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Daytrana

(methylphenidate)

Daytrana (methylphenidate); CII

Full Prescribing Information DailyMed Drug Information

Summary

Daytrana is a long-acting methylphenidate CNS stimulant delivered as an adhesive transdermal patch worn on the hip, approved for ADHD in patients 6 to 17 years only. Dose is set by patch size and by wear time, so a parent can shorten the day by removing it early, which no oral product allows. It is also the only methylphenidate carrying a risk of permanent skin depigmentation. Schedule II; brand and generic.

Forms & Strengths

  • Transdermal system (patch, hip): 10 mg/9 h, 15 mg/9 h, 20 mg/9 h, 30 mg/9 h

Dosing

  • Age: 6-17 y/o; pediatric only
  • Onset: ~ 2 hours after application
  • Duration: through 12 hours after application, on a 9-hour wear time
  • Release Profile: continuous transdermal delivery from an adhesive matrix; no IR fraction and no bead or coat split
  • Initial Dose: 10 mg/9 h patch (12.5 cm2) once daily, including when converting from an oral methylphenidate
  • Titration: one patch size every 7 days, in the order 10, 15, 20, 30 mg/9 h
  • Max Dose: 30 mg/9 h
  • Considerations: Wear time is a second dosing variable: remove at 9 hours, or earlier for a shorter day. Never cut a patch. Heat or inflamed skin under the patch can double or triple absorption.

Pharmacology

  • Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
  • Delivery / Release: Three-layer adhesive matrix; peak plasma ~10 h single dose, ~8 h on repeat. No food effect. Absorption rises with repeat dosing over the first four weeks.
  • Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Half-life after removal 4 to 5 hours.
  • Class Positioning: Bypassing first pass leaves l-methylphenidate at 40% to 46% of the d-isomer instead of near zero, so conversion from an oral product restarts at the smallest patch.

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

  • 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 weight loss; insufficient. (AHRQ 2024)
    • Sites other than the hip: absorption differs and is not adequately studied; insufficient.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse, and addiction, which can lead to substance use disorder, overdose and death.
  • Chemical leukoderma, specific to this product: persistent depigmentation at, around and sometimes distant from the site. It may be permanent. Discontinue for good.
  • Contraindicated:
    • Hypersensitivity to methylphenidate or any system component, adhesives included; the reaction may be to the system, not the drug.
    • Concomitant MAOI, or within 14 days of stopping one.
  • Contact sensitization (0.3% of 305 children): a sensitized patient may react systemically to oral methylphenidate, and some cannot take it.
  • Use with caution:
    • Personal or family history of vitiligo, because of chemical leukoderma.
    • Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; avoid.
    • Prior seizures or EEG abnormality; this label carries a Seizures warning the oral labels do not.
    • Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm.
    • Psychotic or bipolar disorder; tics or Tourette's (tic ran 7.1% versus 0%).
    • Hyperopia, open-angle glaucoma, or raised intraocular pressure; substance use disorder in patient or household.
  • Screen before starting:
    • Cardiac history, family history of sudden death or arrhythmia, and exam.
    • History of tics, vitiligo, eczema or adhesive reactions; inspect the hip sites. Seizure or EEG history; risk factors for mania.
    • Whether the household can manage a timed daily application and removal; abuse risk; baseline growth, vitals and CBC.

Drug Interactions

  • Coumarins, anticonvulsants, TCAs and SSRIs (warfarin; phenobarbital, phenytoin, primidone): metabolism may be inhibited. Reduce their dose and monitor levels, or INR.
  • MAOIs: hypertensive crisis. Do not co-prescribe; allow 14 days after stopping.
  • External heat, which behaves like an interaction: hair dryers, heating pads, electric blankets, hot tubs and prolonged sun raise absorption more than 2-fold; inflamed skin about 3-fold.
  • Antihypertensives: effectiveness may fall; recheck blood pressure and adjust.
  • Halogenated anesthetics: sudden intraoperative pressure and rate rise. Apply no patch on the day of surgery.
  • Risperidone: a dose change either way may raise EPS risk; monitor across any change. Serotonergic agents: serotonin syndrome is postmarketing only here, so counsel on symptoms rather than avoid.

Administration

  • Timing: apply to the hip 2 hours before an effect is needed; remove 9 hours later. Record both times on the carton chart.
  • Wear time is a dose control: remove earlier for a shorter day or late-day effects.
  • Site: clean, dry hip skin, not oily or irritated; avoid the waistline, alternate hips daily.
  • Press firmly with the palm for 30 seconds at the edges. Never cut a patch. Discard one whose liner tore or took adhesive with it.
  • If a patch falls off, apply a new one at a fresh site; the day still ends at 9 hours. Do not tape or re-stick a patch.
  • Removal: peel slowly; work mineral oil under a stubborn edge. Never use acetone or nail polish remover.
  • Disposal: used patches retain drug. Take-back site, or fold adhesive-to-adhesive and flush. A caregiver applies and removes it for children.
  • Switching from an oral methylphenidate (Concerta or any other): start at 10 mg/9 h. Xelstrym is a dextroamphetamine patch, not interchangeable. Do not refrigerate; store securely, preferably locked.

