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Clozapine

CLOZAPINE

Manufacturer: Mylan Institutional Inc.

Score: 148.0

Quick Summary

Clozapine is an atypical antipsychotic used for treatment-resistant schizophrenia and reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. It has a black box warning for severe neutropenia, orthostatic hypotension, bradycardia, syncope, seizures, myocarditis, cardiomyopathy, and increased mortality in elderly patients with dementia-related psychosis. The initial dose is 12.5 mg once or twice daily, with gradual titration to a target dose of 300-450 mg/day. Special considerations are needed for patients with renal or hepatic impairment, CYP2D6 poor metabolizers, pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment-resistant schizophrenia
  • Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder

Important Safety Information

Warning

Severe neutropenia, orthostatic hypotension, bradycardia, syncope, seizures, myocarditis, cardiomyopathy, and increased mortality in elderly patients with dementia-related psychosis

Contraindications

  • History of serious hypersensitivity to clozapine or any other component of clozapine orally disintegrating tablets

Adverse Reactions

  • CNS reactions (sedation, dizziness/vertigo, headache, and tremor)
  • Cardiovascular reactions (tachycardia, hypotension, and syncope)
  • Autonomic nervous system reactions (hypersalivation, sweating, dry mouth, and visual disturbances)
  • Gastrointestinal reactions (constipation and nausea)
  • Fever

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with concomitant use of CYP1A2, CYP2D6, or CYP3A4 inhibitors or inducers

Treatment-resistant schizophrenia

Adult Dose

12.5 mg once or twice daily, with gradual titration to a target dose of 300-450 mg/day

Pediatric Dose

Special Population Considerations

Pregnancy

  • Category B
  • Use during pregnancy only if clearly needed

Nursing Mothers

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

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established

Geriatric Use

  • Elderly patients may be more susceptible to orthostatic hypotension and tachycardia
  • Carefully select doses in elderly patients, taking into consideration their greater frequency of decreased hepatic, renal, or cardiac function
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