• Children less than 6 years of age – Methylphenidate Hydrochloride Chewable Tablets should not be used in children under six years, since safety and efficacy in this age group have not been established.
• Monoamine Oxidase Inhibitors – Methylphenidate Hydrochloride Chewable Tablets are contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
• Anxiety, Tension, and Agitation – Marked anxiety, tension, and agitation are contraindications to Methylphenidate Hydrochloride Chewable Tablets, since the drug may aggravate these symptoms.
• Hypersensitivity – Methylphenidate Hydrochloride Chewable Tablets are also contraindicated in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome.

• Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems
  Stimulant products generally should not be used in children, adolescents, or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems. Stroke, and myocardial infarction have been reported in adults taking stimulant drugs.
• Hypertension and other Cardiovascular Conditions
  Stimulant medications can cause modest changes in blood pressure and heart rate. Use caution when 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).
• Peripheral Vasculopathy, Including Raynaud's Phenomenon – Stimulants, including Methylphenidate Hydrochloride Chewable Tablets, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown.

• Pre-Existing Psychosis – Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
• Bipolar Illness – Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients.
• Emergence of New Psychotic or Manic Symptoms – Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses.
• Aggression – Aggressive behavior or hostility is often observed in children and adolescents with ADHD. Patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
• Seizures – There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

• Priapism – Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients.

• Long-Term Suppression of Growth – Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

• Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

• Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening.
• Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolysis.

PP-MPH-US-0025