Fazaclo ODT
Fazaclo ODT is an atypical antipsychotic medication available as an orally disintegrating tablet. Because of the risk of severe neutropenia (low white blood cell count), it is only available through a restricted distribution program called the Clozapine REMS (Risk Evaluation and Mitigation Strategy). Regular blood monitoring is mandatory during treatment.
Dosage by Body Weight
Dosage must be highly individualized. The starting dose is usually 12.5 mg once or twice daily. The dosage may be increased slowly by 25 mg to 50 mg per day to a target therapeutic dose of 300 mg to 450 mg per day. The maximum recommended daily dose is 900 mg. Disintegrating tablets should be allowed to dissolve on the tongue and swallowed with saliva; no water is needed.
- Body Weight
- Below 5 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and effectiveness in pediatric patients below the age of 18 have not been established.
- Body Weight
- 5-7 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and effectiveness in pediatric patients below the age of 18 have not been established.
- Body Weight
- 8-10 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and effectiveness in pediatric patients below the age of 18 have not been established.
- Body Weight
- 11-15 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and effectiveness in pediatric patients below the age of 18 have not been established.
- Body Weight
- 16-20 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and effectiveness in pediatric patients below the age of 18 have not been established.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not recommended | N/A | Safety and effectiveness in pediatric patients below the age of 18 have not been established. |
| 5-7 kg | Not recommended | N/A | Safety and effectiveness in pediatric patients below the age of 18 have not been established. |
| 8-10 kg | Not recommended | N/A | Safety and effectiveness in pediatric patients below the age of 18 have not been established. |
| 11-15 kg | Not recommended | N/A | Safety and effectiveness in pediatric patients below the age of 18 have not been established. |
| 16-20 kg | Not recommended | N/A | Safety and effectiveness in pediatric patients below the age of 18 have not been established. |
Formulation
Purpose
Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment, and to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.
Generic Name
ClozapineScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.