Clozapine
Clozapine is an atypical antipsychotic medication. Due to the risk of severe neutropenia (agranulocytosis), which can lead to serious and life-threatening infections, clozapine is only available through a restricted program called the Clozapine REMS (Risk Evaluation and Mitigation Strategy). Regular blood monitoring of the Absolute Neutrophil Count (ANC) is mandatory.
Dosage by Body Weight
Treatment is started at a very low dose (usually 12.5 mg once or twice daily) and slowly increased (titrated) over several weeks to a target dose of 300 mg to 450 mg per day. The maximum recommended dose is 900 mg per day. Strict adherence to blood testing schedules is required to continue receiving the medication.
- Body Weight
- Below 5 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and effectiveness in pediatric patients have not been established. Highly contraindicated in this weight range.
- Body Weight
- 5-7 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Atypical antipsychotics like clozapine are not indicated for infants or toddlers in this weight group.
- Body Weight
- 8-10 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Not recommended for use. Pediatric schizophrenia is extremely rare in this age/weight group.
- Body Weight
- 11-15 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and efficacy are not established. Any use requires extreme caution and specialist supervision.
- Body Weight
- 16-20 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Generally not recommended. Only considered in highly exceptional, treatment-resistant adolescent cases under strict specialist guidance.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not recommended | N/A | Safety and effectiveness in pediatric patients have not been established. Highly contraindicated in this weight range. |
| 5-7 kg | Not recommended | N/A | Atypical antipsychotics like clozapine are not indicated for infants or toddlers in this weight group. |
| 8-10 kg | Not recommended | N/A | Not recommended for use. Pediatric schizophrenia is extremely rare in this age/weight group. |
| 11-15 kg | Not recommended | N/A | Safety and efficacy are not established. Any use requires extreme caution and specialist supervision. |
| 16-20 kg | Not recommended | N/A | Generally not recommended. Only considered in highly exceptional, treatment-resistant adolescent cases under strict specialist guidance. |
Formulation
Purpose
Treatment-resistant schizophrenia and reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.
Generic Name
ClozapineBranded Drug Names
Clozapine is listed as a generic drug name. Common branded medicines that may contain the same active ingredient include:
Scheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.