Generic Name and Formulations:
Methylphenidate HCl 18mg, 27mg, 36mg, 54mg; ext-rel tabs.
Janssen Pharmaceuticals, Inc.
Indications for CONCERTA:
Attention deficit hyperactivity disorder.
Adults and Children:
Swallow whole with liquids. Take once daily in the AM. <6yrs: not established. Methylphenidate-naive: 6–12yrs: initially 18mg once daily, max 54mg/day; 13–17yrs: initially 18mg once daily, max 72mg daily or 2mg/kg/day (whichever is less). 18–65yrs: initially 18mg or 36mg/day; max 72mg/day. Switching from methylphenidate 5mg 2 or 3 times daily: initially Concerta 18mg once daily. Switching from methylphenidate 10mg 2 or 3 times daily: initially Concerta 36mg once daily. Switching from methylphenidate 15mg 2 or 3 times daily: initially Concerta 54mg once daily. Switching from methylphenidate 20mg 2 or 3 times daily: initially Concerta 72mg once daily. For all: may adjust in 18mg/day increments at 1-week intervals; max 54mg/day for children; max 72mg/day for adolescents and adults.
Marked anxiety, tension, agitation. Glaucoma. Motor tics. Tourette's syndrome in patient or family. During or within 14 days of MAOIs.
History of drug dependence or alcoholism; monitor for abnormal behavior. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder; screen for risk before initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for new or worsening aggressive behavior or hostility. Seizure disorder. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Preexisting GI narrowing. Monitor growth (esp. children), BP, HR, CBCs, differential, platelet counts. Reduce dose or discontinue if paradoxical worsening of symptoms occurs. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Hypertensive crisis with MAOIs. Caution with pressor agents. May potentiate coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), tricyclics, SSRIs. Risk of serotonin syndrome with serotonergic drugs.
Upper abdominal pain, decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, hyperhidrosis; priapism, hypertension, tachycardia, visual disturbances, possible GI obstruction.
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