Side Effects

  • Common in children 6-12 (n=98 vs 85, 7 weeks): decreased appetite 25.5% vs 4.7%, insomnia 13.3% vs 4.7%, nausea 12.2% vs 2.4%, weight decreased 9.2% vs 0%, tic 7.1% vs 0%. Adolescent rates similar. Site erythema is near-universal and minor.
  • Serious:
    • Chemical leukoderma, possibly permanent, including at sites distant from the patch; and contact sensitization. Discontinue permanently for either.
    • Sudden death with structural cardiac disease; avoid the drug in that group.
    • Seizures; discontinue if one occurs. New psychosis or mania, ~0.1% pooled; consider discontinuing.
    • Priapism, which may require surgery, also during drug holidays. Peripheral vasculopathy including Raynaud's; reduce dose or stop.
    • Growth suppression: ~2 cm and 2.7 kg less over 3 years. Interrupt if growth stalls.
    • Acute angle closure glaucoma; new or worsening tics; angioedema and anaphylaxis; rare NMS; abnormal liver function.

Monitoring & Labs

  • Skin, for depigmentation: examine the hips at every visit, minimum every 3 months, and ask about a pale patch anywhere on the body. Stop at the first sign.
  • Skin, for sensitization: at every visit; escalate if erythema carries edema or vesicles past 48 hours.
  • Hematologic: CBC, differential and platelets at baseline and at least annually. Labeled on Daytrana alone.
  • Application and removal times: review the chart at every visit; drift in the removal hour explains most lost effect.
  • Weeks 2 to 4: reassess tolerability at 4 weeks even without a size change; absorption rises with repeat dosing.
  • Cardiovascular and growth: blood pressure, heart rate, height, weight and BMI at baseline, each size change, and every 6 months.
  • Psychiatric, tics, seizures and digits: at every visit and size change; stop if a seizure occurs.
  • Abuse and diversion: count patches against days at each refill and check the state PDMP per state requirement.

Discontinuation & Taper

  • May be stopped abruptly; the label gives no taper schedule.
  • The offset is delayed. Absorption continues from the skin depot for hours, so a patch off at 4 p.m. does not stop working at 4 p.m.
  • Shortening wear time is a legitimate step-down, and the right lever for evening insomnia rather than a smaller patch.
  • Discontinue permanently for chemical leukoderma, and stop for suspected sensitization or a seizure.
  • After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite. Drug holidays are simply a day without a patch.

Pregnancy & Lactation

  • Pregnancy: Human data insufficient to identify a risk. No reproduction studies with the transdermal system; oral data showed spina bifida in rabbits at 200 mg/kg/day. 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)
  • Milk supply: Methylphenidate lowers prolactin; large doses may interfere before lactation is established. (LactMed 2025)
  • Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

  • Counsel the family on:

    • Watching for any pale or white patch of skin anywhere on the body, not only where the patch was. It can be permanent and must be reported the day it is noticed.
    • Applying two hours before it is needed, and writing the removal time down.
    • Taking it off early being a legitimate adjustment, and that the effect does not stop when it comes off.
    • Redness being normal; swelling, blisters or spreading redness being a reason to call.
    • Alternating hips daily, off the waistline, and keeping heat off the site: no hair dryers, heating pads or long sun, which can double the dose absorbed.
    • Never cutting a patch; if one falls off, a fresh site, and the day still ends at 9 hours.
    • Removing adhesive with olive oil, never nail polish remover, and folding a used patch sticky sides together to dispose of it.

  • Advise them to call for:

    • Any white or pale patch of skin, at the site or anywhere else.
    • Swelling, blisters, or redness spreading beyond the patch edge.
    • Chest pain, fainting, or a racing heart that does not settle.
    • A seizure, new hallucinations, or new fearful thinking.
    • Numbness or colour change in the fingers or toes; a new or worse tic.
    • Weight loss over a few weeks, or a patch that has gone missing.
    • A painful erection lasting more than a few hours, a surgical emergency.

References

  1. DailyMed. Daytrana (methylphenidate transdermal system) prescribing information. Noven Therapeutics LLC. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c312c31-3198-4775-91ab-294e0b4b9e7f
  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. DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling
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