VERSACLOZ- clozapine suspension

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Jazz Pharmaceuticals, Inc.

INN (Международно Name):

CLOZAPINE

Композиция:

CLOZAPINE 50 mg in 1 mL

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

VERSACLOZ is 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, VERSACLOZ 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 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)] . VERSACLOZ is 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 risk for death. The effectivene

Каталог на резюме:

Oral Suspension Free-flowing, yellow suspension (50 mg/mL) in amber bottle containing 100 mL. Each box contains 1 x 1 mL oral syringe, 1 x 9 mL oral syringe and 1 bottle adaptor. NDC No. 18860-121-01 Store VERSACLOZ at or below 25°C (77°F). Do not refrigerate or freeze. Protect from light. Shake well for 10 seconds before use. The suspension is stable for 100 days after initial bottle opening. Keep out of reach of children.

Статус Оторизация:

New Drug Application

Данни за продукта

VERSACLOZ- CLOZAPINE SUSPENSION
JAZZ PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERSACLOZ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VERSACLOZ .
VERSACLOZ (CLOZAPINE) ORAL SUSPENSION
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
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INDICATIONS AND USAGE
VERSACLOZ is an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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SEVERE NEUTROPENIA: CLOZAPINE CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN
LEAD TO SERIOUS AND FATAL
INFECTIONS. PATIENTS INITIATING AND CONTINUING TREATMENT WITH
VERSACLOZ MUST HAVE A BASELINE
BLOOD ABSOLUTE NEUTROPHIL COUNT (ANC) MEASURED BEFORE TREATMENT
INITIATION AND REGULAR ANC
MONITORING DURING TREATMENT (2.1, 5.1).
VERSACLOZ 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, 2.6, 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 AND CARDIOMYOPATHY: 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: VERSACLOZ IS NOT
APPROVED FOR THIS CONDITION (5.7).
Warnings and Precautions, Falls (5.4)
Hepatotoxicity (5.12) 02/2017
Treatment-resistant schizophrenia. Efficacy was established in an
active-controlled study (1.1, 14.1).
Reducing suicidal behavior in patients with schizophrenia or
schizoaffect