Prozac-Fluoxetine

Patient Information

     Fluoxetine is used for the treatment of depression, obsesive-compulsive disorder, and bulimia.

Indications

     Depression:Fluoxetine HCI is indicated for the treatment of depression.  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.

Obsessive-Compulsive Disorder

Fluoxetine HCI is indicated for the treatment of obessions and compulsions in patients with obessive-compulsive disorder (OCD), as defined in the DSM-III-R.  Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

Bulimia Nervosa

Fluoxetine HCI is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa.

Dosage and Administration

     Intial Treatment:In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20mg to 80mg/day.  Studies comparing fluoxetine 20,40,60 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 intial 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 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, and for patients with concurrent disease or on multiple concomitant medications.  Dosage adjustments for renal impairment are not routinely necessary.

     As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer.

     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 HCI 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.