Focalin XR

(dexmethylphenidate XR)
Focalin XR (dexmethylphenidate hydrochloride); CII
Full Prescribing Information
DailyMed Drug Information
Summary
Focalin XR is a once-daily, long-acting bead capsule of dexmethylphenidate, the more pharmacologically active d-threo enantiomer of racemic methylphenidate, approved for ADHD in children from age 6 and in adults. Half of each capsule is immediate-release beads and half enteric-coated delayed-release beads, producing two distinct plasma peaks rather than a flat curve. The capsule can be sprinkled on applesauce, making it the only dexmethylphenidate option for a patient who cannot swallow. Schedule II; brand and generic.
Forms & Strengths
Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg
Dosing
Age:
6-17 y/o: safety and effectiveness established
18 y/o and older: efficacy established at 20, 30 and 40 mg/day
Under 6 y/o: not recommended; higher plasma exposure and more adverse reactions, including weight loss, at the same dosage
Onset: ~ 30 min
Duration: up to 12 hours
Release Profile: 50% IR / 50% delayed-release via enteric-coated beads, giving two plasma peaks about 4 hours apart, the second at about 6.5 hours
Initial Dose:
New to methylphenidate, 6-17 y/o: 5 mg once daily in the morning
New to methylphenidate, 18 y/o and older: 10 mg once daily in the morning
Currently on racemic methylphenidate: half the current total daily dose
Currently on Focalin immediate-release tablets: the same total daily dose
Titration: 5 mg every 7 days (6-17 y/o); 10 mg every 7 days (18 y/o and older)
Max Dose: 30 mg/day (6-17 y/o); 40 mg/day (18 y/o and older)
Considerations: Once daily in the morning, with or without food. Swallow whole or open onto applesauce and take immediately without chewing. A capsule must never be divided.
Pharmacology
Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 50% IR / 50% delayed-release enteric-coated beads; two peaks roughly 4 hours apart. Against IR tablets at the same total dose, a lower second peak, higher trough, equivalent AUC.
Metabolism: De-esterified to d-ritalinic acid, little activity. Not a clinically relevant CYP substrate. Bioavailability 22% to 25%; half-life 2 to 3 hours; ~90% urinary.
Class Positioning: Duration comes from a second discrete release, not continuous delivery like the osmotic Concerta or the prodrug Azstarys, so some patients have a real interpeak dip in the early afternoon.
Indications
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older, including adults
Off-Label Uses
Narcolepsy (ICD-10: G47.419): racemic methylphenidate carries the indication; this enantiomer does not. Insufficient.
ADHD in a child aged 4 to 5 (ICD-10: F90.x): behavioral parent training first (AAP 2019). This label goes further than lacking data: it states use below 6 is not recommended. Not the preschool methylphenidate.
Where the evidence does not support use. AHRQ 2024 grades stimulant head-to-head comparisons as low strength of evidence, so nothing supports choosing this over another long-acting methylphenidate, or any use outside ADHD in youth.
Contraindications & Warnings
Boxed Warning: Abuse, misuse, and addiction, which can lead to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
Hypersensitivity to methylphenidate or any component; angioedema and anaphylaxis reported.
Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid.
Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm.
Pre-existing psychosis or bipolar disorder; new psychotic or manic symptoms in ~0.1% of stimulant-treated patients.
Motor or verbal tics, and Tourette's syndrome.
Open-angle glaucoma, raised intraocular pressure, or significant hyperopia.
Peripheral vasculopathy including Raynaud's; substance use disorder in patient or household.
Screen before starting:
Cardiac disease by history, family history of sudden death, and exam. No routine ECG.
Personal and family history of tics or Tourette's syndrome.
Risk factors for mania; abuse and diversion risk; baseline height, weight, blood pressure and heart rate.
Drug Interactions
MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Do not co-prescribe; allow 14 days after stopping.
Antihypertensives (any class): effectiveness may fall. Monitor blood pressure and adjust their dose.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): sudden intraoperative pressure and rate rise. Avoid on the day of surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans): serotonin syndrome appears postmarketing, not in the interaction table. Counsel and reassess when adding one.
Administration
Once daily in the morning, with or without food.
Swallow whole, or sprinkle the entire contents onto applesauce and eat it all immediately without chewing. Do not store a mixed dose.
