Cotempla XR-ODT

(methylphenidate)
Cotempla XR-ODT (methylphenidate); CII
Full Prescribing Information
DailyMed Drug Information
Summary
Cotempla XR-ODT is a long-acting methylphenidate CNS stimulant supplied as a grape-flavoured extended-release tablet that disintegrates on the tongue, approved for ADHD in patients 6 to 17 years only. Drug is ion-bound to a resin, giving one morning dose a full school-day profile with no water and no swallowing. Its strengths are stated in methylphenidate base, so they do not match the hydrochloride numbers on any other product. Schedule II; brand and generic.
Forms & Strengths
Extended-release orally disintegrating tablets (grape): 8.6 mg, 17.3 mg, 25.9 mg
Dosing
Age: 6-17 y/o; pediatric only
Onset: ~ 1 hour
Duration: up to 12 hours
Release Profile: 25% IR / 75% ER, methylphenidate ion-bound to polystyrene sulfonate resin
Initial Dose: 17.3 mg once daily in the morning
Titration: 8.6 mg to 17.3 mg every 7 days
Max Dose: 51.8 mg/day
Considerations: Strengths are methylphenidate base, so 17.3 mg equals 20 mg of a hydrochloride product. Do not co-prescribe an H2-blocker or PPI; they alter the release profile.
Pharmacology
Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 25% IR / 75% ER; drug exchanges off a coated ion-exchange resin. Monophasic, no second peak. Tmax ~5 h adults, 4.6 h children.
Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Half-life ~4 h adults, 4.4 h children; 90% urinary.
Pediatric exposure: at 51.8 mg, children 6-12 reach roughly twice adult plasma levels; adolescents match adults. Start everyone at 17.3 mg.
Class Positioning: The resin buys a water-free dose, unlike the sprinkle capsule Aptensio XR or the liquid Quillivant XR, and is why gastric pH matters here alone.
Indications
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6-17 y/o. No adult indication.
Off-Label Uses
ADHD in adults (ICD-10: F90.x): reasonable where swallowing is the obstacle; the indication stops at 17. Limited data.
Narcolepsy (ICD-10: G47.411, G47.419): on-label for IR methylphenidate, not this product; limited data.
Where the evidence does not support use.
ADHD under 6 y/o (ICD-10: F90.x): the label records evidence against, with higher exposure and more adverse reactions including weight loss; insufficient. (AHRQ 2024)
Dissolving the tablet in water or juice: not studied, not supported. Prescribe a liquid product if a liquid is needed.
Contraindications & Warnings
Boxed Warning: Abuse, misuse, and addiction. High potential for abuse and misuse, leading to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
Known hypersensitivity to methylphenidate or any component; angioedema and anaphylaxis reported.
Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
Established acid suppression. A child already on a PPI or H2-blocker is a poor candidate; switch formulation rather than stop the acid suppression.
Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid, because of sudden death reports.
Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm.
Psychotic or bipolar disorder; exacerbation and treatment-emergent mania.
Tics or Tourette's syndrome, personal or family.
Significant hyperopia, open-angle glaucoma, or raised intraocular pressure.
Substance use disorder in the patient or household.
Screen before starting:
Cardiac history, family history of sudden death or arrhythmia, and exam.
Personal and family history of tics or Tourette's syndrome.
Current acid-suppression therapy, prescribed or over the counter.
Risk factors for mania: past depression, family history of suicide or bipolar disorder.
Abuse and diversion risk; baseline height, weight, blood pressure and heart rate.
Drug Interactions
Gastric pH modulators (famotidine, omeprazole, pantoprazole): alter the release profile. Concomitant use is not recommended. Switch formulation if acid suppression must continue.
MAOIs: hypertensive crisis, with reported death, stroke and MI. Do not co-prescribe, and allow 14 days after stopping.
Antihypertensives: effectiveness may fall. Recheck blood pressure and adjust their dose.
Halogenated anesthetics: sudden intraoperative pressure and rate rise. Hold on the day of surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.
Serotonergic agents: serotonin syndrome is postmarketing only here; counsel on symptoms rather than avoid.
Administration
Once daily in the morning, consistently either with food or without food.
With dry hands, peel the foil back at the moment of dosing. Never push the tablet through the foil, which crushes the extended-release coating.
