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Metadate CD

(methylphenidate hydrochloride extended-release, biphasic beads)

Metadate CD (methylphenidate hydrochloride extended-release, biphasic beads); CII

Full Prescribing Information DailyMed Drug Information

Summary

Metadate CD is a bead-filled methylphenidate capsule delivering 30% of the dose immediately and holding 70% in extended-release beads, approved for ADHD in children 6 to 15 years. Weighting the dose toward the afternoon is its differentiator: less morning spike and more late coverage than the 50 / 50 bead capsules. The capsule can be opened and sprinkled without changing exposure. Schedule II; brand and generic.

Forms & Strengths

  • Extended-release capsules (biphasic beads, may be opened onto applesauce): 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Dosing

  • Age: 6 to 15 y/o only; no indication at 16, 17 or in adults
  • Onset: ~ 1 hour
  • Duration: about 8 hours
  • Release Profile: 30% IR / 70% ER via biphasic beads
  • Initial Dose: 20 mg once daily in the morning, before breakfast
  • Titration: 10 - 20 mg every 7 days
  • Max Dose: 60 mg/day
  • Considerations: Give before breakfast; a high-fat meal raises Cmax ~30% and delays the peak an hour. Alcohol releases 84% of the dose in the first hour, so counsel adolescents. May be opened onto applesauce.

Pharmacology

  • Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
  • Delivery / Release: 30% IR / 70% ER via biphasic beads. First peak at a median 1.5 h, second at ~4.5 h; a quarter to a third of children show only one peak.
  • Metabolism: De-esterified to ritalinic acid, inactive. Not a CYP substrate. Mean terminal half-life 6.8 hours, against 2.9 h for IR tablets and 3.4 h for OROS.
  • Class Positioning: The most afternoon-weighted bead capsule: 30/70 against the 50/50 of Ritalin LA. Against Concerta it is two-peaked and can be sprinkled. Its liability is alcohol.
  • Alcohol: at 40% alcohol, 84% of the dose is released within the first hour; Concerta shows no such release. The label instructs counseling to avoid alcohol.

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 15 y/o

Off-Label Uses

  • ADHD at 16 and older, including adults (ICD-10: F90.x): easy to do inadvertently, since a stable 15 year old becomes off-label on a birthday. Insufficient. (AHRQ 2024)
  • ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral parent training first line; if medication is needed use IR methylphenidate. Expert consensus. (AAP 2019)
  • Narcolepsy (ICD-10: G47.419): IR methylphenidate carries this indication, Metadate CD does not. Insufficient.
  • Where the evidence does not support use: treatment-resistant depression, binge eating disorder, cancer-related and chronic fatigue. Adult literature only; insufficient in children. (AHRQ 2024)
  • Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse and addiction, with overdose and death. Assess abuse risk before prescribing and reassess throughout treatment.
  • Contraindicated:
    • Hypersensitivity to methylphenidate or any component
    • MAOI use, current or within 14 days: hypertensive crisis
  • Use with caution:
    • Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
    • Pre-existing hypertension: monitor blood pressure and pulse
    • Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
    • Significant hyperopia or angle-closure risk: refer to ophthalmology
    • Personal or family history of tics or Tourette's syndrome
    • Any adolescent drinking alcohol or at risk of it
    • Substance use disorder in patient or household; a bead capsule is not abuse-deterrent
  • Screen before starting:
    • Cardiac history and exam including family sudden death; the label requires no routine ECG
    • Tics, and risk factors for a manic episode
    • Alcohol use in an adolescent, asked directly and separately from other substance use
    • Abuse and diversion risk in patient and household
    • Baseline height, weight, blood pressure and heart rate; age against the 6 to 15 indication

Drug Interactions

  • MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
  • Alcohol: 84% released in the first hour at 40% alcohol. Advise every adolescent to avoid it; pick another agent where drinking is likely.
  • Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
  • Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
  • Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only, not in the interaction table. Counsel on symptoms.

