CLOZAPINE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

CLOZAPINE

Composition:

CLOZAPINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 its 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 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 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, based on history and recent clinical state. Suicidal behavi

Product summary:

Clozapine Orally Disintegrating Tablets are available containing 25 mg, 100 mg, 150 mg or 200 mg of clozapine, USP. The 25 mg tablets are peach, round, unscored tablets debossed with C over 25 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3813-01 bottles of 100 tablets The 100 mg tablets are peach, round, unscored tablets debossed with C over 100 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3815-01 bottles of 100 tablets The 150 mg tablets are peach, round, unscored tablets debossed with C150 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3816-01 bottles of 100 tablets The 200 mg tablets are peach, round, unscored tablets debossed with C200 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3817-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Clozapine orally disintegrating 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 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOZAPINE- CLOZAPINE TABLET, ORALLY DISINTEGRATING
MYLAN PHARMACEUTICALS 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._
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RECENT MAJOR CHANGES
Boxed Warning, Orthostatic Hypotension, Bradycardia, Syncope 4/2023
Dosage and Administration, Re-Initiation of Treatment (2.6) 4/2023
Warnings and Precautions, Orthostatic Hypotension, Bradycardia, and
Syncope (5.3) 4/2023
Warnings and Precautions, Gastrointestinal Hypomotility with Severe
Complications (5.8) 4/2023
INDICATIONS AND USAGE
Clozapine orally disintegrating tablets are an atypical antipsychotic
indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Orally disintegrating tablets: 25 mg, 100 mg, 150 mg and 200 mg (3).
SEVERE NEUTROPENIA: CLOZAPINE CAN CAUSE SEVERE NEUTROPENIA, WHICH CAN
LEAD TO
SERIOUS AND FATAL INFECTIONS. PATIENTS INITIATING AND CONTINUING
TREATMENT WITH
CLOZAPINE ORALLY DISINTEGRATING TABLETS MUST HAVE A BASELINE BLOOD
ABSOLUTE
NEUTROPHIL COUNT (ANC) MEASURED BEFORE TREATMENT INITIATION AND
REGULAR ANC
MONITORING DURING TREATMENT (2.1, 5.1).
CLOZAPINE ORALLY DISINTEGRATING TABLETS ARE 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 (2.3, 2.6,
5.3).
SEIZURE: RISK IS DOSE-RELATED. TITRATE GRADUALLY AND USE DIVIDED
DOSES. USE WITH
CAUTION IN PATIENTS WITH HISTORY OF