Place the whole tablet on the tongue and let it disintegrate. Do not chew, crush, split or add liquid.
Missed dose: resume as scheduled; do not double up or dose late in the day.
Switching from another methylphenidate: re-titrate from 17.3 mg; strengths are in base, not hydrochloride.
Store securely, preferably locked; dispose through a take-back program.
Side Effects
Common (pooled methylphenidate trials; no Cotempla-specific table exists): decreased appetite, insomnia, decreased weight, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, anxiety, irritability, affect lability, dizziness, raised blood pressure and heart rate.
Serious:
Sudden death with structural cardiac disease; avoid the drug in that group.
New psychosis or mania, ~0.1% pooled, including with no psychiatric history; consider discontinuing.
Priapism, which may require surgery; also during drug holidays. Seek immediate care.
Peripheral vasculopathy including Raynaud's, with digital ulceration; reduce dose or stop.
Growth suppression: ~2 cm and 2.7 kg less over 3 years. Interrupt if growth stalls.
Acute angle closure glaucoma and raised intraocular pressure.
New or worsening tics; discontinue if clinically appropriate.
Angioedema and anaphylaxis; postmarketing seizures, rhabdomyolysis, pancytopenia, raised hepatic enzymes.
Monitoring & Labs
Acid-suppression therapy: ask at every visit, including over-the-counter use. A new PPI is the likeliest hidden cause of a regimen that stops working.
Administration technique: at first follow-up and at any loss of effect, have the caregiver demonstrate how the tablet is given.
Cardiovascular: blood pressure and heart rate at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months. Interrupt if the child crosses two major percentile lines.
Appetite, sleep, mood and tics: at every visit and after every dose increase; screen for new psychosis, mania and aggression.
Digital perfusion: inspect fingers and toes at each visit.
Abuse and diversion: tablet counts and PDMP check at each refill, per state requirement. Blister cards make counting easy.
Laboratory: none routine. LFTs only for jaundice, dark urine or unexplained fatigue.
Efficacy stopping rule: discontinue if no improvement after one month of dose adjustment.
Discontinuation & Taper
May be stopped abruptly at therapeutic doses; the label gives no taper schedule.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, psychomotor slowing or agitation. Do not read it as relapse.
Drug holidays are reasonable where appetite or growth limits treatment; priapism has been reported during them.
If the reason for stopping is a newly required PPI or H2-blocker, switch formulation rather than abandoning methylphenidate.
Pregnancy & Lactation
Pregnancy: Human data insufficient to inform risk. No teratogenicity in rats or rabbits at 4 and 18 times the 51.8 mg maximum; spina bifida in rabbits at 60 times. Stimulants reduce placental perfusion.
Lactation: Present in milk; infant receives 0.16% to 0.7% of the maternal weight-adjusted dose. Monitor for agitation, insomnia, poor feeding and low weight gain. (LactMed 2025)
Lactation, milk supply: Methylphenidate lowers prolactin; large doses may interfere before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.
Counseling Points
Counsel the family on:
The handling sequence, demonstrated once: dry hands, peel the foil, tablet on the tongue, let it melt.
Never pushing the tablet through the foil, which turns a 12-hour product into a short one.
No water, no chewing, no crushing, no dissolving in a drink.
Keeping breakfast consistent, fed every morning or fasted every morning.
Telling you before starting any heartburn medicine, including over-the-counter omeprazole or famotidine. Families will not volunteer this.
The numbers looking smaller than on other methylphenidates without being smaller doses.
Appetite suppression: move the largest meal to breakfast and to the evening.
Locked storage, and that sharing a Schedule II medication is a felony.
For adolescents, that spirits can release the whole tablet at once.
Advise them to call for:
Chest pain, fainting, or a racing heart that does not settle.
New hallucinations, or new suspicious or fearful thinking.
Numbness, coldness, or colour change in the fingers or toes.
A new or markedly worse tic, or a new vocal tic.
Weight loss, or clothes fitting more loosely over a few weeks.
A painful erection lasting more than a few hours, which is a surgical emergency.
New eye pain, blurred vision, or haloes around lights.
Swelling of the lips, tongue or face, or a spreading rash.
References
DailyMed. Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets prescribing information. Neos Therapeutics Brands LLC. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33f70f58-c871-42c8-8adb-345caeafefcd
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling