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Efudex is marketed under the name 5-FU in Canada.

What is 5-fluorouracil/5-FU used for?

This medicine is recommended for the treatment of actinic or solar keratosis and basal cell carcinoma

If you have any questions about your medicine, please talk with your doctor, pharmacist, or health care provider. This medicine is only to be used by the patient for whom it is prescribed. Do not give it to others. This information is advisory only. It does not contain all information about this medicine. If you have any questions about your medicine, ask your doctor, pharmacist, or health care provider.

How should 5-fluorouracil/5-FU be stored?

Store at room temperature in a cool dry place, protect from heat and light. Keep all medicines out of the reach of children and pets.

General drug information:

General Information

When should 5-fluorouracil/5-FU not be taken?

Do not take this medicine if you are allergic to any ingredient in this medicine or to similar medications.

What precautions should I follow when taking 5-fluorouracil/5-FU?

Before using this medicine, tell your health care provider about any of the following: if you are pregnant, planning to become pregnant, or breastfeeding if you are taking any other prescription or nonprescription medicine if you have any other medical condition like heart disease, lung disease, impairment of kidney or liver functions.

What special warning(s) should I be aware of when taking 5-fluorouracil/5-FU?

Exposure of the mucous membrane of the eyes, nose, mouth and vagina to this medicine can result in ulceration, inflammation and necrosis. Do not use if you are or may become pregnant during therapy because of potential hazard to the fetus. Cases of miscarriage and birth defects have been reported in women who are pregnant.

What are the side effects of 5-fluorouracil/5-FU?

Most severe: Pain, pruritus, hyperpigmentation and burning at the site of application

Most common: Dermatitis, scarring, soreness and tenderness.

Other: Insomnia, stomatitis, suppuration, scaling, swelling, irritability, medicinal taste, photosensitivity and lacrimation

How should I take 5-fluorouracil/5-FU?

How much medicine you use and how often you use it depends on many factors, including the condition being treated and the age and weight of the patient. If you have any questions about the amount and/or frequency of the medicine you are taking, talk with your health care provider. For external use only. Avoid contact with eyes. This medicine should be applied twice daily with a nonmetal applicator or suitable glove. The amount of the cream should be sufficient to cover the lesion. When applied to a lesion, there is erythema (redness), usually followed by vesiculation, erosion, ulceration, necrosis and epithelization. The skin adjacent to the leision may show this response with a lower frequency and intensity. Medication should be continued until the inflammatory reaction reaches the erosion, necrosis, and ulceration stage, at which time use of the drug should be stopped. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesion may not be evident for 1 to 2 months following cessation of treatment. Do not take more medicine than prescribed unless advised to do so by your health care provider. Do not take any other over-the-counter or prescription medications without talking with your doctor. Patients with previous conditions should talk with their health care provider before taking this medication. If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed, contact your doctor or pharmacist.