no modified-release component; median Tmax 1 hour, but the therapeutic action accrues over weeks.
Metabolism: CYP2D6 to the equipotent 4-hydroxyatomoxetine. Half-life 5.2 hours, 21.6 in poor metabolizers; bioavailability 63%, 94% in poor metabolizers. Protein binding 98%, so dialysis is useless in overdose.
Pharmacogenomics: CYP2D6 poor metabolizers (about 7% White, 2% Asian, 2% Black) have higher exposure and 11% discontinuation against 6%. The action is a 4-week titration interval, not a lower ceiling.
Class Positioning: No striatal DAT blockade, so no euphoriant properties and no schedule; against Concerta the trade-off is weeks-long onset and a smaller effect size. Qelbree titrates in fixed milligram steps, not by weight.

Indications

Attention-Deficit/Hyperactivity Disorder (ICD-10: F90.x): patients 6 y/o and older, and adults, as part of a total treatment program

Off-Label Uses

ADHD with a comorbid tic disorder (ICD-10: F90.x with F95.2): did not worsen tics in a randomized trial; non-worsening only. Postmarketing reports of new tics exist.
ADHD with a comorbid anxiety disorder (ICD-10: F90.x with F41.x): did not worsen anxiety in randomized trials; supported by controlled trials for non-worsening only.
Where the evidence does not support use:
- Oppositional defiant disorder (ICD-10: F91.3) as a target in itself: limited data, and the drug can itself worsen aggression and hostility. [VERIFY: no graded pediatric strength-of-evidence rating located in AHRQ CER 2024]
- ADHD in autism spectrum disorder (ICD-10: F84.0 with F90.x): limited data; no atomoxetine-specific grade for this population. (AHRQ 2024)
- ADHD with substance use disorder (ICD-10: F90.x with F1x.x): limited data

Contraindications & Warnings

Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
- 0.4% (5 of 1,357) against 0% (0 of 851) on placebo; no suicides
- Every event occurred in patients 6 to 12 and within the first month
- Monitor closely at start and at every dose change
Contraindicated:
- Hypersensitivity; anaphylaxis, angioedema, urticaria and rash reported
- MAOI use, or within 14 days of stopping one
- Narrow angle glaucoma; increased risk of mydriasis
- Pheochromocytoma or a history of it
- Severe cardiac or vascular disease that would deteriorate with a rise of 15 to 20 mm Hg or 20 bpm
Use with caution:
- Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; generally should not be used, sudden death reported
- Hypertension, tachycardia, cerebrovascular disease, or predisposition to hypotension
- Bipolar disorder or risk factors; can precipitate mania
- Existing aggression or hostility, which the drug can worsen
- Moderate or severe hepatic impairment; exposure rises two- and four-fold, so reduce the dose
- Urinary retention or hesitancy, and any history of priapism
Screen before starting:
- Personal and family history of bipolar disorder, mania or hypomania
- Cardiovascular history and exam; ECG or echocardiogram only if either suggests cardiac disease
- Heart rate, blood pressure, height and weight on a growth chart
- Routine liver function tests are not recommended before or during treatment

Drug Interactions

MAOIs (phenelzine, tranylcypromine, linezolid, IV methylene blue): risk of a fatal hyperthermic reaction; contraindicated. Allow 14 days in either direction
Strong CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine, bupropion): exposure rises. Do not lower the target dose; lengthen the titration interval to 4 weeks
Antihypertensives and pressor agents (dopamine, dobutamine): blood pressure moves against intent; check it more often and adjust the atomoxetine dose
Systemic beta-2 agonists (oral albuterol): potentiated rise in heart rate and blood pressure; check both more often

Administration

Once daily in the morning, or two evenly divided doses morning and late afternoon; no additional doses
With or without food; food lowers Cmax 37% and delays Tmax about 3 hours, blunting early nausea
Swallow the capsule whole. Do not open it; the contents are an ocular irritant
Splitting the dose is the usual answer to somnolence or nausea, not a dose reduction
For a child who cannot swallow capsules, the Atoncy oral solution is the route, under its own label
Missed dose: take it as soon as possible, never exceeding the daily total in 24 hours
No taper is required when stopping

Side Effects

Common (pediatric acute trials vs placebo):
- Headache 19 vs 15%, abdominal pain 18 vs 10%, decreased appetite 16 vs 4%
- Somnolence 11 vs 4%, vomiting 11 vs 6%, nausea 10 vs 5%, fatigue 8 vs 3%
- Irritability 6 vs 3%, dizziness 5 vs 2%, decreased weight 3 vs 0%
Serious:
- Suicidal thoughts and behavior, the boxed warning
- Severe liver injury including failure requiring transplant; stop permanently and do not rechallenge
- Sudden death with structural cardiac abnormality; stop and evaluate for exertional chest pain or syncope
- Rise in blood pressure and heart rate; recheck after every dose increase
- New psychotic or manic symptoms without prior history; consider discontinuing
- Emergence or worsening of aggression or hostility; consider a drug cause
- Priapism, an erection over 4 hours; ask adolescent males directly
- Urinary retention or hesitancy
- Growth lag over the first 9 to 12 months, then recovery; at 3 years, weight +0.5 kg and height -0.4 cm against prediction, pre-pubertal starters -2.1 kg and -1.2 cm

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, after every dose increase, then every 3 months; act on a rise of 15 to 20 mm Hg or 20 bpm. Poor metabolizers rose 9.4 vs 5 bpm
Suicidality: screen at every visit for 3 months and at every dose change, then each routine visit
Growth: height and weight at baseline, every 3 months for a year, then every 6 months; investigate a sustained drop over one major percentile line
Liver: routine testing is not recommended
- Obtain ALT, AST, bilirubin and INR at the first sign: pruritus, dark urine, jaundice, right upper quadrant tenderness, unexplained flu-like symptoms
- Discontinue permanently for jaundice, laboratory evidence of injury, or aminotransferases above 5x the upper limit of normal. (LiverTox 2020)
Psychiatric: ask about new aggression, agitation and manic or psychotic symptoms at each titration visit and every 3 months
Genitourinary: ask about urinary hesitancy each visit and prolonged erection in males every 6 months

Discontinuation & Taper

No taper is needed (label 2.8); section 9.3 records no symptom rebound and no discontinuation or withdrawal syndrome
Discontinue permanently and do not restart in any patient with jaundice or laboratory evidence of liver injury
Drug holidays are not appropriate. The effect accrues over weeks of continuous exposure, so a break resets the clock rather than pausing a daily effect
Reevaluate the continued need for treatment periodically and document indication and response

Pregnancy & Lactation

Pregnancy: human data insufficient to establish a drug-associated risk. Animal findings include decreased live fetuses and skeletal variants at 3 to 5 times human exposure. Weigh treatment against untreated ADHD.
Lactation: no human milk data in the label; published mean milk concentration 12 mcg/L at 80 mg daily, relative infant dose 0.19%, worst case 0.65%. Two infants slept longer than usual. Monitor for sedation. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications

Counseling Points

Counsel the family on:
- Nothing happening in the first week, with the review point set at 4 to 6 weeks at target dose
- Giving it every day including weekends and holidays; the effect depends on continuous exposure
- Swallowing the capsule whole and never opening it; the powder irritates the eyes
- Moving the second dose later, or taking it with food, for nausea or sleepiness
- Watching daily for new agitation or unusual behaviour in the first month
- Stopping without a taper being safe, so there is no need to ration a dwindling supply
Advise them to call for:
- New talk of self-harm, or any sudden mood or behaviour change, especially early
- Yellow skin or eyes, dark urine, right-sided rib pain, itching, or flu-like illness; same-day call
- Chest pain on exertion, fainting, or a racing heartbeat
- New aggression, hostility, or behaviour out of character
- An erection lasting more than 4 hours, painful or not, which is an emergency
- Difficulty starting to urinate, or inability to urinate

References

DailyMed. Strattera (atomoxetine) capsules prescribing information. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=309de576-c318-404a-bc15-660c2b1876fb
LactMed. Atomoxetine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501732/
LiverTox. Atomoxetine. Clinical and Research Information on Drug-Induced Liver Injury, National Institute of Diabetes and Digestive and Kidney Diseases. 2020. https://www.ncbi.nlm.nih.gov/books/NBK548671/
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
FDA. National Drug Code Directory, openFDA. Queried by generic name atomoxetine. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22atomoxetine%22&limit=1000
DailyMed. Atoncy (atomoxetine hydrochloride) oral solution prescribing information. Validus Pharmaceuticals LLC. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d3d8cf-7f3b-479e-bd9f-e204d4118517

Trileptal

(oxcarbazepine)

Trileptal (oxcarbazepine); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Trileptal is a sodium channel blocking antiepileptic, supplied as tablets and oral suspension, approved only for partial seizures: monotherapy from 4 years, adjunctive from 2 years. It carries no psychiatric indication at any age, so use for aggression, mood dysregulation or impulse control is entirely off-label. Its defining safety issue is hyponatremia, common enough to require scheduled sodium checks. Not controlled; brand and generic.

