Methylphenidate Transdermal System 82.5 mg/mg

methylphenidate · PATCH · PADAGIS US LLC

No Recall HistoryCurrently in Shortage

Plain English

Methylphenidate transdermal system is a prescription patch used to treat attention-deficit/hyperactivity disorder (ADHD) by delivering the stimulant medication through your skin. This central nervous system stimulant helps improve focus and attention in patients with ADHD.

Key Facts

Brand Name: Methylphenidate Transdermal System
Generic Name: methylphenidate
NDC Code (Product): 0574-2430
Manufacturer: PADAGIS US LLC
Strength: 82.5 mg/mg
Dosage Form: PATCH
Route: TRANSDERMAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: NDA021514
Drug Class: Central Nervous System Stimulant [EPC]
Marketing Start: 06/05/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,435 reports

off label use859 reports

fatigue749 reports

anxiety700 reports

nausea692 reports

toxicity to various agents664 reports

headache640 reports

depression550 reports

somnolence480 reports

condition aggravated475 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Methylphenidate Transdermal System (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 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 [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 & 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 ) 2.1 Pretreatment 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 )] . 2.2 Recommended Dosage It is recommended that Methylph…

Contraindications

4 CONTRAINDICATIONS Known hypersensitivity to methylphenidate ( 4.1 ) Patients currently using or within 2 weeks of using an MAO inhibitor ( 4.2 ) 4.1 Hypersensitivity to Methylphenidate Methylphenidate Transdermal System is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product (polyester/ethylene vinyl acetate laminate film backing, acrylic adhesive, silicone adhesive, and fluoropolymer-coated polyester) [see Description ( 11 )] . 4.2 Monoamine 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).

Drug Interactions

7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.2 ) 7.1 Monoamine 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. 7.2 Antihypertensive Drugs Methylphenidate Transdermal System 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 )] . 7.3 Coumarin 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,…

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…

Frequently Asked Questions

What is Methylphenidate Transdermal System used for?

Is Methylphenidate Transdermal System a controlled substance?

Yes, Methylphenidate Transdermal System is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Methylphenidate Transdermal System?

The generic name for Methylphenidate Transdermal System is methylphenidate. There are 12 other brand versions of methylphenidate.

What is the NDC code for Methylphenidate Transdermal System 82.5 mg/mg?

The NDC (National Drug Code) for Methylphenidate Transdermal System 82.5 mg/mg is 0574-2430, listed by PADAGIS US LLC.

Product NDC

0574-2430

Package NDC

0574-2430-65

Other Methylphenidate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)