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1 Indications And Usage Fluoxetine Capsules, Usp Are A Selective Serotonin Reuptake Inhibitor Indicated For: • Acute And Maintenance Treatment Of Major Depressive Disorder (Mdd) In Adult And Pediatric Patients Aged 8 To 18 Years (1.1) • Acute And Maintenance Treatment Of Obsessive Compulsive Disorder (Ocd) In Adult And Pediatric Patients Aged 7 To 17 Years (1.2) • Acute And Maintenance Treatment Of Bulimia Nervosa In Adult Patients (1.3) • Acute Treatment Of Panic Disorder, With Or Without Agoraphobia, In Adult Patients (1.4) Fluoxetine Capsules, Usp And Olanzapine In Combination For: • Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder (1.5) 1.1 Major Depressive Disorder Fluoxetine Capsules, Usp Are Indicated For The Acute And Maintenance Treatment Of Major Depressive Disorder In Adult Patients And In Pediatric Patients Aged 8 To 18 Years [See Clinical Studies (14.1) ]. The Usefulness Of The Drug In Adult And Pediatric Patients Receiving Fluoxetine For Extended Periods, Should Periodically Be Re-Evaluated [See Dosage And Administration (2.1) ] . 1.2 Obsessive Compulsive Disorder Fluoxetine Capsules, Usp Are Indicated For The Acute And Maintenance Treatment Of Obsessions And Compulsions In Adult Patients And In Pediatric Patients Aged 7 To 17 Years With Obsessive Compulsive Disorder (Ocd) [See Clinical Studies (14.2) ]. The Effectiveness Of Fluoxetine Capsules, Usp In Long-Term Use, I.e., For More Than 13 Weeks, Has Not Been Systematically Evaluated In Placebo-Controlled Trials. Therefore, The Physician Who Elects To Use Fluoxetine Capsules, Usp For Extended Periods, Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient [See Dosage And Administration (2.2 )]. 1.3 Bulimia Nervosa Fluoxetine Capsules, Usp Are Indicated For The Acute And Maintenance Treatment Of Binge-Eating And Vomiting Behaviors In Adult Patients With Moderate To Severe Bulimia Nervosa [See Clinical Studies (14.3) ]. The Physician Who Elects To Use Fluoxetine Capsules, Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient [See Dosage And Administration (2.3 )] . 1.4 Panic Disorder Fluoxetine Capsules, Usp Are Indicated For The Acute Treatment Of Panic Disorder, With Or Without Agoraphobia, In Adult Patients [See Clinical Studies (14.4) ] . The Effectiveness Of Fluoxetine Capsules, Usp In Long-Term Use, I.e., For More Than 12 Weeks, Has Not Been Established In Placebo-Controlled Trials. Therefore, The Physician Who Elects To Use Fluoxetine Capsules, Usp For Extended Periods, Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient [See Dosage And Administration (2.4) ]. 1.5 Fluoxetine Capsules, Usp And Olanzapine In Combination: Depressive Episodes Associated With Bipolar I Disorder When Using Fluoxetine Capsules, Usp And Olanzapine In Combination, Also Refer To The Clinical Studies Section Of The Package Insert For Symbyax ® . Fluoxetine Capsules, Usp And Olanzapine In Combination Are Indicated For The Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder. Fluoxetine Capsules, Usp Monotherapy Is Not Indicated For The Treatment Of Depressive Episodes Associated With Bipolar I Disorder.
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