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Abilify

(aripiprazole)

Full Prescribing Information

DailyMed Drug Information

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Forms/Strengths

• Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg
• Orally Disintegrating Tablets (Abilify ODT): 10 mg, 15 mg
• Oral Solution: 1 mg/mL

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Dosing

• Age: >6 y/o

  • Irritability Associated with Autistic Disorder: 6-17 years

  • Bipolar I Disorder (Acute Mania/Mixed): 10-17 years, adults

  • Schizophrenia: 13+ years, adults

  • Tourette’s Disorder: 6-17 years

• Onset: Variable; clinical effect typically within days to weeks for mood/behavioral symptoms
• Duration: ~75 hours (half-life); steady-state typically achieved within 1–2 weeks
  
• Considerations: Monitor for EPS, metabolic and cardiovascular changes, assess behavioral shifts (especially in ADHD/mood dysregulation), and counsel families on potential side effects and gradual titration.
• Initial Dose: 

  • Autism: 2 mg/day

  • Bipolar: 2-5 mg/day (pediatrics), 10-15 mg/day (adults)

  • Schizophrenia: 2 mg/day titrated to 10-15 mg/day

  • Tourette’s: 2 mg/day

• Titration: Increase dose every 1–2 weeks
• Max Dose:

  Indication	Pediatric Max Dose	Adult Max Dose
  Autism	15 mg/day	N/A
  Bipolar I	30 mg/day	30 mg/day
  Schizophrenia	30 mg/day	30 mg/day
  Tourette’s	20 mg/day (6-12 y/o), 30 mg (13-17 y/o)	N/A

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Quick Facts

• Partial agonist at dopamine D2 & serotonin 5-HT1A; antagonist at 5-HT2A receptors
• Modulates neurotransmission to stabilize mood and reduce psychotic symptoms
• Approved for reducing irritability and tantrums in children with autistic disorder
• Effective as adjunctive therapy in major depressive disorder
• Useful in controlling manic symptoms in bipolar I disorder and reducing motor/vocal tics in Tourette's Disorder
• Off-label benefits include use in ADHD-related aggression, disruptive behavior, and impulsivity
• Lower risk of EPS and metabolic burden compared to many first-generation and some second-generation antipsychotics (e.g., olanzapine, clozapine)
• Common side effects: akathisia, restlessness, insomnia, nausea, headache, weight gain, constipation
• Use with caution in patients with cardiovascular/metabolic risks
  

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Indications

• Irritability Associated with Autistic Disorder (ICD-10: F84.0): Reduces aggression and tantrums.
• Major Depressive Disorder, Adjunctive Use (ICD-10: F32.x / F33.x): Enhances antidepressant effects.
• Schizophrenia (ICD-10: F20.x): Reduces delusions and hallucinations.
• Bipolar I Disorder (ICD-10: F31.x): Controls manic episodes and stabilizes mood.
• Tourette’s Disorder (ICD-10: F95.2): Reduces motor and vocal tics.

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Off-Label Uses

• Generalized Anxiety Disorder (ICD-10: F41.1): Sometimes used adjunctively in refractory cases
• Post-Traumatic Stress Disorder (ICD-10: F43.10): May benefit select patients not responding to first-line treatments
• Borderline Personality Disorder (ICD-10: F60.3): May help reduce impulsivity and emotional dysregulation
• Behavioral Control in ADHD/Disruptive Behavior: Although not FDA-approved for this use, aripiprazole is often considered in pediatric patients with significant aggression or impulsivity when first-line ADHD treatments are insufficient
  

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How to Take

• Administration:

  • Can be taken with or without food
  • Orally Disintegrating Tablets (ODT): Place on the tongue and allow to dissolve; do not chew or crush
  • Oral Solution: Measure accurately with a dosing syringe or cup
  • Take at the same time each day for consistency in drug levels

• Missed Dose:

  • Take as soon as possible unless it is near the next scheduled dose; do not double up

• Discontinuation:

  • Taper gradually when discontinuing to avoid withdrawal effects or rebound behavioral symptoms
    

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Side Effects

• • Common:

    • Akathisia, restlessness
    • Fatigue, drowsiness
    • Nausea, vomiting
    • Dizziness, constipation

  • Serious:

    • Black Box Warnings: Increased mortality in elderly patients with dementia-related psychosis; increased suicidality in children/young adults with major depressive disorder
    • Tardive dyskinesia (involuntary facial, tongue, or body movements; risk increases with long-term use)
    • Neuroleptic malignant syndrome (high fever, muscle rigidity, confusion, altered consciousness, autonomic instability; rare but life-threatening)
    • Hyperglycemia and related complications (ketoacidosis, diabetic coma)
    • Orthostatic hypotension
    • Seizures/convulsions
    • Low white blood cell count
    • Laryngeal spasm and dystonic reactions (pharynx, hypopharynx, tongue)
    • Compulsive behaviors (gambling, binge eating, shopping, sexual urges)
    • Allergic reactions (rash, hives, swelling, difficulty breathing/swallowing)
    • Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis (stroke, TIA)
      

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Monitoring / Labs

• Metabolic Effects: Monitor weight, fasting glucose, and lipid profiles regularly.
• Psychiatric Symptoms: Watch for worsening mood, suicidal thoughts, or unusual behavior.
• Tardive Dyskinesia: Assess for abnormal involuntary movements periodically.
• Blood Pressure: Monitor for orthostatic changes, especially in older adults.
• Baseline and Routine Monitoring:
  • Fasting glucose and lipid profile.
  • CBC (if history of leukopenia/neutropenia).
• Others: Monitor prolactin if symptoms of hyperprolactinemia occur.

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Education

• When to Call the Doctor:
  • Signs of allergic reaction (rash, swelling, difficulty breathing).
  • High fever, muscle stiffness, or confusion (possible Neuroleptic Malignant Syndrome).
  • Uncontrolled movements of face, tongue, arms, or legs (possible Tardive Dyskinesia).
  • Sudden mood changes, agitation, suicidal thoughts.
  • Severe dizziness or fainting.
  • Excessive thirst, frequent urination, unexplained weight loss (possible hyperglycemia).

• Safety Tips:

  • Avoid alcohol and CNS depressants, as they may enhance sedation.
  • Caution with activities requiring alertness (e.g., driving) until individual response is known.
  • Slow positional changes to prevent orthostatic hypotension.
  • Maintain hydration and monitor for heat intolerance.
  • Tapering may be necessary before discontinuation to prevent withdrawal effects.

• Parent Tips for Pediatric Patients:

  • Monitor for behavioral changes (e.g., aggression, restlessness, suicidal ideation).
  • Encourage nutrient-dense meals to counteract potential weight gain.
  • Watch for sedation-related school performance issues.
  • Communicate with teachers and caregivers regarding behavioral or academic changes.
  • Ensure adherence; skipping doses may reduce symptom control.

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Additional Information

• Contraindications:
  • Hypersensitivity to aripiprazole or any component of the formulation.
• Pregnancy: May cause extrapyramidal/withdrawal symptoms in neonates; use if benefits > risks (limited data)
• Lactation: Excreted in breast milk; not recommended.
• Drug Interactions:
  • CYP3A4 and CYP2D6 inhibitors (e.g., fluoxetine, ketoconazole) may increase aripiprazole levels.
  • CYP3A4 inducers (e.g., carbamazepine, rifampin) may decrease efficacy.
  • May potentiate effects of antihypertensives, leading to hypotension.
  • Caution with dopamine agonists or antagonists due to possible pharmacodynamic interactions.
    

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References

1. FDA. Abilify (aripiprazole) Full Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/
2. DailyMed: Aripiprazole Monograph. https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=aripiprazole
3. MedlinePlus. Aripiprazole Drug Information. https://medlineplus.gov/druginfo/meds/a603012.html
4. Otsuka Pharmaceutical. Abilify (aripiprazole) Prescribing Information. https://www.otsuka-us.com/
5. GoodRx. Abilify Side Effects. https://www.goodrx.com/abilify/abilify-side-effects
6. NAMI. Aripiprazole Lauroxil Information. https://www.nami.org/
7. FDA. Abilify Safety and Utilization Review. https://www.fda.gov/media/107289/download
8. FDA. Abilify Medication Guide. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016MedG.pdf

Adderall

(amphetamine/dextroamphetamine immediate-release)

Full Prescribing Information

DailyMed Drug Information

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Forms/Strengths

•  Tablets: 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg
• These are mixed amphetamine salts (MAS) in a 3:1 ratio of dextroamphetamine to levoamphetamine salts for balanced effects on focus (dextro) and alertness (levo).

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Dosing

• Age: ≥ 3 y/o
• Onset: 30-60 minutes
• Duration: 4-6 hours
• Considerations: Administer first dose upon awakening; additional doses at 4-6 hour intervals; may take with or without food (high-fat meals may delay absorption)
• Initial Dose:
  • 3-5 y/o: 2.5 mg daily
  • 6+ y/o: 5 mg 1-2 times daily
• Titration:
  • 3-5 y/o: 2.5 mg weekly
  • 6+ y/o: 5 mg weekly
• Max Dose:
  • ≤50 kg: 40 mg/day
  • >50 kg: 60 mg/day (Narcolepsy)

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Quick Facts

• Increases synaptic dopamine and norepinephrine via presynaptic release, reuptake inhibition (DAT/NET), and VMAT2-mediated vesicular efflux
• Enhances focus, attention, impulse control, and wakefulness in ADHD and narcolepsy
• Common side effects: decreased appetite, insomnia, dry mouth, weight loss, increased heart rate/blood pressure
• Schedule II controlled substance with high abuse/misuse potential
• Black box warning: Abuse and dependence; sudden death and serious cardiovascular events reported
• May suppress growth in pediatrics; monitor height/weight
• 3:1 dextro:levo ratio balances cognitive focus (dextro) and peripheral alerting effects (levo)
  

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Indications

• ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9)
• Narcolepsy (ICD-10: G47.419)
  

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Off-Label Uses

• Treatment-resistant depression (ICD-10: F33.9): Adjunctive for low-energy symptoms
• Cognitive enhancement post-TBI (ICD-10: S06.0-S06.9): Improves attention and processing speed
• Augmentation in bipolar depression (ICD-10: F31.4): Short-term for anhedonia
  

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How to Take

• Administer once or multiple times daily, as directed.
• Take with or without food; high-fat meals may delay absorption.
• If using the tablet, swallow whole; do not crush, chew, or split unless scored.
• Avoid dosing late in the day to prevent insomnia.
  

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Side Effects

• Common:
  • Cardiovascular: Tachycardia, hypertension, palpitations
  • CNS: Insomnia, headache, irritability, anxiety, dizziness
  • GI: Dry mouth, anorexia, weight loss, abdominal pain
  • Other: Decreased appetite, euphoria
• Serious:
  • Black box: Risk of abuse/dependence; sudden death, myocardial infarction, stroke in those with cardiac structural abnormalities
  • Psychiatric: Psychosis, mania, aggression, suicidal ideation
  • Cardiovascular: Cardiomyopathy, Raynaud's phenomenon
  • Growth suppression in children; priapism; serotonin syndrome (with serotonergics); hypersensitivity reactions
    

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Monitoring / Labs

• Baseline and periodic: Heart rate, blood pressure, weight, height (pediatrics)
• Psychiatric: Screen for bipolar, psychosis risk; monitor mood/behavior
• Cardiac: ECG if history of heart disease; assess for misuse/diversion
• Growth: Plot height/weight percentiles; consider drug holiday if suppression
• No routine labs required; assess renal/hepatic function if impaired
  

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Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, shortness of breath, or palpitations (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Signs of circulatory issues (e.g., numbness, coldness, or color changes in fingers/toes).
  • Unexplained weight loss or growth suppression in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate regularly, especially in patients with cardiovascular risk.
  • Use caution in patients with history of anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may increase side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Do not abruptly discontinue; tapering may be needed in long-term users.

• Parent Tips for Pediatric Patients:

  • Encourage a high-calorie diet to offset appetite suppression.
  • Monitor school performance and behavioral changes.
  • Administer the first dose before school for optimal effect.
  • Observe for sleep disturbances and adjust dosing schedule if needed.
  • Keep communication open with teachers and caregivers regarding medication effects.
    

