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)

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 Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1­ 800-FDA-1088 or www.fda.gov/medwatch.

• 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 evaluation 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)
• 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 painful or prolonged penile erections or priapism are observed. (5.4)
• 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. (5.5)
• Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (5.7)
• Long-Term Suppression of Growth: monitor height and weight at appropriate intervals in pediatric patients. (5.6)
• Gastrointestinal obstruction with preexisting GI narrowing. (5.8)
• Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy. (5.9)

• 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)

Signs and symptoms of CONCERTA^® overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, muscle twitching, convulsion, grand mal convulsion, confusional state, hallucinations (auditory and/or visual), hyperhidrosis, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus arrhythmia, hypertension, rhabdomyolysis, mydriasis, and dry mouth.

Recommended Treatment: Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway.

Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for pyrexia. Efficacy of peritoneal dialysis or extracorporeal hemodialysis for CONCERTA^® overdosage has not been established. The prolonged release of methylphenidate from CONCERTA^® should be considered when treating patients with overdose.

As with the management of all overdosage, the possibility of multiple-drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.