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Methylphenidate HCl Extended-Release Tablets, USP CII 27 mg

INDICATION

Methylphenidate Hydrochloride Extended-Release Tablets, USP (CII) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.

IMPORTANT RISK INFORMATION
WARNING: DRUG DEPENDENCE
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 extended-release tablets are contraindicated in patients:
    • with a known hypersensitivity to the product or its components
    • with marked anxiety, tension, or agitation
    • with glaucoma
    • with tics or a family history or diagnosis of Tourette's syndrome
    • using or within 2 weeks of using an MAO inhibitor  

WARNINGS AND PRECAUTIONS

  • 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. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
  • 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.
  • May cause long-term suppression of growth: monitor height and weight at appropriate intervals in pediatric patients.
  • May cause gastrointestinal obstruction with preexisting GI narrowing
  • Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

ADVERSE REACTIONS

  • Serious adverse events including sudden death, stroke and myocardial infarction have been reported in patients even at usual doses. 
  • The most common adverse reaction (>5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia. Monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic.

Description Gray Capsule shaped tablet  
Dosage Strength 27 mg
Compares To Concerta® 27 mg Tablet 
Identification Code Imprinted with "M" in a box and “27” on one side in black ink
Rating

BX*

*On November 13, 2014, the FDA changed the therapeutic equivalence (TE) rating for this product from AB to BX. This means that the product is presumed to be therapeutically inequivalent to the referenced product until the agency determines there is adequate information to make a full evaluation of TE. The FDA has not identified any serious safety concerns with this product. Mallinckrodt strongly disagrees with the BX rating and is contesting the change.

Order Information

NDC # Package Size Case Quantity
0406-0127-01 100 12

For additional information on Methylphenidate HCl Extended-Release Tablets, USP CII 27 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

Concerta is a registered trademark of ALZA Corporation.