Schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder, agitation associated with schizophrenia or bipolar mania.
Aripiprazole is an atypical antipsychotic and it has been proposed that the efficacy of Aripiprazole is mediated through a combination of partial agonist activity at Dopamine D2 and Serotonin 5-HT 1A receptors and antagonist activity at Serotonin 5-HT 2A receptors. This is associated with improvement of schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autistic disorder, and agitation associated with schizophrenia or bipolar disorder.
Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults 10-15 mg/day 10-15 mg/day 30 mg/day Schizophrenia – adolescents (ages 13-17 years) 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 10-15 mg/day 15 mg/day 30 mg/day Bipolar mania – pediatric patients (10-17 years): monotherapy or as an adjunct to lithium or valproate 2 mg/day 10 mg/day 30 mg/day As an adjunct to antidepressants for the treatment of major depressive disorder– adults 2-5 mg/day 5-10 mg/day 15 mg/day Irritability associated with autistic disorderpediatric patients (ages 10-17 years) 2 mg/day 5-10 mg/day 15 mg/day • Oral formulations: Administer once daily without regard to meals.
Caution should be exercised when Aripiprazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in Aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit Aripiprazole elimination and cause increased blood levels.
Known hypersensitivity to Aripiprazole. Use caution when operating machinery.
Vomiting, nausea, akathisia, extrapyramidal disorder, somnolence, sedation, dizziness, insomnia, tremor, restlessness, fatigue, blurred vision, salivary hypersecretion, constipation, pyrexia, drooling, decreased appetite. Special warnings & precautions for use Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack, including fatalities). Suicidality & antidepressants: Increased risk of suicidality in children, adolescents, young & adults with major depressive disorder. Tardive dyskinesia: Discontinue if clinically appropriate. Metabolic changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, & body weight gain. Orthostatic hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease. Seizures/Convulsions: Use cautiously in patients with a history of seizures.
Pregnancy: Pregnancy category C. It should be avoided during pregnancy. Lactation: It is recommended that women receiving Aripiprazole should not breast-feed.
Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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