CLOZAPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Accord Healthcare Inc.

INN (International Name):

CLOZAPINE

Composition:

CLOZAPINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clozapine 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, clozapine 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)] . Clozapine is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judge

Product summary:

Clozapine tablets USP, 25 mg are pale yellow, oval shaped, flat faced, beveled edged, uncoated tablets, debossed with 25 on one side and break line on other side.           NDC 16729- 141 -01 bottles of 100’s count with child-resistant closure           NDC 16729- 141 -16 bottles of 500’s count Clozapine tablets USP, 100 mg are pale yellow, oval-shaped, flat faced, beveled edged, uncoated tablets, debossed with 100 on one side and break line on other side.           NDC 16729- 142 -01 bottles of 100’s count with child-resistant closure           NDC 16729- 142 -16 bottles of 500’s count Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOZAPINE- CLOZAPINE TABLET
ACCORD HEALTHCARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOZAPINE TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOZAPINE
TABLETS USP.
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 is 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-controlle