Efudex Topical

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.

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:

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.

Pediatric

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

Geriatric

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.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Tegafur
• Varicella Virus Vaccine

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
• Allopurinol
• Azanidazole
• Bacillus of Calmette and Guerin Vaccine, Live
• Benznidazole
• Cholera Vaccine, Live
• Cimetidine
• Influenza Virus Vaccine, Live
• Isoconazole
• Methotrexate
• Metronidazole
• Nimorazole
• Ornidazole
• Oxypurinol
• Phenprocoumon
• Poliovirus Vaccine, Live
• Secnidazole
• Smallpox Vaccine
• Tamoxifen
• Tinidazole
• Typhoid 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

Interactions with Food/Tobacco/Alcohol

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.

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

This section provides information on the proper use of a number of products that contain fluorouracil. It may not be specific to Efudex. Please read with care.

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:
  • 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.
  • 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:
  • 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.
  • 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.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication must be used under close medical supervision. Be sure to keep all your medical appointments so your doctor can monitor your progress or any side effects.

Discard any unused medication when the treatment is finished. Do not use it for any other skin conditions unless directed to do so by your doctor.

There are different brands and forms of this medication available. Not all have identical effects. Do not change brands or forms without consulting your doctor or pharmacist.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.