# Metadate CD ### (methylphenidate hydrochloride extended-release, biphasic beads) **[Metadate CD](https://wiki.joshnp.com/books/drug-library/page/metadate-cd)** (methylphenidate hydrochloride extended-release, biphasic beads); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=be59f8b4-7842-42cc-9559-bfa747f0baa5&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=be59f8b4-7842-42cc-9559-bfa747f0baa5)
--- ### **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](https://wiki.joshnp.com/link/30). Against [Concerta](https://wiki.joshnp.com/link/11) 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](https://wiki.joshnp.com/link/11) is labeled to 65, [Aptensio XR](https://wiki.joshnp.com/link/38) 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](https://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/