clozapine 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 InterSePTâ„¢ trial [see Clinical Studies (14.2) ] .
Aurobindo Pharma Limited
ROUND YELLOW C C 57
C C 57 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
CLOZAPINE Tablets USP, 25 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘54’ on the other side. Bottles of 100 NDC 65862-844-01 Bottles of 500 NDC 65862-844-05 10 x 10 Unit-dose Tablets NDC 65862-844-78
CLOZAPINE Tablets USP, 50 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘55’ on the other side. Bottles of 100 NDC 65862-845-01 Bottles of 500 NDC 65862-845-05 10 x 10 Unit-dose Tablets NDC 65862-845-78
CLOZAPINE Tablets USP, 100 mg are pale yellow colored, round, flat faced, bevel edged uncoated tablets debossed with ‘C facilitated scoreline (functional) C’ on one side and ‘57’ on the other side. Bottles of 100 NDC 65862-846-01 Bottles of 500 NDC 65862-846-05 10 x 10 Unit-dose Tablets NDC 65862-846-78
CLOZAPINE Tablets USP, 200 mg are pale yellow colored, oval shaped, uncoated tablets debossed with ‘C scoreline (functional) C’ on one side and ‘71’ on the other side. Bottles of 100 NDC 65862-847-01 Bottles of 500 NDC 65862-847-05 10 x 10 Unit-dose Tablets NDC 65862-847-78 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.
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