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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

  1. 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
  2. LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
  3. FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
  4. AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
  5. 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/
  6. DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling
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