CLOZARIL- clozapine tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

HLS Therapeutics (USA), Inc.

INN (Rahvusvaheline Nimetus):

CLOZAPINE

Koostis:

CLOZAPINE 25 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

CLOZARIL ® (clozapine) Tablets 25 mg Round, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on the periphery of one side. Debossed with a facilitated score and “25” once on the other side. Bottle of 100 NDC 69809-0126-05 50 mg Round, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on the periphery of one side. Debossed with “50”, a facilitated score and “mg” on the other side. Bottle of 100 NDC 69809-0130-05 100 mg Round, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on the periphery of one side. Debossed with a facilitated score and “100” once on the other side. Bottle of 100 NDC 69809-0127-05 200 mg Capsule-shaped, pale-yellow, uncoated tablet. Debossed with “CLOZARIL” once on one side. Debossed with “200”, a facilitated score and “mg” on the other side. Bottle of 100 NDC 69809-0135-05 Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.

Volitamisolek:

New Drug Application

Toote omadused

CLOZARIL- CLOZAPINE TABLET
HLS THERAPEUTICS (USA), INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOZARIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOZARIL.
CLOZARIL (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
Boxed Warning 05/2023
Dosage and Administration (2.5) 05/2023
Warnings and Precautions, Orthostatic Hypotension,
Bradycardia, and Syncope (5.3) 05/2023
Warnings and Precautions, Gastrointestinal Hypomotility with
Severe Complications (5.8) 12/2022
INDICATIONS AND USAGE
CLOZARIL is an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
25 mg, 50 mg, 100 mg and 200 mg tablets with a facilitated score on
one side (3)
CONTRAINDICATIONS
Known serious hypersensitivity to clozapine or any other component of
CLOZARIL. (4)
®
SEVERE NEUTROPENIA: CLOZARIL CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN
LEAD TO
SERIOUS AND FATAL INFECTIONS. PATIENTS INITIATING AND CONTINUING
TREATMENT WITH
CLOZARIL MUST HAVE A BASELINE BLOOD ABSOLUTE NEUTROPHIL COUNT (ANC)
MEASURED
BEFORE TREATMENT INITIATION AND REGULAR ANC MONITORING DURING
TREATMENT (2.1, 5.1).
CLOZARIL 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 CARDI