Abilify®Tablets: 2mg, 5mg, 10mg, 15mg, 20mg, 30mg; Orally disintegrating tablets: 10mg, 15mg

ABILIFY Rx
Generic Name and Formulations:
Aripiprazole 2mg, 5mg, 10mg, 15mg, 20mg, 30mg; tabs.

Company:
Otsuka America Pharmaceutical, Inc.
Indications for ABILIFY:
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.

Adult:
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 full labeling 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 Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.

Children:
<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 full labeling. 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.

See Also:
ABILIFY ORAL SOLUTION

ABILIFY DISCMELT

ABILIFY INJECTION

Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. 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. Reeva luate periodically. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Write ℞ for smallest practical amount. 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.

Interactions:
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).

Adverse Reactions:
Headache, anxiety, insomnia, constipation, vomiting, somnolence, fatigue, sedation, restlessness, akathisia, orthostatic hypotension, asthenia, blurred vision, tremor, pyrexia, salivary hypersecretion, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, dyslipidemia, others. Inj: local reactions.

How Supplied:
Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Oral soln (w. dosing cup)—150mL; Discmelt—30; Single use vials—1