Methylphenidate 1.6 mg/h Patch — NDC 0378-8261-93 (Billing 00378-8261-93)
This is a package of Methylphenidate 1.6 mg/h Patch from Mylan Pharmaceuticals Inc., marketed since Jun 2022 and currently FDA-listed, this package's marketing is listed to end Apr 2027; retail pharmacies pay about $6.63 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0378-8261-93 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0378 labeler · 8261 product · 93 package
- Package marketed since
- Jun 27, 2022
- Package marketing ended
- Apr 30, 2027
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 0378826193 0
- Medicaid fills, this package
- 1,539 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Methylphenidate (different manufacturers) — 6 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 060616
- GCN: 26802
- GPI-14 (Medi-Span): 61400020005915
- HICL (First Databank): 033556
- AHFS class code: 28:20.32.00
- RxCUI (RxNorm): 753436
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Methylphenidate transdermal patches are used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Methylphenidate is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.
Read the full MedlinePlus article ↗- It mainly treats ADHD, and some products are also used for narcolepsy. The exact approval depends on the product and the age group. Your prescriber chooses the right one for you.
- It depends on your product. Many extended-release forms are taken once daily in the morning, while Jornay PM is taken in the evening. Swallow extended-release tablets whole, and fo...
- The most common ones are decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety and dizziness. Children and teens may get upper stomach pain. Call your doctor i...
- Call for chest pain, fainting, a racing heartbeat, hallucinations, seizures, painful erections that won’t go away, or color changes in your fingers or toes. Also call if you notice...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Methylphenidate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $6.633 | $198.99 / 30 patch |
| Medicaid paysCMS SDUD · 12 mo | $9.63 | $288.94 / 30 patch |
| Medicare drug plans payPart D · Q2 2026 | $9.41 | $282.18 / 30 patch |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00378-8261-93 You're viewing this Main listing | 30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 9 h in 1 PATCH | 2022-06-27 | Apr 30, 2027 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Daytrana 15 mg/9h 68968-5553-03 | Noven | 30 patches | $5.744 | AB | Availability likely | save 13% |
| Methylphenidate 1.6 mg/hthis 00378-8261-93 | Mylan | 30 patches | $6.633 | AB | Availability likely | — |
| Methylphenidate Transdermal System 41.3 mg/mg 00574-2415-65 | PADAGIS | 30 patches | $6.633 | AB | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Methylphenidate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F05Q2T2JA0
Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII E1NC1JVS3O
A synthetic plastic material that doesn't stick to other substances. It's used as a glidant and lubricant to help medicine particles flow smoothly during manufacturing and to prevent ingredients from clumping together.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Mylan Pharmaceuticals Inc. labeler code 00378
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- Methylphenidate 1.1 mg/h Patch NDC 0378-8260-93
- Methylphenidate 2.2 mg/h Patch NDC 0378-8262-93
- Methylphenidate 3.3 mg/h Patch NDC 0378-8263-93
- Albuterol Sulfate 2.5 mg/3mL Solution NDC 0378-8270-52
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate transdermal system has a high potential for abuse and misuse, which can lead to the development of substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate transdermal system, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate transdermal system, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate transdermal system treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning Methylphenidate transdermal system has high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
Misuse and abuse of CNS stimulants, including methylphenidate transdermal system, can result in overdose and death ( 5.1 , 9.2 , 10 ): • Before prescribing methylphenidate transdermal system, assess each patient’s risk for abuse, misuse, and addiction. • Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. • Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Us e The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8) , Use in Specific Populations (8.4) ] .
Methylphenidate transdermal system is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ( 1 ) Limitations of Use The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.8 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • The recommended starting dose for patients new to or converting from another formulation of methylphenidate is 10 mg. ( 2.2 ) • Methylphenidate transdermal system should be applied to the hip area (using alternating sites) 2 hours before an effect is needed and should be removed 9 hours after application. Methylphenidate transdermal system may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.
( 2.2 , 2.3 ) • Dosage should be titrated to effect. Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient. ( 2.2 )
2.1Pretreatment Screening Prior to treating patients with methylphenidate transdermal system, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating methylphenidate transdermal system [see Warnings and Precautions (5.15) ] .
2.2Recommended Dosage It is recommended that methylphenidate transdermal system be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application. Dosage should be titrated to effect. The recommended dose titration schedule is shown in the table below.
Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient. Table 1 Methylphenidate Transdermal System - Recommended Titration Schedule (Patients New to Methylphenidate) Upward Titration, if Response is Not Maximized Week 1 Week 2 Week 3 Week 4 Transdermal System Size 9.6 cm 2 14.4 cm 2 19.2 cm 2 28.8 cm 2 Nominal Delivered Dose Nominal in vivo delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period. (mg/9 hours) 10 mg 15 mg 20 mg 30 mg Delivery Rate (1.1 mg/hr) (1.6 mg/hr) (2.2 mg/hr) (3.3 mg/hr) Patients converting from another formulation of methylphenidate should follow the above titration schedule due to differences in bioavailability of methylphenidate transdermal system compared to other products.
2.3Application The parent or caregiver should be encouraged to use the administration chart included with each carton of methylphenidate transdermal system to monitor application and removal time, and method of disposal. It is recommended that parents or caregivers apply and remove the transdermal system for children; responsible adolescents may apply or remove the transdermal system themselves if appropriate. If a transdermal system was removed without the parent or caregiver's knowledge, or if a transdermal system is missing from the carton, the parent or caregiver should be encouraged to ask the child when and how the transdermal system was removed.
