Fluoxetine Indications and Dosage
- alcoholism †
- anorexia nervosa †
- anxiety †
- autism †
- borderline personality disorder †
- bulimia nervosa
- depression
- fibromyalgia †
- hot flashes †
- menopause †
- obesity †
- obsessive-compulsive disorder (OCD)
- orthostatic hypotension †
- panic disorder
- posttraumatic stress disorder (PTSD) †
- premature ejaculation †
- premenstrual dysphoric disorder (PMDD)
† non-FDA-approved indication
Fluoxetine Indications and Dosage
For the treatment of major depression:
NOTE: Generally, acute episodes of depression require several months of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to that needed for maintenance is unknown.
- for the treatment of depression with a daily dosage formulation:
Oral dosage (regular capsules, tablets or oral solution):
Adults, including the elderly: Initially, 20 mg/day PO. More than 85% of patients will not need an increase above 20 mg/day to achieve maximum benefit. May increase the dose every month if needed by 10-20 mg to a usual maximum of 80 mg/day. Rarely, a dosage of 100 mg/day may be required. Usually divide into 2 or more doses if >= 40 mg/day. Dosing in the morning and at noon is recommended by the manufacturer. Systematic evaluations of the SSRIs have shown that antidepressant efficacy is maintained for up to 1 year of active treatment.
Adolescents and children >= 8 years: Initially, 10-20 mg/day PO. May increase the 10 mg dose to 20 mg/day PO after 1 week. In lower weight children, 10 mg/day PO may be the initial and target dose; however, may titrate to 20 mg/day PO after several weeks if clinical improvement not seen. In an 8-week pivotal trial (n=219), fluoxetine was associated with statistically greater improvement in the Children’s Depression Rating Scale-Revised (CDRS-R) than placebo. The prospectively defined response criteria of >=30% decrease in CDRS-R score was numerically greater for the fluoxetine group (65%) vs. placebo (53%), but this outcome was not met statistically (p=.093) after 8 weeks. Complete remission of depressive symptoms was rare in one study. An open-label study suggests that roughly 40% of pediatric patients will have a recurrence of depressive symptoms within 12 months after discontinuing fluoxetine treatment, although further study is needed.
- for the once-weekly maintenance treatment of depression:
Oral dosage (Prozac® Weekly™ only):
Adults: 90 mg PO once weekly. Clinical trials involved 501 depressed patients who had previously responded to 3 months of fluoxetine 20 mg/day and who were then randomized to either 90 mg weekly, 20 mg/day or placebo for a 25-week, double-blind period. The rates of relapse with either formulation of fluoxetine were significantly lower than for those treated with placebo. There was no significant difference between the weekly and daily dosage with regard to maintaining control of depression; however, the daily form did have a slightly improved relapse rate. However, the trials were not powered to look at such differences. Compliance has been shown to improve with once-weekly dosing (press release, February 28, 2001). With regard to side effects, a slightly higher incidence of diarrhea occurred with the weekly dosage but other side-effects were similar to other fluoxetine preparations.
Adolescents and children: Safety and efficacy not established for once-weekly dosing; do not use.
For the treatment of certain anxiety † disorders:
- for obsessive-compulsive disorder (OCD):
Oral dosage (regular capsules, tablets or oral solution):
Adults, including the elderly: Initially, 20 mg/day PO. More than 85% of patients will not need an increase above 20 mg/day to achieve maximum benefit. May increase the dose every month by 10-20 mg if needed to a usual maximum of 80 mg/day. Rarely, a dosage of 100 mg/day may be required. Usually divide into 2 or more doses if >= 40 mg/day. Dosing in the morning and at noon is recommended by the manufacturer.
Adolescents and children >= 7 years: Initially, 10 mg/day PO. In higher weight pediatric patients, the dose should be increased to 20 mg/day PO after 2 weeks. After several more weeks, dose titrations up to 60 mg/day PO may be considered if response is not adequate. In lower weight pediatric patients, after several weeks at the 10 mg/day dose, dose titrations up to 20-30 mg/day PO may be considered if response is not adequate. Usually divide into 2 or more doses (morning and noon) if total dose >= 40 mg/day. According to the manufacturer, experience with daily doses > 20 mg/day is very limited; adequate experience with doses > 60 mg/day is non-existent. In a 13-week pivotal trial of patients aged 7-17 (n=103), fluoxetine was associated with a significantly greater improvement in OCD according to the Childrens Yale-Brown Obsessive Compulsive Scale vs. placebo. After 16 weeks, the relative response rate was 30% in the active group (p<0.05).
