Abilify Maintena Aripiprazole for Injection

1. Indications and Usage
Acute Agitation in Schizophrenia:
Treatment of acutely agitated patients with schizophrenia for rapid tranquilization.
Acute Agitation in Bipolar I Disorder:
Treatment of acutely agitated patients with Bipolar I Disorder (Mania or Mixed Episodes).
2. Dosage and Administration
Route of Administration:
For Intramuscular (IM) Injection ONLY.
Note: Not for intravenous (IV) or subcutaneous administration.
Recommended Dosage:
Standard Dose: 9.75 mg administered as a single injection.
Alternative Doses: 5.25 mg or 15 mg may be considered based on clinical judgment.
Maximum Dosage: The maximum cumulative dose should not exceed 30 mg in a 24-hour period.
Dosing Interval: If a second or third injection is required, allow at least 2 hours between injections.
Administration:
Administered by a healthcare professional.
Patients should be monitored for sedation and orthostatic hypotension for at least 1 hour after administration.
3. Mechanism of Action
Receptor Profile:
Aripiprazole is an atypical antipsychotic with high affinity for dopamine D2 and serotonin 5-HT1A receptors, and moderate affinity for 5-HT2A receptors.
Partial Agonist Activity:
Acts as a partial agonist at D2 and 5-HT1A receptors.
Acts as an antagonist at 5-HT2A receptors.
Clinical Effect:
By modulating dopamine and serotonin transmission, it reduces agitation, aggression, and irritability associated with psychosis and mania.
4. Safety and Warnings
Increased Mortality in Elderly with Dementia (Boxed Warning):
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Suicidal Thoughts and Behaviors:
Monitor for the emergence of suicidal ideation and behavior.
Orthostatic Hypotension:
Can cause a drop in blood pressure upon standing, leading to syncope (fainting).
Neuroleptic Malignant Syndrome (NMS):
Monitor for NMS, a potentially fatal reaction.
Tardive Dyskinesia:
Risk of developing abnormal involuntary movements.
5.Adverse Reactions
Most Common:
Nausea, headache, vomiting, dizziness, anxiety, and restlessness.
Injection Site:
Pain at the injection site may occur.
6.Drug Interactions
CYP3A4 and CYP2D6 Substrate:
Aripiprazole is metabolized by CYP3A4 and CYP2D6 enzymes.
Strong CYP3A4 Inhibitors:
Dose reduction is required (e.g., ketoconazole, itraconazole).
Strong CYP2D6 Inhibitors:
Dose reduction is required (e.g., quinidine, fluoxetine).
CYP3A4 Inducers:
Dose increase is required (e.g., carbamazepine, rifampin).
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Aripiprazole.
Available Strength: 9.75 mg/1.3 mL (single-dose vial).
Appearance: Clear, colorless to pale yellow solution.
Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).