1 INDICATIONS AND USAGE
Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years
(1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years
(1.2)
Acute and maintenance treatment of Bulimia Nervosa in adult patients
(1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients
(1.4)
for:
Fluoxetine capsules and olanzapine in combination
Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults
(1.5)
1.1 Major Depressive Disorder
Fluoxetine capsules are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated .
[see ].
Clinical Studies (14.1)
[see ]
Dosage and Administration (2.1)
1.2 Obsessive Compulsive Disorder
Fluoxetine capsules are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) The effectiveness of fluoxetine capsules in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient
[see ].
Clinical Studies (14.2)
[see )].
Dosage and Administration (2.2
1.3 Bulimia Nervosa
Fluoxetine capsules are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa The physician who elects to use fluoxetine capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient .
[see ].
Clinical Studies (14.3)
[see )]
Dosage and Administration (2.3
1.4 Panic Disorder
Fluoxetine capsules are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients . The effectiveness of fluoxetine capsules in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient
[see
Clinical Studies (14.4)
]
[see ].
Dosage and Administration (2.4)
1.5 Fluoxetine Capsules and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder
. Fluoxetine capsules and olanzapine in combination are indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax