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

INN (Tarptautinis Pavadinimas):

CLOZAPINE

Sudėtis:

CLOZAPINE 12.5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Clozapine ODT 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, Clozapine ODT 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 )] . Clozapine ODT 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

Produkto santrauka:

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. 0093-3011-01 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. 0093-3012-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3012-84 100 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. 0093-3010-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3010-84 150 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. 0093-3086-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3086-84 200 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. 0093-3087-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3087-84 Store Clozapine ODT 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. Clozapine ODT 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 Clozapine ODT can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine can be dispensed. Dispensing should be contingent upon the ANC testing results.

Autorizacija statusas:

New Drug Application Authorized Generic

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 ODT (ORALLY
DISINTEGRATING TABLETS) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLOZAPINE
ODT (ORALLY DISINTEGRATING TABLETS).
CLOZAPINE ODT (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_.
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RECENT MAJOR CHANGES
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INDICATIONS AND USAGE
Clozapine ODT is an atypical antipsychotic indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Orally disintegrating tablets: 12.5 mg, 25 mg, 100 mg, 150 mg and 200
mg (3).
CONTRAINDICATIONS
SEVERE NEUTROPENIA: CLOZAPINE CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN
LEAD TO
SERIOUS AND FATAL INFECTIONS. PATIENTS INITIATING AND CONTINUING
TREATMENT WITH
CLOZAPINE ODT MUST HAVE A BASELINE BLOOD ABSOLUTE NEUTROPHIL COUNT
(ANC)
MEASURED BEFORE TREATMENT INITIATION AND REGULAR ANC MONITORING DURING
TREATMENT (2.1, 5.1).
CLOZAPINE ODT 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
ODT IS NOT APPROVED FOR THIS CONDITION (5.7).
Warnings and Precautions, Falls (