Indication and Important Safety Information Including Boxed Warnings
The 18-mg, 27-mg, 36-mg, 45-mg, 54-mg and 63-mg methylphenidate hydrochloride extended-release tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older.
The 72-mg methylphenidate hydrochloride extended-release tablet USP is a CNS stimulant indicated for the treatment of ADHD in adolescents 13 years of age and older, and adults up to the age of 65.
WARNING: DRUG DEPENDENCE
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Methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism.
Chronic abuse can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior.
WARNING: ABUSE AND DEPENDENCE
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- CNS stimulants, including methylphenidate hydrochloride extended-release tablets, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence (5.1, 9.2, 9.3).
- Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy (5.1, 9.2).
- Methylphenidate is a stimulant. Stimulants should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. Stimulants should be used with caution in patients with a history of high blood pressure or increased heart rate. Patients with a history of high blood pressure and for whom methylphenidate is deemed an appropriate therapy should be monitored for changes in heart rate and blood pressure
- Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior psychiatric history. Stimulants may also exacerbate psychiatric symptoms in patients with preexisting psychiatric illness
- Methylphenidate hydrochloride extended-release tablets should not be used in patients with known hypersensitivity to the product; marked anxiety, tension, or agitation; glaucoma; tics or a family history or diagnosis of Tourette's syndrome; or in patients currently using or within 2 weeks of using an MAO inhibitor
- Stimulants may lower the convulsive threshold in patients with epilepsy, potentially leading to seizures. Stimulants should not be taken in the presence of seizures
- Immediate medical attention should be sought if signs or symptoms of prolonged penile erections (priapism) are observed
- Careful observation for peripheral vasculopathy in extremities, including but not limited to Raynaud's phenomenon, is necessary during treatment with ADHD stimulants
- Pediatric patients should be monitored for height and weight at age-appropriate intervals for potential long-term suppression of growth
- Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. Patients with a history of glaucoma should not take stimulants
- This extended-release tablet is nondeformable and does not appreciably change in shape in the GI tract; therefore, gastrointestinal obstruction may potentially occur in patients with prior history of GI narrowing
- Periodic complete blood count (CBC) with differential and platelet counts are advised during prolonged therapy
- The most common adverse reaction in double-blind clinical trials (>5%) in children and adolescents was upper abdominal pain. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decrease, irritability, and hyperhidrosis
You may report side effects to Trigen Laboratories, LLC at 1-800-444-5164, or to the FDA at 1-800-FDA-1088.
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