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Additional Information

• Contraindications:

  • Hypersensitivity to amphetamines or any formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

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References

1. FDA Prescribing Information - Adderall Tablets, 2007, https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf
2. DailyMed - Mixed Salts of a Single Entity Amphetamine Product, 2023, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=175e125c-8df5-484c-a5c0-4b61e05f75ba
3. StatPearls - Dextroamphetamine-Amphetamine, 2023, https://www.ncbi.nlm.nih.gov/books/NBK507808/
4. DrugBank - Amphetamine, 2024, https://go.drugbank.com/drugs/DB00182

Adderall XR

(amphetamine/dextroamphetamine extended-release)

Full Prescribing Information

DailyMed Drug Information

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Forms/Strengths

• Capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg

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Dosing

• Age: Pediatric patients ≥6 years and adults
• Onset: Approximately 30–60 minutes
• Duration: 10–12 hours
• Release Profile: Biphasic – an immediate-release portion followed by a delayed-release phase via beaded capsule technology
• Considerations: May be taken with or without food; avoid concomitant use with acidifying agents (e.g., fruit juices, vitamin C) which may decrease absorption; high-fat meals may delay Tmax by 2.5 hours but do not affect overall bioavailability
• Initial Dose (Pediatric):
  • Typically 10 mg once daily in the morning
• Titration (Pediatric):
  • Increase by 5–10 mg increments at weekly intervals based on clinical response and tolerability
• Max Dose (Pediatric):
  • Generally should not exceed 30 mg per day

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Quick Facts

• Mechanism: Increases the synaptic levels of norepinephrine and dopamine
• Main Benefits: Improves attention, reduces hyperactivity and impulsivity
• Side Effects: Decreased appetite, insomnia, headache, stomach upset
• Formulation Technology: Advanced beaded capsule system providing dual-phase drug release
• Special Notes: High potential for abuse; use with caution in patients with pre-existing cardiovascular conditions

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Mechanism of Action

• Adderall XR contains mixed amphetamine salts that work by enhancing the release of norepinephrine and dopamine, thereby improving neurotransmission which aids in reducing ADHD symptoms.

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Indications

• Attention-Deficit/Hyperactivity Disorder (ADHD) (ICD-10: F90.0)

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Off-Label Uses

• Narcolepsy (ICD-10: G47.4) – Although primarily indicated for ADHD, Adderall XR may be used off-label in adults for the treatment of narcolepsy.

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How to Take

• Take once daily in the morning to avoid insomnia
• May be taken with or without food; note that high-fat meals can delay absorption
• Swallow the capsule whole; do not crush or chew
• General missed-dose advice: Take as soon as remembered unless it is close to the next scheduled dose

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Side Effects

• Common:
  • Central Nervous System: Insomnia, headache, irritability
  • Gastrointestinal: Decreased appetite, stomach upset, dry mouth
• Serious:
  • Cardiovascular: Increased blood pressure, tachycardia, potential for arrhythmias

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Monitoring/Labs

• Vital Signs: Monitor blood pressure and heart rate periodically
• Growth Parameters: In pediatric patients, monitor height and weight at regular intervals
• Mental Health: Monitor for new or worsening psychiatric symptoms, including mood changes and anxiety
• Abuse Potential: Monitor for signs of misuse or diversion

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Education

• When to Call the Doctor:
  • Experiencing chest pain, shortness of breath, or significant changes in mood or behavior
• Safety Tips:
  • Take medication strictly as prescribed
  • Do not share medication with others
  • Keep the medication in a secure place out of reach of children
  • Avoid alcohol and other CNS stimulants
  • Report any concerning side effects promptly to your healthcare provider
• Tips for Pediatric Patients:
  • Ensure dosing is appropriate for your child's weight and age
  • Monitor changes in appetite and growth
  • Maintain regular follow-up visits with the healthcare provider
  • Inform school personnel and caregivers about the medication schedule

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Long-Term Use Considerations

• Periodic evaluation of cardiovascular status, especially in patients with underlying conditions
• Regular monitoring of growth and development in pediatric patients
• Assess for potential abuse or dependency over extended periods of use

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Tapering Guidance

• Clinical Guidelines: Gradual dose reduction is recommended to mitigate withdrawal symptoms
• Caregiver Considerations: Work closely with your healthcare provider to design an individualized tapering schedule

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Additional Information

• Contraindications:
  • History of cardiovascular disease, hyperthyroidism, or glaucoma
• Pregnancy:
  • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus (Category C)
• Lactation:
  • May be excreted in breast milk; consult with your healthcare provider before use
• Drug Interactions:
  • Potential interactions with monoamine oxidase inhibitors (MAOIs), antacids, and other stimulants

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References

• U.S. Food and Drug Administration. (2012). Adderall XR Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s062lbl.pdf
• DailyMed. (2021). Adderall XR Drug Information. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bd6a68a-35a8-41ad-8b8e-d1e4a7b2123f
• Faraone, S. V., Biederman, J., & Mick, E. (2020). Pharmacotherapy of attention-deficit/hyperactivity disorder: Current trends. Current Opinion in Psychiatry, 33(4), 321–326.

Adzenys XR-ODT

(amphetamine extended-release orally disintegrating tablet)

Full Prescribing Information

DailyMed Drug Information

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Forms/Strengths

•  Orally Disintegrating Tablets: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg

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Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30 min
• Duration: ~12 hours
• Release Profile: 50% IR, 50% ER
• Considerations: Orange-flavored. May be taken with or without food. Allow tablet to disintegrate in saliva before swallowing.
  • Adderall XR Equivalent Doses
• Initial Dose:
  • 6-17 y/o: 6.3 mg
    
  • 18+ y/o: 12.5 mg
• Titration: 3.1 mg - 6.3 mg weekly
• Max Dose:
  • 6-12 y/o: 18.8 mg/day
  • 13+ y/o: 12.5 mg/day

Equivalent Doses of ADZENYS XR-ODT and ADDERALL XR
ADZENYS XR-ODT	3.1 mg	6.3 mg	9.4 mg	12.5 mg	15.7 mg	18.8 mg
ADDERALL XR	5 mg	10 mg	15 mg	20 mg	25 mg	30 mg

Important Note: To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis due to different amphetamine base compositions and pharmacokinetic profiles.

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Quick Facts

• Mixed amphetamine salts (75% dextroamphetamine base, 25% levoamphetamine base); increases synaptic norepinephrine and dopamine via enhanced release and reuptake inhibition
• Dual-release profile (50% immediate, 50% extended) for rapid onset and all-day coverage in ADHD
• Improves core ADHD symptoms: inattention, hyperactivity, impulsivity
• Black box warning: High potential for abuse, misuse, addiction, overdose, and death; Schedule II controlled substance
• Unique ODT formulation dissolves on tongue without water; orange flavor improves palatability
• Common effects: appetite suppression, insomnia, ↑BP/HR; monitor growth in children
• Not interchangeable with other amphetamines on mg basis due to base equivalence differences
  

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Indications

•  Attention Deficit Hyperactivity Disorder (ADHD) (ICD-10: F90.0)

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Off-Label Uses

•  Narcolepsy (ICD-10: G47.411): Occasionally used off-label, though not FDA-approved for this indication.

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How to Take

• Take once daily in the morning to reduce the risk of insomnia.
• Do not crush, chew, or split the tablet.
• Place the orally disintegrating tablet (ODT) on the tongue and allow it to dissolve completely; do not swallow whole.
• Can be taken with or without food.
  

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Side Effects

• Common:
  • CNS: insomnia, headache, anxiety, irritability, dizziness
  • GI: decreased appetite, weight loss, dry mouth, nausea, abdominal pain
  • CV: ↑heart rate, ↑blood pressure
  • Other: asthenia (fatigue)
• Serious:
  • Black box: Abuse/misuse/addiction leading to overdose/death
  • CV: sudden death, myocardial infarction, stroke, arrhythmias (esp. with structural heart defects)
  • Psych: new/exacerbated psychosis, mania, aggression, hallucinations
  • Peripheral vasculopathy: Raynaud's-like symptoms (pain, numbness, color change in fingers/toes)
  • Serotonin syndrome (with serotonergics): hyperthermia, rigidity, seizures
  • Growth suppression in children
    

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Monitoring / Labs

• Baseline/periodic: BP, HR, weight, height (pediatrics), BMI
• Assess growth every 3-6 months in children; plot on charts
• Monitor for psychiatric changes, tics, substance misuse
• LFTs, CBC if long-term or symptoms (e.g., dark urine)
• ECG if cardiac history

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Education

• When to Call the Doctor:

  • Chest pain, palpitations, shortness of breath, fainting
  • Severe anxiety, hallucinations, mood changes, suicidal thoughts
  • Finger/toe pain, numbness, color changes (cold/pale/blue)
  • Prolonged erection (>4 hours), uncontrolled tics/movements
  • Signs of overdose: agitation, hallucinations, hyperthermia, seizures

• Safety Tips:

  • Take only as prescribed; store securely (controlled substance)
  • Avoid alcohol, caffeine, OTC decongestants (↑CV effects)
  • Report all meds/supplements to avoid interactions
  • No driving/operating machinery until effects known

  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Give before school to minimize sleep interference
  • Use pill organizer or reminders; track appetite/weight weekly
  • Partner with school (teacher reports on focus/behavior)
  • Promote healthy meals/snacks despite appetite loss
  • Watch for growth delays; annual pediatrician review

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Additional Information

• Contraindications:

  • Known hypersensitivity to amphetamines
  • MAOI use within 14 days (hypertensive crisis)
  • Advanced arteriosclerosis, symptomatic heart disease, moderate-severe HTN, hyperthyroidism, glaucoma
  • History of drug abuse
  • Pregnancy: Category C; potential fetal harm (↓birth weight, withdrawal); use only if benefit > risk (APLENZIN registry)
  • Lactation: Excreted in milk; avoid or discontinue nursing
  • Drug Interactions:
    • CYP2D6 inhibitors (e.g., bupropion, fluoxetine): ↑amphetamine levels
    • MAOIs/serotonergics: serotonin syndrome, hypertensive crisis
    • Acidifiers (vit C): ↓absorption; alkalinizers (NaHCO3): ↑levels
    • Pressors (decongestants): additive HTN/tachycardia

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References

1. Amphetamine XR-ODT Prescribing Information, Aytu BioPharma, 2023, https://www.fffenterprises.com/assets/downloads/product-information/aytu-biopharma/pi-AMPHETAMINE-XR-ODT.pdf
2. DailyMed: Amphetamine extended-release orally disintegrating tablets, 2023, https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=48d0f55c-f847-4d26-b2ed-94b5a2770228

 

Aptensio XR

(methylphenidate XR)

Full Prescribing Information

DailyMed Drug Information

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Forms/Strengths

• Capsules: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg 

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Dosing

• Age: ≥ 6 y/o
• Onset: ~ 60-120 min
• Duration: 8-12 hours
• Release Profile: 40% IR, 60% ER
• Considerations: Capsules may be swallowed whole or opened, and the entire contents can be sprinkled on applesauce.
• Initial Dose: 10 mg
• Titration: 10 mg weekly
• Max Dose: 60 mg/day

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Quick Facts

• Blocks reuptake of dopamine and norepinephrine via DAT and NET inhibition, increasing synaptic levels primarily in prefrontal cortex for improved attention and impulse control
• Biphasic release: ~50% immediate-release beads, ~50% delayed-release beads for rapid onset and sustained effect
• Common side effects include appetite suppression, insomnia, and mild cardiovascular changes
• Black box warning: Potential for abuse, misuse, and dependence; sudden death reported in patients with structural cardiac abnormalities
• Monitor growth in children; caution in patients with tics, bipolar disorder, or psychosis
• Not for use within 14 days of MAOIs due to hypertensive crisis risk
  

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Indications

•  ADHD (ICD-10: F90.0)

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Off-Label Uses

• Narcolepsy (ICD-10: G47.411): Occasionally used for daytime sleepiness
• Treatment-resistant depression (ICD-10: F32.x, F33.x): Adjunct for augmentation in select cases

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How to Take

• Administration: Once daily in the morning with or without food; high-fat meals may delay Tmax and increase exposure; do not crush/chew capsules; if unable to swallow, sprinkle entire contents on ≤1 tablespoon applesauce and swallow immediately
• Missed Dose: Take next dose as scheduled; do not double dose
• Discontinuation/Tapering: May discontinue abruptly after short-term use; taper if long-term (>4 weeks) or high-dose to minimize rebound symptoms
  

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Side Effects

• Common:
  • Appetite/weight loss
  • Insomnia, headache
  • Abdominal pain, nausea, dry mouth
  • Increased heart rate/blood pressure, anxiety/irritability
• Serious:
  • Black box warning: Drug abuse/dependence; assess risk prior to use
  • Cardiovascular: Sudden death/myocardial infarction in patients with cardiac disease, priapism
  • Psychiatric: Psychosis, mania, aggression, suicidal ideation
  • Peripheral vasculopathy (e.g., Raynaud's): Digital ulceration
  • Hypersensitivity: Rash, anaphylaxis

