fluoxetine hydrochloride capsule
1 INDICATIONS AND USAGE Fluoxetine capsules, USP 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, USP and Olanzapine in Combination is 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, USP 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, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine capsules, USP 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, USP and olanzapine in combination for treatment of: • Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) • Treatment Resistant Depression ( 1 )
sandoz inc
CAPSULE WHITE GG 540
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fluoxetine hydrochloride capsule
sandoz inc
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine capsules, USP, 10 mg, 20 mg, and 40 mg are available as: 10 mg: white capsules, imprinted GG 575 with single green ink bands, filled with white powder and supplied as: NDC 0781-2823-31 bottles of 30 NDC 0781-2823-01 bottles of 100 NDC 0781-2823-10 bottles of 1000 20 mg: white capsules, imprinted GG 550 with green and black ink bands, filled with white powder and supplied as: NDC 0781-2822-31 bottles of 30 NDC 0781-2822-01 bottles of 100 NDC 0781-2822-10 bottles of 1000 40 mg: white capsules, imprinted GG 540 with single orange ink bands, filled with white powder and supplied as: NDC 0781-2824-31 bottles of 30 NDC 0781-2824-01 bottles of 100 NDC 0781-2824-10 bottles of 1000 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
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