Forms & Strengths

Tablets: 150 mg, 300 mg, 600 mg
Oral suspension: 300 mg/5 mL
Extended-release tablets: 150 mg, 300 mg, 600 mg

Dosing

Age:
- Partial seizures, monotherapy: 4 y/o and older
- Partial seizures, adjunctive: 2 y/o and older
- Psychiatric and behavioural use: no approved age; entirely off-label
Onset: 2 to 4 weeks, the time titration takes to reach target
Duration: continuous with twice-daily dosing
Initial Dose:
- Pediatric monotherapy, 4 to 16 y/o: 8 to 10 mg/kg/day in two divided doses
- Pediatric adjunctive, 2 to 16 y/o: 8 to 10 mg/kg/day divided, generally not above 600 mg/day
- Under 20 kg: 16 to 20 mg/kg/day may be considered
- Adults, all uses: 600 mg/day in two divided doses
Titration:
- Pediatric monotherapy initiation: 5 mg/kg/day every 3 days
- Pediatric conversion to monotherapy: up to 10 mg/kg/day weekly
- Pediatric adjunctive: reach target over 2 weeks, or 2 to 4 weeks under 4 y/o
- Adults: up to 600 mg/day weekly; 300 mg/day every third day for monotherapy
Max Dose:
- Pediatric adjunctive, 2 to under 4 y/o: 60 mg/kg/day
- Adjunctive 4 to 16 y/o: 900 mg/day at 20 to 29 kg, 1200 mg/day at 29.1 to 39 kg, 1800 mg/day above 39 kg
- Monotherapy maintenance: 600 to 900 mg/day at 20 kg, up to 1500 to 2100 mg/day at 70 kg
- Adults: 2400 mg/day, which most patients cannot tolerate
Considerations: All dosing is twice daily. Halve the starting dose to 300 mg/day and titrate slowly if creatinine clearance is under 30 mL/min; no adjustment for mild to moderate hepatic impairment.

Pharmacology

Mechanism: Blocks voltage-gated sodium channels, stabilising hyperexcited membranes; no demonstrated interaction with brain neurotransmitter or modulator receptors
Delivery / Release: immediate-release, completely absorbed, median Tmax 4.5 hours; with or without food
Metabolism: prodrug converted to the active 10-monohydroxy derivative (MHD); half-life 2 hours parent, 9 hours MHD, 19 hours if creatinine clearance is under 30 mL/min
Pharmacogenomics: HLA-B*1502 carriers risk Stevens-Johnson syndrome and toxic epidermal necrolysis. Test before starting in at-risk ancestry; avoid unless benefit clearly outweighs risk.
Class Positioning: like carbamazepine but with much less enzyme induction; hyponatremia is more frequent, not less. Adjunct to an ADHD regimen (Concerta, Strattera, Qelbree), never a replacement.

Indications

Partial Seizures, monotherapy (ICD-10: G40.1, G40.2): patients 4 y/o and older, and adults
Partial Seizures, adjunctive therapy (ICD-10: G40.1, G40.2): patients 2 y/o and older, and adults
No other approved indication exists, psychiatric or otherwise, at any age.

Off-Label Uses

Aggression, irritability and mood dysregulation (ICD-10: F90.x, F91.x): limited data. Risperidone (Risperdal) has moderate graded evidence here; oxcarbazepine has none. (AHRQ 2017)
Where the evidence does not support use:
- Pediatric bipolar disorder (ICD-10: F31.x): insufficient; the carbamazepine analogy is pharmacological, not evidential.
- Neuropathic pain, trigeminal neuralgia (ICD-10: G50.0, M79.2): insufficient; no pain indication at any age.
- Generalized seizures (ICD-10: G40.3): insufficient and potentially harmful; can worsen some generalized epilepsies.

Contraindications & Warnings

Class warning, suicidal behaviour and ideation: antiepileptics roughly double the risk (adjusted RR 1.8, 95% CI 1.2 to 2.7), from week one, in every indication.
Contraindicated: known hypersensitivity to oxcarbazepine or any component.
Use with caution:
- Prior carbamazepine hypersensitivity: 25% to 30% cross-react. Ask directly.
- Ancestry in a high HLA-B*1502 frequency population, for Stevens-Johnson syndrome and toxic epidermal necrolysis risk.
- Any other sodium-lowering drug: thiazides, SNRIs, drugs causing inappropriate ADH secretion.
- Creatinine clearance under 30 mL/min: halve the starting dose; MHD half-life roughly doubles.
- Hormonal contraception in an adolescent, because oxcarbazepine reduces its effectiveness.
- Pregnancy or possible pregnancy, because oxcarbazepine is likely a human teratogen.
Screen before starting:
- Baseline serum sodium; a later result cannot be interpreted without it.
- Prior reaction to carbamazepine, asked as a direct question.
- Ancestry, to decide whether HLA-B*1502 testing is indicated first.
- Renal function; the medication list for sodium-lowering drugs and hormonal contraception.
- Baseline mood and any history of suicidal ideation.

Drug Interactions

Hormonal contraceptives (oral, patch, ring): effectiveness is reduced. Arrange an alternative or added method before the first dose.
Other antiepileptics (carbamazepine, phenytoin, phenobarbital): mutual changes in exposure above 1200 mg/day. Check their levels through titration and at any dose change.
Calcium antagonists (felodipine, verapamil): exposure is altered. Recheck blood pressure after any change.
Other sodium-lowering drugs (thiazides, SSRIs, SNRIs, desmopressin, carbamazepine): additive hyponatremia. Check sodium 2 to 4 weeks after starting and at any dose change.
Laboratory tests: T4 falls without T3 or TSH change. Read an isolated low T4 as a drug effect, not hypothyroidism.

Administration

Give twice daily at roughly 12-hour intervals. The extended-release oxcarbazepine product is a separate NDA and must not be substituted milligram for milligram.
May be taken with or without food.
Use the oral suspension for weight-based pediatric dosing rather than splitting tablets.
The suspension is 60 mg/mL: divide the milligram dose by 60 for millilitres.
Shake the suspension; measure with a calibrated oral syringe, never a kitchen spoon.
Do not stop abruptly. See Discontinuation & Taper.

Side Effects

Common (at least 5%, above placebo): dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait
Serious:
- Hyponatremia: sodium below 125 mmol/L in 2.5% of treated patients, usually asymptomatic. Reduce the dose or stop.
- Anaphylaxis and angioedema of the larynx, glottis, lips or eyelids: stop and never rechallenge.
- Stevens-Johnson syndrome and toxic epidermal necrolysis, median onset 19 days. Stop for any rash.
- DRESS: fever, rash or lymphadenopathy with organ involvement. Discontinue unless another cause is established.
- Dose-related psychomotor slowing, impaired concentration, speech problems, ataxia and gait disturbance.
- Pancytopenia, agranulocytosis and leukopenia, rare: consider discontinuation.

Monitoring & Labs

Serum sodium: baseline, 2 to 4 weeks after starting, after every dose increase, at 3 months, then at least every 6 months; also 2 to 4 weeks after adding any sodium-lowering drug.
Serum sodium, unscheduled: for nausea, malaise, headache, lethargy, confusion, obtundation, or rising seizure frequency. Act before 125 mmol/L.
Suicidality and mood: at 1 week, 1 month, every dose change, and each routine visit thereafter.
Skin: ask about rash at every visit for the first 3 months; the family reports any rash the same day.
Cognitive and motor function: ask family and school about concentration, sleepiness and falls at each dose increase and every 6 months.
Contraception review: every visit, in any adolescent who could become pregnant.

Discontinuation & Taper

Withdraw gradually, per the label, to minimise increased seizure frequency. This holds even for off-label behavioural use.
Converting to another antiepileptic: withdraw over 3 to 6 weeks while the replacement reaches target over 2 to 4 weeks.
Stop permanently, no rechallenge, for anaphylaxis, angioedema or any serious dermatological reaction.
Discontinue for DRESS unless an alternative cause is established.
Reduce or stop for clinically significant hyponatremia; sodium normalises within a few days.
Drug holidays are not appropriate for either use.

