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Aripiprazole

ARIPIPRAZOLE ORALLY DISINTEGRATING

Manufacturer: Dr. Reddy's Laboratories Inc

Score: 144.0

Quick Summary

Aripiprazole is an atypical antipsychotic used for the treatment of schizophrenia, bipolar mania, major depressive disorder, irritability associated with autistic disorder, and Tourette's disorder. It has a boxed warning for increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors in children, adolescents, and young adults. The recommended dosing varies by condition, with adjustments needed for certain populations, such as pediatric and geriatric patients.

Key Clinical Findings and Indications

  • 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

Important Safety Information

Warning

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

Contraindications

  • Known hypersensitivity to aripiprazole

Adverse Reactions

  • Extrapyramidal disorder
  • Somnolence
  • Tremor
  • Akathisia
  • Insomnia
  • Restlessness
  • Fatigue
  • Blurred vision
  • Nausea
  • Vomiting
  • Constipation
  • Headache
  • Dizziness

Dosing Recommendations

General Guidance

Dosage adjustments needed for certain populations, such as pediatric and geriatric patients, and for concomitant use with other medications

Schizophrenia

Adult Dose

10-15 mg/day

Pediatric Dose

2 mg/day (titrated to 10 mg/day)

Bipolar mania

Adult Dose

15-30 mg/day

Pediatric Dose

2 mg/day (titrated to 10-30 mg/day)

Major depressive disorder

Adult Dose

2-15 mg/day

Pediatric Dose

Not established

Irritability associated with autistic disorder

Adult Dose

Not established

Pediatric Dose

2 mg/day (titrated to 5-15 mg/day)

Tourette's disorder

Adult Dose

Not established

Pediatric Dose

2 mg/day (titrated to 5-20 mg/day)

Special Population Considerations

Pregnancy

  • Pregnancy exposure registry available
  • Use during pregnancy may increase risk of extrapyramidal and/or withdrawal symptoms in neonates

Nursing Mothers

  • Aripiprazole is present in human milk
  • Caution advised when administering to nursing mothers

Pediatric Use

  • Safety and effectiveness established for schizophrenia, bipolar mania, and irritability associated with autistic disorder
  • Not established for major depressive disorder

Geriatric Use

  • No dosage adjustment recommended for elderly patients
  • Increased risk of mortality and other adverse reactions in elderly patients with dementia-related psychosis

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