Generic Name: fluorouracil topical (flore oh YER a sill)Brand names: Carac, Efudex, Fluoroplex, Efudex Occlusion Pack
Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.
Fluorouracil topical is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.
Fluorouracil topical may also be used for purposes other than those listed in this medication guide.
Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.What should I discuss with my healthcare provider before using fluorouracil topical?
Before using fluorouracil topical, tell your doctor if you:
have ever had an allergic reaction to another form of fluorouracil topical (Carac, Efudex, Fluoroplex) or injectable fluorouracil (Adrucil, 5-FU); or
have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
You may not be able to use fluorouracil topical, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical. It is not known whether fluorouracil topical passes into breast milk. Do not use fluorouracil topical without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of fluorouracil topical in patients younger than 18 years of age have not been established.
Use fluorouracil topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.
Clean the area where you will apply fluorouracil topical. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.
Wash your hands before and immediately after applying this medication, unless it is being used to treat a hand condition.
Apply fluorouracil topical to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.Fluorouracil topical should not be applied on the eyelids or in the eyes, nose, or mouth. Use caution when applying fluorouracil topical around the eyes, nose, or mouth. Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical.
Do not cover the area after applying fluorouracil topical. This could cause too much medicine to be absorbed by the body and could be harmful. If a covering is needed, ask your doctor if a porous gauze dressing may be used.
A moisturizer or sun screen may be applied 2 hours after fluorouracil topical has been applied. Do not use any other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor.
The reaction of the skin treated with fluorouracil topical may be unsightly during treatment, and sometimes, for several weeks after completion of therapy.Store fluorouracil topical at room temperature away from moisture and heat.
Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.
Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Skin Cancer:
Superficial basal cell carcinoma:Apply 5% cream or solution to lesions twice daily with gloves or nonmetal applicators.Treatment should continue for at least 3 to 6 weeks, and may be required for as long as 10 to 12 weeks to resolve the lesions.
Usual Adult Dose for Keratosis:
Actinic or solar keratosis:0.5% cream (microsphere formulation): Apply to the affected area once a day. May be applied with the fingers and hands should be washed immediately afterward. 1%, 2%, 5% cream or 2%, 5% solution: Apply to the affected area twice daily with gloves or nonmetallic applicator, using sufficient amount to cover the lesions. The usual duration of therapy is 2 to 4 weeks, until the inflammatory response reaches the erosion state, at which time treatment is discontinued. Lesions may not heal completely for 1 to 2 months after fluorouracil therapy has been discontinued.Solar keratoses which do not respond to treatment should be biopsied to confirm the diagnosis.
Drugs other than those listed here may also interact with fluorouracil topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.