Pregnancy & Lactation

Pregnancy: No adequate controlled studies; the label states oxcarbazepine is likely a human teratogen. Use only if benefit justifies risk.
Pregnancy, dosing: plasma MHD falls through pregnancy and returns after delivery; monitor seizure control across pregnancy and postpartum.
Lactation: milk-to-plasma ratio 0.5; levels low, adverse effects not expected beyond 2 months. Monitor infant drowsiness, weight gain, milestones. (LactMed 2024)
Exposure Registry: North American Antiepileptic Drug Pregnancy Registry, 1-888-233-2334; the patient enrolls herself.

Counseling Points

Counsel the family on:
- This being a seizure medicine; behavioural use is off-label, with no approved dose ladder.
- The sodium blood test schedule, done even when the child feels well; most affected children have no symptoms.
- Reporting any rash the same day; name blistering, peeling and mouth or eye sores.
- Sleepiness, unsteadiness and double vision being dose-related; report after an increase.
- Never stopping suddenly, even if it seems to be doing nothing: that can trigger seizures.
- For an adolescent who could become pregnant: less reliable hormonal birth control, likely fetal harm.
Advise them to call for:
- Blistering or peeling skin, or mouth, eye or genital sores, immediately.
- Swelling of the lips, tongue, eyelids or throat, or trouble breathing.
- Fever with swollen glands, with or without rash.
- Headache with unusual sleepiness, confusion, unsteadiness, or more frequent seizures.
- New or worsening talk of self-harm, or a sudden mood change.
- Unusual bruising, bleeding, or repeated infections.

References

DailyMed. Trileptal (oxcarbazepine) tablets prescribing information. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33af9350-95f3-384e-e054-00144ff88e88
LactMed. Oxcarbazepine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2024. https://www.ncbi.nlm.nih.gov/books/NBK501243/
AHRQ. First- and second-generation antipsychotics in children and young adults: systematic review update. Comparative Effectiveness Review No. 184. 2017. https://www.ncbi.nlm.nih.gov/books/NBK442344/
FDA. National Drug Code Directory, openFDA. Queried by generic name oxcarbazepine. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22oxcarbazepine%22&limit=1000

Vyvanse

(lisdexamfetamine dimesylate)

Vyvanse (lisdexamfetamine dimesylate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Vyvanse is a long-acting amphetamine prodrug approved for ADHD from age 6 and for moderate to severe binge eating disorder in adults only. It is pharmacologically inert until red blood cells hydrolyse it to dextroamphetamine, so its onset is governed by that conversion rather than by a coating, a bead or a matrix. That single property is its differentiator: there is no release mechanism to defeat by crushing, chewing or dissolving, and capsule and chewable tablet interchange milligram for milligram. Schedule II; brand and generic.

Forms & Strengths

Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg
Chewable tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Oral solution (Arynta, a separate NDA product): 10 mg/mL

Dosing

Age:
- ADHD: ≥ 6 y/o; not recommended below 6 years
- Binge eating disorder: ≥ 18 y/o only; not established under 18
Onset: 1.5-2 hours
Duration: 13-14 hours
Release Profile: None. Inactive prodrug hydrolysed by red blood cells; Tmax about 3.5 h from the capsule, 4.4 h from the chewable
Initial Dose:
- ADHD, ≥ 6 y/o and adults: 30 mg once daily in the morning
- BED, adults: 30 mg once daily in the morning
Titration:
- ADHD: 10 mg or 20 mg at approximately weekly intervals
- BED: 20 mg at approximately weekly intervals, to a target of 50 to 70 mg/day
Max Dose:
- ADHD and BED: 70 mg/day
- Severe renal impairment (GFR 15 to < 30): 50 mg/day
- End stage renal disease (GFR < 15): 30 mg/day
Considerations: Give in the morning; avoid afternoon doses. Capsule and chewable substitute milligram for milligram, but there is no 70 mg chewable.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
Prodrug: Dextroamphetamine bound to L-lysine, inactive as swallowed; the parent does not bind DAT or NET
Delivery / Release: None. Hydrolysis in blood means crushing, chewing or dissolving does not accelerate it
Metabolism: Not metabolised by CYP450. Prodrug half-life under 1 hour; dextroamphetamine 8.6-9.5 h in children 6-12, 10-11.3 h in adults
Pharmacogenomics: Activation is CYP-independent; downstream clearance still involves CYP2D6. No genotype-directed dosing
Class Positioning: No bead, coating or pH trigger, so gut pH and PPIs matter far less than for Adderall XR or Mydayis. Shorter than Mydayis but available from age 6

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o and adults
Moderate to severe binge eating disorder (ICD-10: F50.81): adults ≥ 18 y/o only
Limitation of Use: not indicated for weight loss or obesity

Off-Label Uses

Binge eating disorder in adolescents (ICD-10: F50.81): insufficient. Document and consent as off-label if used.
Narcolepsy (ICD-10: G47.419): off-label at every age; insufficient. Use an approved product: Adderall, Zenzedi, Dexedrine Spansule.
Depression augmentation (ICD-10: F33.x): studied as adjunct in adult MDD, indication not granted; insufficient.
ADHD under 6 years (ICD-10: F90.x): studied and rejected; weight loss and insomnia at exposures 44% above the 6-11 band. AAP names behavioral intervention first-line (AAP 2019).
Cognitive enhancement or weight loss: not indications; weight loss is explicitly excluded by the label (AHRQ 2024).

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction; misuse can cause overdose and death. Assess abuse risk before prescribing and monitor throughout. The prodrug design does not exempt this product.
Contraindicated:
- Known hypersensitivity to amphetamine products or any ingredient in Vyvanse
- MAOI use, current or within 14 days
Use with caution (label Warnings, not contraindications):
- Structural cardiac abnormality or serious arrhythmia; the label says avoid
- Pre-existing hypertension; blood pressure and heart rate rise
- Psychosis or bipolar disorder
- Peripheral vasculopathy including Raynaud phenomenon
- Tics or Tourette syndrome, personal or family
- Substance use disorder, patient or household
- Renal impairment; maximum 50 mg severe, 30 mg ESRD
- Restrictive eating features, where appetite suppression is reinforcing
Screen before starting:
- Cardiac and family history of sudden death; ECG only if positive
- Tics, Tourette syndrome and mania risk factors
- Abuse and diversion risk
- Baseline height, weight, blood pressure and heart rate
- Eating attitudes and restrictive or purging behaviour

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, IV methylene blue): hypertensive crisis; do not give within 14 days.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone): serotonin syndrome; counsel on symptoms and stop both if it occurs.
CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion, quinidine): raise dextroamphetamine exposure, though not prodrug activation; start lower.
Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels by reducing renal elimination; adjust the dose.
Acidifying agents (high-dose ascorbic acid, ammonium chloride): lower levels; adjust on response. Orange juice as a dispersal vehicle does not change exposure.

Administration

Once daily in the morning, with or without food; afternoon doses cost sleep.
Swallow whole, or empty the entire contents into yogurt, water or orange juice, mix and drink immediately. Do not store.
A film left in the glass is inactive ingredient, not lost drug.
Chewable tablets must be chewed thoroughly.
Capsule and chewable substitute milligram for milligram with no re-titration; 70 mg exists only as a capsule.
Do not take less than one capsule or tablet daily; do not divide a dose.
A high-fat meal delays Tmax by about an hour without changing absorption.
If a dose is missed, skip it; do not double up.
Store securely, preferably locked; the prodrug limits snorting and injection but does not make diversion safe.

Side Effects

Common, 6 to 12: decreased appetite 39%, insomnia 22%, upper abdominal pain 12%, irritability 10%, vomiting 9%, decreased weight 9%, dizziness 5%, tic 2%
Common, 13 to 17: decreased appetite 34%, insomnia 13%, decreased weight 9%, dry mouth 4%, palpitations 2%, tremor 2%
Serious:
- Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
- Psychosis, mania and new aggression. Consider discontinuing.
- Serotonin syndrome, from coadministration or overdose. Stop both drugs and treat supportively.
- Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
- Growth suppression. Interrupt if height or weight gain falls behind.
- New or worsening motor and verbal tics. Discontinue if clinically appropriate.

