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Fluorouracil belongs to the group of medicines known as antimetabolites. When applied to the skin, it is used to treat certain skin problems, including cancer or conditions that could become cancerous if not treated. Fluorouracil interferes with the growth of abnormal cells, which are eventually destroyed.

Fluorouracil is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Cream
• Solution

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

1. Allergies:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

2. Pediatric Population:

There is no specific information comparing use of fluorouracil on the skin in children with use in other age groups.

3. Geriatric Population:

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.

4. Pregnancy

All trimesters: Category X: Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

5. Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

6. Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brivudine
• Rotavirus Vaccine, Live
• Tegafur

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Allopurinol
• Azanidazole
• Bacillus of Calmette and Guerin Vaccine, Live
• Benznidazole
• Cimetidine
• Clozapine
• Influenza Virus Vaccine, Live
• Isoconazole
• Measles Virus Vaccine, Live
• Methotrexate
• Metronidazole
• Mumps Virus Vaccine, Live
• Nimorazole
• Ornidazole
• Oxypurinol
• Phenprocoumon
• Poliovirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Secnidazole
• Smallpox Vaccine
• Tamoxifen
• Tinidazole
• Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Leucovorin
• Levamisole
• Levoleucovorin
• Phenytoin
• Thiamine

7. Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

8. Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency—May increase your chance of getting serious side effects.
• Other skin problems—May be aggravated

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cream dosage form:

o 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.

o 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:

o 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.

o 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, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. Apply this medicine very carefully when using it on your 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 sunlight may increase the effect of the drug. During this period of time:

• Stay out of direct sunlight, especially between the hours of 10:00 a.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 about this, 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 with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.