ABILIFY MAINTENA Rx
Generic Name and Formulations:
Aripiprazole extended-release injectable suspension 300mg, 400mg; per vial or pre-filled syringe; lyophilized pwd for IM inj after reconstitution.
Indications for ABILIFY MAINTENA:
Schizophrenia. Tourette's disorder.
Treatment-naive: establish tolerability with oral form first. Give by IM inj into the deltoid or gluteal muscle. Initial and maintenance: 400mg once monthly (no sooner than 26 days after the previous inj); may consider reducing to 300mg once monthly if adverse reactions occur. After first Maintena dose, continue with concurrent oral aripiprazole (10mg or 20mg) or other antipsychotic for 14 consecutive days. Dose adjustments for missed dose, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.
<18yrs: not recommended.
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. Reevaluate periodically. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. 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.
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, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.
Tabs, soln, orally disintegrating tabs (YES); Maintena (NO)
Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Prefilled Dual Chamber Syringe—1 (w. supplies); Single-use vials—1 (w. supplies); Oral soln, orally disintegrating tabs—contact supplier
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