Administration

  • Once daily in the morning, before breakfast, which is a labeled instruction.
  • Swallow whole, or sprinkle onto about a tablespoon of applesauce and give immediately with fluids.
  • Sprinkling does not change Cmax or AUC. Never store the mixture.
  • Do not crush or chew; chewing turns the extended fraction into an immediate one.
  • Avoid alcohol: at 40% alcohol, 84% of the dose is released in the first hour.
  • Missed dose: skip it; a late dose peaks in the evening.
  • Store locked; a bead capsule is easily opened.

Side Effects

  • Common, pediatric 6 to 15 y (>= 5% and above placebo): headache 12% vs 8%, anorexia 9% vs 2%, abdominal pain 7% vs 4%, insomnia 5% vs 2%. Anorexia and insomnia show the widest gap over placebo.
  • Serious:
    • Cardiac arrest and sudden death with structural cardiac disease: avoid in that population
    • New psychosis or mania, including with no psychiatric history: consider discontinuing
    • Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
    • Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
    • Long-term growth suppression; acute angle closure glaucoma; new or worsening tics and Tourette's
    • Postmarketing: suicidal behavior including completed suicide, aggression, OCD, thrombocytopenia, angioedema, rhabdomyolysis, convulsions, cerebral hemorrhage

Monitoring & Labs

  • Alcohol use: ask at every visit from about age 12. This product releases 84% of the dose within an hour with alcohol.
  • Appetite and weight: at every visit; ask whether breakfast is actually eaten.
  • Growth: height, weight and BMI at baseline and every 6 months; failure to gain triggers interruption.
  • Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months.
  • Sleep: at every visit and dose change; with 70% extended, an evening problem is likelier the drug than the child.
  • Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at every visit; ask about suicidal thoughts where depression is comorbid.
  • Age against indication: check at every annual visit. The indication ends at 15; plan the switch before 16. Concerta is labeled to 65, Aptensio XR has no upper limit.
  • Abuse and diversion: at every refill, capsule count, ask about sharing and selling, check the PDMP. A boxed-warning obligation.
  • Laboratory: none is required by this label.

Discontinuation & Taper

  • No taper required; the label gives no tapering schedule.
  • Discontinue if no improvement after appropriate dose adjustment over one month.
  • Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
  • Priapism has occurred during drug holidays and on discontinuation.
  • Drug holidays are reasonable where growth limits treatment; a capsule cannot be part-dosed, and the gap is felt most in the afternoon.

Pregnancy & Lactation

  • Pregnancy: no drug-associated risk of major birth defects or miscarriage identified. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%.
  • Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant serum in every reported case. Not a reason to stop breastfeeding. (LactMed 2025)
  • Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, insomnia and poor weight gain. (LactMed 2025)
  • Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

  • Counsel the family on:

    • Alcohol releasing most of the day's dose in an hour. Say it to the adolescent directly, before the first prescription.
    • Giving the capsule before breakfast, not with it; a fatty breakfast raises the peak by a third.
    • About a tablespoon of applesauce, taken at once, never chewed or made up in advance. Exposure matches the intact capsule.
    • The dose being weighted to the afternoon, 30% now and 70% later, so the morning effect is smaller.
    • The approval ending at 15, so the plan changes in mid-adolescence.
    • Locked storage; a capsule of loose beads is easily emptied.

  • Advise them to call for:

    • Chest pain, fainting, or a racing heart that does not settle.
    • New hallucinations, or new suspicious or fearful thinking.
    • Any talk of self-harm or suicide, or a marked drop in mood.
    • Numbness, coldness or colour change in fingers or toes, or a sore that will not heal.
    • A new or markedly worse tic, including throat clearing and blinking.
    • A painful erection lasting more than a few hours, including during a planned break.
    • Unusual bruising or bleeding; eye pain with halos around lights.
    • Clothes fitting more loosely, or no weight gain across a few months.

References

  1. DailyMed. Metadate CD (methylphenidate hydrochloride) extended-release capsules prescribing information. Aytu BioPharma. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=be59f8b4-7842-42cc-9559-bfa747f0baa5
  2. FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
  3. LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
  4. 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/
  5. AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
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