Abilify Maintena Aripiprazole for Injection

1. Indications and Usage
Schizophrenia: Treatment of schizophrenia in adults.
2. Dosage and Administration
Route of Administration: For Intramuscular (IM) Deep Injection OR Intravenous (IV) Use ONLY.
Recommended Dosage: 9.75 mg to 15 mg administered once daily for up to 3 consecutive days. The therapeutic effect is comparable to 10-30 mg/day of oral aripiprazole.
Critical Administration Instructions:
Preparation: The solution is ready for use and does not require reconstitution.
IM Injection: Inject deep into the gluteal muscle. Do not administer intravenously.
IV Injection: Administer slowly over 5 minutes. Do not administer as an IV bolus.
Duration: The injectable formulation is intended for short-term use (up to 3 days) until an appropriate oral regimen can be established.
3. Mechanism of Action
Partial Agonism: Aripiprazole acts as a partial agonist at dopamine D2 and 5-HT1A receptors, and as an antagonist at 5-HT2A receptors.
Stabilization: This pharmacological profile stabilizes neurotransmission, alleviating hallucinations, delusions, and disordered thinking while minimizing the risk of prolactin elevation.
4. Safety and Warnings
Cardiovascular and Metabolic Risks: Potential for orthostatic hypotension, QT prolongation, weight gain, and glucose dysregulation (hyperglycemia/diabetes).
Neurological and Motor Symptoms: Risk of extrapyramidal symptoms (e.g., akathisia), tardive dyskinesia, and neuroleptic malignant syndrome (NMS).
Suicidal Behavior: Antipsychotics increase the risk of suicidal thoughts and behavior in children and young adults.
Dementia-Related Psychosis: Not approved for the treatment of psychosis associated with dementia.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Weight gain, akathisia, insomnia, and injection site reactions (for IM use).
Clinical Research Highlights: Clinical trials demonstrated that the injectable formulation achieves therapeutic efficacy comparable to oral aripiprazole, providing flexibility in acute psychotic episodes or when rapid medication adjustment is necessary.
6. Drug Interactions
CYP3A4 and CYP2D6 Inhibitors: Concomitant use with strong inhibitors of both CYP3A4 and CYP2D6 requires a 50% reduction in the aripiprazole dose.
CYP3A4 and CYP2D6 Inducers: Concomitant use with inducers of both enzymes requires a 100% increase (doubling) of the aripiprazole dose.
Other CNS Agents: Use caution with other centrally acting drugs or antihypertensives due to the risk of additive effects.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Aripiprazole. Excipients: Carboxymethylcellulose sodium, mannitol, sodium phosphate, sodium hydroxide.
Appearance: Clear to pale yellow solution.
Packaging: Single-use pre-filled syringe or cartridge (typically 15 mg/1.5 mL).
Storage: Store in the original carton at 2°C to 8°C. Do not freeze.