FLUOROURACIL (Topical)
Some commonly used brand names are:
In the U.S.?
In Canada?
Another commonly used name is 5-FU.
Category
Description
Fluorouracil (flure-oh-YOOR-a-sill) belongs to thegroup of medicines known as antimetabolites. When applied to the skin, itis used to treat certain skin problems, including cancer or conditions thatcould become cancerous if not treated.
Fluorouracil interferes with the growth of abnormal cells, which are eventuallydestroyed.
Fluorouracil is available only with your doctor's prescription, in thefollowing 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 orallergic reaction to fluorouracil. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Tell your doctor if you are pregnant or if you intendto become pregnant. Although fluorouracil applied to the skin has not beenshown to cause problems in humans, some of it is absorbed through the skinand there is a chance that it could cause birth defects. Be sure that youhave discussed this with your doctor before using this medicine.
Breast-feeding?Although fluorouracil applied to the skin has notbeen shown to cause problems in nursing babies, some of it is absorbed throughthe skin.
Children?There is no specific information comparing use offluorouracil on the skin in children with use in other age groups.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. Although there is no specific information comparinguse 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 problemsin older people than it does in younger adults.
Other medical problems?The presence of other medical problems may affectthe use of fluorouracil on the skin. Make sure you tell your doctor if youhave any other medical problems, especially:
- Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency?Mayincrease your chance of getting serious side effects.
- Other skin problems?May be aggravated
Proper Use of This Medicine
Keep usingthis medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctorordered. Apply enough medicine each time to cover the entire affectedarea with a thin layer.
After washing the area with soap and water and drying carefully, use acotton-tipped applicator or your fingertips to apply the medicine in a thinlayer to your skin.
If you apply this medicine with your fingertips, make sure you wash your hands immediately afterwards, to prevent any of the medicinefrom accidentally getting in your eyes or mouth.
Fluorouracil may cause redness, soreness, scaling, and peeling of affectedskin after 1 or 2 weeks of use. This effect may last for several weeks afteryou stop using the medicine and is to be expected. Sometimes a pink, smootharea is left when the skin treated with this medicine heals. This area willusually fade after 1 to 2 months. Do not stop using this medicine withoutfirst checking with your doctor. If the reaction is very uncomfortable, checkwith your doctor.
Dosing?The dose of fluorouracil will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe 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 skinone 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 timesa 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 oneor 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 twotimes 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 assoon as you remember. However, if more than a few hours have passed, skipthe missed dose and go back to your regular dosing schedule. If you miss morethan 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 otherdamp 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 surethat 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 atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.
Apply this medicine very carefully when using it onyour 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 sunlightmay increase the effect of the drug. During this periodof time:
- Stay out of direct sunlight, especially between the hours of 10:00a.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 aboutthis, 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 withyour doctor.
Side Effects of This Medicine
Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.
Check with your doctorimmediately if the following side effects occur:
Redness and swelling of normal skin
Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue, worsen, or are bothersome:
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Revised: 08/03/2004
