CLOZAPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CLOZAPINE

Composition:

CLOZAPINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 their 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 that put him/he

Product summary:

Clozapine Tablets, USP are available as pale yellow, round tablets, debossed “Ivax hourglass logo” and “4359” on one side and “25” and a bisect on the other side, containing 25 mg clozapine, USP. NDC 0093-4359 -01 25 mg packaged in bottles of 100 tablets NDC 0093-4359 -05 25 mg packaged in bottles of 500 tablets NDC 0093-4359 -93 25 mg packaged in unit-dose boxes of 100 tablets Clozapine Tablets, USP are available as pale yellow, round, flat-faced, beveled-edge tablets, debossed “Ivax hourglass logo” and “4404” on one side and “50” and a bisect on the other side, containing 50 mg clozapine, USP. NDC 0093-4404 -01 50 mg packaged in bottles of 100 tablets NDC 0093-4404 -05 50 mg packaged in bottles of 500 tablets NDC 0093-4404 -93 50 mg packaged in unit-dose boxes of 100 tablets Clozapine Tablets, USP are available as pale yellow, round, flat-faced, beveled-edge tablets, debossed “Ivax hourglass logo” and “7772” on one side and “100” and a bisect on the other side, containing 100 mg clozapine, USP. NDC 0093-7772 -01 100 mg packaged in bottles of 100 tablets NDC 0093-7772 -05 100 mg packaged in bottles of 500 tablets NDC 0093-7772 -93 100 mg packaged in unit-dose boxes of 100 tablets Clozapine Tablets, USP are available as pale yellow, oval-shaped, biconvex tablets, debossed “Ivax hourglass logo” and “4405” on one side and “200” and a deep bisect on the other side, containing 200 mg clozapine, USP. NDC 0093-4405 -01 200 mg packaged in bottles of 100 tablets NDC 0093-4405 -05 200 mg packaged in bottles of 500 tablets NDC 0093-4405 -93 200 mg packaged in unit-dose boxes of 100 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOZAPINE- CLOZAPINE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
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).
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-controlled study (1.2, 14.2).
DOSAGE AND ADMINISTRATION
Starting Dose: 12.5 mg once daily or twice daily (2.2).
Use cautiou