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|Carac Topical

FLUOROURACIL (Topical)

Some commonly used brand names are:

In the U.S.—

• Carac
• Efudex
• Fluoroplex

In Canada—

• Efudex
• Fluoroplex

Another commonly used name is 5-FU .

Category

• Antineoplastic, topical

Description

Fluorouracil (flure-oh-YOOR-a-sill) belongs to the group of medicines known as antimetabolites. When applied to the skin, it is used to treat certain skin problems, including cancer or conditions that could become cancerous if not treated.

Fluorouracil interferes with the growth of abnormal cells, which are eventually destroyed.

Fluorouracil is available only with your doctor"s prescription, in the following dosage forms:

• Topical
• Cream (U.S. and Canada)
• Topical solution (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For topical fluorouracil, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fluorouracil. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Tell your doctor if you are pregnant or if you intend to become pregnant. Although fluorouracil applied to the skin has not been shown to cause problems in humans, some of it is absorbed through the skin and there is a chance that it could cause birth defects. Be sure that you have discussed this with your doctor before using this medicine.

Breast-feeding—Although fluorouracil applied to the skin has not been shown to cause problems in nursing babies, some of it is absorbed through the skin.

Children—There is no specific information comparing use of fluorouracil on the skin in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of fluorouracil on the skin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medical problems—The presence of other medical problems may affect the use of fluorouracil on the skin. Make sure you tell your doctor if you have any other medical problems, especially:

• Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency—May increase your chance of getting serious side effects.

• Other skin problems—May be aggravated

Proper Use of This Medicine

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered . Apply enough medicine each time to cover the entire affected area with a thin layer.

After washing the area with soap and water and drying carefully, use a cotton-tipped applicator or your fingertips to apply the medicine in a thin layer to your skin.

If you apply this medicine with your fingertips, make sure you wash your hands immediately afterwards , to prevent any of the medicine from accidentally getting in your eyes or mouth.

Fluorouracil may cause redness, soreness, scaling, and peeling of affected skin after 1 or 2 weeks of use. This effect may last for several weeks after you stop using the medicine and is to be expected. Sometimes a pink, smooth area is left when the skin treated with this medicine heals. This area will usually fade after 1 to 2 months. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

Dosing—The dose of fluorouracil will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of fluorouracil. If your dose is different, do not change it unless your doctor tells you to do so.

• For cream dosage form:
  • For precancerous skin condition caused by the sun:
    • Adults—Use the 0.5% or 1% cream on the affected areas of skin one or two times a day. The 5% cream is sometimes used on the hands.
    • Children—Use and dose must be determined by your doctor.
  • For skin cancer:
    • Adults—Use the 5% cream on the affected areas of skin two times a day. Treatment may continue for several weeks.
    • Children—Use and dose must be determined by your doctor.
• For topical solution dosage form:
  • For precancerous skin condition caused by the sun:
    • Adults—Use the 1% solution on the affected areas of skin one or two times a day. The 2% or 5% solution is sometimes used on the hands.
    • Children—Use and dose must be determined by your doctor.
  • For skin cancer:
    • Adults—Use the 5% solution on the affected areas of skin two times a day. Treatment may continue for several weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, apply it as soon as you remember. However, if more than a few hours have passed, skip the missed dose and go back to your regular dosing schedule. If you miss more than one dose, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Protect the solution from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Apply this medicine very carefully when using it on your face. Avoid getting any in your eyes, nose, or mouth .

While using this medicine, and for 1 or 2 months after you stop using it, your skin may become more sensitive to sunlight than usual and too much sunlight may increase the effect of the drug. During this period of time :

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat and sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if the following side effects occur:

Redness and swelling of normal skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue, worsen, or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/03/2004

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