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Aripiprazole

CENTRAL NERVOUS SYSTEM

SEDATIVES & ANXIOLYTICS - [ CENTRAL NERVOUS SYSTEM ]

Aripiprazole is a partial D2 antagonist. It inhibits effects of DA and reduces stimulation at the D2 receptor. It is an atypical or ‘second- generation’ anti- psychotic, available for oral and parenteral use.(1)

Oral formulations: Treatment of schizophrenia in adults and adolescents (13- 17 yrs of age) Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate in adults and children (10- 17 yrs of age) Maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate in adults. Adjunctive treatment of major depressive disorder (MDD) in adults. Treatment of irritability associated with autistic disorder in children 6- 17 yrs of age. As injection: Acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.(2)

Known hypersensitivity to aripiprazole or any of the components of the product.(2)

Adults: Akathisia Sedation Restlessness Tremor Extrapyramidal disorder Insomnia Constipation, Fatigue Blurred vision Nausea Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor Pediatric patients: Somnolence Extrapyramidal disorder Fatigue Nausea Akathisia Blurred vision Salivary hypersecretion Dizziness Sedation Vomiting Tremor Pyrexia Drooling Decreased appetite Lethargy.(2)

Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors: increase aripiprazole drug concentrations; dose reduced to one half of the usual dose when used concomitantly xcept when used as adjunctive treatment with antidepressants. If a strong CYP3A4 inhibitor and strong CYP2D6 inhibitor are coadministered or a known CYP2D6 poor metabolizer is receiving a concomitant strong CYP3A4 inhibitor, aripiprazole dose should be reduced to one-quarter (25%) of the usual dose. CYP3A4 inducers (eg, carbamazepine): decrease aripiprazole drug concentrations; double aripiprazole dose when used concomitantly.(2)

Mild or moderate hepatic and renal insufficiency: Dose reduction mandatory.(2)

Schizophrenia Adults: Recommended: 10-15 mg/day. Maximum: 30 mg/ day Adolescents: Recommended: 10 mg/day. Maximum: 30 mg/ day Bipolar mania: Adults: Monotherapy: Recommended: 15 mg/day. Maximum: 30 mg/ day Adjunct to lithium or valproate: Recommended: 10-15 mg/day. Maximum: 30 mg/ day Pediatric patients: Recommended: 10 mg/day. Maximum: 30 mg/ day As an adjunct to antidepressants for the treatment of major depressive disorder: Adults: Recommended: 5- 10 mg/day. Maximum: 15 mg/ day Irritability associated with autistic disorder: Pediatric patients: Recommended: 5- 10 mg/day. Maximum: 15 mg/ day Agitation associated with schizophrenia or bipolar mania: Adults: Recommended: 9.75 mg/1.3 mL injected IM. Maximum: 30 mg/day injected IM.(1,2)

1. Meyer JM. Pharmacotherapy of psychosis and mania. In: Brunton L, Chabner B, Knollmann B eds. Goodman & Gilman’s The Pharmacological basis of Therapeutics. 12th ed. USA: McGraw Hill; 2011: 417- 56 2. Haloperidol. Highlights of prescribing information. [Online] [Cited 2013 Sept 10]. Available from: URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf