FAZACLO- clozapine tablet, orally disintegrating

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

clozapine (UNII: J60AR2IKIC) (clozapine - UNII:J60AR2IKIC)

Mevcut itibaren:

Jazz Pharmaceuticals, Inc.

INN (International Adı):

clozapine

Kompozisyon:

clozapine 12.5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

FAZACLO 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, FAZACLO 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)]. FAZACLO 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 effectiveness o

Ürün özeti:

12.5 mg 1/4-inch diameter round, yellow tablet debossed with “A05” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap …..……………… NDC No. 18860-101-10 25 mg 5/16-inch diameter round, yellow tablet debossed with “A06” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap …..……………… NDC No. 18860-102-10 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card ……………………………….…………………..……….……………... NDC No. 18860-102-01 100 mg 1/2-inch diameter round, yellow tablet debossed with “A08” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap …..……………… NDC No. 18860-104-10 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card ……….…………………………………..….…………….………….… NDC No. 18860-104-01 150 mg 9/16-inch diameter round, yellow tablet debossed with “A09” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap ….…………….… NDC No. 18860-105-10 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card …………………..…………………..…………….………………...….. NDC No. 18860-105-01 200 mg 5/8-inch diameter round, yellow tablet debossed with “A10” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap ……………….… NDC No. 18860-106-10 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card …………………..………………..……..…………………..….…….… NDC No. 18860-106-01 Store FAZACLO at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F). (See USP Controlled Room Temperature.) Protect from moisture. KEEP OUT OF REACH OF CHILDREN. FAZACLO tablets must remain in the original package until used by the patient. 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 FAZACLO can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of FAZACLO can be dispensed. Dispensing should be contingent upon the ANC testing results.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

FAZACLO- CLOZAPINE TABLET, ORALLY DISINTEGRATING
JAZZ PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FAZACLO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FAZACLO.
FAZACLO (CLOZAPINE) ORALLY DISINTEGRATING TABLETS
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
FAZACLO is an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Orally disintegrating 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg
tablets (3)
CONTRAINDICATIONS
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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 FAZACLO
MUST HAVE A BASELINE BLOOD
ABSOLUTE NEUTROPHIL COUNT (ANC) MEASURED BEFORE TREATMENT INITIATION
AND REGULAR ANC MONITORING
DURING TREATMENT (2.1, 5.1).
FAZACLO 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: FAZACLO IS NOT APPROVED
FOR THIS CONDITION (5.7).
Warnings and Precautions, Gastrointestinal Hypomotility with Severe
Complications
(5.8) 02/2020
Warnings and Precautions, Anticholinergi