CLOZAPINE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Cardinal Health

INN (Διεθνής Όνομα):

Clozapine

Σύνθεση:

Clozapine 100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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. 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CLOZAPINE- CLOZAPINE TABLET
CARDINAL HEALTH
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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._
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RECENT MAJOR CHANGES
Warnings and Precautions, Myocarditis, Cardiomyopathy and Mitral Valve
Incompetence (5.6) 12/2016
Warnings and Precautions, Falls (5.4), Hepatotoxicity (5.12) 02/2017
INDICATIONS AND USAGE
Clozapine tablets are an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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).
Treatment-resistant sc