Summary
Abilify Maintena® (aripiprazole) is a long‑acting, extended‑release intramuscular antipsychotic indicated for maintenance treatment of schizophrenia and bipolar I disorder in adults . Supplied as a single‑use pre‑filled dual chamber syringe containing lyophilized aripiprazole monohydrate (300 mg or 400 mg) and sterile water for injection, it is reconstituted at the point of care into a 200 mg/mL milky‑white suspension for deep deltoid or gluteal administration once monthly . The recommended dose is 400 mg every 4 weeks—with oral aripiprazole 10–20 mg daily overlapped for 14 days at initiation—and may be reduced to 300 mg monthly for tolerability or in CYP2D6 poor metabolizers . Aripiprazole’s clinical effects derive from its partial agonism at dopamine D₂/D₃ and serotonin 5‑HT₁A receptors and antagonism at 5‑HT₂A receptors . Common adverse events include weight gain, akathisia, constipation, and injection‑site pain; serious risks encompass neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, and increased mortality in elderly patients with dementia‑related psychosis .
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Composition & Kit Components
Active Ingredient: Aripiprazole monohydrate, 300 mg or 400 mg (anhydrous equivalents), in the front chamber as lyophilized powder .
Diluent: Sterile Water for Injection in the rear chamber .
Kit Includes: One dual‑chamber syringe plus three safety needles—23 G × 1 inch for deltoid (non‑obese), 22 G × 1.5 inch for gluteal (non‑obese) or deltoid (obese), and 21 G × 2 inch for gluteal (obese) administration .
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Indications
Schizophrenia: Maintenance treatment in adults previously stabilized on oral aripiprazole .
Bipolar I Disorder: Maintenance monotherapy in adults following stabilization with oral aripiprazole .
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Mechanism of Action
Aripiprazole’s therapeutic efficacy is primarily due to partial agonist activity at dopamine D₂/D₃ and serotonin 5‑HT₁A receptors and antagonist activity at 5‑HT₂A receptors, modulating neurotransmission across mesolimbic, mesocortical, and other pathways .
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Dosage & Administration
1. Initiation: One 400 mg IM injection; continue oral aripiprazole 10–20 mg daily for 14 days to establish tolerability .
2. Maintenance: 400 mg IM every 4 weeks (administer no sooner than 26 days after the prior injection) .
3. Dose Reduction: For patients with adverse reactions or as the recommended regimen in known CYP2D6 poor metabolizers, reduce to 300 mg IM monthly; further adjustments (200 mg or 160 mg) require use of vial kits .
4. Missed Doses: Specific guidance is provided for delays; see full prescribing information for details .
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Preparation, Reconstitution & Injection Technique
1. Activate Syringe: Depress and rotate plunger to release diluent into the powder chamber.
2. Shake: Vigorously shake for 20 seconds to yield a uniform, opaque, milky‑white suspension .
3. Inspect: Ensure no particulates or discoloration.
4. Inject: Deep IM into deltoid or gluteal muscle using aseptic technique; rotate injection sites monthly .
5. Disposal: Engage needle safety device and discard all components as biohazardous waste .
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Storage & Handling
Prefilled Syringes: Store ≤ 30 °C; do not freeze; protect from light in original carton until use .
Vials: Store at 25 °C (excursions 15–30 °C); protect from moisture .
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Adverse Effects & Warnings
Common (≥ 10%): Weight gain (17%), akathisia (11%), constipation (10%), injection-site pain (5%) .
Serious: Tardive dyskinesia, neuroleptic malignant syndrome, hyperglycemia/diabetes, dyslipidemia, orthostatic hypotension .
Boxed Warnings: Increased mortality in elderly patients with dementia‑related psychosis; not indicated for this population .
Monitoring: Periodic assessment of glucose, lipids, CBC, and movement disorders is recommended .
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**For complete prescribing details, including dosage adjustmen
t tables and patient counseling information, refer to the FDA‑approved label and DailyMed entry.**
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