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EFUDEX

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.

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.

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

• Other skin problems May be aggravated