1 INDICATIONS AND USAGE Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3) ] . Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4) ] . Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax Ā® . Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) ( 1 ) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) ( 1 ) Acute and maintenance treatment of Bulimia Nervosa ( 1 ) Acute treatment of Panic Disorder, with or without agoraphobia ( 1 ) Fluoxetine capsules and olanzapine in combination for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) Treatment Resistant Depression ( 1 )
aurobindo pharma limited
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine Capsules USP, 10 mg* are opaque green cap/opaque green body, size ā3ā hard gelatin capsule filled with white to off-white granular powder and imprinted with āEā on opaque green cap and ā88ā on opaque green body with black ink. Bottles of 30 NDC 65862-192-30 Bottles of 100 NDC 65862-192-01 Bottles of 500 NDC 65862-192-05 Bottles of 1,000 NDC 65862-192-99 Fluoxetine Capsules USP, 20 mg* are opaque green cap/opaque off white body, size ā3ā hard gelatin capsule filled with white to off-white granular powder and imprinted with āEā on opaque green cap and ā91ā on opaque off white body with black ink. Bottles of 30 NDC 65862-193-30 Bottles of 100 NDC 65862-193-01 Bottles of 500 NDC 65862-193-05 Bottles of 1,000 NDC 65862-193-99 Fluoxetine Capsules USP, 40 mg* are opaque green cap/opaque orange body, size ā2ā hard gelatin capsule filled with white to off-white granular powder and imprinted with āEā on opaque green cap and ā92ā on opaque orange body with black ink. Bottles of 30 NDC 65862-194-30 Bottles of 100 NDC 65862-194-01 Bottles of 500 NDC 65862-194-05 Bottles of 1,000 NDC 65862-194-99 *Fluoxetine base equivalent. 16.2 Storage and Handling Store at 20Ā° to 25Ā°C (68Ā° to 77Ā°F); excursions permitted to 15Ā° to 30Ā°C (59Ā° to 86Ā°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers.
aurobindo pharma limited
Aurobindo Pharma Limited
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