clozaril clozapine 25 mg
1 INDICATIONS AND USAGE CLOZARIL is 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 CLOZARIL is 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, CLOZARIL 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 CLOZARIL in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing CLOZARIL 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 CLOZARIL is 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 CLOZARIL 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 )] .
hls therapeutics (usa), inc.
ROUND YELLOW CLOZARIL 25
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied CLOZARIL ® (
CLOZAPINE) Tablets 25 mg round, pale-yellow, uncoated tablet. debossed with “CLOZARIL” once on the periphery of one side. debossed with a facilitated score and “25” once on the other side. Bottle of 100 NDC 69809-0126-05 50 mg round, pale-yellow, uncoated tablet. debossed with “CLOZARIL” once on the periphery of one side. debossed with “50”, a facilitated score and “mg” on the other side. Bottle of 100 NDC 69809-0130-05 100 mg round, pale-yellow, uncoated tablet. debossed with “CLOZARIL” once on the periphery of one side. debossed with a facilitated score and “100” once on the other side. Bottle of 100 NDC 69809-0127-05 200 mg capsule-shaped, pale-yellow, uncoated tablet. debossed with “CLOZARIL” once on one side. debossed with “200”, a facilitated score and “mg” on the other side. Bottle of 100 NDC 69809-0135-05 16.2 Storage and Handling Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.
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