- for panic disorder (with or without agoraphobia):
Oral dosage (regular capsules, tablets or oral solution):
Adults: Initially, 20 mg PO once daily. Dosages of 10-60 mg/day used in trials; the most frequent dosage was 20 mg/day PO. Increase every month by 10-20 mg if needed. Doses above 60 mg/day PO have not been systematically studied. Usually divide into 2 or more doses if >= 40 mg/day.
Adolescents and children >= 7 years † : Initially, 5-10 mg/day PO and titrate upward slowly, mean effective dosage based on the results of clinical trials is roughly 0.7 mg/kg/day PO. Maximum suggested dosages are 1 mg/kg/day PO, not to exceed 60-80 mg/day PO for adolescents, and 1 mg/kg/day PO, not to exceed 40 mg/day PO for children <= 12 years. Usually divide into 2 or more doses if >= 40 mg/day.
- for posttraumatic stress disorder (PTSD) † :
Oral dosage (regular capsules, tablets or oral solution):
Adults: 20-80 mg/day PO has been used; follow recommended dosage titration schedules. Mean effective dosage in most trials has been 40 mg/day PO. Fluoxetine has been effective for a wide variety of traumatic stressors, including combat. Do not exceed 80 mg/day. Usually divide into 2 or more doses if >= 40 mg/day.
For the treatment of bulimia nervosa:
Oral dosage (regular capsules, tablets or oral solution):
Adults: 60 mg PO once daily, administered in the morning. For some patients, it may be necessary to titrate to this dosage over several days. Doses above 60 mg/day PO have not been systematically studied in patients with bulimia. Used for up to 52 weeks in clinical trials.
Adolescents and children >= 6 years † : Safety has not been established, but initial doses of 20 mg PO once daily have been successful.
For the treatment of anorexia nervosa † :
Oral dosage (regular capsules, tablets or oral solution):
Adults and adolescents: Fluoxetine treatment has yielded mixed results in both inpatient and outpatient settings. Fluoxetine has not been proven to add benefit to the acute phase treatment of patients with AN. However, when given after successful weight restoration and resolution of the psychological effects of malnutrition, fluoxetine may reduce the rate of relapse of anorexia nervosa. Initially, 10 mg/day, gradually increased to a maximum of 60 mg/day (mean dose 40 mg/day), has been used.
For the treatment of obesity † :
Oral dosage (regular capsules, tablets or oral solution):
Adults: Studies have used doses of 60 mg/day PO after titration, but results are conflicting. In a 3-month study of obese non-diabetics, fluoxetine (dose unclear) was not superior to placebo however, in a 12-month study of obese non-diabetics, fluoxetine 60 mg/day PO produced significantly greater weight loss than placebo at week 28 but no difference was seen at week 52. Fluoxetine 60 mg/day PO was superior to placebo in obese diabetics in another 12-month study. Usually divide into 2 or more doses if >= 40 mg/day.
For the treatment of alcohol dependence in patients with alcoholism † :
Oral dosage (regular capsules, tablets or oral solution):
Adults: Initially, 20 mg PO once daily and titrate. In early-stage alcoholic dependence, alcohol consumption was decreased by about 20% in patients treated with 60 mg/day PO. In patients receiving 40 mg/day no statistical difference in alcohol consumption was noted. May increase the dose every month if needed by 10-20 mg to a maximum of 80 mg/day PO. Usually divide into two or more doses when the total dose is >= 40 mg/day. Dosing in the morning and at noon is recommended by the manufacturer.
For the treatment of fibromyalgia † :
Oral dosage (regular capsules, tablets or oral solution):
Adults: In a small study comparing amitriptyline to fluoxetine, placebo, or the combination of amitriptyline with fluoxetine, fluoxetine 20 mg PO once daily was superior to placebo.
