INDICATIONS AND USAGE
Major Depressive Disorder
Fluoxetine is indicated for the treatment of major depressive disorder.
Adult- The efficacy of fluoxetine was established in 5 and 6 week trials with depressed adult and geriatric outpatients (18 years of age) whose diagnoses corresponded most closely to the DSM-III (currently DSM-IV) category of major depressive disorder (see Clinical Trials).
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 five of the following nine 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.
Pediatric (Children and Adolescents)-The efficacy of fluoxetine 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 (see Clinical Trials).
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically.
Obsessive Compulsive Disorder
Adult- Fluoxetine 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 fluoxetine 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 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 for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Pediatric (Children and Adolescents)-The efficacy of fluoxetine in children and adolescents was established in a 13 week, dose titration, clinical trial in patients with OCD, as defined in DSM-IV (see Clinical Trials).
Bulimia Nervosa
Fluoxetine is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa.
The efficacy of fluoxetine 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 (see Clinical Trials).
The efficacy of fluoxetine 60 mg/day in maintaining a response, in patients with bulimia who responded during an 8 week acute treatment phase while taking fluoxetine 60 mg/day and were then observed for relapse during a period of up to 52 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Panic Disorder
Fluoxetine is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of fluoxetine was established in two 12 week clinical trials in patients whose diagnoses corresponded to the DSM-IV category of panic disorder (see Clinical Trials).
Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) fear of losing control; 10) fear of dying; 11) paresthesias (numbness or tingling sensations); 12) chills or hot flashes.
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 for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).