CLOZAPINE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

American Health Packaging

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

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