DrugindexOnline^{2nd edition}

Generic Name: Fluorouracil Cream and Solution 5% (flure-oh-URE-a-sil)
Brand Name: Efudex

Efudex Cream is used for:

Treating multiple actinic or solar keratoses (skin growths caused by exposure to sunlight). It may also be used for other conditions as determined by your doctor.

Efudex Cream is an antineoplastic. It works by blocking the growth of certain cells. This causes cell death.

Do NOT use Efudex Cream if:

• you are allergic to any ingredient in Efudex Cream
• you are pregnant or may become pregnant
• you have the metabolic disorder dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

Contact your doctor or health care provider right away if any of these apply to you.

Before using Efudex Cream:

Some medical conditions may interact with Efudex Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if the area of skin being treated is damaged or inflamed, or has open sores

Some MEDICINES MAY INTERACT with Efudex Cream. Because little, if any, of Efudex Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Efudex Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Efudex Cream:

Use Efudex Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use a nonmetallic applicator or wear rubber gloves while applying Efudex Cream.
• Gently wash the area where you will apply Efudex Cream. Rinse well, pat dry with a towel, and wait 10 minutes before applying Efudex Cream.
• Wash your hands immediately after applying Efudex Cream, unless they are part of the treated area.
• Do not bandage or cover the treated area, unless directed to do so by your doctor.
• Efudex Cream is for external use only. Do not get it in your eyes, nose, mouth, or genital area. If you get it in your eyes, rinse with a generous amount of cool water right away and contact your doctor.
• If you miss a dose of Efudex Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Efudex Cream.

Important safety information:

• Complete healing of the lesions may not occur for 1 to 2 months after you stop using Efudex Cream.
• The treated areas may be unattractive during therapy and for several weeks after treatment has stopped.
• Efudex Cream may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to his medicine. Use a sunscreen or wear protective clothing if you must be outside for more than a short period of time.
• Do not use other medicines or products on the treated area without first checking with your doctor.
• Do not use Efudex Cream for future skin problems without first checking with your doctor.
• Lab tests, including biopsies, may be done to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Efudex Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been determined.
• PREGNANCY and BREAST-FEEDING: Do not use Efudex Cream if you are pregnant. It may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if Efudex Cream is found in breast milk. Do not breast-feed while taking Efudex Cream.

Possible side effects of Efudex Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; change in skin color; chills; fever; scarring or sores on the treated area; severe or persistent burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin; severe stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Efudex Cream may be harmful if swallowed.

Proper storage of Efudex Cream:

Store Efudex Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Efudex Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Efudex Cream, please talk with your doctor, pharmacist, or other health care provider.
• Efudex Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Efudex Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.