País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
CLOZAPINE (UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)
Teva Pharmaceuticals USA, Inc.
ORAL
PRESCRIPTION DRUG
Clozapine orally disintegrating 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 their use, clozapine orally disintegrating 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 orally disintegrating tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine orally disintegrating tablets and chlorpromazine in patients who had failed other antipsychotics [see Clinical Studies (14.1)]. Clozapine orally disintegrating 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
150 mg Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with I1 on one side and plain on the other side. Available in bottles of 100 (NDC 0093-5376-01) and cartons of 48 tablets for Institutional Use Only (8x6 blister cards) (NDC 0093-5376-84). 200 mg Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with L1 on one side and plain on the other side. Available in bottles of 100 (NDC 0093-5377-01) and cartons of 48 tablets for Institutional Use Only (8x6 blister cards) (NDC 0093-5377-84). Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results.
Abbreviated New Drug Application
CLOZAPINE- CLOZAPINE TABLET, ORALLY DISINTEGRATING TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOZAPINE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOZAPINE ORALLY DISINTEGRATING TABLETS. CLOZAPINE ORALLY DISINTEGRATING 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, 2.6, 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 AND CARDIOMYOPATHY: 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) INDICATIONS AND USAGE Clozapine orally disintegrating 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-controlled study. (1.2, 14.2) DOSAGE AN Leer el documento completo