Fluoxetine Hydrochloride

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 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 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 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 and olanzapine in combination for treatment of:
• Acute Depressive Episodes Associated with Bipolar I Disorder (1)
• Treatment Resistant Depression (1)

When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.

• Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue (4.1)
• Pimozide: Do not use. Risk of QT prolongation and drug interaction (4.2, 5.11, 7.7, 7.8)
• Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine. Do not use thioridazine within 5 weeks of discontinuing fluoxetine (4.2, 5.11, 7.7, 7.8)