Aripiprazole

What it is and 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 D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

Indications

Aripiprazole Oral Solution is indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette’s disorder

Dosage and administration (summary)

Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults 10 to 15 mg/day 10 to 15 mg/day 30 mg/day Schizophrenia – adolescents 2 mg/day 10 mg/day 30 mg/day Bipolar mania – adults: monotherapy 15 mg/day 15 mg/day 30 mg/day Bipolar mania – adults: adjunct to lithium or valproate 10 to 15 mg/day 15 mg/day 30 mg/day Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate 2 mg/day 10 mg/day 30 mg/day Major Depressive Disorder – Adults adjunct to antidepressants 2 to 5 mg/day 5 to 10 mg/day 15 mg/day Irritability associated with autistic disorder – pediatric patients 2 mg/day 5 to 10 mg/day 15 mg/day Tourette’s – Patients < 50 kg 2 mg/day 5 mg/day 10 mg/da…

Contraindications

Aripiprazole oral solution is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis . Known hypersensitivity to aripiprazole

Warnings and precautions

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring Tardive Dyskinesia: Discontinue if clinically appropriate Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients…

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy.

Storage and supply

How Supplied Aripiprazole Oral Solution, (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. Aripiprazole Oral Solution is available as follows: 150 mL bottle NDC 66689-735-05 Storage Oral Solution Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). .

Source: Aripiprazole (Aripiprazole) — US FDA prescribing information, 2024-09-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.