What it's for (Indications)
- Treatment of schizophrenia, bipolar mania (as monotherapy or adjunct to lithium or valproate), major depressive disorder (as an adjunct to antidepressants), irritability associated with autistic disorder, and Tourette's Disorder.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Administer once daily without regard to meals. **Schizophrenia:** Adults: Initial 10-15 mg/day; Recommended 10-15 mg/day; Maximum 30 mg/day. Adolescents: Initial 2 mg/day; Recommended 10 mg/day; Maximum 30 mg/day. **Bipolar Mania:** Adults (monotherapy): Initial 15 mg/day; Recommended 15 mg/day; Maximum 30 mg/day. Adults (adjunct to lithium or valproate): Initial 10-15 mg/day; Recommended 15 mg/day; Maximum 30 mg/day. Pediatric patients (monotherapy or adjunct): Initial 2 mg/day; Recommended 10 mg/day; Maximum 30 mg/day. **Major Depressive Disorder (adjunct to antidepressants):** Adults: Initial 2-5 mg/day; Recommended 5-10 mg/day; Maximum 15 mg/day. **Irritability associated with autistic disorder (pediatric patients):** Initial 2 mg/day; Recommended 5-10 mg/day; Maximum 15 mg/day. **Tourette's Disorder:** Patients < 50 kg: Initial 2 mg/day; Recommended 5 mg/day; Maximum 10 mg/day. Patients ≥ 50 kg: Initial 2 mg/day; Recommended 10 mg/day; Maximum 20 mg/day. **Known CYP2D6 poor metabolizers:** Half of the usual dose. |
Safety & Warnings
Common Side Effects
- Common side effects include insomnia, restlessness, headache, dizziness, drowsiness, tremor, blurred vision, gastrointestinal upset, muscle weakness, anxiety, sedation, increased secretion of saliva, fatigue, orthostatic hypotension (drop in blood pressure on change of posture), cardiac rhythm disorders, weight changes, increased creatine kinase, and discomfort in swallowing.
- In adolescents, side effects may include weight loss, increased blood insulin, arrhythmia, decreased white blood cells (WBC's), and low serum prolactin.
- Falls may also occur.
Serious Warnings
- Black Box Warning: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults.
- Increased mortality in elderly patients with dementia-related psychosis (aripiprazole is not approved for this indication).
- Cerebrovascular adverse events, including stroke and TIA, particularly in the elderly.
- Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults.
- Neuroleptic Malignant Syndrome (NMS).
- Tardive Dyskinesia: reduce dose or discontinue if involuntary movements of face and jaw occur.
- Metabolic changes including hyperglycemia and diabetes mellitus; monitor for changes in glucose and lipids.
- Pathological gambling, hypersexuality, compulsive spending or eating, and other impulse control disorders; monitor for development of these behaviors.
- Orthostatic hypotension.
- Leukopenia, neutropenia, and agranulocytosis.
- Seizures/convulsions: use with caution in patients with a history of seizures.
- Venous thromboembolism.
- Aspiration pneumonia.
- Use with caution in severe liver impairment, cardiovascular or cerebrovascular disease (especially with history of QT prolongation or hypo- or hypertension).
- Monitor high-risk patients for suicidal behavior.
- Monitor weight gain in adolescents.
- Caution is advised for elderly patients.
How it Works (Mechanism of Action)
The mechanism of action of aripiprazole in schizophrenia or bipolar mania is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors.