Health Vidya

Fluoxetine capsules are indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be reevaluated [see Dosage and Administration (2.1) ]. 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) [see Clinical Studies (14.2)]. The effectiveness of fluoxetine 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 reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2) ]. 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 [see Clinical Studies (14.3)]. The physician who elects to use fluoxetine capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)]. Fluoxetine capsules are indicated for the acute treatment of panic disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)]. The effectiveness of fluoxetine 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 reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4) ]. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®. Fluoxetine and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with bipolar I disorder in adult patients. Fluoxetine capsule monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.