Aripiprazole

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. Irritability Associated with Autistic Disorder. Treatment of Tourette's Disorder

The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

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 Depressive Disorder – adults: adjunct to antidepressants 2 to 5 mg/day 5 to 10 mg/day 15 mg/day Irritability associated with autistic disorder – pediatric patients 2 mg/day 5 to 10 mg/day 15 mg/day Tourette's Disorder –. Patients <50 kg 2 mg/day 5 mg/day 10 mg/day Patients ≥50 kg 2 mg/day 10 mg/day 20 mg/day Known CYP2D6 poor metabolizers: Half of the usual dose

ABILIFY is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis. Known hypersensitivity to ABILIFY

Boxed warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. 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, dyslipidemia, and body weight gain.

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Cerebrovascular Adverse Events, Including Stroke Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Neuroleptic Malignant Syndrome (NMS) Tardive Dyskinesia Metabolic Changes Pathological Gambling and Other Compulsive Behaviors Orthostatic Hypotension Falls Leukopenia, Neutropenia, and Agranulocytosis Seizures/Convulsions Potential for Cognitive and Motor Impairment Body Temperature Regulation Suicide Dysphagia Commonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were: Adult patients with schizophrenia: akathisia Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor Adult patients (monotherapy) with bipolar mania…

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

Store at 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).