Cotempla XR-ODT

(methylphenidate)

Cotempla XR-ODT (methylphenidate); CII

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