CLOZARIL- clozapine tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CLOZAPINE (UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)

Boleh didapati daripada:

TYA Pharmaceuticals

INN (Nama Antarabangsa):

CLOZAPINE

Komposisi:

CLOZAPINE 25 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

CLOZARIL is indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the significant risk of agranulocytosis and 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, 5.4)] 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 action

Ringkasan produk:

NDC:64725-1260-1 in a CONTAINER of 30 TABLETS CLOZARIL® (clozapine) is available as 25 mg and 100 mg round, pale-yellow, uncoated tablets with a facilitated score on one side. Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.

Status kebenaran:

New Drug Application

Ciri produk

CLOZARIL- CLOZAPINE TABLET
TYA PHARMACEUTICALS
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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: AGRANULOCYTOSIS; 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._
AGRANULOCYTOSIS: CAN LEAD TO SERIOUS INFECTION AND DEATH. MONITOR
WHITE BLOOD CELL COUNT AND ABSOLUTE
NEUTROPHIL COUNT PRIOR TO AND DURING TREATMENT. MONITOR FOR SYMPTOMS
OF AGRANULOCYTOSIS AND
INFECTION. ( , ) 2.15.1
BECAUSE OF RISK OF AGRANULOCYTOSIS, CLOZARIL IS AVAILABLE ONLY THROUGH
A RESTRICTED PROGRAM CALLED
THE CLOZARIL NATIONAL REGISTRY. PRESCRIBERS, PATIENTS, AND PHARMACIES
MUST ENROLL IN THE PROGRAM. ( )
5.2
ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE: RISK IS
DOSE-RELATED. STARTING DOSE IS 12.5 MG.
TITRATE GRADUALLY AND USE DIVIDED DOSAGES. ( , , ) 2.22.55.3
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. ( , ) 2.25.4
MYOCARDITIS AND CARDIOMYOPATHY: CAN BE FATAL. DISCONTINUE AND OBTAIN
CARDIAC EVALUATION IF FINDINGS
SUGGEST THESE CARDIAC REACTIONS. ( ) 5.5
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS: CLOZARIL IS NOT APPROVED
FOR THIS CONDITION. ( ) 5.6
RECENT MAJOR CHANGES
Dosage and Administration ( , , ) 07/2013 2.12.62.7
Contraindications ( ) 07/2013 4
Warnings and Precautions ( , ) 07/2013 5.25.3
INDICATIONS AND USAGE
CLOZARIL is an atypical antipsychotic indicated for:
Treatment-resistant schizophrenia. Efficacy was established in an
active-controlled study. ( , ) 1.114.1
Reducing suicidal behavior in patients with schizophrenia or
schizoaffective disorder. Efficacy was established in an
active-control