Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY ® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23 H 27 Cl 2 N 3 O 2 and its molecular weight is 448.38. The chemical structure is: ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and m...

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ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irri...

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Administer once daily without regard to meals Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults 10 to 15 mg/day 10 to 15 mg/day 30 mg/day Schizophrenia – adolescents 2 mg/day 10 mg/day 30 mg/day Bipolar mania – adults: monotherapy 15 mg/day 15 mg/day 30 mg/day Bipolar mania – adults: adjunct to lithium or valproate 10 to 15 mg/day 15 mg/day 30 mg/day Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate 2 mg/day 10 mg/day 30 mg/day Major Depress...

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MedDRA terminology has been used to classify the adverse reactions. Human Experience In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral ABILIFY have been reported worldwide. These include overdoses with ABILIFY alone and in combination with other substances. No fatality was reported with ABILIFY alone. The largest known dose with a known outcome involved acute ingestion of 1,260 mg of ABILIFY (42 times the maximum recommended daily...

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Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring Tardive Dyskinesia: Discontinue if clinically appropriate Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dysli...

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Dosage adjustment due to drug interactions: Factors Dosage Adjustments for ABILIFY Known CYP2D6 Poor Metabolizers Administer half of usual dose Known CYP2D6 Poor Metabolizers and strong CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP2D6 or CYP3A4 inhibitors Administer half of usual dose Strong CYP2D6 and CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP3A4 inducers Double usual dose over 1 to 2 weeks 7.1 Drugs Having Clinically Important Interactions with ABILIFY Ta...

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8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including ABILIFY, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including ABI...

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