Concerta Generic Name & Formulations
Legal Class
CII
General Description
Methylphenidate HCl 18mg, 27mg, 36mg, 54mg; ext-rel tabs.
Pharmacological Class
CNS stimulant.
How Supplied
Tabs—100
Manufacturer
Generic Availability
YES
Concerta Indications
Indications
Attention deficit hyperactivity disorder.
Concerta Dosage and Administration
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.
Concerta Contraindications
Contraindications
Marked anxiety, tension, agitation. Glaucoma. Motor tics. Tourette's syndrome in patient or family. During or within 14 days of MAOIs.
Concerta Boxed Warnings
Boxed Warning
Drug dependence.
Concerta Warnings/Precautions
Warnings/Precautions
History of drug dependence or alcoholism; monitor. 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 factors of developing a manic episode prior to 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 aggravation of symptoms occurs. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.
Concerta Pharmacokinetics
See Literature
Concerta Interactions
Interactions
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. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.
Concerta Adverse Reactions
Adverse Reactions
Upper abdominal pain, decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, hyperhidrosis; priapism, hypertension, tachycardia, visual disturbances, possible GI obstruction.
Concerta Clinical Trials
See Literature
Concerta Note
Not Applicable
Concerta Patient Counseling
See Literature
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