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Monitoring / Labs

• Baseline and periodic: Heart rate, blood pressure, weight/height (pediatrics)
• Psychiatric status for new/worsening symptoms
• Growth parameters every 3-6 months in children; consider drug holiday
• CBC, CMP if long-term use; signs of abuse/diversion
  

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Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate
  • Concurrent/use within 14 days of MAOIs
  • Glaucoma, severe hypertension, symptomatic cardiac disease
• Pregnancy: Category C (older); limited human data—use if benefit outweighs risk; neonatal withdrawal possible
• Lactation: Present in breast milk; weigh risks (irritability, reduced weight gain in infant)
• Drug Interactions:
  • MAOIs/serotonergics: Hypertensive crisis/serotonin syndrome
  • CYP2D6 inhibitors (e.g., bupropion): Increased methylphenidate levels
  • Acidifiers (e.g., vitamin C): Decreased absorption; alkalinizers (e.g., antacids): Increased absorption
  • Pressors (e.g., alpha-agonists): Potentiated hypertension
  • Alcohol: Accelerated release from capsules

---

References

1. FDA. Concerta (methylphenidate HCl) Prescribing Information, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021121s042lbl.pdf
2. DailyMed. Methylphenidate Hydrochloride Extended-Release Capsules, 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=example (generic XR capsules)
3. UpToDate. Methylphenidate: Drug information, 2025. https://www.uptodate.com/contents/methylphenidate-drug-information
4. American Academy of Pediatrics. ADHD Clinical Practice Guideline, 2021. https://publications.aap.org/pediatrics/article/148/6/e2021055352/180000/Clinical-Practice-Guideline-for-the-Diagnosis

 

Azstarys

(serdexmethylphenidate and dexmethylphenidate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Capsules: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg 

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30 min
• Duration: 12-14 hours
• Release Profile: 30% IR, 70% ER
• Considerations: Administer once daily in the morning, with or without food; capsules can be taken whole or opened and sprinkled onto applesauce or mixed with water.
• Initial Dose: 39.2/7.8 mg
• Titration: Increase to 52.3/10.4 mg or decrease to 26.1/5.2 mg after one week
• Max Dose: 52.3/10.4 mg daily

---

Quick Facts

• Prodrug formulation: 30% immediate-release dexmethylphenidate + 70% delayed-release serdexmethylphenidate (converted to dexmethylphenidate in lower GI tract) for rapid onset and sustained 13-hour effect
• Blocks reuptake of dopamine and norepinephrine into presynaptic neurons, increasing synaptic concentrations
• FDA-approved for ADHD in patients ≥6 years; no generic available
• CII controlled substance with high abuse potential; monitor for misuse
• Common side effects include appetite suppression, insomnia, and increased BP/HR
• Low incidence of next-day rebound vs. other stimulants due to extended PK profile
  

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once daily in the morning to reduce the risk of insomnia.
• Can be taken with or without food.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule can be opened, and contents sprinkled on applesauce or water—consume immediately without chewing.

---

Side Effects

• Common:

  • Decreased appetite, weight loss
  • Insomnia
  • Headache
  • Nausea, stomach pain
  • Increased heart rate or blood pressure

• Serious:

  • Cardiovascular events: Sudden death in patients with pre-existing structural cardiac abnormalities or arrhythmias.
  • Psychiatric symptoms: New or worsening anxiety, psychosis, or manic symptoms.
  • Peripheral vasculopathy, including Raynaud’s phenomenon.

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to serdexmethylphenidate, dexmethylphenidate, or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase dexmethylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

References

1. AZSTARYS (serdexmethylphenidate and dexmethylphenidate) Prescribing Information, FDA, 2023, https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211555s004lbl.pdf
2. DailyMed: AZSTARYS, NIH, 2024, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f11dd712-5c66-4c3e-9b2b-14d6e9b2b14d
3. UpToDate: Methylphenidate (dexmethylphenidate), 2025, https://www.uptodate.com/contents/methylphenidate-including-dexmethylphenidate-drug-information
4. Clinical Pharmacology Review: AZSTARYS NDA 211555, FDA, 2021, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211555Orig1s000ClinPharmR.pdf

 

Clonidine

(clonidine)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 0.1 mg, 0.2 mg, 0.3 mg

---

Dosing

• Age: ≥ 6yr
• Onset: 30-60 min (oral)
• Duration: 6-12 hours
• Considerations: Monitor for bradycardia and hypotension; taper gradually over 2-4 days (or longer based on dose/duration) to avoid rebound hypertension; often dosed BID with larger dose at bedtime for ADHD
• Initial Dose:
  • 27-40 kg: 0.05 mg nightly
  • 40+ kg: 0.1 mg nightly
• Titration: 
  • Increase 0.05mg every 3-7 d taper gradually over 2-4 days to discontinue
• Max Dose:
  • 27-40 kg: 0.2 mg/day 
  • 40+ kg: 0.4 mg/day

---

Quick Facts

• Central alpha-2 adrenergic agonist that reduces norepinephrine release and sympathetic outflow from the locus coeruleus.
• Improves ADHD symptoms of hyperactivity, impulsivity, and inattention, especially as adjunct to stimulants.
• Particularly useful off-label for ADHD with tics, aggression, or sleep issues.
• Sedation common early and dose-dependent; often improves with time or bedtime dosing.
• Low abuse potential; not a controlled substance.
• Risk of rebound hypertension with abrupt discontinuation.
• Not FDA-approved for ADHD (extended-release form Kapvay is approved).
  

---

Indications

• Hypertension (ICD-10: I10, I11.0, I11.9)

---

Off-Label Uses

• ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9) – adjunct or monotherapy for hyperactivity/impulsivity.
• Tic disorders/Tourette syndrome (ICD-10: F95.1, F95.2) – reduces tics via noradrenergic modulation.
• Oppositional defiant disorder (ICD-10: F91.3) – decreases aggression when added to stimulants.
• Insomnia/sleep disturbances in ADHD (ICD-10: G47.00) – promotes sleep with bedtime dosing.
  

---

How to Take

• Take at the same time each day for consistency.
• Can be taken with or without food.
• Swallow whole; do not crush or chew.
• If used for ADHD, often given twice daily, with the larger dose at bedtime to minimize drowsiness.
• Do not suddenly stop taking; tapering may be required to prevent rebound hypertension.
  
• Transdermal patches should be applied to a hairless area on the upper outer arm or chest.

---

Side Effects

• Common:
  • Sedation/drowsiness (most prominent initially)
  • Dry mouth
  • Dizziness/orthostatic hypotension
  • Constipation
  • Fatigue/headache
• Serious:
  • Bradycardia/hypotension
  • Rebound hypertension (with abrupt stop)
  • Depression, hallucinations (rare)
  • AV block (in cardiac disease)

---

Monitoring / Labs

• Baseline and periodic blood pressure and heart rate (supine and standing).
• ECG if history of cardiac disease.
• Renal function (dose adjust in impairment).
• Growth parameters in children (long-term use).
  

---

Education

• When to Call the Doctor:

  • Severe dizziness, fainting, or low blood pressure.
  • Slow or irregular heart rate.
  • Signs of over-sedation, such as excessive drowsiness or difficulty waking.
  • Mood changes, hallucinations, or unusual behavior.
  • Severe headache, blurred vision, or confusion (possible hypertensive rebound if stopped abruptly).

• Safety Tips:

  • Monitor blood pressure and heart rate regularly.
  • Avoid alcohol and sedatives, which may enhance drowsiness.
  • Rise slowly from sitting or lying positions to prevent dizziness.
  • Do not suddenly discontinue, as this may lead to rebound hypertension.
  • Be cautious when driving or operating machinery until individual response is known.

• Parent Tips for Pediatric Patients:

  • May cause daytime drowsiness; consider giving the larger dose at bedtime.
  • Monitor for irritability, behavioral changes, or mood swings.
  • Encourage hydration and salt intake if dizziness occurs.
  • Ensure the child does not engage in high-risk activities (e.g., climbing, swimming unsupervised) if excessively drowsy.
  • Keep in child-proof packaging to prevent accidental overdose.

---

Additional Information

• Contraindications:

  • Hypersensitivity to clonidine or formulation components.
  • Use with caution in patients with severe heart disease, bradycardia, or hypotension.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms.

• Lactation:

  • Excreted in breast milk; use with caution due to potential effects on infant blood pressure.

• Drug Interactions:

  • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
  • Beta-blockers may enhance bradycardia; caution if discontinuing either drug.
  • Stimulants (e.g., amphetamines) may counteract clonidine’s effects.
  • Antihypertensive medications may lead to excessive blood pressure lowering.

References

1. Clonidine HCl Tablets Prescribing Information (DailyMed/FDA), 2023, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fe10c92-621a-4d36-b030-34098351a1e2
2. StatPearls: Clonidine, 2024, https://www.ncbi.nlm.nih.gov/books/NBK459124/
3. Safety and Efficacy of Clonidine in Children with ADHD (PMC), 2014, https://pmc.ncbi.nlm.nih.gov/articles/PMC3926778/
4. AACAP Practice Parameters for ADHD (via UpToDate integration), 2022, https://www.uptodate.com/contents/attention-deficit-hyperactivity-disorder-in-children-and-adolescents-treatment-with-nonstimulant-medications

 

Concerta

(methylphenidate ER [OROS])

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Tablets: 18 mg, 27 mg, 36 mg, 54 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30-60 min
• Duration: Up to 12 hours
• Release Profile: 22% IR, 78% CR via osmotic delivery
• Considerations: Must be swallowed whole; the non-absorbable shell may pass in stool. Administer once daily in the morning, with or without food. Do not chew or crush the tablet.
• Initial Dose:
  • 6-12 y/o: 18 mg daily
  • 13+ y/o: 18 mg - 36 mg daily
• Titration: 18 mg/day at weekly intervals
• Max Dose:
  • 6-12 y/o: 54 mg/day
  • 13+ y/o: 72 mg/day

---

Quick Facts

• Blocks dopamine and norepinephrine reuptake; central nervous system stimulant
• Uses OROS technology for immediate release followed by slow, consistent release; minimizes plasma fluctuations
• Can cause psychiatric adverse events; assess for bipolar disorder before starting
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once daily in the morning to reduce the risk of insomnia.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the tablet whole with water; do not crush, chew, or split.
• The osmotic-controlled release system (OROS) shell may appear in the stool; this is normal.
  

---

Side Effects

•  Common: Decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, hyperhidrosis
• Serious: Cardiovascular events, psychiatric adverse events, seizures, visual disturbances, growth suppression in children

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Cotempla XR-ODT

(methylphenidate XR-ODT)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• ODT: 8.6 mg, 17.3 mg, 25.9 mg

---

Dosing

• Age: 6-17 y/o
• Onset: ~ 30-60 min
• Duration: ~ 8 hours
• Release Profile: 25% IR, 75% ER
• Considerations: Grape-flavored, allow to dissolve in saliva. Advise to take consistently either with food or without food.
• Initial Dose: 17.3 mg
• Titration: 8.6 mg - 17.3 mg weekly
• Max Dose: 51.8 mg

---

Quick Facts

• Increases synaptic norepinephrine and dopamine through amphetamine action
• Enhances focus, attention, and impulse control
• Extended-release ODT with dual-phase release: immediate onset and sustained effect
• Unique orally disintegrating tablet—dissolves on the tongue without water
• Common side effects: decreased appetite, insomnia, headache, dry mouth 

---

Indications

•  ADHD age 6-17 (ICD-10: F90.0)

---

Off-Label Uses

•  ADHD after age 17 (ICD-10: F90.0)

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Orally disintegrating tablet (ODT) should be placed on the tongue and allowed to dissolve completely—do not chew or crush.
• Can be taken with or without food.
• Ensure hands are dry before handling the tablet.
  

---

Side Effects

• Common:

  • Decreased appetite, weight loss
  • Insomnia
  • Stomach pain, nausea
  • Headache
  • Irritability

• Serious:

  • Cardiovascular events: Sudden death in patients with structural cardiac abnormalities or arrhythmias.
  • Psychiatric symptoms: New or worsening anxiety, psychosis, or manic symptoms.
  • Growth suppression in children (monitor height and weight).
  • Peripheral vasculopathy, including Raynaud’s phenomenon.

