Efudex (Topical)

Fluorouracil topical is used to treat actinic or solar keratoses and a type of skin cancer called superficial basal cell carcinoma.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. If you have a severe reaction from the sun, check with your doctor.

This medicine may cause black, tarry stools, blurred or double vision, chills, cough, diarrhea, difficulty in walking, drooping eyelids, fever, headache, jaw pain, lower back or side pain, numbness or tingling in the fingers and toes, pain in the fingers, toes, and testicles, painful or difficult urination, pale skin, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swelling or inflammation of the mouth, unusual bleeding or bruising, or unusual tiredness or weakness. Check with your doctor right away if you notice any of these serious side effects.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how fluorouracil topical affects children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how fluorouracil topical affects older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together but could require dose adjustments or other precautions. When taking this medicine, it is important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Acenocoumarol
• Adenovirus Vaccine
• Allopurinol
• Azanidazole
• Bacillus of Calmette and Guerin Vaccine, Live
• Benznidazole
• Cholera Vaccine, Live
• Cimetidine
• Dengue Tetravalent Vaccine, Live
• Fosphenytoin
• Influenza Virus Vaccine, Live
• Isoconazole
• Leucovorin
• Levoleucovorin
• Methotrexate
• Metronidazole
• Nimorazole
• Ornidazole
• Oxypurinol
• Phenindione
• Phenprocoumon
• Phenytoin
• Poliovirus Vaccine, Live
• Secnidazole
• Smallpox Vaccine
• Tamoxifen
• Tinidazole
• Typhoid Vaccine, Live
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Levamisole
• Rolapitant
• Thiamine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Make sure to tell your doctor about any other medical issues, especially:

• Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency—This medicine should not be used in patients with this condition.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

Incidence not known

• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Chest pain
• Chills
• Cough
• Fever
• Painful or difficult urination
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Swollen glands
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

Incidence not known

• Dry, rough, or scaly skin
• Loss or thinning of the hair
• Raised, dark red, wart-like spots on the skin, especially when used on the face
• Swelling or inflammation of the mouth
• Tearing of the eyes
• Trouble sleeping

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.

In the U.S.

• Carac
• Efudex
• Fluoroplex

Available Dosage Forms:

• Cream
• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated.

This medicine is for use on the skin only. Do not get any of this medicine near or around your eyes, nose, or mouth. If it does get on these areas, rinse it off with water and check with your doctor right away.

To use the cream or solution:

• Wash your hands with soap and water before and after using this medicine.
• Apply enough amount of the medicine to each affected area.
• You may use a glove, nonmetal applicator, or fingers to apply this medicine.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by 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 topical dosage form (cream and solution): For actinic or solar keratosis: Adults—Apply to the affected area 2 times a day for 2 to 4 weeks. Children—Use and dose must be determined by your doctor. For superficial basal cell carcinomas: Adults—Apply to the affected area 2 times a day for 3 to 6 weeks. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep this medicine away from pets. Do not allow pets to contact the skin where the medicine is applied. Throw away or clean any cloth or applicator that may still have some of this medicine. Do not leave any medicine on your hands, clothing, carpet, or furniture.

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