Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
CLOZAPINE (UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)
American Health Packaging
ORAL
PRESCRIPTION DRUG
Clozapine tablets are indicated for the 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 [see Warnings and Precautions (5.1, 5.5)]. The effectiveness of clozapine tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine tablets and chlorpromazine in patients who had failed other antipsychotics [see Clinical Studies (14.1)]. Clozapine tablets are indicated for 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, based on history and recent clinical state. Suicidal behavior refers to actions by a patient
Clozapine Tablets USP, 25 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘54’ on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-404-01 Clozapine Tablets USP, 50 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘55’ on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-548-01 Clozapine Tablets USP, 100 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘57’ on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-415-01 Clozapine Tablets USP, 200 mg are pale yellow colored, oval shaped, uncoated tablets debossed with ‘C scoreline (functional) C’ on one side and ‘71’ on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-426-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
CLOZAPINE- CLOZAPINE TABLET AMERICAN HEALTH PACKAGING ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOZAPINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOZAPINE TABLETS. CLOZAPINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1989 WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ . SEVERE NEUTROPENIA: CLOZAPINE CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN LEAD TO SERIOUS AND FATAL INFECTIONS. PATIENTS INITIATING AND CONTINUING TREATMENT WITH CLOZAPINE MUST HAVE A BASELINE BLOOD ABSOLUTE NEUTROPHIL COUNT (ANC) MEASURED BEFORE TREATMENT INITIATION AND REGULAR ANC MONITORING DURING TREATMENT ( 2.1, 5.1). CLOZAPINE IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE CLOZAPINE REMS 5.2). ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE: RISK IS DOSE-RELATED. STARTING DOSE IS 12.5 MG. TITRATE GRADUALLY AND USE DIVIDED DOSAGES. ( 2.2, 2.5, 5.3) SEIZURE: RISK IS DOSE-RELATED. TITRATE GRADUALLY AND USE DIVIDED DOSES. USE WITH CAUTION IN PATIENTS WITH HISTORY OF SEIZURE OR RISK FACTORS FOR SEIZURE. ( 2.2, 5.5) MYOCARDITIS, CARDIOMYOPATHY AND MITRAL VALVE INCOMPETENCE: CAN BE FATAL. DISCONTINUE AND OBTAIN CARDIAC EVALUATION IF FINDINGS SUGGEST THESE CARDIAC REACTIONS. ( 5.6) INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: CLOZAPINE IS NOT APPROVED FOR THIS CONDITION. ( 5.7) RECENT MAJOR CHANGES Warnings and Precautions, Gastrointestinal Hypomotility with Severe Complications ( 5.8) 12/2022 INDICATIONS AND USAGE Clozapine tablets are an atypical antipsychotic indicated for: Treatment-resistant schizophrenia. Efficacy was established in an active-controlled study. (1.1, 14.1) Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Efficacy was established in an active- cont Läs hela dokumentet