Fluoxetine

Fluoxetine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Disclaimer

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Black Box Warning

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete Boxed Warning. Suicidal thoughts and behavior: Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Fluoxetine is not approved for use in children less than 7 years of age. When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.

Overview

Fluoxetine is an antidepressive agent that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fluoxetine in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluoxetine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Fluoxetine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Fluoxetine in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluoxetine in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete Boxed Warning. Suicidal thoughts and behavior: Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Fluoxetine is not approved for use in children less than 7 years of age. When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fluoxetine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Fluoxetine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluoxetine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fluoxetine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fluoxetine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Fluoxetine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Fluoxetine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Fluoxetine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fluoxetine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fluoxetine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fluoxetine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fluoxetine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fluoxetine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Fluoxetine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Fluoxetine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Fluoxetine in the drug label.

Pharmacology

There is limited information regarding Fluoxetine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Fluoxetine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fluoxetine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fluoxetine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fluoxetine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fluoxetine in the drug label.

How Supplied

Storage

There is limited information regarding Fluoxetine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fluoxetine in the drug label.

Precautions with Alcohol

• Alcohol-Fluoxetine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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