Never divide a capsule. Adjust by strength, not by splitting.
Switching from racemic methylphenidate: half the total daily dose. From Focalin tablets: the same total daily dose. The two rules differ; this is the commonest conversion error here.
Stop the drug if a month of dose adjustment brings no improvement. Store securely, preferably locked.
Side Effects
Common (pediatric controlled trial): decreased appetite 30% vs 9%, headache 25% vs 11%, dyspepsia 8% vs 4%, anxiety 6% vs 0%. Dose related: insomnia rose from 5% at 10 mg/day to 17% at 30 mg/day, vomiting from 2% to 9%.
Serious:
Sudden death with structural cardiac disease; avoid use, and evaluate exertional syncope promptly.
New psychosis or mania, including with no psychiatric history; consider discontinuing.
Priapism, sometimes requiring surgery, including during drug holidays. Immediate care.
Peripheral vasculopathy including Raynaud's, with digital ulceration; reduce dose or stop.
Growth suppression: mean weight change minus 0.5 kg on drug against plus 0.4 kg on placebo over 7 weeks. Interrupt if a child is not gaining.
Acute angle closure glaucoma and raised intraocular pressure.
Angioedema and anaphylaxis.
Monitoring & Labs
Cardiovascular: blood pressure and heart rate at baseline, at every dose change, and at least every 6 months. A rise beyond the expected 2 to 4 mmHg triggers dose reduction.
Growth: height, weight and BMI at baseline and every 6 months, more often in the first year; this label documents net weight loss over 7 weeks.
Appetite and sleep: at every visit and dose change. Insomnia triples between 10 mg and 30 mg here, so treat it as a dose signal first.
Afternoon coverage: ask about the early to mid afternoon at each visit; a dip there is a formulation problem, not necessarily a dose problem.
Psychiatric and tics: screen for new psychosis, mania, aggression and emergent tics at every visit. Inspect fingers and toes for colour change or ulceration.
Abuse and diversion: at every refill reassess risk, reconcile the pill count, and check the state PDMP per state requirement.
Laboratory: no routine laboratory monitoring is required.
Discontinuation & Taper
May be stopped abruptly at therapeutic doses; this label gives no taper instruction.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, agitation.
Priapism has occurred during withdrawal and planned holidays; mention it before a holiday in an adolescent male.
A drug holiday is a skipped morning dose. There is no partial-dose option, since capsules must not be divided.
Pregnancy & Lactation
Pregnancy: Published studies and postmarketing reports have not identified a drug-associated risk. Stimulants reduce placental perfusion. Delayed fetal ossification in rats at 5 times the maximum human dose; spina bifida in rabbits at 200 mg/kg/day.
Lactation: Present in milk; infant doses were 0.16% to 0.7% of the maternal weight-adjusted dose, with no reported infant effects. Monitor for agitation, insomnia, poor feeding and low weight gain.
Dexmethylphenidate specifically: no clinical use data in lactation; a maternal requirement is not a reason to stop breastfeeding. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, https://womensmentalhealth.org/adhd-medications/
Counseling Points
Counsel the family on:
The two-peak shape of the day: some children dip in the early afternoon. Ask them to note when in the day the trouble happens.
Coverage running about 12 hours, so a child dosed at 7 a.m. does homework and dinner off medication.
The sprinkle method: onto applesauce, eaten at once, never chewed, never saved. Chewing destroys the delayed-release half.
That the milligram number is deliberately half what a racemic methylphenidate bottle showed, and is not a dose reduction.
Appetite suppression: move the largest meal to breakfast and to the evening.
Locked storage, and that sharing a Schedule II medication is a felony.
Advise them to call for:
Chest pain, fainting, or a racing heart that does not settle.
New hallucinations, or new suspicious, fearful or grandiose thinking.
Numbness or colour change in the fingers or toes; eye pain or blurred vision.
A new tic, or a marked worsening of an existing one.
Weight loss, or clothes fitting more loosely over a few weeks.
Insomnia appearing or worsening after a dose increase.
A painful erection lasting more than a few hours, including during a planned break.
References
DailyMed. Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules prescribing information. Novartis. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a1da905-42a0-4748-9c39-67eca45deccc
LactMed. Dexmethylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK500764/
FDA. National Drug Code Directory, openFDA. Queried by generic name dexmethylphenidate. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/