Fluoxetine indications

List of Indications
Adults with Major depressive disorder Children with Major depressive disorder Adults with Obsessive-Compulsive Disorder Children with Obsessive-Compulsive Disorder Bulimia Nervosa

Adults with Major depressive disorder
The efficacy of Fluoxetine was established in 5- and 6-week trials with depressed adult andgeriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM-III (currently DSM-IV) category of major depressive disorder. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of Fluoxetine in hospitalized depressed patients have not been adequately studied. The efficacy of Fluoxetine 20 mg once daily in maintaining a response in major depressive disorder for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial. The efficacy of Fluoxetine once weekly in maintaining a response in major depressive disorder has been demonstrated in a placebo-controlled trial for up to 25 weeks following open-label acute treatment of 13 weeks with Fluoxetine 20 mg daily for a total treatment of 38 weeks. However, it is unknown whether or not Fluoxetine given on a once-weekly basis provides the same level of protection from relapse as that provided by Fluoxetine 20 mg daily. Return to top

Children with Major depressive disorder
The efficacy of Prozac in children and adolescents was established in two 8- to 9-week placebo-controlled clinical trials in depressed outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically. Return to top

Adults with Obsessive-Compulsive Disorder
Prozac is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Prozac was established in 13-week trials with obsessive-compulsive outpatients whose diagnoses corresponded most closely to the DSM-III-R category of OCD (see CLINICAL TRIALS). OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of Prozac 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 Prozac for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Return to top

Children with Obsessive-Compulsive Disorder
Pediatric (children and adolescents) — The efficacy of Prozac in children and adolescents was established in a 13-week, dose titration, clinical trial in patients with OCD, as defined in DSM-IV. Return to top

Bulimia Nervosa
Prozac is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. The efficacy of Prozac was established in 8- to 16-week trials for adult outpatients with moderate to severe bulimia nervosa, i.e., at least 3 bulimic episodes per week for 6 months. Return to top