INDICATIONS AND USAGE
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 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 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
).