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Cymbalta

(duloxetine)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Capsules: 20 mg, 30 mg, 60 mg

---

Dosing

• Age: 7 years for GAD
• Considerations: Monitor for suicidal thoughts and behaviors, especially during initial treatment or dosage changes. Regularly monitor weight and growth in pediatric patients.
• Initial Dose:
  • Major Depressive Disorder (MDD): Start with 40–60 mg/day (e.g., 20 mg BID or 30 mg QD).
  • Generalized Anxiety Disorder (GAD):
    • Adults: Start with 60 mg QD.
    • Pediatrics (≥ 7 years): Start with 30 mg QD, increase to 60 mg QD after 1 week.
• Titration: Increase to 60 mg/day after one week if tolerated
• Max Dose: 120 mg/day

---

Quick Facts

• Inhibits serotonin (5-HT) and norepinephrine (NE) reuptake for mood regulation and pain relief
• Improves mood, alleviates anxiety, modulates pain
• Oral capsule; doses >60 mg/day typically divided (e.g., 30 mg BID)
• Common side effects: nausea, dry mouth, dizziness, constipation, fatigue
• Dual action on mood and pain symptoms; monitor for suicidal ideation in younger patients

---

Indications

•  Generalized Anxiety Disorder (F41.1)

---

Off-Label Uses

• Major Depressive Disorder (F32.x)
• Diabetic Peripheral Neuropathic Pain (G63.2)
• Chronic Musculoskeletal Pain (M79.1)

---

How to Take

• Take once daily, preferably at the same time each day.
• Can be taken with or without food; taking with food may help reduce nausea.
• Swallow capsule whole; do not crush, chew, or open.
• Do not abruptly stop; tapering is required to prevent withdrawal symptoms.
  

---

Side Effects

•  Common: Nausea, diarrhea, decreased weight, dizziness, decreased appetite, vomiting, fatigue
• Serious: Suicidal thoughts and behaviors, severe skin reactions, activation of mania or hypomania, angle-closure glaucoma, seizures, blood pressure increases, hyponatremia

---

Monitoring / Labs

• Monitor for suicidal thoughts and behaviors.
• Regularly monitor weight and growth.
• Monitor blood pressure periodically.

---

Education

• When to Call the Doctor:

  • Severe mood changes, suicidal thoughts, or unusual behavior.
  • Symptoms of serotonin syndrome (e.g., confusion, rapid heart rate, muscle rigidity, high fever).
  • Signs of liver damage (e.g., yellowing of the skin/eyes, dark urine, persistent nausea).
  • Unusual bruising or bleeding.
  • Severe dizziness, fainting, or difficulty urinating.

• Safety Tips:

  • Monitor blood pressure regularly, as Cymbalta may increase blood pressure.
  • Use caution when driving or operating machinery, as drowsiness and dizziness may occur.
  • Avoid alcohol, as it may increase the risk of liver toxicity.
  • May cause sexual dysfunction; discuss with provider if problematic.
  • Taper gradually if discontinuing to minimize withdrawal effects (e.g., dizziness, nausea, irritability).

• Parent Tips for Pediatric Patients:

  • Monitor for suicidal thoughts, mood changes, or behavioral changes, especially during the first few weeks.
  • May cause drowsiness or agitation; observe how the child responds to the medication.
  • Encourage hydration and a balanced diet to help with potential nausea.
  • If taken for chronic pain or fibromyalgia, assess response regularly.

---

Additional Information

• Contraindications:

  • Hypersensitivity to duloxetine or formulation components.
  • Use within 14 days of MAOI therapy (risk of serotonin syndrome).
  • Uncontrolled narrow-angle glaucoma.
  • Severe hepatic or renal impairment.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause withdrawal symptoms in newborns if taken in the third trimester.

• Lactation:

  • Excreted in breast milk; use with caution as effects on the infant are unknown.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, St. John’s Wort) increase serotonin syndrome risk.
  • CYP1A2 and CYP2D6 inhibitors (e.g., fluvoxamine, quinidine) may increase duloxetine levels.
  • NSAIDs, anticoagulants, and antiplatelets may increase bleeding risk.
  • May enhance the hypertensive effects of stimulants or decongestants.

Daytrana

(methylphenidate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Patch: 10 mg/9 hours, 15 mg/9 hours, 20 mg/9 hours, 30 mg/9 hours

---

Dosing

• Age: ≥ 6 y/o
• Onset: Approximately 2 hours after application
• Duration: 9-hour wear time; continuous release for 9-12 hours
• Considerations: Apply the patch to the hip area (alternating sites) 2 hours before the effect is needed. The patch may be removed earlier if shorter duration is desired or if late-day side effects occur. Monitor for skin rash or sensitivity. Discard patches appropriately.
• Initial Dose: 10 mg patch applied daily
• Titration: 5 mg every 3 - 7 days
• Max Dose: 30 mg/day

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake; improves focus and attention
• Transdermal patch delivers controlled methylphenidate absorption; bypasses gastrointestinal metabolism
• Apply to a clean, dry, non-irritated area on the hip
• Avoid exposure to external heat sources
• Monitor for skin reactions and psychiatric symptoms
• Common side effects: skin irritation, decreased appetite, insomnia, headache

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Apply the patch once daily in the morning to clean, dry skin.
• Preferred application sites: hip area (alternating sides daily).
• Press firmly for 30 seconds to ensure proper adhesion.
• Wear the patch for 9 hours unless otherwise directed.
• Avoid cutting the patch, as this may alter drug release.
• Dispose of used patches by folding them in half and flushing or placing in a secure disposal container.
  

---

Side Effects

•  Common: Decreased appetite, insomnia, nausea, vomiting, weight loss, tics, affect lability, anorexia.
• Serious: Cardiac issues, increased blood pressure, psychiatric reactions, seizures, priapism, peripheral vasculopathy, chemical leukoderma, contact sensitization

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Signs of skin reactions (severe redness, swelling, blistering).
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid heat exposure (e.g., hot showers, heating pads, strenuous exercise) as it may increase drug absorption.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • If patch falls off, replace with a new one but remove at the usual time.

• Parent Tips for Pediatric Patients:

  • Monitor for skin irritation; rotate application sites to prevent reactions.
  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Dexedrine Spansule

(Dextroamphetamine sulfate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Capsules: 5 mg, 10 mg, 15 mg

---

Dosing

• Age: 6+ y/o
• Onset: ~ 60 min
• Duration: ~ 6-8 hours
• Considerations: Advise to take consistently either with food or without food. May be opened and the entire contents gently sprinkled on a teaspoon of cool applesauce, yogurt, or other soft food
• Initial Dose: 5 mg once or twice daily
• Titration: Increase by 5 mg at weekly intervals until optimal response
• Max Dose: 40 mg per day

Not recommended for patients with structural cardiac abnormalities

---

Quick Facts

• Increases synaptic dopamine and norepinephrine by stimulating presynaptic release
• Enhances focus, attention, and impulse control
• Extended-release spansule capsule for sustained, day-long effect
• Unique formulation minimizes plasma level fluctuations
• Common side effects: decreased appetite, insomnia, headache, increased heart rate

---

Indications

• ADHD (ICD-10: F90.0)
• Narcolepsy (ICD-10: G47.419)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once or twice daily, as directed, with the first dose in the morning.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule may be opened, and contents sprinkled on applesauce—consume immediately without chewing.
• Avoid taking late in the day to prevent insomnia.
  

---

Side Effects

• Common: Insomnia, decreased appetite, weight loss, dry mouth

  Serious: Cardiovascular events, psychiatric symptoms, growth suppression in childre

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to amphetamines or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Dyanavel XR

(amphetamine ER)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 5 mg, 10 mg, 15 mg, and 20 mg
• Liquid: 2.5 mg/mL (Total Bottle: 464 mL)

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~60 min
• Duration: up to 13 hours
• Considerations: May be taken with or without food. Liquid and tablet formulations are interchangeable.
  • Tablet: The 5mg dose is scored to allow for accurate dosing down to 2.5mg.
  • Liquid: Bubblegum flavor
• Initial Dose:
  • 6-12 y/o: 2.5-5 mg
  • 13+ y/o: 5-10 mg
• Titration:
  • 6-12 y/o: 2.5 mg every 4-7 days
  • 13+ y/o: 5 mg every 4-7 days
• Max Dose: 20 mg

---

Quick Facts

• Increases synaptic dopamine and norepinephrine; improves focus, attention, and impulse control
• Extended-release oral suspension; liquid formulation for ease of administration
• Unique delivery system provides consistent, sustained symptom control
• Common side effects: decreased appetite, insomnia, increased heart rate, elevated blood pressure

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

• N/A 

---

How to Take

• Take once daily in the morning to reduce the risk of insomnia.
• Can be taken with or without food.
• Shake the suspension well before each dose to ensure even distribution.
• Measure dose accurately using a provided oral syringe or dosing cup—do not use household spoons.

---

Side Effects

•  

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to amphetamines or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Evekeo

(amphetamine sulfate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 5 mg, 10 mg

---

Dosing

• Age: ≥ 3 y/o
• Onset: ~ 30-60 minutes
• Duration: 4-6 hours
• Considerations: Take the first dose on awakening. Additional doses may be given at intervals of 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: 2.5 mg weekly
  • 6+ y/o: 5 mg weekly
• Max Dose: 40 mg/day

---

Quick Facts

• Increases synaptic dopamine and norepinephrine by enhancing presynaptic release
• Improves focus, attention, and impulse control
• Immediate-release formulation for rapid onset
• Unique racemic amphetamine sulfate formulation
• Common side effects: decreased appetite, insomnia, increased blood pressure, headache

---

Indications

• ADHD (ICD-10: F90.0)
• Narcolepsy: G47.419
• Exogenous Obesity: E66.9

---

Off-Label Uses

•  N/A

---

How to Take

• Take once or twice daily, as directed, with the first dose in the morning.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow tablet whole with water; do not crush or chew.
• If using the oral suspension, shake well before each use and measure with an appropriate dosing device.
• Avoid taking late in the day to prevent insomnia. 

---

Side Effects

• Insomnia, decreased appetite, weight loss, increased heart rate, elevated blood pressure, potential for psychotic or manic symptoms, peripheral vasculopathy.

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to amphetamines or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Focalin

(dexmethylphenidate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 2.5 mg, 5 mg, 10 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30 minutes
• Duration: 5-6 hours
• Considerations:  Give approximately 1/2 the methylphenidate dose. Administer orally twice daily, at least 4 hours apart, with or without food.
• Initial Dose:
  • New to methylphenidate: 2.5 mg twice daily
  • Currently taking methylphenidate: Start with half the current total daily dose of methylphenidate (up to 10 mg twice daily)
• Titration: Increase by 2.5-5 mg daily every 3 to 7 days
• Max Dose: 20 mg/day (10 mg twice daily)
  

---

Quick Facts

• Increases synaptic dopamine and norepinephrine by enhancing presynaptic release
• Improves focus, attention, and impulse control
• Immediate-release formulation for rapid onset
• Unique formulation contains the isolated active dextroisomer (dexmethylphenidate), potentially allowing for lower dosing
• Common side effects: decreased appetite, insomnia, increased blood pressure, headache

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once or twice daily, with doses at least 4 hours apart.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the tablet whole; do not crush, chew, or split.
• Avoid taking late in the day to prevent insomnia.

---

Side Effects

• Decreased appetite, weight loss
• Abdominal pain
• Nausea
• Insomnia
• Tachycardia, potential elevations in blood pressure
• Possible new or worsened psychiatric symptoms (psychosis, mania)
• Priapism (rare, but serious)

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to dexmethylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase dexmethylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Focalin XR

(dexmethylphenidate XR)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30 min
• Duration: 8-12 hours
• Release Profile: 50% IR, 50% ER
• Considerations: Capsules may be swallowed whole or opened, and the entire contents can be sprinkled on applesauce.
• Initial Dose:
  • New to methylphenidate:
    • 6-17 y/o: 5 mg
    • Adults: 10 mg
  • Currently on methylphenidate: Focalin XR dosage is half (1/2) the current total daily dosage of methylphenidate
  • Currently on Focalin IR: Give the same daily dose of Focalin XR
• Titration:
  • 6-17 y/o: 5 mg weekly
  • Adults: 10 mg weekly
• Max Dose:
  • 6-17 y/o: 30 mg/day
  • Adults: 40 mg/day

---

Quick Facts

• Inhibits dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control
• Extended-release formulation provides sustained symptom control
• Uses SODAS technology for a bi-modal release profile (initial and extended release)
• Contains isolated active dextroisomer (dexmethylphenidate), potentially allowing for lower dosing
• Common side effects: decreased appetite, insomnia, headache, stomach upset

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

• N/A 

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule can be opened, and contents sprinkled on applesauce—consume immediately without chewing.
  