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if the child crosses two major percentile lines.
Appetite and Sleep: at every visit and dose change; ask about sleep-onset latency and midday intake.
Psychiatric and tics: psychosis, mania, aggression, affect lability and new tics at every visit.
Peripheral vasculopathy: inspect fingers and toes at every visit.
Abuse and Diversion: adherence, pill counts and PDMP check at every refill.
Renal function: at baseline where impairment is suspected, and annually.
Eating behaviour where BED or restrictive features exist: at every visit.
Laboratory: none routinely.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; no taper is required.
Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
Rebound irritability and hunger land in the evening, not after school.
In BED, the label instructs discontinuing if binge eating does not improve; apply that stopping rule.
Interrupt treatment where growth or weight gain falls behind.
Drug holidays work better here; restarting needs no re-titration.

Pregnancy & Lactation

Pregnancy: No identified risk of major birth defects or miscarriage. Premature delivery and low birth weight reported. Monitor exposed newborns for withdrawal.
Lactation: Label says breastfeeding is not recommended. Relative infant dose 2 to 13.8%; no reported infant adverse effects.
Lactation, drug-specific: Two small series found colic, restlessness and delayed birthweight regain in a minority, with normal follow-up. (LactMed 2026)
Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.

Counseling Points

Counsel the family on:
- The capsule does nothing until the body converts it, so effect starts around 90 minutes.
- Emptying it into water, yogurt or juice is a complete option for a child who cannot swallow capsules.
- Capsule and chewable interchange milligram for milligram, except that no 70 mg chewable exists.
- The prodrug makes snorting or injection harder; it does not make sharing safe.
- Appetite loss 39% at ages 6 to 12, the highest here. Move the largest meal to breakfast and evening.
- Where a family has heard Vyvanse "treats binge eating": adults only, never for weight loss.
- Locked storage; sharing or selling a Schedule II medication is a felony.
- Bring a teacher rating scale to the next visit.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness, coldness or colour change in the fingers or toes.
- A new or markedly worse tic, motor or verbal.
- Weight loss, or a child eating nothing between breakfast and dinner.
- New meal skipping, hiding food, or a stated wish to lose weight.
- Agitation, shivering, sweating or confusion after an antidepressant change.

References

DailyMed. VYVANSE (lisdexamfetamine dimesylate) capsules and chewable tablets prescribing information. Takeda Pharmaceuticals America. Revised 4/2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=704e4378-ca83-445c-8b45-3cfa51c1ecad
LactMed. Lisdexamfetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501741/
openFDA. NDC Directory, generic_name "lisdexamfetamine". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis
Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
DailyMed. Arynta (lisdexamfetamine dimesylate) oral solution prescribing information. Azurity Pharmaceuticals, Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71cdfc97-96af-4378-a44a-6d5d77e7d6b7

Wellbutrin XL

(bupropion hydrochloride)

Wellbutrin XL (bupropion hydrochloride); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Wellbutrin XL is an aminoketone antidepressant supplied as a once-daily extended-release tablet, approved for major depressive disorder and for prevention of seasonal affective disorder in adults. It has no pediatric indication at any age, so every use in a child or adolescent is off-label. Among antidepressants it is distinctive for no serotonergic action and no sexual dysfunction or weight gain, at the cost of a dose-related seizure risk. Not controlled; brand and generic.

Forms & Strengths

Extended-release (XL) tablets: 150 mg, 300 mg, the only two XL strengths
Sustained-release (SR) tablets: 100 mg, 150 mg, 200 mg, dosed twice daily
Immediate-release tablets: 75 mg, 100 mg, dosed three times daily
Separate NDAs: Forfivo XL 450 mg; Aplenzin (hydrobromide) 174 mg, 348 mg, 522 mg
Combination products: dextromethorphan-bupropion (Auvelity); naltrexone-bupropion (Contrave)

Dosing

Age: adults only. No pediatric indication at any age and no pediatric ADHD indication at any age; any use in a young person is off-label.
Onset: 1 to 2 weeks for early effect; 4 to 6 weeks for full response
Duration: continuous with once-daily dosing; bupropion half-life 21 hours, hydroxybupropion about 20 hours
Release Profile: once-daily matrix tablet, bioequivalent over 24 hours to immediate-release 100 mg three times daily
Initial Dose: 150 mg once daily, for both approved indications
Titration:
- Major depressive disorder: may increase to 300 mg once daily after 4 days
- Seasonal affective disorder: may increase to 300 mg once daily after 1 week
- Increase gradually; abrupt escalation raises the seizure risk
Max Dose: 300 mg/day. The 450 mg ceiling belongs to Forfivo XL, a different product
Considerations: Moderate to severe hepatic impairment caps the dose at 150 mg every other day; mild impairment or GFR under 90 mL/min needs a reduced dose or frequency.

Pharmacology

Mechanism: norepinephrine-dopamine reuptake inhibitor; no serotonin reuptake or monoamine oxidase inhibition
Metabolism: CYP2B6 to hydroxybupropion, the principal active metabolite. Renal excretion of metabolites means impairment causes accumulation
Class Positioning: chosen for the absent serotonergic action: no sexual dysfunction, appetite suppression rather than weight gain. Approved non-stimulant alternatives are Strattera and Qelbree

Indications

Major Depressive Disorder (ICD-10: F32.x, F33.x): adults only
Seasonal Affective Disorder, prevention (ICD-10: F33.x seasonal pattern): adults only. Start in autumn, continue through winter
No pediatric indication at any age, and specifically no pediatric ADHD indication

Off-Label Uses

ADHD in children and adolescents (ICD-10: F90.x): limited data. Second-line where a stimulant is not tolerated and depression coexists.
- The label carries no ADHD indication and no ADHD trial.
- AHRQ found medication improves ADHD symptoms overall but graded no bupropion-specific pediatric evidence. (AHRQ 2024)
- Weigh the seizure risk against the two approved non-stimulants first.
Pediatric major depressive disorder (ICD-10: F32.x, F33.x): insufficient; the adult indication does not extend downward.
Adolescent smoking or vaping cessation (ICD-10: F17.2x): insufficient. The label's neuropsychiatric warning applies at any age.
Any use in a patient with an eating disorder (ICD-10: F50.x): contraindicated, not merely unsupported.

Contraindications & Warnings

Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS. Antidepressants increased suicidal thinking and behaviour in children, adolescents and young adults. Monitor for worsening and emergent suicidality, including in off-label pediatric use.
Contraindicated:
- Seizure disorder.
- Current or prior bulimia or anorexia nervosa; absolute, and easily missed in an adolescent.
- Abrupt discontinuation of alcohol, benzodiazepines, barbiturates or antiepileptics; withdrawal lowers the seizure threshold.
- Concomitant MAOI, or use within 14 days of stopping one; initiation on linezolid or intravenous methylene blue.
- Known hypersensitivity to bupropion or any other ingredient.
Use with caution:
- Conditions lowering the seizure threshold: severe head injury, arteriovenous malformation, CNS tumour or infection, stroke, hypoglycemia, hyponatremia, hypoxia.
- Never co-prescribe two bupropion products, and see Drug Interactions for other threshold-lowering drugs.
- Insulin- or oral-hypoglycemic-treated diabetes, and anorectic drugs; both predispose to seizure.
- Pre-existing hypertension, because bupropion raises blood pressure.
- Bipolar disorder or risk factors: activation of mania or hypomania.
- Untreated anatomically narrow angles: angle-closure glaucoma.
- Renal impairment below GFR 90 mL/min; active metabolites accumulate.
Screen before starting:
- Seizure and head injury history, and any eating disorder. Ask the adolescent alone; bulimia is rarely volunteered.
- Current alcohol, benzodiazepine or antiepileptic use, and any plan to stop.
- Personal and family history of bipolar disorder or mania.
- Blood pressure, measured before initiation.
- Medication list for MAOIs, other bupropion products, seizure-threshold drugs.
- Hepatic and renal function where impairment is plausible; both change the dose.

Drug Interactions

MAOIs (phenelzine, tranylcypromine, linezolid, intravenous methylene blue): hypertensive reactions. Contraindicated; allow 14 days in either direction.
CYP2D6 substrates (venlafaxine, nortriptyline, paroxetine, fluoxetine, risperidone, metoprolol, flecainide, atomoxetine): bupropion raises exposure. Reduce the substrate dose.
CYP2B6 inducers (ritonavir, efavirenz, carbamazepine, phenytoin): exposure falls. An increase may be needed, never above 300 mg/day.
CYP2B6 inhibitors (ticlopidine, clopidogrel): bupropion exposure rises 38% to 85%. Adjust on clinical response.
Seizure-threshold drugs (other bupropion products, antipsychotics, tricyclics, theophylline, corticosteroids, tramadol): additive risk. Avoid, or hold at 150 mg/day.
Levodopa and amantadine: CNS toxicity. Use lower doses.
Urine drug screens: false-positive for amphetamines. Confirm before treating a positive as diversion of a prescribed amphetamine (Adderall).

