Monday, April 21, 2025

Abilify tablet

 Summary


Abilify® (aripiprazole) is an atypical antipsychotic available as oral tablets in strengths of 2, 5, 10, 15, 20, and 30 mg for once‑daily dosing . It acts as a “dopamine‑serotonin stabilizer,” functioning as a partial agonist at dopamine D₂/D₃ and serotonin 5‑HT₁A receptors, and as an antagonist at serotonin 5‑HT₂A receptors . Abilify is FDA‑approved for schizophrenia, acute and maintenance treatment of bipolar I disorder, adjunctive therapy for major depressive disorder, irritability in autism spectrum disorder, and Tourette’s disorder . Typical adult dosing ranges from 10 mg to 30 mg once daily, with lower starting doses (2–5 mg) in pediatric and adjunctive depression settings . Common adverse effects include akathisia, insomnia, nausea, and constipation; serious risks encompass neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, and orthostatic hypotension . Tablets should be stored at 20–25 °C, protected from moisture and light .


Composition & Mechanism of Action


Active & Inactive Ingredients


Active: Aripiprazole USP, available in tablets of 2, 5, 10, 15, 20, or 30 mg .


Inactive: Excipients include microcrystalline cellulose, magnesium stearate, croscarmellose sodium, tartaric acid, and colorants (ferric oxides, FD&C Blue No. 2) .



Pharmacodynamics


Dopamine D₂/D₃ Partial Agonism: Modulates dopaminergic tone—stimulating when dopamine is low and blocking when high .


Serotonin 5‑HT₁A Partial Agonism: Contributes to anxiolytic and antidepressant effects .


Serotonin 5‑HT₂A Antagonism: Mitigates psychotic symptoms and reduces extrapyramidal side effects compared to typical antipsychotics .


Inverse Agonism at 5‑HT₂B & Partial Agonism at 5‑HT₂C: May underlie weight‑neutral profile and cardiovascular safety .



Indications


Schizophrenia in adults and adolescents (≥ 13 years) .


Bipolar I Disorder: Acute manic/mixed episodes and maintenance, in adults and pediatric patients (10–17 years) .


Major Depressive Disorder (Adjunctive): With antidepressants in adults with inadequate response .


Irritability in Autism Spectrum Disorder: Pediatric patients 6–17 years .


Tourette’s Disorder: Management of tics in children and adolescents .



Dosage & Administration



Tablet Formulation


Administration: Swallow tablets whole, with or without food .


Titration: Adjust by ≤ 5 mg increments at ≥ 1 week intervals .


Special Populations: Reduce dose by 50 % in CYP2D6 poor metabolizers and when co‑administered with CYP3A4 inhibitors .



Adverse Effects & Warnings


Common


Akathisia, insomnia, headache, nausea, vomiting, constipation, anxiety, restlessness .



Serious


Neuroleptic malignant syndrome, tardive dyskinesia, cerebrovascular events in dementia, orthostatic hypotension, leukopenia, metabolic changes (hyperglycemia, dyslipidemia, weight gain) .



Boxed Warnings


Increased mortality in elderly with dementia‑related psychosis; increased risk of suicidal thoughts and behaviors in children/adolescents .



Contraindications


Hypersensitivity to aripiprazole; use during dementia‑related psychosis .



Storage & Handling


Store tablets at 20–25 °C (68–77 °F), with permitted excursions of 15–30 °C; protect from moisture and light .


Keep out of reach of children.



Availability & Pricing


Manufacturer: Otsuka Pharmaceutical Co., Ltd.; distributed in the U.S. by Otsuka America Pharmaceutical, Inc. .


Packaging: Bottles or blister packs of 30 tablets per strength.


Cost (U.S. Average Wholesale Price): Approximately USD 1,200–1,500 for a 30‑day supply of 15 mg tablets (varies by insurer and pharmacy).




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References


DailyMed: ARIPIPRAZOLE tablet prescribing information 


FDA AccessData: ABILIFY prescribing label 


Drugs.com: Abilify uses and side effects 


Mayo Clinic: Aripiprazole oral route description 


RxLi

st: Abilify (aripiprazole) drug overview 


Drugs.com Medical Q&A: Aripiprazole receptor activity 



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