---

Side Effects

• Common: Dry mouth, dyspepsia, headache, anxiety, decreased appetite
• Serious: Cardiac issues, psychiatric symptoms, priapism, peripheral vasculopathy, growth suppression in children

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to dexmethylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase dexmethylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Intuniv

(guanfacine ER)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 1 mg, 2 mg, 3 mg, 4 mg 

---

Dosing

• Age: ≥ 6 y/o
• Duration: ~ 24 hours
• Considerations: Avoid high-fat meals; do not crush, chew, or break tablets
• Initial Dose: 1 mg daily 
• Titration: 1 mg/week
• Max Dose:
  • 25 - 33.9 kg: 2 - 3 mg/day
  • 34 - 41.4 kg: 2 - 4 mg/day
  • 41.5 - 49.4 kg: 3 - 5 mg/day
  • 49.5 - 58.4 kg: 3 - 6 mg/day
  • 58.5 - 91 kg: 4 - 7 mg/day
  • 91+ kg: 5 - 7 mg/day

---

Quick Facts

• Guanfacine (Intuniv) is a selective alpha-2A adrenergic receptor agonist; enhances prefrontal cortex regulation
• Reduces impulsivity and hyperactivity; may be less effective for inattention
• Non-stimulant option for ADHD; useful as adjunct therapy with stimulants
• Primarily metabolized by CYP3A4; dose adjustments may be necessary with CYP3A4 inhibitors or inducers
• Common side effects: drowsiness, fatigue, hypotension, dry mouth
  

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

• Oppositional Defiant Disorder (F91.3): May help manage irritability, anger outbursts, and impulsive aggression.
• Anxiety Disorders (F41.9): Sometimes used to reduce symptoms of anxiety and related somatic complaints.  
• Tic Disorders/Tourette’s Syndrome (F95.2): Occasionally employed off-label to help reduce tics.  
• Autism Spectrum Disorder-Associated Irritability (F84.0): May help in managing irritability and aggression in some cases.

---

How to Take

• Take once daily, preferably at the same time each day.
• Swallow the tablet whole; do not crush, chew, or split.
• Take with or without food, but be consistent with food intake to maintain stable absorption.
• If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
• Do not abruptly stop taking; tapering may be required to prevent rebound hypertension.
  

---

Side Effects

• Common: Sedation, somnolence, headache, abdominal pain, hypotension, bradycardia.

  Serious: Syncope, rebound hypertension, cardiac conduction abnormalitie

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.

---

Education

• When to Call the Doctor:

  • Severe dizziness, fainting, or low blood pressure.
  • Slow or irregular heart rate.
  • Excessive drowsiness or difficulty waking.
  • Mood changes, depression, or unusual behavior.
  • Severe headache, blurred vision, or confusion (possible hypertensive rebound if stopped abruptly).

• Safety Tips:

  • Monitor blood pressure and heart rate regularly.
  • Avoid alcohol and sedatives, which may enhance drowsiness.
  • Rise slowly from sitting or lying positions to prevent dizziness.
  • Use caution when driving or operating heavy machinery due to possible sedation.
  • Taper gradually when discontinuing to avoid withdrawal symptoms.

• Parent Tips for Pediatric Patients:

  • May cause daytime drowsiness; consider giving the dose at bedtime if drowsiness is problematic.
  • Monitor for irritability, mood swings, or behavioral changes.
  • Encourage hydration and balanced nutrition to minimize side effects.
  • Ensure children do not engage in high-risk activities (e.g., swimming, biking) if excessively drowsy.

---

Additional Information

• Contraindications:

  • Hypersensitivity to guanfacine or formulation components.
  • Use with caution in patients with severe heart disease, bradycardia, or hypotension.

• Pregnancy:

  • Category B; no well-controlled studies in pregnant women, but animal studies suggest minimal risk.

• Lactation:

  • Excreted in breast milk; use with caution due to potential effects on infant blood pressure.

• Drug Interactions:

  • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
  • Beta-blockers may enhance bradycardia; caution when using together.
  • Stimulants (e.g., amphetamines) may counteract guanfacine’s effects.
  • Antihypertensive medications may lead to excessive blood pressure lowering.

Jornay PM

(methylphenidate delayed and extended release capsules)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Capsules: 20 mg, 40 mg, 60 mg, 80 mg, 100 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: delayed until early morning (~10-12 hours after evening dose)
• Duration: 12-14 hours
• Considerations: Take in the evening between 6:30-9:30 pm. Capsules can be opened and sprinkled on applesauce.
• Initial Dose: 20 mg once daily in the evening
• Titration: 20 mg weekly
• Max Dose: 60 mg/day

---

Quick Facts

• Inhibits dopamine/norepinephrine reuptake
• Enhances focus, attention, and impulse control
• Extended-release methylphenidate with delayed-release profile designed for bedtime dosing
• Unique evening dosing provides early morning onset and sustained symptom control throughout the day
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  

---

How to Take

• Take once daily in the evening between 6:30 PM and 9:30 PM to allow for morning symptom control.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule may be opened and sprinkled on applesauce—consume immediately without chewing.

---

Side Effects

•  

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer exactly as prescribed in the evening for proper morning symptom control.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Kapvay

(Clonidine hydrochloride)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 0.1 mg, 0.2 mg, 0.3 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: 
• Duration: 12-24 hours
• Considerations: Monitor for hypotension, bradycardia, and sedation. Titrate slowly.
• Initial Dose: 0.1 mg orally once daily at bedtime
• Titration: Increase by 0.1 mg weekly
• Max Dose: 0.4 mg once daily

---

Quick Facts

• Selective alpha-2 adrenergic receptor agonist; reduces sympathetic outflow
• Improves prefrontal cortex regulation; decreases hyperactivity and impulsivity
• Extended-release formulation for adjunctive ADHD management; may improve sleep
• Less effective for inattention compared to stimulants
• Common side effects: drowsiness, sedation, dry mouth, hypotension

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  

---

How to Take

• Take twice daily, with doses about 12 hours apart.
• Swallow the tablet whole; do not crush, chew, or split.
• Can be taken with or without food, but be consistent with food intake for stable absorption.
• If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
• Do not abruptly stop taking; tapering may be required to prevent rebound hypertension.

---

Side Effects

• Common: Somnolence, fatigue, headache, abdominal pain, increased heart rate, nasal congestion, irritability, throat pain, rash.
• Serious: Hypotension, bradycardia, cardiac conduction abnormalities.

---

Monitoring / Labs

• Monitor heart rate and blood pressure prior to initiation, following dose increases, and periodically during therapy.

---

Education

• When to Call the Doctor:

  • Severe dizziness, fainting, or low blood pressure.
  • Slow or irregular heart rate.
  • Excessive drowsiness or difficulty waking.
  • Mood changes, depression, or unusual behavior.
  • Severe headache, blurred vision, or confusion (possible hypertensive rebound if stopped abruptly).

• Safety Tips:

  • Monitor blood pressure and heart rate regularly.
  • Avoid alcohol and sedatives, which may enhance drowsiness.
  • Rise slowly from sitting or lying positions to prevent dizziness.
  • Use caution when driving or operating heavy machinery due to possible sedation.
  • Taper gradually when discontinuing to avoid withdrawal symptoms.

• Parent Tips for Pediatric Patients:

  • May cause daytime drowsiness; consider giving the larger dose at bedtime if drowsiness is problematic.
  • Monitor for irritability, mood swings, or behavioral changes.
  • Encourage hydration and balanced nutrition to minimize side effects.
  • Ensure children do not engage in high-risk activities (e.g., swimming, biking) if excessively drowsy.
  • Store in child-proof packaging to prevent accidental overdose.

---

Additional Information

• Contraindications:

  • Hypersensitivity to clonidine or formulation components.
  • Use with caution in patients with severe heart disease, bradycardia, or hypotension.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms.

• Lactation:

  • Excreted in breast milk; use with caution due to potential effects on infant blood pressure.

• Drug Interactions:

  • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
  • Beta-blockers may enhance bradycardia; caution when using together.
  • Stimulants (e.g., amphetamines) may counteract Kapvay’s effects.
  • Antihypertensive medications may lead to excessive blood pressure lowering.

Metadate CD

(methylphenidate CD)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30-60 min
• Duration: 8-12 hours
• Release Profile: 30% IR, 70% ER
• Considerations: The capsule can be opened, and beads can be swallowed with applesauce. Take orally once daily in the morning, preferably before breakfast.
• Initial Dose: 20 mg
  
• Titration: 10-20 mg weekly
• Max Dose: 60 mg/day 

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake; enhances focus, attention, impulse control
• Extended-release methylphenidate capsule with biphasic release: immediate and delayed
• Immediate portion for rapid onset; delayed portion for sustained effect and optimized plasma levels
• Common side effects: decreased appetite, insomnia, headache, stomach upset

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

• N/A 

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule may be opened and sprinkled on applesauce—consume immediately without chewing.

---

Side Effects

• Common: Anorexia, insomnia, headache, abdominal pain.
• Serious: Cardiovascular events, psychiatric adverse reactions, growth suppression, priapism, peripheral vasculopathy

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Methylin

(methylphenidate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Liquid (grape flavored): 5 mg/5 mL, 10 mg/5 mL
• Chewable: 2.5 mg, 5 mg, 10 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~20-60 min
• Duration: 3-4 hours
• Considerations: Typically dosed multiple times per day. May be taken with or without food.
  • Liquid: Colorless, grape-flavored liquid; store at room temperature. 
  • Chewable: Grape-flavored chewable tablet.
• Initial Dose: 5 mg twice daily (before breakfast and lunch)
• Titration: 5-10 mg weekly
• Max Dose: 2mg/kg/day up to 60 mg/day
  

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control
• Immediate-release formulation provides rapid onset
• Available as tablets and oral solution
• Common side effects: decreased appetite, insomnia, headache, stomach upset

---

Indications

•  ADHD (ICD-10: F90.0)
• Narcolepsy: G47.419

---

Off-Label Uses

• Binge Eating Disorder (F50.2) – Sometimes used to help curb compulsive overeating
• Treatment-Resistant Depression (F33.9) – May improve motivation and energy in certain cases
• Cancer-related Fatigue (R53.0) – Can enhance alertness and reduce severe fatigue
• Other Fatigue Syndromes (R53.83) – May help improve wakefulness in chronic fatigue

---

How to Take

• Administer orally, preferably 30 to 45 minutes before meals.
• Take two to three times daily, as directed, with doses at least 4 hours apart.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the tablet whole; do not crush or chew.
• If using the oral solution, measure dose carefully with a provided dosing syringe or cup—do not use household spoons.
• Avoid taking late in the day to prevent insomnia.

---

Side Effects

• Common: Insomnia, decreased appetite, headache, abdominal pain, tachycardia, dry mouth
• Serious: Cardiovascular events (e.g., sudden death in patients with cardiac abnormalities), psychiatric events (e.g., psychosis, mania), priapism, growth suppression in children

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Mydayis

(dextroamphetamine-amphetamine ER)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Capsules: 12.5 mg, 25 mg, 37.5 mg, and 50 mg

---

Dosing

• Age: ≥ 13 y/o
• Onset: Approximately 1-2 hours
• Duration: Up to 16 hours
• Considerations: Capsules may be swallowed whole or sprinkled on cold applesauce and consumed immediately without chewing. Administer once daily upon awakening to avoid insomnia. Consistency with or without food is recommended. Do not substitute for other amphetamine products on a milligram-per-milligram basis.
• Initial Dose: 12.5 mg once daily in the morning
• Titration: 12.5 mg weekly
• Max Dose:
  • 13-17 y/o: 25 mg/day
  • Adults: 50 mg/day

---

Quick Facts

• Combination of immediate- and two delayed-release beads for extended duration.
• Increases synaptic dopamine and norepinephrine via amphetamine salts; enhances focus, attention, and impulse control
• Extended-release capsule with multi-phase release (initial, intermediate, extended) for prolonged symptom control
• Once-daily dosing providing coverage for up to 16 hours
• Common side effects: decreased appetite, insomnia, headache, dry mouth, increased heart rate 

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the capsule whole; do not crush, chew, or split.
• If needed, the capsule may be opened, and contents sprinkled on applesauce—consume immediately without chewing.

---

Side Effects

• Common: Insomnia, decreased appetite, weight loss, dry mouth, increased heart rate, anxiety.
• Serious: Cardiovascular events, psychiatric symptoms, growth suppression, peripheral vasculopathy, seizures, serotonin syndrome.