Administration

Give once daily in the morning to limit early insomnia.
Swallow whole; breaking the matrix converts a daily dose into an immediate-release bolus.
An intact tablet shell in the stool is expected, not a missed dose.
Never escalate faster than the label allows: 4 days to 300 mg for depression, 1 week for SAD.
Switching from immediate-release or SR: same total daily dose as one XL dose; confirm the product.
For seasonal affective disorder, start in autumn, continue through winter, taper in early spring.
Do not stop abruptly from 300 mg. See Discontinuation & Taper.

Side Effects

Common (at least 5% and twice placebo): dry mouth, nausea, insomnia, dizziness, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, anorexia, rash
Serious:
- Suicidal thoughts and behaviour: the boxed warning.
- Seizure, dose-related: about 0.1% up to 300 mg/day sustained-release, about 0.4% at 300 to 450 mg/day immediate-release. Discontinue permanently.
- Serious neuropsychiatric events during smoking cessation: depression, mania, psychosis, hallucinations, aggression, agitation, panic.
- Hypertension.
- Activation of mania or hypomania: stop and reassess the diagnosis.
- Angle-closure glaucoma: sudden eye pain, redness or visual change needs same-day ophthalmology.
- Hypersensitivity, including serum-sickness-like reactions.

Monitoring & Labs

Suicidality: weekly for 4 weeks, every visit through 3 months, every dose change, then each routine visit.
Blood pressure: baseline, 4 weeks, every dose change, then every 3 months.
Seizure risk review: at every dose increase and at least every 6 months. Re-ask about threshold-lowering drugs, alcohol or benzodiazepine use, and disordered eating.
Weight and appetite: baseline and every 3 months. Unexplained loss prompts a direct question about disordered eating.
Psychiatric: ask about mania, agitation, anxiety and insomnia each visit during titration, then every 3 months.
Renal and hepatic function: no routine schedule; recheck when circumstances change.
Urine drug screens: confirm any positive amphetamine result rather than acting on the immunoassay.

Discontinuation & Taper

Taper before stopping: from 300 mg once daily, decrease to 150 mg once daily before discontinuation.
Discontinue permanently and never restart if a seizure occurs.
Stop and seek review for serious neuropsychiatric symptoms.
Drug holidays are not appropriate; the effect depends on continuous exposure.
For seasonal affective disorder, taper in early spring rather than continuing year-round.

Pregnancy & Lactation

Pregnancy: first-trimester studies show no increased risk of congenital malformations overall.
- Registry cardiovascular malformation rate 1.3% against a roughly 1% background; cardiac findings are inconsistent.
- Background risk is 2 to 4% for birth defects, 15 to 20% for miscarriage; weigh continuation against relapse.
Lactation: maternal doses up to 300 mg daily give low milk levels. Case reports describe possible seizure in partially breastfed 6-month-olds; prefer another agent for a newborn. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for Antidepressants, 1-844-405-6185, womensmentalhealth.org

Counseling Points

Counsel the family on:
- This being an adult medication used off-label, with no pediatric dose ladder.
- Never taking two bupropion products; the drug is sold under several brands.
- Swallowing the tablet whole; an empty shell in the stool is normal.
- Insomnia and jitteriness in the first weeks, fixed by morning dosing.
- Telling any clinician ordering a urine drug test, because it reads as amphetamine.
- Stepping the dose down before stopping rather than stopping outright.
Advise them to call for:
- Any seizure, including a staring spell or single whole-body jerk; stop and call the same day.
- New or worsening talk of self-harm, or a sudden mood change.
- A burst of high energy, reduced need for sleep, or racing speech.
- Hearing or seeing things that are not there, or new suspiciousness.
- Sudden eye pain, redness or blurred vision.
- Rash, hives, facial or tongue swelling, or joint pains with fever.
- Any plan to stop alcohol, a benzodiazepine, or a seizure medicine abruptly.

References

DailyMed. Wellbutrin XL (bupropion hydrochloride extended-release tablets) prescribing information. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21
LactMed. Bupropion. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501184/
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
FDA. National Drug Code Directory, openFDA. Queried by generic name bupropion. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22bupropion%22&limit=1000

Xelstrym

(dextroamphetamine)

Xelstrym (dextroamphetamine); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Xelstrym is a dextroamphetamine transdermal system, the only amphetamine patch on the U.S. market, approved for ADHD from age 6 and worn up to 9 hours a day. It delivers single-entity d-amphetamine through the skin, bypassing swallowing and letting a caregiver end the exposure early by removing the patch. That reversibility is its differentiator; its cost is the skin, where irritation and discomfort were near-universal. Schedule II; brand only.

Forms & Strengths

Transdermal system (9 hour wear; dose set by patch area): 4.5 mg/9 h, 9 mg/9 h, 13.5 mg/9 h, 18 mg/9 h

Dosing

Age: ≥ 6 y/o
Onset: ~ 2 hours
Duration: up to 12 hours
Release Profile: continuous transdermal delivery, about 90% of content over 9 hours; peak plasma at 6 to 9 hours, ~6 hours on repeat
Initial Dose:
- 6-17 y/o: 4.5 mg/9 h daily
- ≥ 18 y/o: 9 mg/9 h daily
Titration: 4.5 mg/9 h every 7 days, patients 6-17
Max Dose:
- All ages: 18 mg/9 h, one system per 24 hours
- Severe renal impairment, GFR 15 to under 30 mL/min/1.73 m²: 13.5 mg/9 h
- End-stage renal disease, GFR under 15 mL/min/1.73 m²: 9 mg/9 h
Considerations: Apply 2 hours before effect is needed, remove within 9 hours, and use a shorter wear to shorten the day. Rotate sites daily, never cut a patch, and keep external heat off it.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: Dextroamphetamine in an acrylic adhesive matrix; absorption tracks wear time and area, not site, with 20% to 30% variability
Formulation: d-isomer only, unlike Adderall or Evekeo
Metabolism: CYP2D6, polymorphic, forms active 4-hydroxyamphetamine. Half-life after a 9 hour wear is 6.4 h in children, 11.5 h in adults; not dialyzable, hence the ESRD cap
Class Positioning: the only amphetamine whose exposure can be curtailed mid-day; the cost is daily adhesive on skin and a 1.5-fold rise under heat. Daytrana is methylphenidate, not interchangeable

Indications

ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o

Off-Label Uses

None established for this formulation by graded pediatric evidence.
Where the evidence does not support use:
- Children under 6: argued against by this label.
- Wear beyond 9 hours: a dose increase without a dose change.
- Cutting a patch: forbidden.
- Non-ADHD indications, and cognitive enhancement without ADHD: AHRQ CER 267 graded none (AHRQ 2024).

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction. High abuse potential leading to substance use disorder; overdose and death, more so at higher doses. Assess risk before prescribing; reassess throughout.
Contraindicated:
- Known hypersensitivity to amphetamine or components
- MAOI use, current or within 14 days, including linezolid and IV methylene blue
Contact sensitization: suspect it if erythema comes with edema, papules or vesicles that fail to improve within 48 hours or spread beyond the site. Discontinue.
Its consequence is not local: a sensitized patient may be unable to take amphetamine in ANY form.
Use with caution (Warnings, not contraindications):
- Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid
- Hypertension; psychosis; bipolar disorder; tics or Tourette syndrome; Raynaud phenomenon
- Dermatitis, eczema or fragile skin at candidate sites
- Regular external heat at the site (see Interactions)
- Severe renal impairment and ESRD, capping the dose at 13.5 and 9 mg/9 h
- Substance use disorder in the household; a worn patch is removable by anyone
Screen before starting: cardiac and family cardiac history with exam; tic history; skin at candidate sites and any prior adhesive reaction.
Also screen: renal function, which sets the ceiling; abuse and diversion risk; baseline height, weight, BP, HR.

Drug Interactions

MAOIs (also linezolid, IV methylene blue): hypertensive crisis. Confirm a 14 day washout before the first patch.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, tramadol): serotonin syndrome. Start lower; remove the patch and stop the other agent if symptoms appear.
CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
Urinary pH agents: acidifiers lower levels; alkaline urine raises exposure. Adjust strength by clinical response.
External heat is a pharmacokinetic interaction: a heating pad over the system for 6 hours raised Cmax to about 116% and AUC to about 150%. Instruct explicitly against it.
Sympathomimetics: additive cardiovascular effect; avoid OTC decongestants.

