CLOZAPINE (AUROBINDO) TAB
Clinical Criteria Summary
Indications
- Treatment-resistant schizophrenia
- Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder
Contraindications
- Hypersensitivity to clozapine or any other component of clozapine
Boxed Warnings
- Severe neutropenia
- Orthostatic hypotension, bradycardia, syncope
- Seizures
- Myocarditis, pericarditis, cardiomyopathy, and mitral valve incompetence
- Increased mortality in elderly patients with dementia-related psychosis
Precautions
- Eosinophilia
- QT interval prolongation
- Metabolic Changes
- Neuroleptic malignant syndrome
- Hepatotoxicity
- Fever
- Pulmonary embolism
- Anticholinergic toxicity
- Interference with cognitive and motor performance
- Use with caution in patients with decreased GI motility
- Special populations: Poor metabolizers of CYP2D6; Smokers via CYP1A2 induction – with respect to forced absence during hospitalization
Dosing
- Starting Dose: 12.5 mg once daily or twice daily
- Use cautious titration and divided dosage schedule
- Titration: increase the total daily dosage in increments of 25 mg to 50 mg per day, if well-tolerated
- Target dose: 300 mg to 450 mg per day, in divided doses, by the end of 2 weeks
- Subsequent increases: increase in increments of 100 mg or less, once, or twice weekly
- Maximum daily dose: 900 mg
ANC Monitoring Recommendations
- Obtain baseline ANC before treatment initiation
- Weekly from initiation to 6 months
- Every 2 weeks from 6 to 12 months (if the ANC remains in the normal range; ANC greater than or equal to 1500/μL for the general population, ANC greater than or equal to 1000/μL for patients with Benign Ethnic Neutropenia)
- Monthly after 12 months, using shared decision making (if ANC continues to remain in the normal range)