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Aripiprazole

ARIPIPRAZOLE ORAL

Manufacturer: Camber Pharmaceuticals, Inc.

Score: 144.0

Quick Summary

Aripiprazole is an atypical antipsychotic used for the treatment of schizophrenia, bipolar 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 drug is available as an oral solution and has various dosing recommendations for different conditions and patient populations. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Schizophrenia
  • Bipolar disorder
  • Irritability associated with autistic disorder
  • 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
  • Fatigue
  • Nausea
  • Akathisia
  • Blurred vision
  • Salivary hypersecretion
  • Dizziness

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with hepatic or renal impairment, or those taking concomitant medications that affect CYP2D6 or CYP3A4

Schizophrenia

Adult Dose

10-15 mg/day

Pediatric Dose

2 mg/day, titrated to 10 mg/day

Bipolar disorder

Adult Dose

15 mg/day

Pediatric Dose

2 mg/day, titrated to 10 mg/day

Irritability associated with autistic disorder

Adult Dose

Not recommended

Pediatric Dose

2 mg/day, titrated to 5-10 mg/day

Tourette's disorder

Adult Dose

Not recommended

Pediatric Dose

2 mg/day, titrated to 5-10 mg/day

Special Population Considerations

Pregnancy

  • Pregnancy category C
  • Use during pregnancy only if potential benefit justifies potential risk to fetus

Nursing Mothers

  • Aripiprazole is excreted in human breast milk
  • Caution should be exercised when administering to nursing mothers

Pediatric Use

  • Safety and efficacy established in pediatric patients 10-17 years old with schizophrenia and bipolar disorder
  • Safety and efficacy established in pediatric patients 6-17 years old with irritability associated with autistic disorder

Geriatric Use

  • No dosage adjustment recommended for elderly patients
  • Use with caution in elderly patients with dementia-related psychosis