CLOZAPINE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Heartwood Pharma

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Clozapine 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 its use, clozapine 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 tablets 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 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, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at

Prehľad produktov:

Clozapine tablets are available as 25 mg, 50 mg, and 100 mg round, pale-yellow, uncoated tablets with a facilitated score on one side. Clozapine 200 mg tablets are available as capsule-shaped, pale-yellow, uncoated tablets with a facilitated score on one side. 25 mg Debossed with "CZ 25" once on the periphery of one side. Debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1725-5 50 mg Debossed with "CZ 50" once on the periphery of one side. Debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1750-5 100 mg Debossed with “CZ 100” once on the periphery of one side. Debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1760-5 200 mg Debossed with "CZ 200" once on the periphery of one side. Debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1770-5 Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

CLOZAPINE- CLOZAPINE TABLET
HEARTWOOD PHARMA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOZAPINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOZAPINE
TABLETS.
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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INDICATIONS AND USAGE
Clozapine tablets are 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
WARNINGS AND PRECAUTIONS
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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
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, 2.5, 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 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)
Treatment-resistant schizophrenia. Efficacy was established in an
active-controlled study. (1.1, 14.1)
Reducing suicidal behavio