Fluorouracil Topical

Fluorouracil Topical
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: Vignesh Ponnusamy, M.B.B.S. [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Fluorouracil Topical is a that is FDA approved for the {{{indicationType}}} of . 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 Fluorouracil Topical in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fluorouracil Topical 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 Fluorouracil Topical 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 Fluorouracil Topical in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Fluorouracil Topical Pharmacology in the drug label.

Mechanism of Action

• There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency that provokes unbalanced growth and death of the cell. The effects of DNA and RNA deprivation are most marked on those cells that grow more rapidly and take up fluorouracil at a more rapid rate. The contribution to efficacy or safety of individual components of the vehicle has not been established.

Structure

• Carac® (fluorouracil cream) Cream, 0.5%, contains fluorouracil for topical dermatologic use. Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The molecular formula is C4H3FN2O2. Fluorouracil has a molecular weight of 130.08.

This image is provided by the National Library of Medicine.

• Carac Cream contains 0.5% fluorouracil, with 0.35% being incorporated into a patented porous microsphere (Microsponge®)1 composed of methyl methacrylate / glycol dimethacrylate crosspolymer and dimethicone. The cream formulation contains the following other inactive ingredients: Carbomer Homopolymer Type C, dimethicone, glycerin, methyl gluceth-20, methyl methacrylate / glycol dimethacrylate crosspolymer, methylparaben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propylparaben, purified water, sorbitan monooleate, stearic acid, and trolamine.

Pharmacodynamics

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

Pharmacokinetics

• A multiple-dose, randomized, open-label, parallel study was performed in 21 patients with actinic keratoses. Twenty patients had pharmacokinetic samples collected: 10 patients treated with Carac and 10 treated with Efudex®2 5% Cream. Patients were treated for a maximum of 28 days with Carac, 1 g once daily in the morning; or Efudex® 5% Cream, 1 g twice daily, in the morning and evening. Steady-state plasma concentrations and the amounts of fluorouracil in urine resulting from the topical application of either product were measured.

• Three patients who received Carac and nine patients who received Efudex® 5% Cream had measurable plasma fluorouracil levels; however, only one patient receiving Carac and six patients receiving Efudex® 5% Cream had a sufficient number of data points to calculate mean pharmacokinetic parameters.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Fluorouracil Topical 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 Fluorouracil Topical in the drug label.

Precautions with Alcohol

• Alcohol-Fluorouracil Topical 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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