The Medication Guide includes a timetable to calculate when to remove methylphenidate transdermal system, based on the 9-hour application time. The adhesive side of methylphenidate transdermal system should be placed on a clean, dry area of the hip. The area selected should not be oily, damaged, or irritated.
Apply methylphenidate transdermal system to the hip area avoiding the waistline, since clothing may cause the transdermal system to rub off. When applying the transdermal system the next morning, place on the opposite hip at a new site if possible. If patients or caregivers experience difficulty separating the transdermal system from the release liner or observe transfer of adhesive to the liner, tearing and/or other damage to the transdermal system during removal from the liner, the transdermal system should be discarded and a new transdermal system should be applied.
Patients or caregivers should inspect the release liner to ensure that no adhesive containing medication has transferred to the liner. If adhesive transfer has occurred, the transderm… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Four dosage strengths of Methylphenidate Transdermal System are available as 10 mg/9 hrs (1.1 mg/hr), 15 mg/9 hrs (1.6 mg/hr), 20 mg/9 hrs (2.2 mg/hr) or 30 mg/9 hrs (3.3 mg/hr) of methylphenidate. • Each dosage form is a translucent rectangular transdermal system with rounded corners consisting of a matte backing film randomly printed with “Methylphenidate Transdermal System” and the “mg/hr” strength in white ink, an adhesive layer and a clear to slightly hazy oversized release liner that is slit.
Each transdermal system is overlaid with an additional clear to slightly hazy oversized release liner and is contained in a square, flat pouch that is imprinted with lot number and expiration date. Nominal Dose Delivered (mg) Over 9 Hours Nominal in vivo delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period. Dosage Rate (mg/hr) Transdermal System Size (cm 2 ) Methylphenidate Content per Transdermal System (mg) 10 1.1 9.6 10.4 15 1.6 14.4 15.6 20 2.2 19.2 20.7 30 3.3 28.8 31.1 • Transdermal system: 10 mg/9 hours (1.1 mg/hr), 15 mg/9 hours (1.6 mg/hr), 20 mg/9 hours (2.2 mg/hr), 30 mg/9 hours (3.3 mg/hr) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Known hypersensitivity to methylphenidate ( 4.1 ) • Patients currently using or within 2 weeks of using an MAO inhibitor ( 4.2 )
4.1Hypersensitivity to Methylphenidate Methylphenidate transdermal system is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product (fluoropolymer-coated polyester, hydrophobic colloidal silica, mineral oil, polyester/ethylene vinyl acetate laminate film backing, polyisobutylene adhesive and white ink). The white ink contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide [see Description (11) ] .
4.2Monoamine Oxidase Inhibitors Methylphenidate transdermal system is contraindicated during treatment with monoamine oxidase inhibitors, and within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. ( 5.2 ) • Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. ( 5.3 ) • Psychiatric Adverse Reactions: Prior to initiating methylphenidate transdermal system, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing methylphenidate transdermal system. ( 5.4 ) • Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures.
( 5.5 ) • Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. ( 5.6 ) • Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful observation for digital changes is necessary during methylphenidate transdermal system treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
( 5.7 ) • Long-Term Suppression of Growth in Pediatric Patients: Closely monitor (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. ( 5.8 ) • Chemical Leukoderma: Methylphenidate transdermal system use may result in a persistent loss of skin pigmentation at and around the application site.
Loss of pigmentation, in some cases, has been reported at other sites distant from the application site. Monitor for signs of skin depigmentation. Discontinue methylphenidate transdermal system if it occurs.
( 5.9 ) • Contact Sensitization: Use of methylphenidate transdermal system may lead to contact sensitization. Treatment should be discontinued if contact sensitization is suspected. Erythema is commonly seen with use of methylphenidate transdermal system and is not by itself an indication of sensitization.
However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the transdermal system site. ( 5.10 ) • External Heat: Patients should be advised to avoid exposing the methylphenidate transdermal system application site to direct external heat sources. When heat is applied to methylphenidate transdermal system after application, both the rate and extent of absorption are significantly increased.
( 5.11 ) • Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy. ( 5.12 ) • Acute Angle Closure Glaucoma: Methylphenidate transdermal system-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. ( 5.13 ) • Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe methylphenidate transdermal system to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor patients with a history of increased IOP or open angle glaucoma. ( 5.14 ) • Motor and Verbal Tics and Worsening of Tourette’s Syndrome: Before initiating methylphenidate transdermal system, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome.
