Clozapine 150 MG Disintegrating Oral Tablet

1 INDICATIONS AND USAGE Clozapine ODT 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 Clozapine ODT 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, Clozapine ODT 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 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 ODT 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 clozapine 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 )] .

teva pharmaceuticals usa inc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] pain` `[5] diarrhoea` `[6] headache` `[7] dyspnoea` `[8] off label use` `[9] arthralgia` `[10] vomiting`

3 years ago

ROUND YELLOW A09

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 12.5 mg 1/4-inch diameter round yellow tablet debossed with “A05” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap……....................... NDC No. 0093-3011-01 25 mg 5/16-inch diameter round yellow tablet debossed with “A06” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap……....................... NDC No. 0093-3012-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3012-84 100 mg 1/2-inch diameter round yellow tablet debossed with “A08” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap…………………... NDC No. 0093-3010-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3010-84 150 mg 9/16-inch diameter round, yellow tablet debossed with “A09” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap…………………... NDC No. 0093-3086-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3086-84 200 mg 5/8-inch diameter round, yellow tablet debossed with “A10” on one side. Bottles of 100: 100 tablets in an HDPE bottle with child-resistant cap…………………... NDC No. 0093-3087-01 Cartons of 48 for Institutional Use Only: 8 cards, 6 non child-resistant blisters per card... NDC No. 0093-3087-84 16.2 Storage and Handling Store Clozapine ODT at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F). (See USP Controlled Room Temperature.) Protect from moisture. KEEP OUT OF REACH OF CHILDREN. Clozapine ODT must remain in the original package until used by the patient. 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 ODT can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine can be dispensed. Dispensing should be contingent upon the ANC testing results.

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