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 their 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 orally disintegrating tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine orally disintegrating 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 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 orally disintegrating 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 )] .
teva pharmaceuticals usa, inc.
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 150 mg yellow, round, flat-faced, beveled-edge, unscored tablet. debossed with I1 on one side and plain on the other side. Available in bottles of 100 (NDC 0093-5376-01) and cartons of 48 tablets for Institutional Use Only (8x6 blister cards) (NDC 0093-5376-84). 200 mg yellow, round, flat-faced, beveled-edge, unscored tablet. debossed with L1 on one side and plain on the other side. Available in bottles of 100 (NDC 0093-5377-01) and cartons of 48 tablets for Institutional Use Only (8x6 blister cards) (NDC 0093-5377-84). 16.2 Storage and Handling Store
CLOZAPINE Orally Disintegrating Tablets at 20Â° to 25Â°C (68Â° to 77Â°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
CLOZAPINE Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). 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.
teva pharmaceuticals usa, inc.
Gilead Sciences, Inc.
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