# Cotempla XR-ODT ### (methylphenidate) **[Cotempla XR-ODT](https://wiki.joshnp.com/books/drug-library/page/cotempla-xr-odt)** (methylphenidate); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=33f70f58-c871-42c8-8adb-345caeafefcd&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33f70f58-c871-42c8-8adb-345caeafefcd)
--- ### **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](https://wiki.joshnp.com/link/38) or the liquid [Quillivant XR](https://wiki.joshnp.com/link/28), 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