Discontinue treatment if clinically appropriate. ( 5.15 )
5.1Abuse, Misuse, and Addiction Methylphenidate transdermal system has a high potential for abuse and misuse. The use of methylphenidate transdermal system exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate can be diverted fo… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Detailed information on serious and adverse reactions of particular importance is provided in the Boxed Warning and Warnings and Precautions (5) sections: • Abuse, Misuse, and Addiction [see Boxed Warning ] • Hypersensitivity to Methylphenidate [see Contraindications (4.1) ] • Monoamine Oxidase Inhibitors [see Contraindications (4.2) and Drug Interactions (7.1) ] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] • Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] • Seizures [see Warnings and Precautions (5.5) ] • Priapism [see Warnings and Precautions (5.6) ] • Peripheral Vasculopathy [see Warnings and Precautions (5.7) ] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.8) ] • Chemical Leukoderma [see Warnings and Precautions (5.9) ] • Contact Sensitization [see Warnings and Precautions (5.10) ] • External Heat [see Warnings and Precautions (5.11) ] • Hematologic Monitoring [see Warnings and Precautions (5.12) ] • Acute Angle Closure Glaucoma [see Warnings and Precautions (5.13) ] • Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.14) ] • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.15) ] • Pediatric patients (ages 6 to 12 years): The most commonly (≥ 5% and twice the rate of placebo) reported adverse reactions in pediatric patients ages 6 to 12 years included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia.
( 6.1 ) • Pediatric patients (ages 13 to 17 years): The most commonly (≥ 5% and twice the rate of placebo) reported adverse reactions in pediatric patients ages 13 to 17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of subjects in these trials had erythema at the application site. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in children aged 6-12 included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia.
The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in adolescents aged 13-17 were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia [see Adverse Reactions (6.1) ] . The most common (≥ 2% of subjects) adverse reaction associated with discontinuations in double-blind clinical trials in children or adolescents was application site reactions [see Adverse Reactions (6.1) ] . The overall methylphenidate transdermal system development program included exposure to methylphenidate transdermal system in a total of 2,152 participants in clinical trials, including 1,529 children aged 6-12, 223 adolescents aged 13-17, and 400 adults.
The 1,752 child and adolescent subjects aged 6-17 years were evaluated in 10 controlled clinical studies, 7 open-label clinical studies, and 5 clinical pharmacology studies. In a combined studies pool of children using methylphenidate transdermal system with a wear time of 9 hours, 212 subjects were exposed for ≥ 6 months and 115 were exposed for ≥ 1 year; 85 adolescents were exposed for ≥ 6 months. Most patients studied were exposed to methylphenidate transdermal system sizes of 12.5 cm 2 , 18.75 cm 2 , 25 cm 2 , or 37.5 cm 2 , with a wear time of 9… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.2 )
7.1Monoamine Oxidase Inhibitors (MAOI) Concomitant use of MAOIs and CNS stimulants, including methylphenidate transdermal system, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications (4.2) ] . Concomitant use of methylphenidate transdermal system with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.
7.2Antihypertensive Drugs Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed [see Warnings and Precautions (5.2) ] .
7.3Coumarin Anticoagulants, Antidepressants, and Selective Serotonin Reuptake Inhibitors Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some tricyclic drugs (e.g., imipramine, clomipramine, desipramine) and selective serotonin reuptake inhibitors. Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.
7.4Halogenated Anesthetics Concomitant use of halogenated anesthetics and methylphenidate may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of methylphenidate transdermal system in patients being treated with anesthetics on the day of surgery.
7.5Risperidone Combined use of methylphenidate with risperidone when there is a change in dosage, whether an increase or decrease, of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate transdermal system, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of CNS stimulants during pregnancy (see Clinical Considerations ) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis. However, spina bifida was observed in rabbits when given oral doses of 200 mg/kg/day.
When methylphenidate was administered orally to rats throughout pregnancy and lactation, offspring growth and survival were decreased at maternally toxic doses (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinical recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions CNS stimulants, such as methylphenidate transdermal system, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
Data Animal Data Animal reproduction toxicity studies with transdermal methylphenidate have not been performed. In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally to pregnant animals during the period of organogenesis, at doses up to 100 and 200 mg/kg/day, respectively. No evidence of morphological development effects was found in either of the species; however, increased incidences of fetal skeletal variations were observed in rats at 60 mg/kg or greater and an increase in fetal visceral variations was seen in rabbits at the highest dose.
In a previous study, methylphenidate was shown to have malformations (increased incidence of fetal spina bifida) in rabbits when given oral doses of 200 mg/kg/day. When methylphenidate was administered orally to rats throughout pregnancy and lactation at doses of up to 60 mg/kg/day, offspring growth and survival were decreased at maternally toxic doses. In a study in which oral methylphenidate was given to rats throughout pregnancy and lactation at doses up to 60 mg/kg/day, offspring weights and survival were decreased at 40 mg/kg/day and above; these doses caused some maternal toxicity.
8.2Lactation Risk Summary Limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate transdermal system and any potential adverse effects on the breastfed infant from methylphenidate or from the underlying maternal condition. Clinical C… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate transdermal system, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of CNS stimulants during pregnancy (see Clinical Considerations ) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis. However, spina bifida was observed in rabbits when given oral doses of 200 mg/kg/day.
When methylphenidate was administered orally to rats throughout pregnancy and lactation, offspring growth and survival were decreased at maternally toxic doses (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinical recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions CNS stimulants, such as methylphenidate transdermal system, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
Data Animal Data Animal reproduction toxicity studies with transdermal methylphenidate have not been performed. In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally to pregnant animals during the period of organogenesis, at doses up to 100 and 200 mg/kg/day, respectively. No evidence of morphological development effects was found in either of the species; however, increased incidences of fetal skeletal variations were observed in rats at 60 mg/kg or greater and an increase in fetal visceral variations was seen in rabbits at the highest dose.
