Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CLOZAPINE (UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)
Jazz Pharmaceuticals, Inc.
CLOZAPINE
CLOZAPINE 50 mg in 1 mL
ORAL
PRESCRIPTION DRUG
VERSACLOZ is 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, VERSACLOZ 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 in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics [see Clinical Studies (14.1)] . VERSACLOZ is 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 that put him/herself at risk for death. The effectivene
Oral Suspension Free-flowing, yellow suspension (50 mg/mL) in amber bottle containing 100 mL. Each box contains 1 x 1 mL oral syringe, 1 x 9 mL oral syringe and 1 bottle adaptor. NDC No. 18860-121-01 Store VERSACLOZ at or below 25°C (77°F). Do not refrigerate or freeze. Protect from light. Shake well for 10 seconds before use. The suspension is stable for 100 days after initial bottle opening. Keep out of reach of children.
New Drug Application
VERSACLOZ- CLOZAPINE SUSPENSION JAZZ PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VERSACLOZ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VERSACLOZ . VERSACLOZ (CLOZAPINE) ORAL SUSPENSION 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._ • • • • • • RECENT MAJOR CHANGES • INDICATIONS AND USAGE VERSACLOZ is an atypical antipsychotic indicated for: • • DOSAGE AND ADMINISTRATION • • • • • • • • DOSAGE FORMS AND STRENGTHS • ® ® SEVERE NEUTROPENIA: CLOZAPINE CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN LEAD TO SERIOUS AND FATAL INFECTIONS. PATIENTS INITIATING AND CONTINUING TREATMENT WITH VERSACLOZ MUST HAVE A BASELINE BLOOD ABSOLUTE NEUTROPHIL COUNT (ANC) MEASURED BEFORE TREATMENT INITIATION AND REGULAR ANC MONITORING DURING TREATMENT (2.1, 5.1). VERSACLOZ 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: VERSACLOZ IS NOT APPROVED FOR THIS CONDITION (5.7). Warnings and Precautions, Falls (5.4) Hepatotoxicity (5.12) 02/2017 Treatment-resistant schizophrenia. Efficacy was established in an active-controlled study (1.1, 14.1). Reducing suicidal behavior in patients with schizophrenia or schizoaffect Olvassa el a teljes dokumentumot