Methylphenidate

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) ] . …

• The recommended starting dose for patients new to or converting from another formulation of methylphenidate is 10 mg. • 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. • 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
• 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 ] . • 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 ]
• Recommended 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. …

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” stre …

• 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. …

Methylphenidate transdermal system has not been studied in patients greater than 65 years of age.

• 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 , Drug Abuse and Dependence , Overdosage ]
• 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. …

• 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, mineral oil, polyester/ethylene vinyl acetate laminate film backing, polyisobutylene adhesive and white ink). …

• 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. …

• 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. …

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) ] …

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/. …

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. …

9.1 Controlled Substance Methylphenidate transdermal system contains methylphenidate, a Schedule II controlled substance. 9.2 Abuse 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. …

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.