In a previous study, methylphenidate was shown to have malformations (increased incidence of fetal spina bifida) in rabbits when given oral doses of 200 mg/kg/day. When methylphenidate was administered orally to rats throughout pregnancy and lactation at doses of up to 60 mg/kg/day, offspring growth and survival were decreased at maternally toxic doses. In a study in which oral methylphenidate was given to rats throughout pregnancy and lactation at doses up to 60 mg/kg/day, offspring weights and survival were decreased at 40 mg/kg/day and above; these doses caused some maternal toxicity.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of methylphenidate transdermal system has not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to < 6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to < 6 years of age also had a higher incidence of adverse reactions, including weight loss.
The safety and effectiveness of methylphenidate transdermal system for the treatment of ADHD have been established in pediatric patients 6 to 17 years. Long Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate transdermal system. Children who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.8) ] .
Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. Studies with transdermal methylphenidate have not been performed in juvenile animals.
In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose.
The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day. The clinical significance of the long-term behavioral effects observed in rats is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use Methylphenidate transdermal system has not been studied in patients greater than 65 years of age.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations.
Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful.
Remove all transdermal systems immediately and cleanse the area(s) to remove any remaining adhesive. The continuing absorption of methylphenidate from the skin, even after removal of the transdermal system, should be considered when treating patients with overdose. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Methylphenidate is a CNS stimulant. Its mode of therapeutic action in ADHD is not known.
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d - and l -enantiomers. The d -enantiomer is more pharmacologically active than the l -enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
12.3Pharmacokinetics The pharmacokinetics of methylphenidate transdermal system when applied to the hip for 9 hours have been studied in ADHD patients 6 to 17 years old. Absorption The amount of methylphenidate absorbed systemically is a function of both wear time and transdermal system size. In patients with ADHD, peak plasma levels of methylphenidate are reached at about 10 hours after single application and 8 hours after repeat transdermal system applications (12.5 cm 2 to 37.5 cm 2 ) when worn up to 9 hours.
On single dosing of children or adolescents with methylphenidate transdermal system, there was a delay of, on average, 2 hours before d -methylphenidate was detectable in the circulation. On repeat dosing, low concentrations (1.2-3.0 ng/mL in children and 0.5-1.7 ng/mL in adolescents, on average across the dose range) were observed earlier in the profile, due to carry-over effect. Following the application of methylphenidate transdermal system once daily with a 9-hour wear time, the mean pharmacokinetic parameters of d -methylphenidate in children and adolescents with ADHD after 4 weeks of therapy are summarized in Table 3.
Table 3 Mean Plasma d-Methylphenidate Pharmacokinetic Parameters After Repeated 9 Hour Applications of Methylphenidate Transdermal System or Oral ER MPH for up to 28 days to Pediatric ADHD Patients (Aged 6 - 17 years) Children Parameter Methylphenidate Transdermal System Dose maintained fixed for 28 days; 12.5 cm 2 (N = 12) Methylphenidate Transdermal System Dose escalated at 7 day intervals from 12.5 cm 2 through 18.75 cm 2 and 25 cm 2 to 37.5 cm 2 ; 37.5 cm 2 (N = 10) Oral ER MPH Dose escalated at 7 day intervals from 18 mg through 27 mg and 36 mg to 54 mg; 18 mg Oral ER MPH 54 mg C ssmax (ng/mL) 15.7 ± 9.39 42.9 ± 22.4 8.37 ± 4.14 26.1 ±
11.2C ssmin (ng/mL) 1.04 ± 1.17 1.96 ± 1.73 0.708 ± 1.08 1.19 ±
1.54AUC ss (ng∙hr/mL) 163 ± 101 447 ± 230 97.7 ± 67.0 317 ± 160 t lag (h)4 0 (0 - 2.0) 0 (0 - 1.0) 0 0 Adolescents C ssmax (ng/mL) 8.32 ± 4.60 16.5 ± 6.94 5.23 ± 1.72 18.0 ±
6.97C ssmin (ng/mL) 0.544 ± 0.383 1.02 ± 0.629 0.360 ± 0.478 1.50 ± 0.937 AUC ss (ng∙hr/mL) 85.7 ± 50.0 167 ± 66.0 59.7 ± 19.1 216 ± 80.8 t lag (h) Median (minimum – maximum); t lag = Last Sampling Time Prior to Time of First Quantifiable Plasma Concentration 0 (0 - 2.0) 0 (0 - 2.0) 0 0 Following administration of methylphenidate transdermal system 12.5 cm 2 to pediatric and adolescent ADHD patients daily for 7 days, there were 13% and 14% increases, respectively, in steady state area under the plasma concentration-time curve (AUC ss ) relative to that anticipated on the basis of single dose pharmacokinetics (AUC 0-∞ ); after 28 days administration, these increments increased to 64% and 76%, respectively.
C max increased by nearly 69% and 100% within 4 weeks of daily administration of the starting dose in children and adolescents, respectively. The observed exposures with methylphenidate transdermal system could not be explained by drug accumulation predicted from observed single dose pharmacokinetics and there was no evidence that clearance or rate of elimination changed between single and repeat dosing. Neither were they explainable by differences in dosing patterns between treatments, age, race, or gender.
