This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
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Usage Information:
Major Depressive DisorderFluoxetine 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 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.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 DisorderAdult – 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 NervosaFluoxetine 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 DisorderFluoxetine 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).