Administration

One system per 24 hours, applied 2 hours before effect is needed and removed within 9 hours.
Early removal is a legitimate dose adjustment: absorption tracks wear time, so it answers an evening appetite or sleep problem.
Clean, dry, intact skin free of lotion or oil: hip, upper arm, chest, upper back or flank. Rotate daily; 28 days on one adult site raised Cmax 86% against 46% with rotation.
Avoid touching the adhesive side. Press a lifting edge down, replace one that falls off, and never tape, cut or trim.
A used system still contains drug; dispose of it as a Schedule II item.
From any other amphetamine: stop the previous drug and titrate from the starting strength.

Side Effects

Common, 6-17, dose optimization: decreased appetite 54%, insomnia 32%, headache 21%, irritability, abdominal pain and affect lability 16% each, site pain 13%, nausea 9%, fatigue 5%.
Application site reactions are near-universal and are the defining tolerability issue: at double-blind clinic assessment, irritation 94% vs 54% placebo, any discomfort 69% vs 9%, severe 10% vs 4%.
What to tell them: pain, itch, burning, erythema and edema during or just after wear; discomfort resolves in 2 to 4 hours, and nobody in the pediatric study stopped for it.
Serious:
- Contact sensitization, which may end the ability to take amphetamine in any form.
- Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor.
- Psychosis or mania, roughly 0.1% in pooled stimulant trials, and serotonin syndrome; remove the patch, stop any serotonergic agent, consider discontinuing.
- Anaphylaxis, angioedema, urticaria, Stevens-Johnson syndrome; stop and do not rechallenge.
- Peripheral vasculopathy with digital ulceration; growth suppression, mean weight falling over the 7 week trial; new or worsening tics, 2% vs 0%.

Monitoring & Labs

Application sites: inspect at every visit and at 2 weeks, when irritation peaks; ask whether a site is being reused.
Contact sensitization: apply the criteria above at any visit where erythema is reported.
Cardiovascular: HR and BP at baseline, each dose change, and every 6 months.
Growth, appetite and sleep: height, weight and BMI charted at baseline and every 6 months; appetite and sleep every visit. The first response to insomnia is earlier removal.
Psychiatric and tics: psychosis, mania, aggression, affect lability and tics at each visit and 2 weeks after any increase; inspect the digits.
Renal function: at baseline and whenever GFR could change, since the ceiling drops to 13.5 then 9 mg/9 h.
Abuse and diversion: adherence, patch counts and PDMP check at each refill; used patches retain drug. No routine labs.

Discontinuation & Taper

Can be stopped abruptly; no taper required.
Offset is not immediate on removal; half-life after a 9 hour wear is 6.4 h in children, up to 11.5 h in adults.
Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
Drug holidays are easy: a holiday is a day without a patch.
If stopped for contact sensitization, do not simply switch to an oral amphetamine. Some sensitized patients cannot take amphetamine at all.

Pregnancy & Lactation

Pregnancy: Published data have not identified a drug-associated risk of major birth defects or miscarriage; background risk is 2% to 4% and 15% to 20%.
Pregnancy, clinical: amphetamines vasoconstrict, may reduce placental perfusion and stimulate contractions; premature delivery and low birth weight are reported.
Neonate: monitor for withdrawal: feeding difficulty, irritability, agitation, drowsiness.
Lactation: in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5; the label does not recommend breastfeeding.
Lactation, dextroamphetamine: four mothers on a mean 18 mg daily gave a median milk level of 219 mcg/L, 5.7% of the maternal dose, with all four infants normal. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychiatric Medications, ADHD arm, 1-866-961-2388, https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/

Counseling Points

Counsel the family on:
- That the skin under the patch will almost certainly be red, often itchy or stinging, and that this is expected rather than an allergy.
- The numbers, out loud: most children had irritation, about one in ten severely, and none stopped for it. Warned in advance, families get through week one.
- That discomfort settles within 2 to 4 hours; apply 2 hours before it is needed, so before breakfast on a school morning.
- Daily site rotation, since reusing one spot hurts more and delivers more drug.
- That early removal shortens the day, but effect fades over hours rather than at removal.
- No heat over the patch, no touching the sticky side, and never cutting one.
- That a used patch still contains medication and is disposed of as a controlled substance.
Advise them to call for:
- Redness under the patch with swelling, bumps or blisters, or that does not settle within two days or spreads outside the outline; any rash elsewhere on the body.
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or new suspicious or fearful thinking.
- Numbness or colour change in the fingers or toes; a new tic; weight loss; a patch that fell off and cannot be found.

References

DailyMed. Xelstrym (dextroamphetamine) transdermal system prescribing information. Noven Therapeutics. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0862f02a-72a8-41cc-8845-57cf4974bb6f
FDA. openFDA National Drug Code Directory, generic_name "dextroamphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22dextroamphetamine%22&limit=1000
LactMed. Dextroamphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/
AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/

Zenzedi

(dextroamphetamine sulfate)

Zenzedi (dextroamphetamine sulfate); CII

Full Prescribing Information

DailyMed Drug Information

Summary

Zenzedi is an immediate-release, short-acting dextroamphetamine tablet approved for narcolepsy and for ADHD in patients aged 3 to 16. It is single-isomer dextroamphetamine, carrying no levoamphetamine and less peripheral noradrenergic load than an equivalent mixed-salt dose. Its differentiator is the age floor: 3 years is the lowest approved age in this library, and the seven-step ladder starting at 2.5 mg is what makes that band dosable. Schedule II; brand and generic.

Forms & Strengths

Tablets: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg
Scoring: the 5 mg tablet is scored, the 10 mg tablet double scored

Dosing

Age:
- ADHD: 3-16 y/o, the lowest approved age here. Not recommended under 3
- Narcolepsy: no age bound stated; dose ladder given from age 6
Onset: 30-60 min
Duration: 4-6 hours, the label's own redosing interval
Initial Dose:
- ADHD, 3-5 y/o: 2.5 mg daily
- ADHD, 6-16 y/o: 5 mg once or twice daily
- Narcolepsy, 6-11 y/o: 5 mg daily
- Narcolepsy, ≥ 12 y/o: 10 mg daily
Titration:
- ADHD, 3-5 y/o: 2.5 mg at weekly intervals until optimal response
- ADHD, 6-16 y/o: 5 mg at weekly intervals until optimal response
- Narcolepsy, 6-11 y/o: 5 mg at weekly intervals
- Narcolepsy, ≥ 12 y/o: 10 mg at weekly intervals
Max Dose:
- ADHD, 6-16 y/o: 40 mg/day; only in rare cases will it be necessary to exceed this
- ADHD, 3-5 y/o: no maximum stated in this label. Titrate to optimal response; 40 mg/day is not transferable downward to a preschooler
- Narcolepsy: usual range 5-60 mg/day in divided doses
Considerations: First dose on waking, one or two further doses at 4 to 6 hour intervals; avoid late evening doses. The label directs interrupting treatment occasionally to test continued need.

Pharmacology

Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
Delivery / Release: Immediate release. Cmax 36.6 ng/mL at about 3 hours, against 23.5 ng/mL at 8 hours for the SR capsule
Formulation: Single-isomer dextroamphetamine sulfate; no levoamphetamine
Metabolism: CYP2D6 to 4-hydroxyamphetamine. Half-life about 12 hours; the shorter duration is the peak-and-fall profile, not faster clearance
Pharmacogenomics: No genotype-directed dosing in the label; the actionable consequence is the CYP2D6-inhibitor interaction
Class Positioning: A higher earlier peak than Dexedrine Spansule, a finer ladder, and the 3 to 5 year band it lacks. Single-isomer where IR Adderall is mixed salts

Indications

Narcolepsy (ICD-10: G47.419): no age bound stated; dosing from age 6
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 3 to 16 y/o, within a total treatment program

Off-Label Uses

Preschool ADHD, where approval and guideline diverge (ICD-10: F90.x): FDA approves from age 3; evidence for amphetamine in preschoolers is limited.
AAP places behavioral parent training first-line at 4 to under 6 (grade A) and names methylphenidate, not amphetamine, if medication is added (AAP 2019).
ADHD at 17 and older (ICD-10: F90.x): this label stops at 16; switch to a product with an adult indication.
Binge eating disorder (ICD-10: F50.81): lisdexamfetamine holds it, adults only; insufficient here.
Where the evidence does not support use: depression augmentation; no pediatric evidence for IR dextroamphetamine (AHRQ 2024).
Cognitive enhancement without ADHD: not an indication.

