Abilify Asimtufii

ARIPIPRAZOLE

Manufacturer: Otsuka America Pharmaceutical, Inc

Score: 144.0

Quick Summary

Aripiprazole is an atypical antipsychotic used for the treatment of schizophrenia. It has a unique mechanism of action, with partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors, and antagonist activity at serotonin 5-HT2A receptors. The drug is available in orally disintegrating tablets and has a recommended starting dose of 10-15 mg/day for adults and 2 mg/day for adolescents, with a maximum dose of 30 mg/day. Aripiprazole has been shown to be effective in treating schizophrenia, but it also carries important safety information, including a boxed warning for increased mortality in elderly patients with dementia-related psychosis and a risk of suicidal thoughts and behaviors in children, adolescents, and young adults. The drug is contraindicated in patients with a history of hypersensitivity reaction to aripiprazole. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of schizophrenia
Partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors
Antagonist activity at serotonin 5-HT2A receptors
Effective in treating schizophrenia in adults and adolescents

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis and risk of suicidal thoughts and behaviors in children, adolescents, and young adults

Contraindications

History of hypersensitivity reaction to aripiprazole

Adverse Reactions

Extrapyramidal disorder
Somnolence
Tremor
Nausea
Vomiting
Constipation
Headache
Dizziness
Akathisia
Insomnia
Restlessness

Dosing Recommendations

General Guidance

Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers

Schizophrenia

Adult Dose

10-15 mg/day

Pediatric Dose

2 mg/day (for adolescents 13-17 years old)

Special Population Considerations

Pregnancy

Pregnancy Category C
Risk of extrapyramidal and/or withdrawal symptoms in neonates

Nursing Mothers

Aripiprazole is present in human breast milk
Decision should be made whether to discontinue nursing or to discontinue the drug

Pediatric Use

Safety and effectiveness established in pediatric patients 13-17 years old with schizophrenia
Juvenile animal studies showed mortality, CNS clinical signs, impaired memory and learning, and delayed sexual maturation

Geriatric Use

No dosage adjustment is recommended for elderly patients
Aripiprazole is not approved for the treatment of patients with psychosis associated with Alzheimer's disease

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