Abilify

Treatment of schizophrenia. As monotherapy & as adjunctive therapy to lithium or valproate for the acute treatment of manic & mixed episodes associated w/ bipolar I disorder & for the maintenance treatment of bipolar I disorder. Adjunctive therapy to antidepressants for the treatment of major depressive disorder. Treatment of irritability associated w/ autistic disorder.

Schizophrenia Adult Initial & target dose: 10 or 15 mg/day. Do not increase dose before 2 wk. Ped patient 13-17 yr Initially 2 mg/day, titrated to 5 mg/day after 2 days, & to the target dose of 10 mg/day after 2 additional days. Subsequently increase dose in 5-mg/day increments. Bipolar I disorder Adult Initial dose: 15 mg/day as monotherapy & 10-15 mg/day as adjunctive therapy to lithium or valproate. Target dose: 15 mg/day. May be increased to 30 mg/day based on clinical response. Ped patient 10-17 yr Initially 2 mg/day, titrated to 5 mg/day after 2 days, & to the target dose of 10 mg/day after 2 additional days. Subsequently increase dose in 5-mg/day increments if needed. Major depressive disorder Adult Initially 2-5 mg/day as adjunctive therapy to antidepressants. Gradually adjust dose up to 5 mg/day at intervals of no less than 1 wk. Irritability associated w/ autistic disorder Ped patient 6-17 yr Initially 2 mg/day, increased to 5 mg/day, w/ subsequent increases to 10 or 15 mg/day if needed. Gradually adjust dose up to 5 mg/day at intervals of no less than 1 wk.

May be taken with or without food.

Hypersensitivity.

Increased mortality & incidence of cerebrovascular adverse events in elderly patients w/ dementia-related psychosis. Not approved for the treatment of patients w/ dementia-related psychosis. Increased risk of suicidal thoughts & behavior in childn, adolescents, & young adults. Closely monitor patients of all ages for worsening & for emergence of suicidal thoughts & behaviors. Risk of NMS; tardive dyskinesia; metabolic changes (including hyperglycemia/DM, dyslipidemia, & body wt gain); pathological gambling & other compulsive behaviors; orthostatic hypotension; leukopenia, neutropenia, & agranulocytosis; seizures/convulsions; disruption of body's ability to reduce core body temp; esophageal dysmotility & aspiration. Frequently perform CBC during the 1st few mth of therapy in patients w/ history of clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia. Discontinue treatment in patients w/ severe neutropenia (ANC <1,000/mm³). Caution in patients w/ known CV disease, cerebrovascular disease, or conditions which would predispose patients to hypotension; w/ history of seizures or conditions that lower seizure threshold; at risk for aspiration pneumonia. May cause somnolence, postural hypotension, motor & sensory instability, which may lead to falls &, consequently, fractures or other injuries. Potential for cognitive & motor impairment. Risk for extrapyramidal &/or w/drawal symptoms in neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy. Should be used during pregnancy only if potential benefit justifies potential risk to fetus. Consider development & health benefits of breastfeeding along w/ mother's clinical need for Abilify & any potential adverse effects on the breastfed infant from Abilify or from the underlying maternal condition. Safety & effectiveness have not been established in ped patients w/ major depressive disorder or agitation associated w/ schizophrenia or bipolar mania. High conc in known CYP2D6 poor metabolizers.

Adult: Nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, restlessness. Ped: Somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, increased wt.

Increased exposure w/ strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Decreased exposure w/ strong CYP3A4 inducers (eg, carbamazepine, rifampin). Potential to enhance effect of certain antihypertensive agents. Increased sedation & orthostatic hypotension w/ benzodiazepines (eg, lorazepam).

Antipsychotics

N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.

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