This suggests that transdermal absorption of methylphenidate may increase with repeat dosing with methylphenidate transdermal system; on average, steady-state is likely to have been achieved by approximately 14 days of dosing. In the single- and… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Methylphenidate is a CNS stimulant. Its mode of therapeutic action in ADHD is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Transdermal System is supplied in a carton containing 30 individually pouched transdermal systems. See the chart below for information regarding available strengths. Each dosage form is a translucent rectangular transdermal system with rounded corners consisting of a matte backing film randomly printed with “Methylphenidate Transdermal System” and the “mg/hr” strength in white ink, an adhesive layer and a clear to slightly hazy oversized release liner that is slit.
Each transdermal system is overlaid with an additional clear to slightly hazy oversized release liner and is contained in a square, flat pouch that is imprinted with lot number and expiration date. Nominal Dose Delivered (mg) Over 9 Hours Dosage Rate Nominal in vivo delivery rate per hour in children and adolescents when applied to the hip, based on a 9-hour wear period. (mg/hr) Transdermal System Size (cm 2 ) Methylphenidate Content per Transdermal System Methylphenidate content in each transdermal system.
(mg) Transdermal Systems Per Carton NDC Number 10 1.1 9.6 10.4 30 0378-8260-93 15 1.6 14.4 15.6 30 0378-8261-93 20 2.2 19.2 20.7 30 0378-8262-93 30 3.3 28.8 31.1 30 0378-8263-93 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] . Do not store transdermal systems unpouched. Do not store transdermal systems in refrigerators or freezers.
Apply the transdermal system immediately upon removal from the individual protective pouch. For transdermal use only. See the Patient Counseling Information (17) for specific disposal instructions for unused or expired methylphenidate transdermal systems.
PHARMACIST: Dispense a Medication Guide with each prescription.
📋 Description ▾
11 DESCRIPTION Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether.
Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C 14 H 19 NO 2 .
The structural formula of methylphenidate is: Transdermal System Components Methylphenidate transdermal system contains methylphenidate in a polyisobutylene adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time. Methylphenidate transdermal system consists of four layers, as seen in the figure below (cross-section of the transdermal system) Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing and white ink which contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide, (2) a solid matrix drug reservoir of methylphenidate, polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, (3) a skin contact adhesive formulation of polyisobutylene adhesive, mineral oil and hydrophobic colloidal silica, and (4) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used.
The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate transdermal systems are packaged with an additional piece of protective film above the system within each pouch.
This piece of protective film is removed and discarded at the time of use. Methylphenidate Structural Formula Four layers of patch and cross-section of the patch
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate transdermal system, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) , Overdosage (10) ] . Advise patients to store methylphenidate transdermal system in a safe place, preferably locked, and instruct patients to not give methylphenidate transdermal system to anyone else.
Special Disposal Instructions Advise patients that there are special disposal instructions for unused or expired methylphenidate transdermal system [see Warnings and Precautions (5.1) ] . Instruct patients to find a take back location to dispose of unused or expired methylphenidate transdermal system. If a take back program is unavailable, instruct them to: 1.
Remove methylphenidate transdermal system from its pouch, separate it from its protective liner, fold it in half with the adhesive sides touching each other, and immediately flush it down the toilet, and 2. Place the pouch and protective liner in a container, close the container, and throw out the container in the trash (advise patients not to flush the pouch and liner down the toilet). Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with methylphenidate transdermal system use.
Instruct patients to contact a healthcare provider immediately if they develop symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2) ] . Priapism Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.6) ] .
Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] [see Warnings and Precautions (5.7) ] • Instruct patients beginning treatment with methylphenidate transdermal system about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and its associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. • Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. • Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while using methylphenidate transdermal system. • Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Long-Term Suppression of Growth in Pediatric Patients Advise patients that methylphenidate transdermal system may cause slowing of growth including weight loss [see Warnings and Precautions (5.8) ] . Chemical Leukoderma Advise patients of the possibility of a persistent loss of skin pigmentation at, around and distant from the application site. Advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur [see Warnings and Precautions (5.9) ] .
Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with methylphenidate transdermal system [see Warnings and Precautions (5.14) ] . Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with methylphenidate transdermal system. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.15) ] .
Important Prepara… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
Medication Guide Methylphenidate Transdermal System CII (meth'' il fen' i date) Important: Methylphenidate Transdermal System is for use on the skin only. What is the most important information I should know about methylphenidate transdermal system? Methylphenidate transdermal may cause serious side effects, including: • Abuse, misuse, and addiction .
Methylphenidate transdermal system has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate transdermal system, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate transdermal system or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before starting treatment with methylphenidate transdermal system and will monitor your child during treatment. o Methylphenidate transdermal system may lead to physical dependence after prolonged use, even if used as directed by your healthcare provider. o Do not give methylphenidate transdermal system to anyone else.
See “ What is methylphenidate transdermal system? ” for more information. o Keep methylphenidate transdermal system in a safe place and properly dispose of any unused medicine. See “ How should I store methylphenidate transdermal system? ” for more information. o Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease . Sudden death has happened in people who have heart defects or other serious heart disease.
Your child’s healthcare provider should check your child carefully for blood pressure and heart problems before starting treatment with and while you are using methylphenidate transdermal system. Tell your child’s healthcare provider if your child has any heart problems, heart disease or heart defects. Remove the methylphenidate transdermal system (patch) and call your child’s healthcare provider or go to the nearest emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with methylphenidate transdermal system. • Increased blood pressure and heart rate.
