Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).

DOSAGE AND ADMINISTRATION

• Administer orally twice daily, 4 hours apart with or without food (2)
• For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily) (2.2).
• For patients currently taking methylphenidate: Initiate Focalin therapy with half (1/2) the current total daily dose of methylphenidate (2.3).
• Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily) (2.2).

———————DOSAGE FORMS AND STRENGTHS———————

Tablets: 2.5 mg, 5 mg, and 10 mg (3)

The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo) in pediatric patients 6 to 17 years were abdominal pain, fever, nausea, and anorexia (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA1088 or www.fda.gov/medwatch.

• Known hypersensitivity to methylphenidate or other components of Focalin (4).
• Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4).

WARNINGS AND PRECAUTIONS

• Serious Cardiovascular Events: Sudden death has been reported in association with CNS-stimulant treatment at usual doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, arrhythmias, or coronary artery disease (5.2).
• Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider the benefits and risk in patients for whom an increase in blood pressure or heart rate would be problematic (5.3).
• Psychotic Adverse Reactions: Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for preexisting psychotic or bipolar disorder prior to Focalin use (5.4).
• Priapism: Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed (5.5).
• Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants (5.6).
• Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals in the pediatric population (5.7).

• Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7.1).
• Halogenated Anesthetics: Avoid use of Focalin on the day of surgery if halogenated anesthetics will be used (7.1).

Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes, and rhabdomyolysis.

Overdose Management: Consult with a Certified Poison Control Center (1-800-222-1222) for latest recommendations.