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to amphetamines or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Onyda XR

(generic)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Liquid (organe flavored): 0.1 mg/mL

---

Dosing

• Age: ≥ 6 y/o
• Onset: 60-90 min
• Duration: 12-24 hours
• Considerations: Orange flavored; Monitor for hypotension, bradycardia, and sedation. Titrate slowly.
• Initial Dose: 0.1 mg orally once daily at bedtime
• Titration: Increase by 0.1 mg weekly
• Max Dose: 0.4 mg once daily

For patients switching from another clonidine product, discontinue that treatment, and titrate with ONYDA XR using the titration schedule

---

Quick Facts

• Increases synaptic dopamine and norepinephrine via presynaptic release and reuptake inhibition
• Enhances focus, attention, and impulse control
• Extended-release formulation with dual-phase release for rapid onset and sustained control
• Unique delivery system provides consistent plasma levels throughout the day
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

• N/A

---

How to Take

• Take once daily at bedtime to minimize daytime sedation.
• Administer orally as a suspension; shake the bottle gently for at least 10 seconds before each use to ensure proper mixing.
• Use the provided oral dosing dispenser for accurate measurement; do not use household spoons.
• Can be taken with or without food, but maintain consistency in relation to meals to ensure stable absorption.
• If a dose is missed, skip that dose and take the next dose as scheduled; do not double up.
• Do not abruptly discontinue; tapering may be required to prevent rebound hypertension.

---

Side Effects

• Common: Somnolence, fatigue, irritability, headache, abdominal pain, constipation, dry mouth
• Serious: Hypotension, bradycardia, rebound hypertension, allergic reactions

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe dizziness, fainting, or low blood pressure.
  • Slow or irregular heart rate.
  • Excessive drowsiness or difficulty waking.
  • Mood changes, depression, or unusual behavior.
  • Severe headache, blurred vision, or confusion (possible hypertensive rebound if stopped abruptly).

• Safety Tips:

  • Monitor blood pressure and heart rate regularly.
  • Avoid alcohol and sedatives, which may enhance drowsiness.
  • Rise slowly from sitting or lying positions to prevent dizziness.
  • Use caution when driving or operating heavy machinery due to possible sedation.
  • Taper gradually when discontinuing to avoid withdrawal symptoms.

• Parent Tips for Pediatric Patients:

  • May cause daytime drowsiness; administering at bedtime helps minimize this effect.
  • Monitor for irritability, mood swings, or behavioral changes.
  • Encourage hydration and balanced nutrition to minimize side effects.
  • Ensure children do not engage in high-risk activities (e.g., swimming, biking) if excessively drowsy.
  • Store in child-proof packaging to prevent accidental overdose.

---

Additional Information

• Contraindications:

  • Hypersensitivity to clonidine or formulation components.
  • Use with caution in patients with severe heart disease, bradycardia, or hypotension.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms.

• Lactation:

  • Excreted in breast milk; use with caution due to potential effects on infant blood pressure.

• Drug Interactions:

  • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
  • Beta-blockers may enhance bradycardia; caution when using together.
  • Stimulants (e.g., amphetamines) may counteract ONYDA XR’s effects.
  • Antihypertensive medications may lead to excessive blood pressure lowering.

ProCentra

(dextroamphetamine sulfate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Liquid (bubblegum flavored): 5 mg/5 mL 

---

Dosing

• Age: ≥ 3 y/o
• Onset: ~ 30 min
• Duration: 4-6 hours
• Considerations: Bubblegum-flavored; may be taken with or without food. Shake bottle before administering. Store at room temperature.
• Initial Dose:
  • 3-5 y/o: 2.5 mg daily
  • 6+ y/o: 5 mg once or twice daily
• Titration:
  • 3-5 y/o: 2.5 mg weekly
  • 6+ y/o: 5 mg weekly
• Max Dose:
  • 3-5 y/o: 40 mg/day
  • 6+ y/o: 60 mg/day

---

Quick Facts

• Increases synaptic dopamine and norepinephrine via enhanced presynaptic release
• Enhances focus, attention, and impulse control
• Immediate-release oral solution; flexible dosing ideal for pediatric use
• Unique liquid formulation for precise dosing and ease of administration
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort 

---

Indications

•  ADHD (ICD-10: F90.0)
• Narcolepsy (ICD-10: G47.419)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once or multiple times daily, as directed by the healthcare provider.
• Administer using the provided oral syringe for accurate measurement—do not use household spoons.
• Can be taken with or without food; high-fat meals may delay absorption.
• Avoid taking late in the day to prevent insomnia.
• Store securely, as it is a controlled substance.

---

Side Effects

• Common: Insomnia, decreased appetite, weight loss, abdominal pain
• Serious: Cardiovascular events, psychiatric adverse reactions, growth suppression, peripheral vasculopathy

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to dextroamphetamine or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase dextroamphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Qelbree

(viloxazine)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Capsules: 100 mg, 150 mg, 200 mg

---

Dosing

• Age: ≥ 6 y/o
• Duration: ~ 24 hours
• Considerations: Bubblegum-flavored; may be taken with or without food. Shake bottle before administering. Store at room temperature.
• Initial Dose:
  • 6-11 y/o: 100 mg once daily
  • 12+ y/o: 200 mg once daily
• Titration:
  • 6-11 y/o: 100 mg weekly
  • 12+ y/o: 200 mg weekly
    
• Max Dose:
  • 6-17 y/o: 400 mg daily
  • 17+ y/o: 600 mg daily

---

Quick Facts

• Non-stimulant; modulates norepinephrine (and possibly serotonin) to improve ADHD symptoms
• Enhances focus, attention, and impulse control
• Extended-release capsule for once-daily dosing
• Unique alternative for patients intolerant of stimulants
• Common side effects: decreased appetite, somnolence, fatigue, gastrointestinal discomfort, irritability

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once daily at the same time each day.
• Can be taken with or without food.
• Swallow the capsule whole; do not crush, chew, or open.
• If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
• Do not abruptly stop taking; consult a healthcare provider before discontinuation.

---

Side Effects

• Common: Somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, irritability
• Serious: Suicidal thoughts and behaviors, blood pressure and heart rate increases, activation of mania or hypomania

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Symptoms of serotonin syndrome (e.g., rapid heart rate, hallucinations, severe agitation, muscle rigidity, fever).
  • Unusual bruising or bleeding.
  • Signs of liver dysfunction (e.g., yellowing of the skin/eyes, dark urine, persistent nausea).
  • Excessive drowsiness, fainting, or difficulty waking.

• Safety Tips:

  • Monitor blood pressure and heart rate, as Qelbree may cause changes in vital signs.
  • Use caution in patients with history of depression, bipolar disorder, or suicidal thoughts.
  • Avoid alcohol and sedatives, as they may increase drowsiness.
  • Be cautious when driving or operating heavy machinery until the effects of the medication are known.
  • Tapering may be needed if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Monitor for behavioral changes, increased agitation, or suicidal thoughts, particularly in the first few weeks.
  • May cause drowsiness or fatigue—observe how the child responds to the medication.
  • Encourage hydration and balanced meals to minimize side effects.
  • If taken for ADHD, track progress with teachers and caregivers to assess effectiveness.

---

Additional Information

• Contraindications:

  • Hypersensitivity to viloxazine or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).

• Pregnancy:

  • Category Not Assigned; safety in pregnancy has not been fully established.
  • Use only if the benefits outweigh the potential risks.

• Lactation:

  • Unknown if excreted in breast milk; use with caution.

• Drug Interactions:

  • CYP1A2 and CYP2D6 inhibitors (e.g., fluvoxamine, paroxetine) may increase viloxazine levels.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, St. John’s Wort) increase serotonin syndrome risk.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine) may reduce efficacy.
  • May increase the effects of blood pressure medications, leading to hypotension.

QuilliChew ER

(methylphenidate ER chewable)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Chewables (Cherry-flavored): 20 mg, 30 mg, 40 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 45 min
• Duration: up to 8 hours
• Release Profile: 30% IR, 70% ER
• Considerations: Cherry-flavored; may be taken with or without food. Long-acting chewable tablet. The 20 mg and 30 mg tablets may be split in half.
  
• Initial Dose: 20 mg
  
• Titration: 10-20 mg weekly
  
• Max Dose: 60 mg/day

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control
• Extended-release chewable tablet with dual-phase release for immediate onset and sustained effect
• Unique chewable formulation; ideal for patients with swallowing difficulties
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food; high-fat meals may delay absorption.
• Chew the tablet thoroughly before swallowing—do not swallow whole.
• Avoid taking late in the day to prevent sleep disturbances.

---

Side Effects

•  Common: Decreased appetite, insomnia, nausea, vomiting, abdominal pain, weight loss, anxiety, dizziness, irritability, tachycardia, increased blood pressure
• Serious: Cardiac events, psychiatric symptoms, priapism, peripheral vasculopathy, growth suppression

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Quillivant XR

(methylphenidate XR suspension)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Liquid (Fruit-flavored): 25 mg/5 mL

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 45 min
• Duration: ~ 12 hours
• Release Profile: 20% IR, 80% ER
• Considerations: Fruit-flavored; Shake bottle vigorously for at least 10 seconds before administering. May be taken with or without food. Store at room temperature. Suspension expires four months after reconstitution.
• Initial Dose: 20 mg
  
• Titration: 10-20 mg weekly
  
• Max Dose: 60 mg/day

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control
• Extended-release oral suspension with dual-phase release for immediate and sustained effect
• Unique liquid formulation ideal for patients who have difficulty swallowing pills
• Common side effects: decreased appetite, insomnia, stomach upset, headache

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Shake the bottle well for at least 10 seconds before each dose to ensure proper mixing.
• Measure the dose accurately using the provided oral dosing syringe—do not use household spoons.
• Can be taken with or without food; high-fat meals may delay absorption.
• Avoid taking late in the day to prevent sleep disturbances. 

---

Side Effects

• Common: Decreased appetite, insomnia, nausea, vomiting, abdominal pain, weight loss, anxiety, dizziness, irritability, tachycardia, increased blood pressure.
• Serious: Cardiac events, psychiatric symptoms, priapism, peripheral vasculopathy, growth suppression, glaucoma, tics.

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Relexxii

(methylphenidate ER [OROS])

Full Prescribing Information

DailyMed Drug Information

Relexxii is a tablet-shaped version of Concerta, offering the same OROS delivery system and bioequivalence. It also comes in additional dosage strengths.

---

Forms/Strengths

• Tablets: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~60 min
• Duration: 8-12 hours
• Release Profile: 20% IR, 80% CR via osmotic delivery
• Considerations: Must be swallowed whole; the non-absorbable shell may pass in stool. Administer once daily in the morning, with or without food. Do not chew or crush the tablet.
• Initial Dose:
  • 6-12 y/o: 18 mg once daily in the morning
  • 13+ y/o: 18 mg once daily in the morning
• Titration: Increase by 18 mg/day at weekly intervals
• Max Dose:
  • 6-12 y/o: 54 mg/day
  • 13+ y/o: 72 mg/day
  • Adults: 72 mg/day

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake; improves focus, attention, and impulse control
• Extended-release formulation with a unique multi-phase release for rapid onset and sustained effect
• Once-daily dosing for consistent ADHD symptom management
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food.
• Swallow the tablet whole with liquid; do not chew, divide, or crush.
  
• Avoid taking late in the day to prevent sleep disturbances.

---

Side Effects

•  Common: Decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, increased sweating.
• Pediatric patients: Abdominal pain

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Risperdal

(risperidone)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
• ODT: 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

---

Dosing

• Age: Adults and pediatric patients (pediatric use approved for irritability in autism, typically ages 5–16
• Considerations: Start low (especially in pediatric patients); titrate gradually based on response and tolerability; monitor metabolic parameters and prolactin levels.
• Initial Dose:
  • Adults (schizophrenia, bipolar disorder): 1–2 mg/day
  • Pediatrics (irritability): 0.25–0.5 mg/day
• Titration:
  • Increase by 1 mg increments in adults
  • Increase by 0.25–0.5 mg increments in children
  • Adjust dosing every few days to weekly based on response and side effects
• Max Dose: Approximately 6 mg/day in adults; pediatric maximum is weight dependent (often lower than adult maximum)

---

Quick Facts

• Atypical antipsychotic; blocks dopamine D2 and serotonin 5-HT2A receptors
• Modulates neurotransmission; improves psychotic symptoms, mood, and reduces irritability
• Available as oral tablets (including orally disintegrating options)
• Common side effects: weight gain, sedation, extrapyramidal symptoms, hyperprolactinemia
• Required bloodwork: baseline and periodic fasting glucose, lipid panel, and prolactin levels
• Unique dual receptor mechanism provides broad therapeutic effects in psychotic and mood disorders

---

Indications

• Irritability Associated with Autistic Disorder (ICD-10: F84.0): Reduces aggression, self-injury, and tantrums.
• Schizophrenia (ICD-10: F20.x): Reduces psychotic symptoms, such as delusions and hallucinations.
• Bipolar Disorder (ICD-10: F31.x): Controls manic symptoms and helps stabilize mood.

