Fluoxetine 20 MG Oral Capsule
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 ® . 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 )
Major Pharmaceuticals
CAPSULE WHITE PLIVA 648
PLIVA 648 CAPSULE WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
FLUOXETINE capsules USP, 10 mg are available as white, opaque capsules in cartons of 100 capsules (10 capsules each blister pack x 10) NDC 0904-5784-61, printed “PLIVA 647” in green band on cap and body.
FLUOXETINE capsules USP, 20 mg are available as white, opaque capsules in cartons of 100 capsules (10 capsules each blister pack x 10) NDC 0904-5785-61, printed “PLIVA 648” in green band on cap only. 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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