clozapine 200 mg
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 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 )] .
heartwood pharma
OVAL YELLOW G G CZ 200
G G CZ 200 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clozapine tablets are available as 25 mg, 50 mg, and 100 mg round, pale-yellow, uncoated tablets with a facilitated score on one side. Clozapine 200 mg tablets are available as capsule-shaped, pale-yellow, uncoated tablets with a facilitated score on one side. 25 mg debossed with "CZ 25" once on the periphery of one side. debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1725-5 50 mg debossed with "CZ 50" once on the periphery of one side. debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1750-5 100 mg debossed with “CZ 100” once on the periphery of one side. debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1760-5 200 mg debossed with "CZ 200" once on the periphery of one side. debossed with a facilitated score on the other side. Bottle of 100 tablets NDC 72721-1770-5 16.2 Storage and Handling Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.
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