For the treatment of borderline personality disorder † :
Oral dosage (regular capsules, tablets or oral solution):
Adults: Initially, 20 mg PO once daily. Patients treated with 80 mg/day showed a sustained improvement that lasted longer than the 3 week duration placebo response commonly seen in these difficult patients. Increase every month by 20 mg to a maximum of 80 mg/day if needed. Usually divide into 2 or more doses if >= 40 mg/day.
For the treatment of autism † :
Oral dosage (regular capsules, tablets or oral solution):
Adults: Although data are limited, fluoxetine may be useful for autistic patients with coexisting OCD or depressive symptoms. Initially, 20 mg/day PO or 20 mg every other day PO titrated to a maximum of 80 mg/day has been recommended. Usual dose ranges 20-40 mg/day PO.
For the treatment of severe refractory orthostatic hypotension † :
Oral dosage (regular capsules, tablets or oral solution):
Adults: In a case report, 5 patients with symptomatic orthostatic hypotension received 20 mg PO once daily for 6-8 weeks; 4 patients experienced a complete or partial reduction of symptoms.
For the treatment of premature ejaculation † :
Oral dosage (regular capsules, tablets or oral solution):
Adult males: In one study, men with lifelong rapid ejaculation (<= 1 minute) received fluoxetine 20 mg/day PO, another SSRI, or placebo for 6 weeks. Patients treated with an SSRI experienced increased intravaginal ejaculation latency time (IELT) to about 110 seconds, compared with the placebo group (mean IELT of 20 seconds).
For the treatment of premenstrual dysphoric disorder (PMDD) according to the criteria of the DSM-IV:
Oral dosage (e.g., Sarafem® or other regular capsules, tablets or oral solution):
Adult females: Initially, 20 mg PO once daily, given continuously or during the luteal phase only (i.e., the 14 days prior to the anticipated start of menses). Fluoxetine has been found superior to placebo for treating PMDD. In one of the initial published trials, patients were assigned to fluoxetine 20 mg/day PO, 60 mg/day PO, or placebo beginning on the third day of the menstrual cycle, and continued for 6 cycles. Patients receiving fluoxetine at either dosage had at least 50% improvement from baseline versus 22% of women receiving placebo. The women receiving 60 mg/day of fluoxetine had increased side effects and drop-out rates compared to those receiving 20 mg/day PO. Luteal-phase only administration (i.e., 14 days prior to menses, in doses of 20 mg/day) has been effective for some women.
For the treatment of hot flashes † in women with breast cancer experiencing symptoms of menopause † :
Oral dosage (regular capsules, tablets or oral solution):
Adult females: One phase III study reported that 20 mg/day PO reduced the weekly incidence and severity of hot flashes 50% compared to 36% in the placebo in women with a history of breast cancer or a concern regarding the use of estrogen (because of breast cancer risk); some women were taking tamoxifen or raloxifene therapy. The modest improvement noted with fluoxetine was statistically significant (P =0.02).
Maximum Dosage Limits:
- Adults: 80 mg/day PO of conventional oral dosage forms; rare patients may require up to 100 mg/day PO.
- Elderly: 80 mg/day PO of conventional oral dosage forms.
- Adolescents: 60 mg/day PO of conventional oral dosage forms.
- Children >= 7 years: In lower weight children 30 mg/day PO suggested; in higher weight children 60 mg/day PO of conventional oral dosage forms.
- Children < 7 years: Safe and effective use has not been established.
Patients with hepatic impairment:
Dosage should be modified depending on clinical response and degree of hepatic impairment, but no quantitative recommendations are available. Lower doses or less frequent dosing intervals may be needed, particularly in patients with cirrhosis.
Patients with renal impairment:
CrCl >= 10 ml/min: No dosage adjustment routinely needed (manufacturers information). Modify based on individual clinical response.
CrCl < 10 ml/min: A decrease in dosage is not routinely recommended, but modify if needed based on individual clinical response.
Intermittent hemodialysis:
In patients on hemodialysis (HD) in manufacturer studies, no excessive accumulation of fluoxetine or norfluoxetine (active metabolite) occurred at dosages of 20 mg/day PO; the pharmacokinetics of fluoxetine were not substantially altered. Modify dosage if needed based on individual clinical response.
† non-FDA-approved indication
[ Last revised: 7/26/2005 1:01:00 PM ]
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