Your child’s healthcare provider should check your child’s blood pressure and heart rate regularly during treatment with methylphenidate transdermal system. • Mental (psychiatric) problems, including: o new or worse behavior or thought problems o new or worse bipolar illness o new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or manic symptoms Tell your child’s healthcare provider about any mental problems your child has or about a family history of suicide, bipolar illness, or depression.
Call your child’s healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with methylphenidate transdermal system, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms. What is methylphenidate transdermal system? Methylphenidate transdermal system is a central nervous system (CNS) stimulant prescription medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age.
Methylphenidate transdermal system may help increase attention and decrease impulsiveness and hyperactivity in children with ADHD. Methylphenidate transdermal system is not recommended for use in children under 6 years of age with ADHD. Methylphenidate transdermal system is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.
Keep methylphenidate transdermal system in a safe place to protect… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of methylphenidate transdermal system when applied to the hip for 9 hours have been studied in ADHD patients 6 to 17 years old. Absorption The amount of methylphenidate absorbed systemically is a function of both wear time and transdermal system size. In patients with ADHD, peak plasma levels of methylphenidate are reached at about 10 hours after single application and 8 hours after repeat transdermal system applications (12.5 cm 2 to 37.5 cm 2 ) when worn up to 9 hours.
On single dosing of children or adolescents with methylphenidate transdermal system, there was a delay of, on average, 2 hours before d -methylphenidate was detectable in the circulation. On repeat dosing, low concentrations (1.2-3.0 ng/mL in children and 0.5-1.7 ng/mL in adolescents, on average across the dose range) were observed earlier in the profile, due to carry-over effect. Following the application of methylphenidate transdermal system once daily with a 9-hour wear time, the mean pharmacokinetic parameters of d -methylphenidate in children and adolescents with ADHD after 4 weeks of therapy are summarized in Table 3.
Table 3 Mean Plasma d-Methylphenidate Pharmacokinetic Parameters After Repeated 9 Hour Applications of Methylphenidate Transdermal System or Oral ER MPH for up to 28 days to Pediatric ADHD Patients (Aged 6 - 17 years) Children Parameter Methylphenidate Transdermal System Dose maintained fixed for 28 days; 12.5 cm 2 (N = 12) Methylphenidate Transdermal System Dose escalated at 7 day intervals from 12.5 cm 2 through 18.75 cm 2 and 25 cm 2 to 37.5 cm 2 ; 37.5 cm 2 (N = 10) Oral ER MPH Dose escalated at 7 day intervals from 18 mg through 27 mg and 36 mg to 54 mg; 18 mg Oral ER MPH 54 mg C ssmax (ng/mL) 15.7 ± 9.39 42.9 ± 22.4 8.37 ± 4.14 26.1 ±
11.2C ssmin (ng/mL) 1.04 ± 1.17 1.96 ± 1.73 0.708 ± 1.08 1.19 ±
1.54AUC ss (ng∙hr/mL) 163 ± 101 447 ± 230 97.7 ± 67.0 317 ± 160 t lag (h)4 0 (0 - 2.0) 0 (0 - 1.0) 0 0 Adolescents C ssmax (ng/mL) 8.32 ± 4.60 16.5 ± 6.94 5.23 ± 1.72 18.0 ±
6.97C ssmin (ng/mL) 0.544 ± 0.383 1.02 ± 0.629 0.360 ± 0.478 1.50 ± 0.937 AUC ss (ng∙hr/mL) 85.7 ± 50.0 167 ± 66.0 59.7 ± 19.1 216 ± 80.8 t lag (h) Median (minimum – maximum); t lag = Last Sampling Time Prior to Time of First Quantifiable Plasma Concentration 0 (0 - 2.0) 0 (0 - 2.0) 0 0 Following administration of methylphenidate transdermal system 12.5 cm 2 to pediatric and adolescent ADHD patients daily for 7 days, there were 13% and 14% increases, respectively, in steady state area under the plasma concentration-time curve (AUC ss ) relative to that anticipated on the basis of single dose pharmacokinetics (AUC 0-∞ ); after 28 days administration, these increments increased to 64% and 76%, respectively.
C max increased by nearly 69% and 100% within 4 weeks of daily administration of the starting dose in children and adolescents, respectively. The observed exposures with methylphenidate transdermal system could not be explained by drug accumulation predicted from observed single dose pharmacokinetics and there was no evidence that clearance or rate of elimination changed between single and repeat dosing. Neither were they explainable by differences in dosing patterns between treatments, age, race, or gender.
This suggests that transdermal absorption of methylphenidate may increase with repeat dosing with methylphenidate transdermal system; on average, steady-state is likely to have been achieved by approximately 14 days of dosing. In the single- and multiple dose study described above, exposure to l -methylphenidate was 46% of the exposure to d -methylphenidate in children and 40% in adolescents. l -methylphenidate is less pharmacologically active than d -methylphenidate [see Pharmacodynamics (12.2) ] . In a phase 2 PK/PD study in children aged 6-12 years, 2/3 of patients had 2-hour d -MPH concentrations < 5 ng/mL on chronic dosing, and at 3 hours 40% of patients had d -MPH concentrations < 5 ng/mL [see Clinical Studies (14)… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d - and l -enantiomers. The d -enantiomer is more pharmacologically active than the l -enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Methylphenidate transdermal system was demonstrated to be effective in the treatment of ADHD in two (2) randomized double-blind, placebo-controlled studies in children aged 6 to 12 years and one (1) randomized, double-blind, placebo-controlled study in adolescents aged 13 to 17 years who met Diagnostic and Statistical Manual (DSM-IV-TR ® ) criteria for ADHD. Methylphenidate transdermal system wear time was 9 hours in all three (3) studies. In Study 1, conducted in a classroom setting, symptoms of ADHD were evaluated by school teachers and observers using the Deportment Subscale from the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale which assesses behavior symptoms in the classroom setting.
