Generic Name and Formulations:
Aripiprazole 2mg, 5mg, 10mg, 15mg, 20mg, 30mg; tabs.
Company:
BMS/Otsuka Partnership
Acute and maintenance treatment of manic or mixed episodes in bipolar disorder as monotherapy; or as an adjunct to lithium or valproate. Adjunct to antidepressants for major depressive disorder. Irritability associated with autistic disorder.
Tabs and soln may be interchanged on a mg–to–mg basis up to 25mg; 30mg as tablet is equivalent to 25mg oral soln. Discmelt: Dissolve on tongue; take without liquids. Bipolar disorder: initially 15mg once daily; may increase to max 30mg/day; maintenance: 15mg/day or 30mg/day (see literature for duration of therapy). Adjunct to major depressive disorder: initially 2–5mg/day; may adjust by 5mg/day increments at intervals of ≥1 week; usual range: 2–15mg/day. Reduce aripiprazole dose by at least ½ with CYP3A4 inhibitors or CYP2D6 inhibitors. Double aripiprazole dose (max 30mg/day) with CYP3A4 inducers. Adjust dose to normal range when these drugs are withdrawn.
<10yrs: not recommended. 10–17yrs: Bipolar disorder: initially 2mg/day, then increase to 5mg/day after 2 days, then increase to target dose of 10mg/day after 2 days. Subsequent dose increases may be adjusted by increments of 5mg/day; max 30mg/day. Maintenance: continue at lowest dose to maintain remission; see literature. Irritability w. autistic disorder: 6–17yrs: initially 2mg/day, then increase to 5mg/day; adjust dose by 5mg/day at ≥1 week intervals; usual range 5–15mg/day.
Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Reevaluate periodically. Monitor for hyperglycemia. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Write ℞ for smallest practical amount. Elderly (not for dementia-related psychosis). Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid alcohol. Caution with other centrally-acting drugs. Potentiates antihypertensives. Levels may be reduced by CYP3A4 inducers (eg, carbamazepine). Levels may be increased by CYP3A4 inhibitors (eg, ketoconazole) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Caution with drugs that interfere with temperature regulation (eg, anticholinergics).
Headache, anxiety, insomnia, GI upset, somnolence, fatigue, akathisia, orthostatic hypotension, asthenia, blurred vision, tremor, pyrexia, salivary hypersecretion, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, dyslipidemia, others. Inj: local reactions.
Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Oral soln (w. dosing cup)—150mL; Discmelt—30; Single use vials—1
Schizophrenia.
Tabs and soln may be interchanged on a mg–to–mg basis up to 25mg; 30mg as tablet is equivalent to 25mg oral soln. Discmelt: Dissolve on tongue; take without liquids. Initially 10mg or 15mg once daily; may increase at intervals of at least 2 weeks; usual maintenance 15mg/day; max 30mg/day. Reduce aripiprazole dose by at least ½ with CYP3A4 inhibitors or CYP2D6 inhibitors. Double aripiprazole dose (max 30mg/day) with CYP3A4 inducers. Adjust dose to normal range when these drugs are withdrawn.
<13yrs: not recommended. 13–17yrs: initially 2mg daily, then increase to 5mg after 2 days, then increase to target dose of 10mg after 2 days. Subsequent doses may be adjusted by increments of 5mg/day; max 30mg/day. Maintenance: continue at lowest dose to maintain remission; see literature.
Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Reevaluate periodically. Monitor for hyperglycemia. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Write ℞ for smallest practical amount. Elderly (not for dementia-related psychosis). Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid alcohol. Caution with other centrally-acting drugs. Potentiates antihypertensives. Levels may be reduced by CYP3A4 inducers (eg, carbamazepine). Levels may be increased by CYP3A4 inhibitors (eg, ketoconazole) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Caution with drugs that interfere with temperature regulation (eg, anticholinergics).
Headache, anxiety, insomnia, GI upset, somnolence, fatigue, akathisia, orthostatic hypotension, asthenia, blurred vision, tremor, pyrexia, salivary hypersecretion, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, dyslipidemia, others. Inj: local reactions.
Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Oral soln (w. dosing cup)—150mL; Discmelt—30; Maintena Kit—1 (w. supplies); Single use vials—1