Contraindications & Warnings

Boxed Warning: Abuse, misuse, and addiction; misuse can cause overdose and death. Assess abuse risk and monitor throughout.
Contraindicated:
- Known hypersensitivity to amphetamine products
- MAOI use, current or within 14 days
Use with caution (label Warnings, not contraindications):
- Structural cardiac abnormality or serious arrhythmia; the label says avoid
- Pre-existing hypertension; blood pressure and heart rate rise
- Psychosis or bipolar disorder
- Prior seizure or EEG abnormality
- Peripheral vasculopathy including Raynaud phenomenon
- Tics or Tourette syndrome, personal or family
- Substance use disorder, patient or household
- The 3 to 5 year band: no maximum stated, long-term pediatric effects not established. Hold at the lowest effective dose
Screen before starting:
- Cardiac and family history of sudden death; ECG only if positive
- Tics and Tourette syndrome, in child and family
- Mania risk factors, including family history
- Household abuse and diversion risk
- Baseline height, weight, blood pressure and heart rate
- Whether behavioral treatment has been tried, for any child under 6 (AAP 2019)

Drug Interactions

MAOIs (phenelzine, tranylcypromine, selegiline, linezolid): hypertensive crisis and malignant hyperpyrexia, sometimes fatal. Do not give within 14 days.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol): serotonin syndrome; counsel on symptoms and stop both if it occurs.
CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure; start lower.
Alkalinizing agents (sodium bicarbonate, acetazolamide): raise absorption and reduce excretion; avoid or reduce the dose.
Acidifying agents (ascorbic acid, fruit juices, methenamine): lower absorption and raise excretion; adjust on response.
Tricyclics (desipramine, protriptyline): sustained rise in brain d-amphetamine; monitor.
Antiepileptics (phenytoin, phenobarbital, ethosuximide): delayed absorption; separate dosing, check levels after a stimulant change.
Antihypertensives and antihistamines: effects antagonised; recheck blood pressure, and do not rely on an antihistamine for sleep.
Chlorpromazine and haloperidol: inhibit the stimulant effect; expect loss of benefit.

Administration

First dose on waking, further doses at 4 to 6 hour intervals.
Avoid late evening doses; a third dose in a young child costs sleep.
Splitting a scored tablet is legitimate for an intermediate dose where 2.5 mg is not stocked.
Prescribe at the lowest effective dosage.
Interrupt treatment occasionally to see whether therapy is still needed; this label makes that explicit.
If a dose is missed, skip it; do not double up.
Store securely, preferably locked, in a child-resistant container.

Side Effects

Common: loss of appetite, weight loss, insomnia, overstimulation, restlessness, dry mouth, headache, dizziness, tremor, dysphoria, palpitations, raised blood pressure
Serious:
- Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope.
- Psychotic episodes at recommended doses (rare), mania and new aggression. Consider discontinuing.
- Serotonin syndrome. Stop both drugs and treat supportively.
- Seizures. Discontinue.
- Peripheral vasculopathy with digital ulceration. Reduce or stop.
- Growth suppression. Interrupt if height or weight gain falls behind.
- New or worsening motor and verbal tics. Discontinue if clinically appropriate.
- Prolonged erections; painful erection beyond a few hours is a surgical emergency.

Monitoring & Labs

Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months.
Growth, 6 to 16 y/o: height, weight and BMI charted at baseline and every 6 months; interrupt if two percentile lines are crossed.
Growth, 3 to 5 y/o: height, weight and BMI at baseline and every 3 months; with no dose ceiling here, growth is the ceiling.
Appetite and Sleep: at every visit and dose change; ask when the last dose is given.
Psychiatric and tics: psychosis, mania, aggression and new tics at every visit.
Peripheral vasculopathy: inspect fingers and toes at every visit.
Continued need: schedule a deliberate interruption at least annually, per this label.
Abuse and Diversion: adherence, pill counts and PDMP check at every refill.
Age boundary: review the indication at the 17th birthday. No routine labs.

Discontinuation & Taper

May be stopped abruptly at therapeutic doses; no taper is required.
Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
Rebound at 4 to 6 hours is offset, not withdrawal; the family may be describing the gap between doses.
Planned interruption is a labelled instruction here: stop occasionally to test whether symptoms recur at a level requiring continued therapy.
Interrupt treatment where growth or weight gain falls behind.

Pregnancy & Lactation

Pregnancy: No adequate controlled studies; animal teratogenicity only far above human doses. Amphetamine-dependent mothers have more premature delivery and low birth weight. Use only if benefit justifies fetal risk.
Lactation: Label advises against nursing. LactMed: infant dose about 5.7% of the maternal weight-adjusted dose, all four infants studied growing normally. (LactMed 2025)
Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2025)
Exposure Registry: None on this label; the National Pregnancy Registry for Psychostimulants (1-866-961-2388) takes amphetamine exposures.

Counseling Points

Counsel the family on:
- The 4 to 6 hour window and the need for a second, sometimes third, dose.
- For a preschooler: AAP puts behavioral parent training first and names a different class at that age.
- For a preschooler: no maximum dose is set, so the growth chart is the ceiling, checked every three months.
- The 2.5 mg tablet has only one generic supplier; if the pharmacy cannot fill it, split a scored 5 mg tablet.
- The planned yearly interruption, so it is not heard later as doubt about the diagnosis.
- Vitamin C and fruit juice can mimic treatment failure; bicarbonate and antacids raise levels.
- Moving the largest meal to breakfast and to the evening.
- Locked storage and the child-resistant container.
Advise them to call for:
- Chest pain on exertion, fainting, or a racing heart that does not settle.
- New hallucinations, or a young child describing things that are not there.
- Numbness, coldness or colour change in the fingers or toes.
- A new or markedly worse tic, or a seizure of any kind.
- Weight loss, or shoes still fitting after several months.
- A painful erection lasting more than a few hours.
- Agitation, shivering, sweating or confusion after an antidepressant change.

References

DailyMed. ZENZEDI (dextroamphetamine sulfate) tablets, USP prescribing information. Azurity Pharmaceuticals. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
LactMed. Dextroamphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/
openFDA. NDC Directory, generic_name "dextroamphetamine". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis
Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/

Zoloft

(sertraline)

Zoloft (sertraline); not controlled

Full Prescribing Information

DailyMed Drug Information

Summary

Zoloft is a selective serotonin reuptake inhibitor supplied as a scored tablet and an oral concentrate, with one pediatric indication: obsessive-compulsive disorder from 6 years of age. Response is judged over weeks of continuous dosing. Its short half-life reaches steady state within a week, which is why it titrates fast and why it must be tapered. Not controlled; brand and generic.

Forms & Strengths

Tablets, film coated, scored: 25 mg, 50 mg, 100 mg
Oral solution (concentrate, 12% alcohol): 20 mg/mL
Capsules: 150 mg, 200 mg. Separate label; maintenance only

Dosing

Age:
- OCD: 6 y/o and older. The only pediatric indication
- MDD, panic, PTSD, social anxiety: adults only; PMDD: adult women
Onset: 2 to 3 weeks for early effect; 12 weeks for full response in OCD
Duration: continuous with once-daily dosing
Initial Dose:
- Pediatric OCD, 6 to 12 y/o: 25 mg daily
- Pediatric OCD, 13 to 17 y/o: 50 mg daily
- Adults: 50 mg daily; 25 mg for panic, PTSD and social anxiety
Titration:
- 25 to 50 mg/day increments at intervals of no less than 1 week
- Therapeutic range 50 to 200 mg/day; halve both in mild hepatic impairment
Max Dose:
- 200 mg/day at any age from 6 years; 100 mg/day in mild hepatic impairment
- Moderate or severe hepatic impairment: not recommended
Considerations: Do not initiate or titrate with the 150 mg or 200 mg capsules; their own label forbids it. Screen for bipolar history first; taper when stopping.

