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INDICATIONS
Depression: Fluoxetine HCl is indicated for the treatment of depression. The efficacy of
fluoxetine HCl was established in 5- and 6-week trials with depressed outpatients (≥18 years
of age) whose diagnoses corresponded most closely to the DSM-III category of major
depressive disorder (see CLINICAL STUDIES).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of fluoxetine HCl in hospitalized depressed patients has not been adequately studied. The efficacy of fluoxetine HCl in maintaining an antidepressant response for up to 38 weeks
following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a
placebo-controlled trial. The usefulness of the drug in patients receiving fluoxetine HCl for
extended periods should be reevaluated periodically (see CLINICAL STUDIES).
Obsessive-Compulsive Disorder: Fluoxetine HCl 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 HCl was established in 13-week trials with obsessive-compulsive
outpatients whose diagnoses corresponded most closely to the DSM-III-R category of
obsessive-compulsive disorder (see CLINICAL STUDIES).
Obsessive-compulsive disorder 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 HCl 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 HCl for extended periods should periodically reevaluate the long-term
usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Bulimia Nervosa: Fluoxetine HCl is indicated for the treatment of binge-eating and vomiting
behaviors in patients with moderate to severe bulimia nervosa.
The efficacy of fluoxetine HCl 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 STUDIES.)
The effectiveness of fluoxetine HCl in long-term use (i.e., for more than 16 weeks) has not
been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects
to use fluoxetine HCl for extended periods should periodically reevaluate the long-term
usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
Depression
Initial Treatment: In controlled trials used to support the efficacy of fluoxetine, patients were
administered morning doses ranging from 20 mg to 80 mg/day. Studies comparing fluoxetine
20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory
antidepressant response in most cases. Consequently, a dose of 20 mg/day, administered in
the morning, is recommended as the initial dose.
A dose increase may be considered after several weeks if no clinical improvement is observed. Doses above 20 mg/day may be administered on a once a day (morning) or b.i.d. schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients
with hepatic impairment. A lower or less frequent dosage should also be considered for the
elderly (see PRECAUTIONS, Geriatric Use), and for patients with concurrent disease or on
multiple concomitant medications. Dosage adjustments for renal impairment are not routinely
necessary (see CLINICAL PHARMACOLOGY, Liver Disease and Renal Disease, and
PRECAUTIONS, Use in Patients with Concomitant Illness).
Maintenance/Continuation/Extended Treatment: It is generally agreed that acute episodes
of depression require several months or longer of sustained pharmacologic therapy. Whether
the dose of antidepressant needed to induce remission is identical to the dose needed to
maintain and/or sustain euthymia is unknown.
Systematic evaluation of fluoxetine HCl has shown that its antidepressant efficacy is
maintained for periods of up to 38 weeks following 12 weeks of open-label acute treatment
(50 weeks total) at a dose of 20 mg/day (see CLINICAL STUDIES).
Obsessive-Compulsive Disorder
Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in
the treatment of obsessive-compulsive disorder, patients were administered fixed daily doses
of 20, 40, or 60 mg of fluoxetine or placebo (see CLINICAL STUDIES). In one of these
studies, no dose response relationship for effectiveness was demonstrated. Consequently, a
dose of 20 mg/day, administered in the morning, is recommended as the initial dose. Since
there was a suggestion of a possible dose response relationship for effectiveness in the second
study, a dose increase may be considered after several weeks if insufficient clinical
improvement is observed. The full therapeutic effect may be delayed until 5 weeks of
treatment or longer.
Doses above 20 mg/day may be administered on a once a day (i.e., morning) or b.i.d. schedule (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended, however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day. As with the use of fluoxetine HCl in depression, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see PRECAUTIONS, Geriatric Use), and for patients with
concurrent disease or on multiple concomitant medications. Dosage adjustments for renal
impairment are not routinely necessary (see CLINICAL PHARMACOLOGY, Liver
Disease and Renal Disease and PRECAUTIONS, Use in Patients with Concomitant
Illness).
Maintenance/Continuation Treatment: While there are no systematic studies that answer the
question of how long to continue fluoxetine HCl, OCD is a chronic condition and it is
reasonable to consider continuation for a responding patient. Although the efficacy of
fluoxetine HCl after 13 weeks has not been documented in controlled trials, patients have
been continued in therapy under double-blind conditions for up to an additional 6 months
without loss of benefit. However, dosage adjustments should be made to maintain the patient
on the lowest effective dosage, and patients should be periodically reassessed to determine the
need for treatment.
Bulimia Nervosa
Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in
the treatment of bulimia nervosa, patients were administered fixed daily fluoxetine doses of
20 or 60 mg, or placebo (see CLINICAL STUDIES). Only the 60 mg dose was statistically
significantly superior to placebo in reducing the frequency of binge-eating and vomiting.
Consequently, the recommended dose is 60 mg/day, administered in the morning. For some
patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses
above 60 mg/day have not been systematically studied in patients with bulimia.
As with the use of fluoxetine HCl in depression and OCD, a lower or less frequent dosage
should be used in patients with hepatic impairment. A lower or less frequent dosage should
also be considered for the elderly (see PRECAUTIONS, Geriatric Use), and for patients
with concurrent disease or on multiple concomitant medications. Dosage adjustments for
renal impairment are not routinely necessary (see CLINICAL PHARMACOLOGY, Liver
Disease and Renal Disease, and PRECAUTIONS, Use in Patients with Concomitant
Illness).
Maintenance/Continuation Treatment: While there are no systematic studies that answer the
question of how long to continue fluoxetine HCl, bulimia is a chronic condition and it is
reasonable to consider continuation for a responding patient. Although the efficacy of
fluoxetine HCl after 16 weeks has not been documented in controlled trials, some patients
have been continued in therapy under double- blind conditions for up to an additional 6
months without loss of benefit. However, patients should be periodically reassessed to
determine the need for continued treatment.
Switching Patients to a Tricyclic Antidepressant (TCA)
Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be
monitored temporarily when fluoxetine is coadministered or has been recently discontinued
(see DRUG INTERACTIONS, Other Antidepressants).
Switching Patients to or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with fluoxetine HCl. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping fluoxetine HCl before starting an MAOI (see CONTRAINDICATIONS and
PRECAUTIONS).
HOW SUPPLIED
Controller-F 10 Capsules
Controller-F 20 Capsules
Controller-FS 20 Sublingual Tablets
ControllerLiquid, Oral Solution: 20 mg per 5 ml with mint flavor.
Dispense in a tight, light-resistant container. Storage: Store at controlled room temperature, 59° to 86°F (15° to 30°C).

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