INDICATIONS AND USAGE

CONCERTA® is a CNS stimulant 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. (1)

DOSAGE AND ADMINISTRATION

• CONCERTA® should be taken once daily in the morning and swallowed whole with the aid of liquids. CONCERTA® should not be chewed or crushed. CONCERTA® may be taken with or without food. (2.1)
• For children and adolescents new to methylphenidate, the recommended starting dosage is 18 mg once daily. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 54 mg/day in children and 72 mg/day in adolescents. (2.2)
• For adult patients new to methylphenidate, the recommended starting dose is 18 or 36 mg/day. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 72 mg/day for adults. (2.2)
• For patients currently using methylphenidate, dosing is based on current dose regimen and clinical judgment. (2.3)

DOSAGE FORMS AND STRENGTHS

Tablets: 18, 27, 36, and 54 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to the product (4.1)

Marked anxiety, tension, or agitation (4.2)

• Glaucoma (4.3)
• Tics or a family history or diagnosis of Tourette's syndrome (4.4)
• Do not use CONCERTA® in patients currently using or within 2 weeks of using an MAO inhibitor (4.5)

WARNINGS AND PRECAUTIONS

• Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. (5.1)
• Increase in Blood Pressure: 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. (5.1)
• Psychiatric Adverse Events: 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 eva luation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior. (5.2)
• Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures. (5.3)
• Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (5.5)
• Long-Term Suppression of Growth: monitor height and weight at appropriate intervals in pediatric patients. (5.4)
• Gastrointestinal obstruction with preexisting GI narrowing. (5.6)
• Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy. (5.7)

ADVERSE REACTIONS

The most common adverse reaction in double-blind clinical trials (>5%) in children and adolescents was abdominal pain upper. 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 decreased, irritability, and hyperhidrosis. (6.1 and 6.2)

The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased. (6.3)

To report SUSPECTED ADVERSE REACTIONS, contact McNeil Pediatrics at 1-888-440-7903 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Do not use CONCERTA® in patients currently using or within 2 weeks of using an MAO inhibitor (7.1)
• CONCERTA® may increase blood pressure; use cautiously with vasopressors (7.2)
• Inhibition of metabolism of coumarin anticoagulants, anticonvulsants, and some antidepressants (7.3)

USE IN SPECIFIC POPULATIONS

Caution should be exercised if administered to nursing mothers (8.3)

• Safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age (8.4 and 8.5)