Clozapine 25 MG Disintegrating Oral Tablet
1 INDICATIONS AND USAGE Clozapine orally disintegrating tablets are an atypical antipsychotic indicated for: • Treatment-resistant schizophrenia. Efficacy was established in an active-controlled study ( 1.1 , 14.1 ). • Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Efficacy was established in an active-controlled study ( 1.2 , 14.2 ). 1.1 Treatment-Resistant Schizophrenia 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) ]. 1.2 Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorder 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 behavior refers to actions by a patient that put him/herself at risk for death. The effectiveness of clozapine in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the InterSePT™ trial [see Clinical Studies (14.2) ] .
Mylan Pharmaceuticals Inc.
ROUND ORANGE C 25
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
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 16.2 Storage and Handling 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.
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