INDICATIONS AND USAGE
Major Depressive DisorderProzac is indicated for the treatment of major depressive
disorder.
Adult
The efficacy of Prozac was established
in 5 and 6week trials with depressed adult and geriatric outpatients (18
years of age) whose diagnoses corresponded most closely to the DSMIII
(currently DSMIV) category of major depressive disorder (see
CLINICAL TRIALS).
A major depressive episode (DSMIV) 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 Prozac in hospitalized depressed patients have not been
adequately studied.
The efficacy of Prozac 20mg once daily in maintaining a response in major
depressive disorder for up to 38 weeks following 12 weeks of openlabel acute
treatment (50 weeks total) was demonstrated in a placebocontrolled trial.
The efficacy of Prozac Weekly once weekly in maintaining a response in major
depressive disorder has been demonstrated in a placebocontrolled trial for up
to 25 weeks following openlabel acute treatment of 13 weeks with Prozac 20mg
daily for a total treatment of 38 weeks. However, it is unknown whether or not
Prozac Weekly given on a onceweekly basis provides the same level of protection
from relapse as that provided by Prozac 20mg daily (see CLINICAL TRIALS).
Pediatric (children and adolescents)
The
efficacy of Prozac in children and adolescents was established in two 8 to
9week placebocontrolled clinical trials in depressed outpatients whose
diagnoses corresponded most closely to the DSMIIIR or DSMIV 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
Prozac is indicated for the
treatment of obsessions and compulsions in patients with obsessive compulsive
disorder (OCD), as defined in the DSMIIIR; i.e., the obsessions or compulsions
cause marked distress, are timeconsuming, or significantly interfere with
social or occupational functioning.
The efficacy of Prozac was established in 13week trials with obsessive
compulsive outpatients whose diagnoses corresponded most closely to the
DSMIIIR category of OCD (see
CLINICAL TRIALS).
OCD is characterized by recurrent and persistent ideas, thoughts, impulses,
or images (obsessions) that are egodystonic and/or repetitive, purposeful, and
intentional behaviors (compulsions) that are recognized by the person as
excessive or unreasonable.
The effectiveness of Prozac in longterm use, i.e., for more than 13 weeks,
has not been systematically evaluated in placebocontrolled trials. Therefore,
the physician who elects to use Prozac for extended periods should periodically
reevaluate the longterm usefulness of the drug for the individual patient
(see
DOSAGE AND
ADMINISTRATION).
Pediatric (children and adolescents)
The
efficacy of Prozac in children and adolescents was established in a 13week,
dose titration, clinical trial in patients with OCD, as defined in DSMIV (see
CLINICAL TRIALS).
Bulimia NervosaProzac is indicated for the treatment of bingeeating and
vomiting behaviors in patients with moderate to severe bulimia nervosa.
The efficacy of Prozac was established in 8 to 16week 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 Prozac 60mg/day in maintaining a response, in patients with
bulimia who responded during an 8week acute treatment phase while taking Prozac
60mg/day and were then observed for relapse during a period of up to 52 weeks,
was demonstrated in a placebocontrolled trial (see
CLINICAL TRIALS). Nevertheless, the physician who elects
to use Prozac for extended periods should periodically reevaluate the longterm
usefulness of the drug for the individual patient (see
DOSAGE AND
ADMINISTRATION).
Panic DisorderProzac is indicated for the treatment of panic disorder, with or
without agoraphobia, as defined in DSMIV. 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 Prozac was established in two 12week clinical trials in
patients whose diagnoses corresponded to the DSMIV category of panic disorder
(see
CLINICAL TRIALS).
Panic disorder (DSMIV) 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 Prozac in longterm use, i.e., for more than 12 weeks,
has not been established in placebocontrolled trials. Therefore, the physician
who elects to use Prozac for extended periods should periodically reevaluate the
longterm usefulness of the drug for the individual patient (see
DOSAGE AND
ADMINISTRATION).