Fluoxetinedosage

Indication Adult Pediatric MDD 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa 60 mg/day in am - Panic Disorder 10 mg/day (initial dose) - A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications.

2.1 Major Depressive

Disorder Initial Treatment: Adult: In controlled trials used to support the efficacy of fluoxetine tablets, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine tablets 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder 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 insufficient clinical improvement is observed. Doses above 20 mg/day may be administered on a once-a-day (morning) or BID schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day. Pediatric (Children and Adolescents): In the short-term (8 to 9 week) controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine tablets doses of 10 to 20 mg/day. Treatment should be initiated with a dose of 10 or 20 mg/day. After one week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.

All Patients: As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.

Maintenance/Continuation/Extended Treatment: It is generally agreed that acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

Daily Dosing: Systematic evaluation of fluoxetine tablets in adult patients has shown that its efficacy in Major Depressive Disorder 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. 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 tablets is coadministered or has been recently discontinued.

2.2 Obsessive

Compulsive Disorder Initial Treatment: Adult: In the controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20 mg, 40 mg, or 60 mg of fluoxetine tablets 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 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 daily (i.e., morning) or BID 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 tablets dose should not exceed 80 mg/day. Pediatric (Children and Adolescents): In the controlled clinical trial of fluoxetine tablets supporting its effectiveness in the treatment of OCD, patients were administered fluoxetine tablets doses in the range of 10 to 60 mg/day. In adolescents and higher weight children, treatment should be initiated with a dose of 10 mg/day. After 2 weeks, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 60 mg/day is recommended. In lower weight children, treatment should be initiated with a dose of 10 mg/day. Additional dose increases may be considered after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg.

Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine tablets, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine tablets after 13 weeks has not been documented in controlled trials, adult 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.

2.3 Bulimia

Nervosa Initial Treatment: In the controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily fluoxetine tablets doses of 20 mg 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 tablets doses above 60 mg/day have not been systematically studied in patients with bulimia.

Maintenance/Continuation Treatment: Systematic evaluation of continuing fluoxetine tablets 60 mg/day for periods of up to 52 weeks in patients with bulimia who have responded while taking fluoxetine tablets 60 mg/day during an 8-week acute treatment phase has demonstrated a benefit of such maintenance treatment. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

2.4 Panic Disorder

Initial Treatment: In the controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of Panic Disorder, patients were administered fluoxetine tablets doses in the range of 10 to 60 mg/day. Treatment should be initiated with a dose of 10 mg/day. After one week, the dose should be increased to 20 mg/day. The most frequently administered dose in the two flexible-dose clinical trials was 20 mg/day. A dose increase may be considered after several weeks if no clinical improvement is observed. Fluoxetine tablets doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder.

Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine tablets, Panic Disorder is a chronic condition and it is reasonable to consider continuation for a responding patient. Nevertheless, patients should be periodically reassessed to determine the need for continued treatment.

2.7 Dosing in

Specific Populations Treatment of Pregnant Women: When treating pregnant women with fluoxetine tablets, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Geriatric: A lower or less frequent dosage should be considered for the elderly.

Hepatic Impairment: As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment.

Concomitant Illness: Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments.

2.8 Discontinuation of

Treatment Symptoms associated with discontinuation of fluoxetine tablets, SNRIs, and SSRIs, have been reported.

2.9 Switching a

Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluoxetine tablets. Conversely, at least 5 weeks should be allowed after stopping fluoxetine tablets before starting an MAOI intended to treat psychiatric disorders.

2.10 Use of Fluoxetine

Tablets with Other MAOIs such as Linezolid or Methylene Blue Do not start fluoxetine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered. In some cases, a patient already receiving fluoxetine tablet therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluoxetine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluoxetine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluoxetine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.