Medications and Drugs
GENERIC NAME: fluorouracil topical
BRAND NAME: Carac, Efudex, Fluoroplex
DRUG CLASS AND MECHANISM: Topical fluorouracil is a drug that is used to treat conditions of the skin in which there is rapid multiplication (division) of cells, for example, skin cancer. In order to multiply or divide, cells must produce DNA for each new cell. The DNA is critical since it is the genetic material that directs the activity of all cells. Production of DNA depends on the production of RNA which serves as a messenger during the production of DNA.
Fluorouracil prevents the formation of RNA which, in turn, prevents the formation of DNA. As a result, cells cannot multiply. With continued treatment, the remaining cells also die.
GENERIC: No
PRESCRIPTION: Yes
PREPARATIONS: Cream 0.5%, 1% and 5%. Solution 2%.
STORAGE: Cream and lotion should be stored at room
temperature, between 20-25 °C (68-77 °F).
PRESCRIBED FOR: Topical fluorouracil is used to treat certain
skin conditions in which cells are multiplying rapidly. It is used to treat cancerous or precancerous conditions including
solar keratoses, actinic keratosis, superficial basal cell carcinoma, and Bowen's
disease (a type of skin cancer). It also is used to treat some noncancerous conditions in which cells are dividing rapidly, including psoriasis,
genital warts, and porokeratosis (an unusual inherited skin condition
causing dry patches on the arms and legs). Fluorouracil works best on the face and scalp
and is less effective on other areas of the body. It also destroys sun-damaged skin
cells making the skin smoother and more youthful-appearing.
DOSING: The cream or solution is applied once or twice daily
after washing the area that is to be treated with plain water. The course of treatment
continues for up to four weeks. A tiny amount of the cream should
be gently rubbed into all of the treated areas with a fingertip. It is
important to apply it to all of the skin and not just visible lesions.
Afterwards, the finger should be rinsed thoroughly with water. (Alternatively, a glove can be used.) After a few days, the lesion becomes red and may
even blister and weep. There may be some soreness. Tretinoin cream enhances the effect of 5-fluorouracil by
peeling off the top layer of skin.
When fluorouracil is
prescribed with tretinoin cream, the combination works best if the
tretinoin has been used for at least two weeks prior to starting
fluorouracil.
DRUG INTERACTIONS: There are no known drug interactions with
topical fluorouracil.
PREGNANCY: Although
very little fluorouracil is absorbed from normal skin, about 20% can be
absorbed into the blood when fluorouracil is applied to
damaged skin. Fluorouracil can cause damage to the fetus, and it should
not be used by pregnant women.
NURSING MOTHERS: It is not
known whether fluorouracil passes into breast milk, and, therefore, nursing mothers should not use fluorouracil.
SIDE EFFECTS: With application of fluorouracil, initially there usually is a mild to severe stinging
or burning sensation or irritation. It also sensitizes the skin to sun and promotes sunburn. After five
to ten days of treatment, the sun-damaged parts of treated skin can become
red and irritated. If exposure to sun is unavoidable, sunscreen with SPF of 15 or greater should be used,
especially during summer months and mid-day.
Fluorouracil also may cause prolonged hypo-pigmentation (lightening of the
skin), which is more noticeable in dark-skinned persons. Such individuals
may wish to first test fluorouracil in a cosmetically unimportant areas.
Certain areas are more sensitive to severe irritation, including skin folds,
the lips, and the eyelids. Make-up may increase the irritation.
Occasionally, one or more of the following complications may arise:
excessive inflammation resulting in ulcer formation, persistent white marks
or scarring, and secondary bacterial infections.
Reference: FDA Prescribing Information
Last Editorial Review: 10/1/2001
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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