Fluoxetine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Premenstrual Dysphoric Disorder

Note: Only fluoxetine marketed as Sarafem (R) is approved by the FDA for the treatment of Premenstrual Dysphoric Disorder (PMDD). All other formulations of fluoxetine are not FDA approved for PMDD.

Initial dose: 20 mg orally once daily
Maintenance dose: 20 mg/day orally continuously or, alternatively, 20 mg orally daily during the luteal phase of the menstrual system (the 14 days prior to the anticipated start of menses). The 20 mg daily dosage has been shown to be effective for up to six months of treatment. A 60 mg daily dosage has also been studied, but has not been shown to be significantly more effective than 20 mg daily.
Maximum dose: 80 mg orally daily

Approved indication (for Sarafem (R) only): PMDD

Usual Adult Dose for Obsessive Compulsive Disorder

Initial dose: 20 mg orally once daily in the morning.
Maintenance dose: 20 to 60 mg orally daily in 1 to 2 divided doses.
Maximum dose: 80 mg orally daily

Comments:
-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 daily (morning) or twice daily schedule (i.e., morning and noon).
-The full effect may be delayed until 4 weeks of treatment or longer.
-Acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown.

Approved indication: For the acute and maintenance treatment of obsessions and compulsions

Usual Adult Dose for Bulimia

Initial dose: 60 mg orally once daily in the morning. Some patients have started with lower doses. Doses greater than 60 mg daily have not been studied.

Approved indication: For the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa.

Usual Adult Dose for Depression

Initial dose: 20 mg orally once a day in the morning
Maintenance dose: 20 to 60 mg/day in 1 to 2 divided doses
Maximum dose: 80 mg/day

Fluoxetine weekly: 90 mg orally once weekly

Comments:
-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 daily (morning) or twice daily schedule (i.e., morning and noon).
-The full effect may be delayed until 4 weeks of treatment or longer.
-Acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown.
-Weekly dosing with fluoxetine weekly is recommended to be initiated 7 days after the last daily dose of fluoxetine 20 mg.

Approved indication: Major Depressive Disorder

Usual Adult Dose for Panic Disorder

Initial dose: 10 mg orally once daily in the morning. After one week, the dose should be increased to 20 mg orally once daily in the morning.
Maintenance dose: 20 to 60 mg orally daily in 1 to 2 divided doses
Maximum dose: 80 mg orally daily

Comments:
-A dose increase may be considered after several weeks if no clinical improvement is observed.

Approved indication: For the acute treatment of Panic Disorder

Usual Pediatric Dose for Depression

7 years or younger:
Safety and efficacy have not been established.

8 years to less than 18 years:
Initial dose: 10 to 20 mg orally once daily. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day.

Lower weight children:
Due to higher plasma levels in lower weight children, the starting and dose in this group should generally be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if clinical improvement is insufficient.

Approved indication: Major Depressive Disorder

Usual Pediatric Dose for Obsessive Compulsive Disorder

6 years or younger:
Safety and efficacy have not been established.

7 years to less than 18 years:
Initial dose: 10 mg orally once daily

Adolescents and higher weight children:
Initial dose: 10 mg orally daily
After 2 weeks at 10 mg/day, the dose should be increased to 20 mg/day. Additional dose increases may be considered after several more weeks if clinical improvement is insufficient. A dose range of 20 to 60 mg/day is recommended.

Lower weight children:
Initial dose: 10 mg orally once daily
Additional dose increases may be considered after several weeks if clinical improvement is insufficient. A dose range of 20 to 30 mg/day is recommended. There is minimal experience with doses greater than 20 mg/day and none with doses greater than 60 mg/day.

Approved indication: For the acute and maintenance treatment of obsessions and compulsions

Renal Dose Adjustments

Dosage adjustments for renal dysfunction are not routinely necessary.

Liver Dose Adjustments

Adults:
Initial dose: 20 mg orally every other day or 10 mg once a day in the morning.
Maintenance dose: May increase to 20 mg/day after 2 to 3 weeks. Additional increases may be made in 10 to 20 mg/day increments every 2 to 3 weeks.

Children:
Lower or less frequent doses are recommended; however, there is not enough information to make any specific recommendations.

Dose Adjustments

A dose increase may be considered after several weeks if no clinical improvement is observed. Doses above 20 mg/day may be administered once a day (morning) or twice a day (i.e., morning and noon).

A lower or less frequent dosage should be used in patients with renal and/or hepatic impairment.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Fluoxetine is not removed by dialysis.

Other Comments

The full therapeutic effects of fluoxetine may not be observed until 4 weeks or more after initiation of therapy.

Doses greater than 20 mg/day may be divided into morning and noon doses.

Because fluoxetine can cause insomnia, nighttime dosing should be limited to those patients experiencing sedation.

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