Methylphenidate transdermal system was applied for 9 hours before removal. There was a 5-week open-label methylphenidate transdermal system dose optimization phase using dosages of 10 mg/9 hours, 15 mg/9 hours, 20 mg/9 hours, and 30 mg/9 hours, followed by a 2-week randomized, double-blind, placebo-controlled crossover treatment phase using the optimal transdermal system dose for each patient or placebo. The mean differences between methylphenidate transdermal system and placebo in change from baseline in SKAMP Deportment Scores were statistically significant in favor of methylphenidate transdermal system beginning at 2 hours and remained statistically significant at all subsequent measured time points through 12 hours after application of the methylphenidate transdermal system.
In Study 2, conducted in the outpatient setting, methylphenidate transdermal system or placebo was blindly administered in a flexible-dose design using doses of 10 mg/9 hours, 15 mg/9 hours, 20 mg/9 hours, and 30 mg/9 hours to achieve an optimal regimen over 5 weeks, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient. Symptoms of ADHD were evaluated by the ADHD-Rating Scale (RS)-IV. Methylphenidate transdermal system was statistically significantly superior to placebo as measured by the mean change from baseline for the ADHD-RS-IV total score.
Although this study was not designed specifically to evaluate dose response, in general there did not appear to be any additional effectiveness accomplished by increasing the transdermal system dose from 20 mg/9 hours to 30 mg/9 hours. In Study 3, conducted in the outpatient setting, methylphenidate transdermal system or placebo was blindly administered in a flexible-dose design using doses of 10 mg/9 hours, 15 mg/9 hours, 20 mg/9 hours, and 30 mg/9 hours during a 5-week dose-optimization phase, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient.
Symptoms of ADHD were evaluated using the ADHD-Rating Scale (RS)-IV. Methylphenidate transdermal system was statistically significantly superior to placebo as measured by the mean change from baseline in the ADHD-RS-IV total score.
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE
9.1Controlled Substance Methylphenidate transdermal system contains methylphenidate, a Schedule II controlled substance.
9.2Abuse Methylphenidate transdermal system has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . Methylphenidate transdermal system can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect.
Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including methylphenidate transdermal system, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
9.3Dependence Physical Dependence Methylphenidate transdermal system may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including methylphenidate transdermal system include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance Methylphenidate transdermal system may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
🔒 Controlled Substance ▾
9.1Controlled Substance Methylphenidate transdermal system contains methylphenidate, a Schedule II controlled substance.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of transdermal methylphenidate have not been performed. In a lifetime carcinogenicity study of oral methylphenidate carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type.
There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown. Orally administered methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.
In a 24-week oral carcinogenicity study in the transgenic mouse strain p53 +/- , which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. In this study, male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay.
Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese hamster ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study.
The study was conducted at doses up to 160 mg/kg/day.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of transdermal methylphenidate have not been performed. In a lifetime carcinogenicity study of oral methylphenidate carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type.
There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown. Orally administered methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.
In a 24-week oral carcinogenicity study in the transgenic mouse strain p53 +/- , which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. In this study, male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay.
Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese hamster ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study.
The study was conducted at doses up to 160 mg/kg/day.
📖 Instructions for Use ▾
Instructions for Use Methylphenidate Transdermal System CII (meth'' il fen' i date) 1. Methylphenidate Transdermal System Dosing Chart Each carton of methylphenidate transdermal systems contains a methylphenidate transdermal system Dosing Chart to help you keep track of your methylphenidate transdermal system including: • when you apply the transdermal system to the skin on your hip each morning • when you remove the transdermal system • how and where you threw the methylphenidate transdermal system away To use the methylphenidate transdermal system Dosing Chart, follow these instructions: • Each day, when a new methylphenidate transdermal system is applied to your hip, write down the date and time that you applied the transdermal system. • Use the methylphenidate transdermal system schedule below so you can decide when to remove the transdermal system.
For example, if the transdermal system is applied to the skin at 6:00 a.m., remove the transdermal system at 3:00 p.m. on the same day. After you remove and throw away the transdermal system, write down the time you removed the transdermal system and how and where you threw it away. • If the transdermal system you placed on your child is missing, ask your child: o when the transdermal system came off o how the transdermal system came off o where the transdermal system is Methylphenidate Transdermal System Schedule for 9 Hour Dosing If you put the transdermal system patch on at: On the same day, remove the transdermal system patch at: 5:00 a.m.
2:00 p.m. 6:00 a.m. 3:00 p.m.
7:00 a.m. 4:00 p.m. 8:00 a.m.
5:00 p.m. 9:00 a.m. 6:00 p.m.
10:00 a.m. 7:00 p.m. 11:00 a.m.
8:00 p.m. 12:00 p.m. 9:00 p.m.
