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
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
FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
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/
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/