Schizophrenia, Bipolar I disorder

Antimanic Agent; Second Generation (Atypical) Antipsychotic
Aripiprazole is an atypical antipsychotic agent that may exert its effects through partial agonist activity at dopamine D2 and serotonin 5-HT2(1A) receptors and antagonism of serotonin 5-HT2(2A) receptors.

Absorption
1. Time to peak: IM, 1 to 3 hour [40]; IM, Abilify Maintena(R) extended-release suspension: 5 to 7 days (gluteal muscle injection); 4 days (deltoid muscle injection)
Distribution
1. Vd: 404 L or 4.9 L/kg
2. Protein binding: Albumin: greater than 99%
Metabolism: Hepatic: extensive via CYP2D6 and CYP3A4
Excretion
1.Half-life Elimination:29.9 days (300 mg extended-release IM suspension, gluteal injection); 46.5 days (400 mg extended-release IM suspension, gluteal injection)

Hypersensitivity (eg, anaphylaxis, pruritus, urticaria) to aripiprazole or any component of the formulation.

Aripiprazole crosses the placenta; aripiprazole and dehydro-aripiprazole can be detected in the cord blood at delivery.
Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery.

Infant risk cannot be ruled out.

1.Endocrine & metabolic: Decreased HDL cholesterol (14%), increased LDL cholesterol (10% to 14%), increased serum cholesterol (4% to 22%), increased serum triglycerides (7% to 27%), weight gain (17% to 22%).
2.Nervous system: Akathisia (2% to 12%) , headache (12%)

Bipolar disorder Monthly injection (Abilify Maintena)
1.Single injection start: IM: 400 mg once monthly (doses should be separated by 26 days). Continue (overlap) oral aripiprazole or other oral antipsychotic for 14 days during initiation of the injection.
2.Double injection start: IM: Initial: Administer a single oral aripiprazole 20 mg dose, plus two 400 mg injections in separate injection sites (eg, right deltoid and left gluteal muscle). Maintenance: 400 mg once monthly (doses should be separated by 26 days) .
Schizophrenia Monthly injection (Abilify Maintena)
1.Single injection start: IM: 400 mg once monthly (doses should be separated by 26 days). Continue (overlap) oral aripiprazole or other oral antipsychotic for 14 days during initiation of the ER injection.
2.Double injection start: IM: Initial: Administer a single oral aripiprazole 20 mg dose, plus two 400 mg injections in separate injection sites (eg, right deltoid and left gluteal muscle). Maintenance: 400 mg once monthly (doses should be separated by 26 days).

Dosage adjustment in patients with renal impairment (GFR between 15 and 90 mL/min) is not necessary.

No dosage adjustment necessary.