Methylphenidate
Generic Name: methylphenidate
Brand Names:
Methylphenidate
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 .
Overview
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 .
Uses
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.
Dosage
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.
Side Effects
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 Sup...
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 may decrease the effectiveness of drugs used to treat hypertension.
Warnings
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. 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. 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 (fluoropolymer-coated polyester, hydrophobic colloidal silica,...
Pregnancy
8.1 Pregnancy 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/.
Storage
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.
Frequently Asked Questions
What is Methylphenidate used for?▼
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.
What are the side effects of Methylphenidate?▼
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 Sup...
Can I take Methylphenidate during pregnancy?▼
8.1 Pregnancy 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/.
What are the important warnings for Methylphenidate?▼
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. 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. 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 (fluoropolymer-coated polyester, hydrophobic colloidal silica,...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.