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Methylphenidate HCl Extended-Release Tablets, USP CII 10 mg

INDICATION

Methylphenidate Hydrochloride Tablets, USP and Methylphenidate Hydrochloride Extended Release Tablets, USP are indicated in Attention Deficit Disorders and Narcolepsy.

IMPORTANT RISK INFORMATION

WARNING: DRUG DEPENDENCE
Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior.  Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

CONTRAINDICATIONS

  • Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets are contraindicated in patients:
    • with a known hypersensitivity to the drug
    • with marked anxiety, tension, or agitation
    • with glaucoma
    • with motor tics or a family history or diagnosis of Tourette's syndrome
    • using or within 2 weeks of using an MAO inhibitor

WARNINGS AND PRECAUTIONS

  • Sudden death has been reported in association with CNS stimulants in pediatrics with serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities or other serious cardiac problems that may place them at increased risk even at usual doses.  Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Adults have a greater risk for these cardiac abnormalities.
  • Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g. those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.
  • Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness, including bipolar or pre-existing psychosis. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
  • Consistently medicated children may exhibit a temporarily slowed growth rate.
  • Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures
  • Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
  • Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets should not be used in children under 6 years old.
  • Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy. 

ADVERSE REACTIONS

  • Serious adverse events include sudden death, stroke, myocardial infarction, slowing of growth, seizures, changes in vision, tachycardia, angina, cardiac arrhythmia,
  • The most common adverse reactionsinclude nervousness and insomnia, hypersensitivity, anorexia, nausea, dizziness, palpitations, dyskinesia, drowsiness, blood pressure and pulse changes, abdominal pain and weight loss.

Description White to Off-White/Round Tablet
Dosage Strength 10 mg
Compares To Ritalin SR®
Identification Code Boxed M; Debossed with 1423 on reverse side
Rating AB

Order Information

NDC # Package Size Case Quantity
0406-1445-01 100 12

For additional information on Methylphenidate HCl Extended-Release Tablets, USP CII 10 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

Ritalin SR is a registered trademark of Novartis Corporation.