CLOZAPINE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Actavis Pharma, Inc.

INN (আন্তর্জাতিক নাম):

CLOZAPINE

রচনা:

CLOZAPINE 25 mg

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CLOZAPINE- CLOZAPINE TABLET
ACTAVIS PHARMA, 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 USP, 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, 5.4).
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: CLOZAPINE IS NOT APPROVED
FOR THIS CONDITION (5.6).
RECENT MAJOR CHANGES
Indications and Usage (1.1) 09/2015
Boxed Warning, Severe Neutropenia 09/2015
Dosage and Administration, Required Laboratory Testing Prior to
Initiation and During Therapy (2.1), Discontinuation
of Treatment(2.4) 09/2015
Contraindications, History of Clozapine-induced Agranulocytosis or
Severe Granulocytopenia (4), Hypersensitivity
(4.1) 09/2015
Warnings and Precautions, Severe Neutropenia (5.1), Clozapine REMS
Program (5.2)
09/2015
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