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Quetiapine Fumarate

QUETIAPINE FUMARATE

Manufacturer: Golden State Medical Supply, Inc.

Score: 144.0

Quick Summary

Quetiapine fumarate is an atypical antipsychotic used for the treatment of schizophrenia, bipolar I disorder, and major depressive disorder. It has a unique mechanism of action, involving dopamine and serotonin antagonism. The drug is available in various dosages and has a range of potential side effects, including somnolence, dry mouth, and dizziness. Quetiapine fumarate is contraindicated in patients with a known hypersensitivity to the drug or its components. Important safety information includes the risk of increased mortality in elderly patients with dementia-related psychosis, suicidal thoughts and behaviors in children and adolescents, and the potential for extrapyramidal symptoms, such as dystonia and parkinsonism.

Key Clinical Findings and Indications

  • Treatment of schizophrenia
  • Treatment of bipolar I disorder
  • Treatment of major depressive disorder
  • Unique mechanism of action involving dopamine and serotonin antagonism

Important Safety Information

Warning

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

Contraindications

  • Known hypersensitivity to quetiapine or its components

Adverse Reactions

  • Somnolence
  • Dry mouth
  • Dizziness
  • Extrapyramidal symptoms (e.g., dystonia, parkinsonism)

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in elderly patients, patients with hepatic impairment, and patients taking CYP3A4 inhibitors or inducers

Schizophrenia

Adult Dose

25 mg twice daily, increasing to 150-750 mg/day

Pediatric Dose

25 mg twice daily, increasing to 400-800 mg/day (13-17 years old)

Bipolar I disorder

Adult Dose

50 mg twice daily, increasing to 400-800 mg/day

Pediatric Dose

25 mg twice daily, increasing to 400-600 mg/day (10-17 years old)

Special Population Considerations

Pregnancy

  • Pregnancy exposure registry available
  • Animal studies showed embryo-fetal toxicity at doses approximately 1-2 times the maximum recommended human dose

Nursing Mothers

  • Quetiapine is excreted in human milk, caution advised

Pediatric Use

  • Safety and efficacy established in adolescents (13-17 years old) with schizophrenia
  • Safety and efficacy established in children and adolescents (10-17 years old) with bipolar I disorder

Geriatric Use

  • Elderly patients may require lower starting doses and slower titration due to decreased clearance

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