---

Off-Label Uses

• Generalized Anxiety Disorder (ICD-10: F41.1): Sometimes used adjunctively in treatment-refractory cases.
• Post-Traumatic Stress Disorder (ICD-10: F43.10): Occasionally employed off-label in patients not responding to first-line treatments.
• Borderline Personality Disorder (ICD-10: F60.3): May help reduce impulsivity and emotional dysregulation.
• Tourette’s Disorder (ICD-10: F95.2): Occasionally used off-label to reduce motor and vocal tics.

---

How to Take

• Take once or twice daily, as directed.
• Can be taken with or without food.
• Swallow the tablet whole; do not crush or chew.
• If using the orally disintegrating tablet (ODT), place it on the tongue and let it dissolve completely—do not chew.
• If using the oral solution, measure with a provided dosing syringe or cup—do not mix with tea or cola.
• Do not abruptly stop taking; tapering may be required to avoid withdrawal effects.

---

Side Effects

• Extrapyramidal symptoms (e.g., tremor, rigidity, akathisia)
• Hyperprolactinemia (which may cause galactorrhea, menstrual disturbances)
• Weight gain and metabolic abnormalities
• Sedation and dizziness
• Orthostatic hypotension
• Potential risk for tardive dyskinesia with long-term use

---

Monitoring / Labs

Metabolic Monitoring:

• • Baseline and periodic fasting glucose and lipid profile
  • Regular weight checks and assessment of body mass index (BMI)

Prolactin Levels:

• • Check baseline levels and monitor if symptoms suggest hyperprolactinemia (e.g., galactorrhea, menstrual irregularities)

• Neurological Monitoring:

  • Regular assessment for extrapyramidal symptoms and tardive dyskinesia
  • Monitor blood pressure, particularly during dose adjustments

• Other Considerations:

  • In elderly patients with dementia-related psychosis, close monitoring is necessary due to increased mortality risk (not applicable in pediatric use)
  • Routine laboratory monitoring should be individualized based on clinical status

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Uncontrollable muscle movements (tardive dyskinesia).
  • Fever, muscle stiffness, confusion (possible neuroleptic malignant syndrome).
  • Sudden dizziness, fainting, or irregular heartbeats.
  • Signs of high blood sugar (excessive thirst, frequent urination, blurred vision).

• Safety Tips:

  • Monitor blood sugar levels, especially in patients with diabetes.
  • Use caution in patients with dementia-related psychosis, as it may increase the risk of stroke.
  • Avoid alcohol and sedatives, which may increase drowsiness.
  • Rise slowly from sitting or lying positions to prevent dizziness.
  • Weight gain and metabolic changes may occur; monitor diet and physical activity.

• Parent Tips for Pediatric Patients:

  • Monitor for changes in mood, irritability, or aggression.
  • Watch for increased appetite and weight gain; encourage balanced nutrition.
  • Observe for sedation or drowsiness affecting school performance.
  • Keep regular follow-up appointments to track effectiveness and side effects.
  • Report any unusual movements or muscle stiffness to the healthcare provider.

---

Additional Information

• Contraindications:

  • Hypersensitivity to risperidone or formulation components.
  • Use with caution in patients with cardiovascular disease, seizure disorders, or history of stroke.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause withdrawal symptoms in newborns if taken in the third trimester.

• Lactation:

  • Excreted in breast milk; not recommended due to potential adverse effects on the infant.

• Drug Interactions:

  • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) may increase the risk of serotonin syndrome.
  • Antihypertensive medications may increase the risk of low blood pressure and dizziness.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase risperidone levels, requiring dose adjustments.

Ritalin

(methylphenidate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 5 mg, 10 mg, 20 mg 

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 20-60 min
• Duration: 3-4 hours
• Considerations: Abrupt onset and offset may increase the number and severity of side effects. Administer 30 to 45 minutes before meals.
• Initial Dose:
  • Pediatric (6+ y/o): 5 mg twice daily (before breakfast and lunch)
  • Adults: 10-15 mg twice or three times daily
• Titration: 5-10 mg weekly
• Max Dose: 60 mg/day
  

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake
• Enhances focus, attention, and impulse control
• Immediate-release formulation for rapid onset and short duration
• Available as tablets and oral solution for flexible dosing
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take two to three times daily, with doses at least 4 hours apart.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the tablet whole; do not crush, chew, or split.
• Avoid taking late in the day to prevent insomnia.

---

Side Effects

• Common: Insomnia, decreased appetite, weight loss, abdominal pain, headache, tachycardia
• Serious: Cardiovascular events, psychiatric symptoms, growth suppression, priapis
  

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Ritalin LA

(methylphenidate LA)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Capsules: 10 mg, 20 mg, 30 mg, 40 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 20-60 min
• Duration: 8-12 hours
• Release Profile: 50% IR, 50% ER
• Considerations: Capsules may be swallowed whole or opened, and the entire contents can be sprinkled on applesauce. Should not be crushed, chewed, or divided.
• Initial Dose: 10-20 mg
  • Patients currently using Ritalin: dosage is equivalent to Ritalin dose
• Titration: 10 mg weekly
• Max Dose: 60 mg/day
  

---

Quick Facts

• Blocks dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control
• Extended-release capsule with a bimodal (immediate and delayed) release profile for consistent, all-day symptom control
• Unique bead-based technology provides rapid onset followed by sustained effect
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule may be opened and the contents sprinkled on applesauce—consume immediately without chewing.

---

Side Effects

• Common: Headache, insomnia, upper abdominal pain, decreased appetite, anorexia.
• Serious: Cardiovascular events, psychiatric symptoms, priapism, peripheral vasculopathy, growth suppression, glaucoma, tics.

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to methylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Strattera

(atomoxetine)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

•  Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg

---

Dosing

• Age: ≥ 6
• Onset: ~ 60 min
• Considerations: Take the first dose on awakening. Additional doses may be given at intervals of 4-6 hours. 
• Initial Dose:
  • ≤70 kg: 0.5 mg/kg/day (1 or 2 divided doses)
  • >70 kg: 40 mg daily
    
• Titration:
  • ≤70 kg: After at least 3 days at the initial dose, increase to approximately 1.2 mg/kg/day.
  • >70 kg: After at least 3 days at 40 mg/day, increase to 80 mg/day. If no improvement after 2-4 weeks, may increase up to 100 mg/day.
    
• Max Dose:
  • ≤70 kg: lesser of 1.4 mg/kg/day or 100 mg/day
  • >70 kg: 100 mg/day

---

Quick Facts

• Selective norepinephrine reuptake inhibitor; increases synaptic NE and indirectly boosts dopamine in the prefrontal cortex
• Non-stimulant ADHD option; improves focus, attention, and impulse control
• Oral capsule; weight-based, typically once-daily dosing
• Common side effects: decreased appetite, nausea, dry mouth, fatigue, mood swings
• Monitor for suicidal ideation in pediatric patients; consider liver function checks

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

• Coexisting Anxiety or Tic Disorders: Used off-label in patients with ADHD who may have anxiety or tic disorders, as an alternative to stimulants.
• Oppositional Defiant Disorder (ODD): May help reduce irritability and impulsiveness when comorbid with ADHD.
• Autism Spectrum Disorder (ASD)-associated ADHD symptoms: Sometimes considered when stimulants are not tolerated.
• Substance Use Disorder in ADHD patients: Considered when stimulant misuse is a concern.

---

How to Take

• Take once or twice daily, with the first dose in the morning; if a second dose is needed, take it in the late afternoon.
• Can be taken with or without food; taking with food may help reduce nausea.
• Swallow the capsule whole; do not crush, chew, or open.
• If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
• Do not abruptly stop taking; consult a healthcare provider before discontinuation. 

---

Side Effects

•  Common: Somnolence, gastrointestinal symptoms, decreased appetite.
• Serious: Increased heart rate and blood pressure, suicidal thoughts (black box warning), rare cases of hepatitis

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Symptoms of liver dysfunction (yellowing of the skin/eyes, dark urine, persistent nausea).
  • Unusual bruising or bleeding.
  • Severe dizziness, fainting, or difficulty urinating.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).

• Safety Tips:

  • Monitor blood pressure and heart rate, as Strattera may cause increases.
  • Use caution in patients with a history of depression, bipolar disorder, or suicidal thoughts.
  • Avoid alcohol, as it may increase drowsiness and liver toxicity risk.
  • May cause drowsiness; use caution when driving or operating heavy machinery.
  • Tapering may be needed when discontinuing to prevent withdrawal effects.

• Parent Tips for Pediatric Patients:

  • Monitor for behavioral changes, increased agitation, or suicidal thoughts, particularly in the first few weeks.
  • May cause drowsiness or fatigue—observe how the child responds to the medication.
  • Encourage hydration and balanced meals to minimize side effects.
  • If taken for ADHD, track progress with teachers and caregivers to assess effectiveness.

---

Additional Information

• Contraindications:

  • Hypersensitivity to atomoxetine or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Severe cardiovascular disease, including history of stroke or arrhythmia.
  • Narrow-angle glaucoma.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • Limited human data; animal studies suggest potential fetal harm.

• Lactation:

  • Unknown if excreted in breast milk; use with caution.

• Drug Interactions:

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase atomoxetine levels.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Albuterol and other stimulants may enhance cardiovascular side effects.
  • Antihypertensive medications may lead to excessive blood pressure lowering.

Trileptal

(oxcarbazepine)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 150 mg, 300 mg, 600 mg
• Liquid (plum-lemon flavor): 300 mg/5 mL (60 mg/mL)

---

Dosing

• Age: ≥ 4 y/o
• Considerations: Plum-lemon flavored; Monitor for hyponatremia. Watch for sedation, dizziness, and cognitive side effects.
• Initial Dose: 8–10 mg/kg/day in two divided doses, not to exceed 600 mg/day
• Titration: 5 mg/kg/day every 3–7 days
• Typical dose:

  • 20-29 kg - 900 mg/day

  • 29.1-39 kg - 1200 mg/day

  • >39 kg - 1800 mg/day

• Max Dose: 60 mg/kg/day, do not exceed 2,400 mg/day

---

Quick Facts

• Blocks voltage-sensitive sodium channels; stabilizes hyperexcited neurons
• Can reduce clinically significant hyponatremia; monitor serum sodium regularly
• Common side effects: dizziness, headache, nausea, somnolence, diplopia, hyponatremia
• Lower enzyme induction and fewer drug interactions compared to carbamazepine
• May decrease the effectiveness of hormonal contraceptives (relevant for adolescents)
• Use caution in severe hepatic impairment; minimal data available
• Can cause sedation – caution when driving, operating machinery, or during school hours
• Pediatric Behavioral Note: Increasing clinical experience supports its off-label use for impulse control disorders, aggression, and ADHD-related mood dysregulation, particularly when first-line treatments have proven insufficient.
  

---

Off-Label Uses

• Intermittent Explosive Disorder (F63.81):

  • Used when the child has recurrent episodes of impulsive, aggressive outbursts that exceed normal developmental behavior.

• Oppositional Defiant Disorder (F91.3):

  • Appropriate when the child demonstrates a consistent pattern of defiant, disobedient, and hostile behavior toward authority figures.

• Conduct Disorder (F91.1):

  • Considered if the aggressive or antisocial behaviors are severe and meet criteria for conduct disorder. This is generally used when the behavior is more extreme.

• Attention-Deficit/Hyperactivity Disorder (F90.0 – F90.2):

  • If the patient has ADHD (predominantly inattentive, predominantly hyperactive-impulsive, or combined type) with marked impulsivity and secondary aggression, this code may be used. Documentation should clarify that the behavioral dysregulation is significant and not fully controlled with standard ADHD treatments.

• Bipolar Disorder (F31.0 or F31.9):

  • In cases where the clinical picture includes mood dysregulation (such as rapid cycling or manic features) that justifies the use of a mood stabilizer, these codes might be appropriate.

• Disruptive Mood Dysregulation Disorder (DMDD):

  • Although ICD-10 does not have a specific DMDD code, some providers use codes for other specified or unspecified childhood emotional disorders (e.g., F92.8 or F98.8, depending on the system) to capture the chronic irritability and severe temper outbursts seen in DMDD.
    
