CLOZARIL clozapine tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Novartis Pharmaceuticals Corporation

INN (Internationale Bezeichnung):

CLOZAPINE

Zusammensetzung:

CLOZAPINE 25 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

New Drug Application

Fachinformation

CLOZARIL- CLOZAPINE TABLET
NOVARTIS PHARMACEUTICALS CORPORATION
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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: 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: CLOZARIL CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN
LEAD TO SERIOUS AND FATAL
INFECTIONS. PATIENTS INITIATING AND CONTINUING TREATMENT WITH CLOZARIL
MUST HAVE A BASELINE BLOOD
ABSOLUTE NEUTROPHIL COUNT (ANC) MEASURED BEFORE TREATMENT INITIATION
AND REGULAR ANC MONITORING
DURING TREATMENT (2.1, 5.1).
CLOZARIL 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, 5.4)
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
Indications and Usage (1.1)
9/2015
Boxed Warning, Severe Neutropenia
9/2015
Dosage and Administration, Required Laboratory Testing Prior to
Initiation and During Therapy (2.1),
Discontinuation of Treatment (2.4)
9/2015
Contraindications, Hypersensitivity (4.1)
9/2015
Warnings and Precautions, Severe Neutropenia (5.1), Clozapine REMS
Program (5.2)
9/2015
INDICATIONS AND USAGE
CLOZARIL is an atypical antipsychotic indicated for:
Treatment-resista