Prozac - page 2

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. 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 intial 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 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 recommmended, 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 HCI 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, and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary.

      Maintenance/Continuation Treatment:While there are no systematic studies that answer the question of how long to continue fluoxetine HCI, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine HCI 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 with 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. 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 HCI in depression and OCD, a lower and less frequent dosage should be used in patients with hepatic impairment. A lower and less frequent dosage should also be considered for the elderly and for patients with concurrent disease or on multiple medications. Dosage adjustments for renal impairment are not routinely necessary.

      Maintenance/Continuation Treatment:While there are no systematic studies that answer the question of how long to continue fluoxetine HCI, bulimia is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine HCI after 16 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 with 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.

      Switching Patients to or From a Momoamine Oxidase Inhibitor:At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with fluoxetine HCI. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping fluoxetine HCI before starting and MAOI.

How Supplied

10 mg pulvule

is opaque green and green, imprinted with DISTA 3104 on the cap and Prozac 10 mg on the body

20 mg pulvule

is an opaque green cap and off-white body, imprinted with DISTA 3105 on the cap and Prozac 20 mg on the body.

Liquid

oral solution is available with mint flavor