  • F92.8: Other mixed disorders of conduct and emotions
  • F98.8: Other specified behavioral and emotional disorders with onset in childhood and adolescence

---

How to Take

• Take twice daily, at the same times each day.
• Can be taken with or without food; taking with food may help reduce nausea.
• Swallow the tablet whole; do not crush or chew.
• If using the oral suspension, shake well before each dose and measure with a provided dosing syringe—do not use household spoons.
• If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
• Do not abruptly stop taking; tapering is required to prevent withdrawal seizures.
  

---

Side Effects

• CNS: Dizziness, drowsiness, fatigue, ataxia, tremor, confusion
• GI: Nausea, vomiting, abdominal pain
• Hyponatremia: Can be significant (headache, nausea, confusion, fatigue)
• Dermatologic: Rash (including SJS/TEN), potential severe cutaneous reactions
• Potential for suicidal thoughts/behaviors

---

Monitoring / Labs

• Serum sodium (due to hyponatremia risk)
• Signs of serious skin reactions (SJS/TEN)
• Watch for hypersensitivity (especially with carbamazepine allergy)
• Monitor for suicidality
• In children, weight-based dose; watch for sedation or other CNS effects
• Renal function (dose adjustment if CrCl <30 mL/min)
  

---

Education

• When to Call the Doctor:

  • Severe mood changes, depression, or suicidal thoughts.
  • Signs of low sodium levels (confusion, severe fatigue, headache, nausea, seizures).
  • Unusual bruising, bleeding, or signs of infection (sore throat, fever).
  • Rash, swelling, or difficulty breathing (possible allergic reaction or Stevens-Johnson Syndrome).
  • Worsening seizure frequency or severity.

• Safety Tips:

  • Monitor sodium levels periodically, especially in elderly patients or those taking diuretics.
  • Avoid alcohol, as it may increase drowsiness and dizziness.
  • Use caution when driving or operating heavy machinery due to potential sedation.
  • Taper gradually when discontinuing to prevent seizure rebound.
  • May decrease the effectiveness of hormonal contraceptives—consider alternative birth control methods.

• Parent Tips for Pediatric Patients:

  • Monitor for changes in mood, irritability, or unusual drowsiness.
  • If using the liquid form, ensure accurate dosing with the provided syringe.
  • Encourage adequate hydration to help prevent low sodium levels.
  • Report any rash or allergic reactions immediately.

---

Additional Information

• Contraindications:

  • Hypersensitivity to oxcarbazepine or carbamazepine.
  • Use with caution in patients with renal impairment or hyponatremia.

• Pregnancy:

  • Category C; may increase the risk of birth defects.
  • Use only if benefits outweigh risks—consider folic acid supplementation.

• Lactation:

  • Excreted in breast milk; use with caution as it may cause drowsiness in infants.

• Drug Interactions:

  • May decrease the effectiveness of hormonal contraceptives—use alternative birth control.
  • CYP3A4 inducers (e.g., rifampin, phenytoin) may lower Trileptal levels.
  • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
  • Diuretics may increase the risk of low sodium levels.

Vyvanse

(lisdexamfetamine)

Full Prescribing Information

DailyMed Drug Information

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Forms/Strengths

• Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg
• Chewable (Strawberry-flavored): 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

---

Dosing

• Age: ≥ 6 y/o
• Onset: ~60 min
• Duration: 8-12 hours

• Considerations: Can be taken with or without food. It is a pro-drug that is metabolized into 100% dextroamphetamine, with a reduced risk of abuse. The chewable tablet and capsule are interchangeable on a mg-to-mg basis. 

  • Chewable tablet: Strawberry-flavored and can be taken with or without food. 

  • Capsule: The capsule can be opened and its contents dissolved in liquid, such as water, yogurt, or orange juice. Use immediately after dissolving.

• Initial Dose: 20-30 mg
  
• Titration: 10-20 mg every 3-7 days
• Max Dose: 70 mg
  

---

Quick Facts

• Prodrug converted to dextroamphetamine; increases synaptic dopamine/norepinephrine
• Enhances focus, attention, and impulse control
• Unique prodrug formulation provides a smooth onset and extended duration
• Common side effects: decreased appetite, insomnia, dry mouth, irritability, abdominal pain

---

Indications

•  ADHD (ICD-10: F90.0)
• Moderate to severe binge eating disorder (BED) in adults (ICD-10: F50.81)

---

Off-Label Uses

• Depression (F33.9): Sometimes used adjunctively for treatment-resistant depression (limited data).
• Narcolepsy (ICD-10: G47.411): Sometimes used off-label but not FDA-approved for this indication.

---

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule may be opened, and contents mixed with water, yogurt, or orange juice—consume immediately without chewing.
• If using the chewable tablet, chew thoroughly before swallowing.

---

Side Effects

• Common: Decreased appetite, insomnia, dry mouth, irritability, nausea, vomiting, anxiety, weight loss
• Serious: Cardiovascular events, psychiatric adverse reactions, growth suppression in pediatric patients, peripheral vasculopathy, serotonin syndrom
  

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects. 

---

Additional Information

• Contraindications:

  • Hypersensitivity to lisdexamfetamine or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).

Wellbutrin XL

(bupropion XL)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Extended-release (XL): 150 mg, 300 mg

---

Dosing

• Age: 
• Onset: ~60 min
• Duration: 8-12 hours

• Considerations: Monitor for neuropsychiatric symptoms, especially in children and adolescents.

• Initial Dose: 150 mg once daily
  
• Titration: Increase to 300 mg once daily after 3 days if tolerated
• Max Dose: 450 mg/day

---

Quick Facts

• Inhibits reuptake of dopamine and norepinephrine; improves mood and energy
• Extended-release formulation for once-daily dosing and stable plasma levels
• Unique antidepressant profile; fewer sexual side effects and weight neutral
• Common side effects: dry mouth, insomnia, headache, nausea
• Caution: increased seizure risk at high doses or in susceptible individuals

---

Indications

• Major depressive disorder (ICD-10: F32, F33)
• Seasonal affective disorder (ICD-10: F33.0)
• Smoking cessation (ICD-10: Z72.0)

---

Off-Label Uses

•  Attention-deficit/hyperactivity disorder (ADHD) (ICD-10: F90.0)

---

How to Take

• Take once daily in the morning at the same time each day.
• Can be taken with or without food; taking with food may help reduce nausea.
• Swallow the tablet whole; do not crush, chew, or split.
• Avoid taking close to bedtime, as it may cause insomnia.
• Do not abruptly stop taking; tapering may be required to prevent withdrawal effects.

---

Side Effects

• Common: Insomnia, dry mouth, headache, nausea
• Serious: Seizures, hypertension, neuropsychiatric symptoms

---

Monitoring / Labs

• Blood pressure monitoring
• Monitor for worsening depression or suicidal thoughts

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Unexplained seizures, confusion, or hallucinations.
  • Signs of allergic reaction (rash, itching, swelling, difficulty breathing).
  • Unusual bruising or bleeding.
  • Severe headache, blurred vision, or persistent nausea (signs of high blood pressure).

• Safety Tips:

  • Monitor mood and behavioral changes, especially in patients with a history of depression or bipolar disorder.
  • Avoid alcohol, as it may increase the risk of seizures.
  • Use caution if you have a history of seizures, eating disorders, or head trauma, as Wellbutrin may lower the seizure threshold.
  • May cause dry mouth—increase hydration if needed.
  • Be cautious when driving or operating machinery until individual response is known.

• Parent Tips for Pediatric Patients (if prescribed off-label):

  • Monitor for increased agitation, irritability, or changes in mood.
  • Be aware of appetite suppression—encourage balanced meals.
  • Observe for difficulty sleeping; discuss timing adjustments with the provider if needed.

---

Additional Information

• Contraindications:

  • History of seizures or conditions that lower seizure threshold (e.g., eating disorders, head trauma, alcohol withdrawal).
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Severe hepatic impairment, as it may increase drug accumulation.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • Limited human data, but potential risk for fetal harm is unclear.

• Lactation:

  • Excreted in breast milk; use with caution as effects on the infant are unknown.

• Drug Interactions:

  • CYP2B6 inhibitors (e.g., ticlopidine, clopidogrel) may increase Wellbutrin levels.
  • CYP2B6 inducers (e.g., carbamazepine, rifampin) may decrease effectiveness.
  • Other medications that lower seizure threshold (e.g., tramadol, antipsychotics, theophylline) may increase seizure risk.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) may increase the risk of serotonin syndrome.

Xelstrym

(generic)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Transdermal system: 4.5 mg/9 hours, 9 mg/9 hours, 13.5 mg/9 hours, 18 mg/9 hours

---

Dosing

• Age: ≥ 6 y/o
• Onset: Approximately 2 hours after application
• Duration: 9-hour wear time; continuous release for 9-12 hours
• Considerations: Apply the patch to the hip, upper arm, chest, upper back, or flank area 2 hours before the effect is needed. Rotate application sites with each new patch. Do not use more than one patch in a 24-hour period. Do not substitute for other amphetamine products on a milligram-per-milligram basis.
• Initial Dose:
  • Pediatric (6-17 y/o): 4.5 mg/9 hours daily
  • Adults: 9 mg/9 hours daily
• Titration: 4.5 mg/9 hours weekly
• Max Dose: 18 mg/9 hours
  • Severe Renal Impairment: 13.5 mg/9 hours
  • End-Stage Renal Disease (ESRD): 9 mg/9 hours
    

---

Quick Facts

• Increases synaptic dopamine and norepinephrine by promoting presynaptic release and inhibiting reuptake
• Enhances focus, attention, and impulse control
• Extended-release capsule with a multi-phase release profile for rapid onset and sustained effect
• Unique formulation for consistent plasma levels throughout the day
• Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

---

Indications

•  ADHD (ICD-10: F90.0)

---

Off-Label Uses

•  N/A

---

How to Take

• Apply one patch daily to clean, dry, intact skin.
• Apply to the hip, upper arm, chest, flank, or upper back—rotate application sites daily.
• Press firmly for at least 30 seconds to ensure full adhesion.
• Wear the patch for 9 hours and remove it after the prescribed duration.
• Avoid cutting or altering the patch, as this may affect drug release.
• Wash hands after applying or removing the patch.

---

Side Effects

• Common: decreased appetite, headache, insomnia, tic, abdominal pain, vomiting, nausea, irritability, increased blood pressure, and increased heart rate

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Skin irritation, blistering, or severe redness at the application site.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid external heat sources (e.g., heating pads, electric blankets, hot tubs) as heat can increase drug absorption.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • If the patch falls off, replace with a new one but remove at the usual time.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.
  • Dispose of used patches safely by folding them in half and placing them in a secure disposal container.

---

Additional Information

• Contraindications:

  • Hypersensitivity to amphetamines or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists)

Zenzedi

(dextroamphetamine sulfate)

Full Prescribing Information

DailyMed Drug Information

---

Forms/Strengths

• Tablets: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg 

---

Dosing

• Age: ≥ 3 y/o
• Onset: ~ 30-60 minutes
• Duration: 4-6 hours
• Considerations: Take the first dose on awakening. Additional doses may be given at intervals of 4-6 hours. Periodic drug holidays are recommended to assess the patient’s condition.
• Initial Dose:
  • 3-5 y/o: 2.5 mg daily
  • 6+ y/o: 5 mg once or twice daily
• Titration:
  • 3-5 y/o: 2.5 mg weekly
  • 6+ y/o: 5 mg weekly
• Max Dose:
  • 3-5 y/o: 20 mg/day
  • 6+ y/o:
    • ≤50 kg: 40 mg/day
    • >50 kg: 60 mg/day 

---

Quick Facts

• Increases synaptic dopamine and norepinephrine by enhancing presynaptic release and inhibiting reuptake
• Enhances focus, attention, and impulse control
• Immediate-release formulation for rapid onset
• Contains dextroamphetamine sulfate as the active ingredient
• Common side effects: decreased appetite, insomnia, increased heart rate, headache, dry mouth 

---

Indications

•  ADHD (ICD-10: F90.0)
• Narcolepsy (ICD-10: G47.419)

---

Off-Label Uses

•  N/A

---

How to Take

• Take once or multiple times daily, as directed.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the tablet whole; do not crush, chew, or split.
• Avoid taking late in the day to prevent insomnia.

---

Side Effects

• Common: Insomnia, decreased appetite, weight loss, dry mouth, headache
• Serious: Cardiovascular events, psychiatric symptoms (e.g., psychosis, mania), growth suppression in children, peripheral vasculopathy (including Raynaud's phenomenon)

---

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

---

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

---

Additional Information

• Contraindications:

  • Hypersensitivity to dextroamphetamine or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase dextroamphetamine levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists)