Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CLOZAPINE (UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)
HLS Therapeutics (USA), Inc.
CLOZAPINE
CLOZAPINE 25 mg
ORAL
PRESCRIPTION DRUG
CLOZARIL 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, CLOZARIL 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 CLOZARIL in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing CLOZARIL and chlorpromazine in patients who had failed other antipsychotics [see Clinical Studies (14.1)] . CLOZARIL 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 effectiveness of C
CLOZARIL ® (clozapine) Tablets 25 mg Round, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on the periphery of one side. Debossed with a facilitated score and “25” once on the other side. Bottle of 100 NDC 69809-0126-05 50 mg Round, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on the periphery of one side. Debossed with “50”, a facilitated score and “mg” on the other side. Bottle of 100 NDC 69809-0130-05 100 mg Round, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on the periphery of one side. Debossed with a facilitated score and “100” once on the other side. Bottle of 100 NDC 69809-0127-05 200 mg Capsule-shaped, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on one side. Debossed with “200”, a facilitated score and “mg” on the other side. Bottle of 100 NDC 69809-0135-05 Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.
New Drug Application
CLOZARIL- CLOZAPINE TABLET HLS THERAPEUTICS (USA), INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOZARIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOZARIL. CLOZARIL (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._ • • • • • • RECENT MAJOR CHANGES Boxed Warning 05/2023 Dosage and Administration (2.5) 05/2023 Warnings and Precautions, Orthostatic Hypotension, Bradycardia, and Syncope (5.3) 05/2023 Warnings and Precautions, Gastrointestinal Hypomotility with Severe Complications (5.8) 12/2022 INDICATIONS AND USAGE CLOZARIL is an atypical antipsychotic indicated for: • • DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS 25 mg, 50 mg, 100 mg and 200 mg tablets with a facilitated score on one side (3) CONTRAINDICATIONS Known serious hypersensitivity to clozapine or any other component of CLOZARIL. (4) ® SEVERE NEUTROPENIA: CLOZARIL CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN LEAD TO SERIOUS AND FATAL INFECTIONS. PATIENTS INITIATING AND CONTINUING TREATMENT WITH CLOZARIL MUST HAVE A BASELINE BLOOD ABSOLUTE NEUTROPHIL COUNT (ANC) MEASURED BEFORE TREATMENT INITIATION AND REGULAR ANC MONITORING DURING TREATMENT (2.1, 5.1). CLOZARIL 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 CARDI Belgenin tamamını okuyun