CLOZAPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clozapine (UNII: J60AR2IKIC) (Clozapine - UNII:J60AR2IKIC)

Available from:

Mayne Pharma

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 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 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/herself at

Product summary:

Clozapine tablets are available as 25 mg, 50 mg, and 100 mg round, flat face, bevel edge, pale-yellow, tablets with a score on one side and as a 200 mg oval shape, pale-yellow tablet with a score on one side. Clozapine Tablets 25 mg Engraved with "25 " on one side and engraved with "W " score "P " on the other side. 50 mg Engraved with "50 " on one side and engraved with "W " score "P " on the other side. 100 mg Engraved with "WPI " score "100 " on one side and engraved with "2529 " on the other side. 200 mg Engraved with "200 " on one side and engraved with "W " score "P " on the other side. 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
MAYNE PHARMA
----------
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 TABLETS CAN CAUSE SEVERE NEUTROPENIA,
WHICH CAN
LEAD TO SERIOUS AND FATAL INFECTIONS. PATIENTS INITIATING AND
CONTINUING TREATMENT WITH
CLOZAPINE TABLETS MUST HAVE A BASELINE BLOOD ABSOLUTE NEUTROPHIL COUNT
(ANC)
MEASURED BEFORE TREATMENT INITIATION AND REGULAR ANC MONITORING DURING
TREATMENT
(2.1, 5.1).
CLOZAPINE TABLETS ARE 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
TABLETS ARE NOT APPROVED FOR THIS CONDITION (5.7).
RECENT MAJOR CHANGES
Warnings and Precautions, Gastrointestinal Hypomotility with Severe
Complications (5.8)
02/20
Warnings and Precautions, Anticholinergic Toxicity (5.16)
02/20
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 schizoph