CLOZAPINE tablet, orally disintegrating

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Teva Pharmaceuticals USA, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Clozapine orally disintegrating 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 orally disintegrating 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 orally disintegrating tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine orally disintegrating tablets and chlorpromazine in patients who had failed other antipsychotics [see Clinical Studies (14.1)]. Clozapine orally disintegrating 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

Produkto santrauka:

150 mg Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with I1 on one side and plain on the other side. Available in bottles of 100 (NDC 0093-5376-01) and cartons of 48 tablets for Institutional Use Only (8x6 blister cards) (NDC 0093-5376-84). 200 mg Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with L1 on one side and plain on the other side. Available in bottles of 100 (NDC 0093-5377-01) and cartons of 48 tablets for Institutional Use Only (8x6 blister cards) (NDC 0093-5377-84). Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CLOZAPINE- CLOZAPINE TABLET, ORALLY DISINTEGRATING
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOZAPINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CLOZAPINE ORALLY DISINTEGRATING TABLETS.
CLOZAPINE ORALLY DISINTEGRATING 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 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, 2.6,
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: CLOZAPINE
IS NOT APPROVED FOR THIS CONDITION. (5.7)
INDICATIONS AND USAGE
Clozapine orally disintegrating 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 schizophrenia or
schizoaffective disorder. Efficacy was
established in an active-controlled study. (1.2, 14.2)
DOSAGE AN