2. Where to apply methylphenidate transdermal system • Apply the transdermal system to your hip area. Do not put the transdermal system near your waist.
Clothing and movement may make your transdermal system rub off (See Figure A). • Use your other hip when you apply a new transdermal system the next morning. Make sure there is no redness, small bumps or itching at the site where the transdermal system is going to be applied. Figure A 3.
Before you apply methylphenidate transdermal system Make sure your skin: • Is clean (freshly washed), dry, and cool • Does not have any powder, oil, or lotion • Does not have any cuts and irritation (rashes, inflammation, redness, or other skin problems). 4. How to apply methylphenidate transdermal system • Each transdermal system is sealed in its own protective pouch. • Carefully cut the protective pouch open with scissors, being careful not to cut the transdermal system.
Do not use transdermal systems that have been cut or damaged in any way (See Figure B). Figure B • Remove the transdermal system from the protective pouch and discard additional piece of protective film above the transdermal system. • Look at the transdermal system to make sure it is not damaged. The transdermal system should separate easily from the protective liner.
Throw away the transdermal system if the protective liner is hard to remove. The methylphenidate transdermal system has 4 layers. The 4 layers are pictured below.
The pictures show both sides of the transdermal system: Figure C Figure D Layers: • Protective liner: The protective liner is the layer that you remove before you put the transdermal system on (See Figure C). • Adhesive layers with medicine: The adhesive layers with medicine consist of an adhesive reservoir layer that contains drug and an adhesive layer that sticks to your skin (See Figure C). • Outside backing: The outside backing is the layer that you see after you put the transdermal system on your skin. The words “Methylphenidate Transdermal System” are printed on this layer (See Figure D). • Apply the transdermal system right away after you remove the transdermal system from protective pouch . • Hold the transdermal system with the hard protective liner facing you.
The words “Methylphenidate Transdermal System” will appear backwards. • Gently bend the transd… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1 ) 09/2025 Warnings and Precautions ( 5.8 ) 09/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – 1.1 mg/hour Contains: 30 Systems NDC 0378-8260-93 Rx only Methylphenidate Transdermal System CII 1.1 mg/hr Delivers 10 mg over 9 hours (1.1 mg/hr) Transdermal system should be worn for approximately 9 hours. Each transdermal system contains 10.4 mg of methylphenidate. Active ingredient release is limited; please see recommended dosing in patient instructions.
For transdermal use only (applied only to skin). Important: Keep out of the reach of children. It is important that this product be disposed of properly.
See patient instructions for disposal information. Pharmacist: Dispense the accompanying Medication Guide to each patient. Inactive components: fluoropolymer-coated polyester release liner, hydrophobic colloidal silica, mineral oil, polyester/ethylene vinyl acetate laminate backing film and polyisobutylene adhesive.
The white ink contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide. Keep all transdermal systems within provided containers and dispense one transdermal system daily. Apply immediately upon removal from pouch.
Do not store unpouched. Do not store in refrigerators or freezers. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dosage and Administration: See package insert.
Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. 1-877-446-3679 (1-877-4-INFO-RX) Mylan.com M8260:93:30C:R3 Date of Transdermal System Application MM/DD/YYYY Time Applied Time Removed Application Site Disposal Method _AM _PM _AM _PM _Right _Left _Fold & flush _Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _Fold & trash Methylphenidate Transdermal System 1.1 mg/hr Carton Label
PRINCIPAL DISPLAY PANEL – 1.6 mg/hour Contains: 30 Systems NDC 0378-8261-93 Rx only Methylphenidate Transdermal System CII 1.6 mg/hr Delivers 15 mg over 9 hours (1.6 mg/hr) Transdermal system should be worn for approximately 9 hours. Each transdermal system contains 15.6 mg of methylphenidate. Active ingredient release is limited; please see recommended dosing in patient instructions.
For transdermal use only (applied only to skin). Important: Keep out of the reach of children. It is important that this product be disposed of properly.
See patient instructions for disposal information. Pharmacist: Dispense the accompanying Medication Guide to each patient. Inactive components: fluoropolymer-coated polyester release liner, hydrophobic colloidal silica, mineral oil, polyester/ethylene vinyl acetate laminate backing film and polyisobutylene adhesive.
The white ink contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide. Keep all transdermal systems within provided containers and dispense one transdermal system daily. Apply immediately upon removal from pouch.
Do not store unpouched. Do not store in refrigerators or freezers. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dosage and Administration: See package insert.
Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. 1-877-446-3679 (1-877-4-INFO-RX) Mylan.com M8261:93:30C:R3 Date of Transdermal System Application MM/DD/YYYY Time Applied Time Removed Application Site Disposal Method _AM _PM _AM _PM _Right _Left _Fold & flush _Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _Fold & trash Methylphenidate Transdermal System 1.6 mg/hr Carton Label
PRINCIPAL DISPLAY PANEL – 2.2 mg/hour Contains: 30 Systems NDC 0378-8262-93 Rx only Methylphenidate Transdermal System CII 2.2 mg/hr Delivers 20 mg over 9 hours (2.2 mg/hr) Transdermal system should be worn for approximately 9 hours. Each transdermal system contains 20.7 mg of methylphenidate. Active ingredient release is limited; please see recommended dosing in patient instructions.
For transdermal use only (applied only to skin). Important: Keep out of the reach of c… [Excerpted — this section continues on DailyMed.]