Efudex

What is Efudex?

• Efudex (Fluorouracil (Topical))Topical Solutions and Cream are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.

File:Fluorouracil.svg

Fluorouracil

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Fluorouracil-from-xtal-3D-bs-17

What are the uses of this medicine?

• Efudex (Fluorouracil (Topical)) is used for the topical treatment of multiple actinic or solar keratoses.
• In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas.

How does this medicine work?

• Efudex stops cells from making DNA and may kill cancer cells.
• It contains the active ingredient fluorouracil.
• Efudex is a type of antimetabolite.
• Fluorouracil is believed to block thymidylate synthase and decrease production of thymidylate, a necessary precursor of DNA.
• This action interferes with the synthesis of DNA, RNA and protein and blocks cell division.
• Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency which provokes unbalanced growth and death of the cell.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are or may become pregnant during therapy
• with known hypersensitivity to any of its components
• with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, especially other topical medications.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Is this medicine FDA approved?

• Fluorouracil was patented in 1956 and came into medical use in 1962.

How should this medicine be used?

Recommended dosage: Actinic or Solar Keratosis:

• Apply cream or solution twice daily in an amount sufficient to cover the lesions.
• The usual duration of therapy is from 2 to 4 weeks.
• Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Efudex therapy.

Superficial Basal Cell Carcinomas:

• Only the 5% strength is recommended.
• Apply cream or solution twice daily in an amount sufficient to cover the lesions.
• Treatment should be continued for at least 3 to 6 weeks.

Administration:

• Efudex should be applied preferably with a nonmetal applicator or suitable glove.
• If Efudex is applied with the fingers, the hands should be washed immediately afterward.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Topical Solutions and Cream

This medicine is available in fallowing brand namesː

• Efudex

What side effects can this medication cause?

The most common side effects of this medicine include:

• burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness, and ulceration
• Ulcerations, other local reactions, cases of miscarriage, and a birth defect (ventricular septal defect) have been reported when Efudex was applied to mucous membrane areas.
• Leukocytosis is the most frequent hematological side effect.

What special precautions should I follow?

• Tell your doctor if you have or have ever had dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (a lack of a naturally occurring enzyme in your body).
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluorouracil , call your doctor immediately. Fluorouracil can harm the fetus.
• Plan to avoid unnecessary or prolonged exposure to sunlight and UV light (such as tanning booths) and to wear protective clothing, sunglasses, and sunscreen. Fluorouracil may make your skin sensitive to sunlight.
• Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency.
• Fluorouracil, including Efudex may be fatal if ingested by pets. Avoid allowing pets to contact the Efudex container or the skin where Efudex has been applied. Store Efudex out of reach of pets.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Efudex may cause fetal harm when administered to a pregnant woman.
• Efudex is contraindicated in women who are or may become pregnant during therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Fluorouracil

Inactive ingredients include:

• propylene glycol
• Tromethamine
• methylparaben
• propylparaben
• edetate disodium
• HYDROXYPROPYL CELLULOSE

Who manufactures and distributes this medicine?

Distributed by:

• Bausch Health US, LLC
• Bridgewater, NJ USA

Manufactured by:

• Mylan Institutional Inc.
• Sugar Land, TX USA

• Efudex is a trademark of Bausch Health Companies Inc. or its affiliates.

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

• Dailymed label info on Efudex
• FDA Efudex