Clozapine is the generic equivalent of the brand-name drug CLOZAPINE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Clozapine through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Clozapine tablets is an atypical antipsychotic indicated for: Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment. (1.1) Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior. (1.2) 1.1 Treatment-Resistant Schizophrenia Clozapine tablets are indicated for the treatment…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Severe Neutropenia [see Warnings and Precautions (5.1) ] Orthostatic Hypotension, Bradycardia, and Syncope [see Warnings and Precautions (5.2) ] Falls [see Warnings and Precautions (5.3) ] Seizures [see Warnings and Precautions (5.4) ] Myocarditis, Pericarditis, Cardiomyopathy, and Mitral Valve Incompetence [see Warnings and Precautions (5.5) ] Increased Mortality in Elderly Patien…
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of Strong CYP1A2 Inhibitors: Reduce clozapine dose to one-third when coadministered with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin). ( 2.7 , 7.1 ) Concomitant use of Strong CYP3A4 Inducers is not recommended. ( 2. 7 , 7.1 ) Discontinuation of CYP1A2 or CYP3A4 Inducers: Consider reducing clozapine dose when CYP1A2 inducers (e.g., tobacco smoke) or CYP3A4 inducers (e.g., carbamazepine) are discontinued. ( 2.7 , 7.1 ) Anticholinergic dr…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended starting oral dosage is 12.5 mg once daily or twice daily. ( 2.2 ) If well-tolerated, increase the total daily dosage in increments of 25 mg to 50 mg per day to achieve a target dosage of 150 mg to 225 mg twice per day by the end of two weeks ( 2.2 ). Subsequently may increase the dosage in increments up to 100 mg once or twice weekly ( 2.2 ). Maximum dosage is 450 mg twice daily ( 2.2 ). Administer with or without food (2.2) . See the dosage modifications…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Discuss the following issues with patients and caregivers: Severe Neutropenia: Instruct patients (and caregivers) [see Warnings and Precautions (5.1)]: - About the risk of developing severe neutropenia and infection with clozapine tablets treatment. - Instruct patients to immediately report to their health care provider any symptom or sign of during clozapine tablets treatment. - About the importance of having frequent ANC testing. Orthostatic Hypotension, Bradycardia, and Syncope…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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