Fluoxetinedosage

This product is only available in a 60 mg dosage form. A 30 mg dose may be achieved with one-half of the scored tablet. Use of this product requires initial titration with another fluoxetine product according to the dosing guidelines indicated below. Use another fluoxetine product for initial doses of 10 to 20 mg/day or for doses other than 30 mg or 60 mg: Indication Adult Pediatric MDD 20 mg/day in morning (initial dose) 20 mg/day (target dose) 80 mg/day (maximum dose studied) 10 to 20 mg/day (initial dose)* *This product has not been studied in doses greater than 20 mg/day in pediatric MDD. OCD 20 mg/day in morning (initial dose) 20 to 60 mg/day (target dose) 10 mg/day (initial dose) 10 to 60 mg/day (target dose) Bulimia Nervosa 60 mg/day in morning – Panic Disorder 10 mg/day (initial dose) 20 mg/day (target dose) 60 mg/day (maximum dose studied) – No additional benefits seen at higher doses above 20 mg/day in MDD Use a lower or less frequent dosage 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 —Initiate fluoxetine tablets 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). The maximum fluoxetine tablets dose should not exceed 80 mg/day. 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 MDD in most cases. Pediatric (children and adolescents) —Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 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. In the short-term (8- to 9-week) controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of MDD, patients were administered fluoxetine tablets doses of 10 to 20 mg/day. Doses greater than 20 mg/day have not been studied in pediatric patients with MDD. This product is only available in a 60 mg dosage form. Administration of doses with demonstrated efficacy of fluoxetine tablets 10 to 20 mg/day in pediatric MDD requires the use of another formulation. All patients —As with other drugs effective in the treatment of MDD, the full effect may be delayed until 4 weeks of treatment or longer. Periodically reassess to determine the need for maintenance 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 tablets are co-administered or has been recently discontinued.

2.2 Obsessive

Compulsive Disorder Initial Treatment Adults —Initiate fluoxetine tablets 20 mg/day, orally in the morning. Consider a dose increase 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 twice daily 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. In the controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine tablets or placebo. In one of these studies, no dose-response relationship for effectiveness was demonstrated. Pediatric (children and adolescents) —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. 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. Periodically reassess to determine the need for treatment.

2.3 Bulimia

Nervosa Initial Treatment —Administer fluoxetine tablets 60 mg/day 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 Nervosa. 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 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. Periodically reassess to determine the need for maintenance treatment.

2.4 Panic Disorder

Initial Treatment —Treatment should be initiated with a dose of 10 mg/day. After 1 week, the dose should be increased to 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. 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. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day. Periodically reassess to determine the need for continued treatment.

2.5 Dosing in

Specific Populations Geriatrics —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.

2.6 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.

2.7 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 tablets 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 nonintravenous 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.

2.1 Major Depressive

Disorder Initial Treatment Adult —Initiate fluoxetine tablets 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). The maximum fluoxetine tablets dose should not exceed 80 mg/day. 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 MDD in most cases. Pediatric (children and adolescents) —Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 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. In the short-term (8- to 9-week) controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of MDD, patients were administered fluoxetine tablets doses of 10 to 20 mg/day. Doses greater than 20 mg/day have not been studied in pediatric patients with MDD. This product is only available in a 60 mg dosage form. Administration of doses with demonstrated efficacy of fluoxetine tablets 10 to 20 mg/day in pediatric MDD requires the use of another formulation. All patients —As with other drugs effective in the treatment of MDD, the full effect may be delayed until 4 weeks of treatment or longer. Periodically reassess to determine the need for maintenance 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 tablets are co-administered or has been recently discontinued.

2.2 Obsessive

Compulsive Disorder Initial Treatment Adults —Initiate fluoxetine tablets 20 mg/day, orally in the morning. Consider a dose increase 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 twice daily 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. In the controlled clinical trials of fluoxetine tablets supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine tablets or placebo. In one of these studies, no dose-response relationship for effectiveness was demonstrated. Pediatric (children and adolescents) —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. 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. Periodically reassess to determine the need for treatment.

2.3 Bulimia

Nervosa Initial Treatment —Administer fluoxetine tablets 60 mg/day 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 Nervosa. 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 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. Periodically reassess to determine the need for maintenance treatment.

2.4 Panic Disorder

Initial Treatment —Treatment should be initiated with a dose of 10 mg/day. After 1 week, the dose should be increased to 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. 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. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day. Periodically reassess to determine the need for continued treatment.

2.5 Dosing in

Specific Populations Geriatrics —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.