Fluoxetine

Fluoxetine
FLUOXETINE (fluoxetine hydrochloride) solution® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
PROZAC (fluoxetine hydrochloride) capsule® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
PROZAC WEEKLY (fluoxetine hydrochloride) capsule, delayed release® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Fluoxetine
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

For patient information about Fluoxetine, click here.

Synonyms / Brand Names: Fluoxetinum^®, Fluoxetine Hydrochloride^®, Fluoxetine Hcl^®, Fluoxetina^®, Fluoxetina^®, Animex-On^®, Deprex^®, Eufor^®, Fluctin^®, Fluoxeren^®, Fluval^®, Fontex^®, Foxetin^®, Portal^®, Prozac^®, Prozac Weekly^®, Pulvules^®, Reneuron^®, Sarafem^®, Adofen^®

FLUOXETINE (fluoxetine hydrochloride) solution Normal 0 false false false EN-US X-NONE X-NONE

Indications and Usage | Dosage and Administration | Dosage Forms and Strengths | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Use in Specific Populations | Overdosage | Description | Clinical Pharmacology | Nonclinical Toxicology | Clinical Studies | How Supplied/Storage and Handling | Patient Counseling Information | Labels and Packages

PROZAC (fluoxetine hydrochloride) capsule

  Normal  0          false  false  false    EN-US  X-NONE  X-NONE                                                                                                                                                                                                                                                                                                                                                               Normal  0          false  false  false    EN-US  X-NONE  X-NONE                                                                                                                                                                                                                                                                                                                                                            

Indications and Usage | Dosage and Administration | Dosage Forms and Strengths | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Use in Specific Populations | Overdosage | Description | Clinical Pharmacology | Nonclinical Toxicology | Clinical Studies | How Supplied/Storage and Handling | Patient Counseling Information | Labels and Packages

PROZAC WEEKLY (fluoxetine hydrochloride) capsule, delayed release Normal 0 false false false EN-US X-NONE X-NONE

Indications and Usage | Dosage and Administration | Dosage Forms and Strengths | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Use in Specific Populations | Overdosage | Description | Clinical Pharmacology | Nonclinical Toxicology | Clinical Studies | How Supplied/Storage and Handling | Patient Counseling Information | Labels and Packages

Dosing and Administration

Major Depressive Disorder
Adult — In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 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.

Obsessive-Compulsive Disorder
Adult — In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine or placebo. In 1 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-a-day (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 dose should not exceed 80 mg/day.

Bulimia Nervosa
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.

Panic Disorder
In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of panic disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day. Treatment should be initiated with a dose of 10 mg/day. After 1 week, the dose should be increased to 20 mg/day. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day.

For more detailed information on dosing please refer to Instructions for administration

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FDA Package Insert Resources
Indications, Contraindications, Side Effects, Drug Interactions, etc.

Calculate Creatine Clearance
On line calculator of your patients Cr Cl by a variety of formulas.

Convert pounds to Kilograms
On line calculator of your patients weight in pounds to Kg for dosing estimates.

Publication Resources
Recent articles, WikiDoc State of the Art Review, Textbook Information

Trial Resources
Ongoing Trials, Trial Results

Guidelines & Evidence Based Medicine Resources
US National Guidelines, Cochrane Collaboration, etc.

Media Resources
Slides, Video, Images, MP3, Podcasts, etc.

Patient Resources
Discussion Groups, Handouts, Blogs, News, etc.

International Resources
en Español

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FDA Package Insert Resources

Indications

Contraindications

Side Effects

Drug Interactions

Precautions

Overdose

Instructions for Administration

How Supplied

Pharmacokinetics and Molecular Data

FDA label

FDA on Fluoxetine

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Publication Resources

Most Recent Articles on Fluoxetine

Review Articles on Fluoxetine

Articles on Fluoxetine in N Eng J Med, Lancet, BMJ

WikiDoc State of the Art Review

Textbook Information on Fluoxetine

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Trial Resources

Ongoing Trials with Fluoxetine at Clinical Trials.gov

Trial Results with Fluoxetine

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Guidelines & Evidence Based Medicine Resources

US National Guidelines Clearinghouse on Fluoxetine

Cochrane Collaboration on Fluoxetine

Cost Effectiveness of Fluoxetine

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Media Resources

Powerpoint Slides on Fluoxetine

Images of Fluoxetine

Podcasts & MP3s on Fluoxetine

Videos on Fluoxetine

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Patient Resources

Patient Information from National Library of Medicine

Patient Resources on Fluoxetine

Discussion Groups on Fluoxetine

Patient Handouts on Fluoxetine

Blogs on Fluoxetine

Fluoxetine in the News

Fluoxetine in the Marketplace

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International Resources

Fluoxetine en Español

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References

Adapted from the FDA Package Insert.