Fluoxetine 10 MG Oral Capsule
1. INDICATIONS AND USAGE Fluoxetine is 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 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 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 and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine is 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 and olanzapine in combination for treatment of: • Acute Depressive Episodes Associated with Bipolar I Disorder (1) • Treatment Resistant Depression (1)
Alembic Pharmaceuticals Inc.
CAPSULE BLUE 10 A105
10 A105 CAPSULE BLUE
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16. HOW SUPPLIED/STORAGE AND HANDLING 16.1. How Supplied The following products are manufactured by Alembic Pharmaceuticals Limited, India.
FLUOXETINE capsules USP, are available in: The 10-mg 1 , capsule is blue opaque cap and white opaque body, imprinted with “10” on the cap and “A105” on the body: NDC 62332-022-30 - Bottles of 30 2 NDC 62332-022-31 - Bottles of 100 2 NDC 62332-022-71 - Bottles of 500 2 NDC 62332-022-91 - Bottles of 1000 2 The 20-mg 1 , capsule is a Dark blue opaque cap and Light blue opaque body, imprinted with “20” on the cap and “A106” on the body: NDC 62332-023-30 - Bottles of 30 2 NDC 62332-023-31 - Bottles of 100 2 NDC 62332-023-71 - Bottles of 500 2 NDC 62332-023-91 - Bottles of 1000 2 The 40-mg 1 , capsule is a Light blue opaque cap and Light blue opaque body, imprinted with “40” on the cap and “A107” on the body: NDC 62332-024-30 - Bottles of 30 2 NDC 62332-024-31 - Bottles of 100 2 NDC 62332-024-71 - Bottles of 500 2 NDC 62332-024-91 - Bottles of 1000 2 ___________________ 1
FLUOXETINE base equivalent 2 Protect from light. 16.2. Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59 to 86ºF), (See USP Controlled Room Temperature).
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