Clozapine 25 MG Oral Tablet
1 INDICATIONS AND USAGE Clozapine 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 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 tablets 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 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 tablets 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 M C 7
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
CLOZAPINE Tablets, USP are available containing 25 mg, 50 mg, 100 mg or 200 mg of
CLOZAPINE, USP. The 25 mg tablets are peach, round, functionally scored tablets debossed with C to the left of the score and 7 to the right of the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0825-01 bottles of 100 tablets The 50 mg tablets are green, round, functionally scored tablets debossed with C72 above the score and blank below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0972-01 bottles of 100 tablets The 100 mg tablets are green, round, functionally scored tablets debossed with C11 above the score and blank below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0860-01 bottles of 100 tablets NDC 0378-0860-05 bottles of 500 tablets The 200 mg tablets are green, round, functionally scored tablets debossed with C73 above the score and blank below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0973-01 bottles of 100 tablets 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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