Pharmacology

Mechanism: Inhibits serotonin reuptake at SERT with very weak effect on norepinephrine and dopamine, and an unusually clean receptor panel
Delivery / Release: immediate-release tablet or concentrate, approximately bioequivalent; food is no constraint
Metabolism: first-pass N-demethylation to the less active N-desmethylsertraline. Half-life about 26 hours, steady state in one week. Mild hepatic impairment triples exposure
Class Positioning: steady state in a week against fluoxetine's 4 to 5 weeks, so it titrates weekly, at the cost of a discontinuation syndrome Prozac lacks

Indications

Obsessive-Compulsive Disorder (ICD-10: F42.x): 6 y/o and older. The only pediatric indication
Major Depressive Disorder (ICD-10: F32.x, F33.x): adults only
Panic Disorder, PTSD, Social Anxiety Disorder (ICD-10: F41.0, F43.1, F40.10): adults only
Premenstrual Dysphoric Disorder (ICD-10: N94.3): adult women only

Off-Label Uses

Pediatric anxiety disorders (ICD-10: F41.1, F40.10, F93.0): sertraline with CBT beat either alone; CBT alone beat sertraline alone for remission (AHRQ 2017). On-label option: Cymbalta from 7 y/o
Pediatric major depressive disorder (ICD-10: F32.x): two trials did not support an indication. Prozac carries that one
Pediatric PTSD (ICD-10: F43.1): insufficient, despite the adult indication
Anxiety and irritability in autism (ICD-10: F84.0): insufficient; a trial in children 24 to 72 months found no difference (Potter 2019)

Contraindications & Warnings

Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS in children, adolescents and young adults.
- Monitor closely for clinical worsening and emergent suicidality in the initial few months and at every dose change, up or down.
- Counsel family members to watch for behaviour change and alert the prescriber.
Contraindicated:
- An MAOI concurrently or within 14 days either way, including linezolid and methylene blue, because of serotonin syndrome.
- Pimozide; and known hypersensitivity, including anaphylaxis and angioedema.
- ORAL SOLUTION ONLY: concurrent disulfiram, because of its 12% alcohol.
Use with caution:
- Seizure disorder, unstudied; those patients were excluded from the trials.
- Untreated narrow angles: the label says AVOID; pupillary dilation can trigger angle closure.
- QTc risk factors; mild hepatic impairment, halving both dose and ceiling.
- NSAIDs, aspirin or anticoagulants; diuretics; bipolar disorder or family history.
Screen before starting:
- Personal or family history of bipolar disorder; the label makes this a numbered dosing step.
- Baseline height, weight, sexual function and QTc risk; disulfiram if using the solution.

Drug Interactions

MAOIs (selegiline, phenelzine, linezolid, methylene blue): contraindicated. 14 days in both directions, unlike fluoxetine's 5-week exit
CYP2D6 substrates, atomoxetine named by the label (Strattera, propafenone, metoprolol): sertraline raises substrate exposure.
- Decrease the substrate dose if needed; raise it again once sertraline stops.
- For atomoxetine, lengthen the titration interval to 4 weeks. This pair, and Qelbree, stack two pediatric suicidality boxed warnings.
Bupropion (Wellbutrin XL): doubles 2D6 inhibition and stacks seizure cautions
Other serotonergic drugs (SSRIs, SNRIs, triptans, TCAs, opioids, lithium, AMPHETAMINES): serotonin syndrome. Stop all for agitation, hyperthermia, rigidity or myoclonus
Phenytoin: check the level when sertraline starts and at each titration step
Antiplatelets and anticoagulants (aspirin, warfarin, NSAIDs): bleeding; monitor the INR
QTc-prolonging drugs (ziprasidone, erythromycin, amiodarone): avoid, or obtain an ECG before each increase

Administration

Give once daily, morning or evening, with or without food; fix the time and keep it fixed.
Tablets are scored at every strength, so a 12.5 mg half-step needs no liquid.
Oral solution: use the SUPPLIED dropper, graduated at 25 mg and 50 mg only. Dilute in 4 ounces of water, ginger ale, lemonade or orange juice ONLY, and drink immediately.
Do not start or titrate with the 150 mg or 200 mg capsules; their label says do not initiate treatment with them.
Missed dose: take it the same day; do not double up.
Switching to or from an MAOI: allow 14 days in either direction.

Side Effects

Common: nausea, insomnia, diarrhea, dry mouth, fatigue, dizziness, somnolence, tremor, agitation, decreased appetite, hyperhidrosis.
- Pediatric trials add fever, hyperkinesia, urinary incontinence, aggression, epistaxis and purpura.
Serious:
- Suicidal thoughts and behavior: the boxed warning. Change or stop the regimen if suicidality emerges.
- Serotonin syndrome: stop every serotonergic agent immediately and treat supportively.
- Discontinuation syndrome, which on this label explicitly includes SEIZURES. Do not stop abruptly.
- Mania or hypomania, in 0.4%. Stop and reassess the diagnosis.
- Hyponatremia and SIADH; QTc prolongation and torsades; bleeding.
- Weight loss: about 1 kg against placebo; 7% of children aged 6 to 11 lost over 7% of body weight.
- Angle-closure glaucoma; sexual dysfunction.

Monitoring & Labs

Suicidality: every visit for 3 months, at every dose change either way, then every 3 months. Instruct caregivers to watch for behaviour change at home
Activation and mania: screen for bipolar history before the first dose, then ask about reduced sleep need and pressured speech every 3 months
Growth and weight: plot at baseline, every 3 months for the first year, then every 6 months. Act on a loss over 7%
Hyponatremia and bleeding: check sodium for new headache or confusion; ask about bruising, nosebleeds and purpura every 3 months
Urine drug screening: FALSE-POSITIVE benzodiazepine immunoassays for days after stopping; confirm by mass spectrometry
Response: do not judge OCD efficacy before full titration and 12 weeks; reassess every 6 months, with sexual function

Discontinuation & Taper

Sertraline must be tapered; label 2.6 directs gradual reduction, and the 26-hour half-life gives no cushion.
The contrast that drives drug choice: Prozac is effectively self-tapering. Where a family may run out of a refill, pick fluoxetine.
Discontinuation reactions include nausea, sweating, dysphoric mood, irritability, dizziness, electric shock sensations, TINNITUS and SEIZURES.
If intolerable symptoms follow a reduction, return to the previous dose and go slower.
Drug holidays are not appropriate; a break produces a discontinuation syndrome, not a pause.

Pregnancy & Lactation

Pregnancy: first-trimester studies and meta-analysis show no increase in total or cardiac malformations against background.
- Later exposure may raise the risk of persistent pulmonary hypertension of the newborn and neonatal respiratory support.
- Weigh rather than abstain: women who stopped antidepressants relapsed more often.
- The ORAL SOLUTION contains 12% alcohol and is not recommended in pregnancy.
Lactation: low levels in human milk, with no adverse reactions in a pooled analysis.
- Relative infant dose about 0.5% to 1%; most authoritative reviewers consider sertraline preferred during breastfeeding (LactMed 2026).
- Exceptions: neonatal sleep myoclonus, restlessness, diarrhea or agitation, and reduced milk supply (LactMed 2026).
Exposure Registry: National Pregnancy Registry for Antidepressants, 1-866-961-2388, womensmentalhealth.org

Counseling Points

Counsel the family on:
- Nothing much happening for two to three weeks; the OCD trial ran 12 weeks.
- The same time daily, never skipping a weekend; stopping produces withdrawal, not an absent effect.
- Splitting the scored tablet if the starting dose is too much, rather than skipping days.
- The liquid: only the supplied dropper, mixed into half a cup of water or juice, drunk straight away.
- Never accepting a 150 mg or 200 mg capsule while starting or titrating.
- A urine drug screen reading positive for benzodiazepines for days after stopping.
Advise them to call for:
- New or worsening talk of self-harm, or an abrupt mood change after a dose change.
- Days without needing sleep, much faster speech, or a jump in energy.
- New hitting or aggression, or a child dry at night wetting again.
- Shivering, twitching, stiffness, racing heart, sweating and confusion together.
- A seizure, especially after missed doses or an abrupt stop.

References

DailyMed. Zoloft (sertraline) tablets and oral solution. Viatris Specialty LLC. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7
DailyMed. Sertraline HCl capsules. Almatica Pharma LLC, NDA 215133. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c8bcba9-eaeb-aa44-f9ea-b580de55a439
LactMed. Sertraline. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501191/
AHRQ. Anxiety in children. CER No. 192, 17-EHC023-EF. 2017. https://www.ncbi.nlm.nih.gov/books/NBK476277/
Potter. Sertraline in young children with autism spectrum disorder. Frontiers in Psychiatry. 2019. https://pmc.ncbi.nlm.nih.gov/articles/PMC6851992/
FDA. NDC Directory, openFDA, generic name sertraline. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22sertraline%22&limit=1000