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Olanzapine

OLANZAPINE

Manufacturer: Macleods Pharmaceuticals Limited

Score: 144.0

Quick Summary

Olanzapine is an atypical antipsychotic used to treat schizophrenia and bipolar I disorder. It has a boxed warning for increased mortality in elderly patients with dementia-related psychosis. The recommended starting dose for adults is 5 to 10 mg once daily, and for adolescents, it is 2.5 to 5 mg once daily. Olanzapine can cause various side effects, including weight gain, somnolence, and increased risk of diabetes and dyslipidemia. Special considerations are needed for patients with hepatic or renal impairment, and for pregnant and nursing women.

Key Clinical Findings and Indications

  • Treatment of schizophrenia in adults and adolescents
  • Treatment of bipolar I disorder (manic or mixed episodes) in adults and adolescents
  • Treatment of depressive episodes associated with bipolar I disorder in adults
  • Treatment of treatment-resistant depression in adults

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

  • None with olanzapine tablets monotherapy

Adverse Reactions

  • Weight gain
  • Somnolence
  • Increased risk of diabetes and dyslipidemia
  • Extrapyramidal symptoms
  • Seizures

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with hepatic or renal impairment

Schizophrenia

Adult Dose

Start at 5 to 10 mg once daily, target dose 10 mg/day

Pediatric Dose

Start at 2.5 to 5 mg once daily, target dose 10 mg/day

Bipolar I disorder (manic or mixed episodes)

Adult Dose

Start at 10 or 15 mg once daily

Pediatric Dose

Start at 2.5 to 5 mg once daily, target dose 10 mg/day

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including olanzapine, during pregnancy

Nursing Mothers

  • Olanzapine is present in human milk, and there is a potential for serious adverse reactions in nursing infants

Pediatric Use

  • Safety and effectiveness of olanzapine in children under 13 years of age have not been established

Geriatric Use

  • Of the 2500 patients in premarketing clinical studies with oral olanzapine, 11% (263) were 65 years of age or over
  • Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo

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