Fluorouracil topical (for the skin) is used to treat scaly overgrowths of skin (actinic or solar keratosis).

Fluorouracil topical is also used to treat superficial basal cell carcinoma.

Fluorouracil topical may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and immediately after applying this medicine, unless it is being used to treat a hand condition. Caregivers who apply this medicine should wear rubber gloves.

Apply only enough medicine to cover the affected skin with a thin film. Do not cover the treated skin area with bandaging or plastic unless your doctor tells you to.

Do not apply fluorouracil topical to skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical.

You may need to use fluorouracil topical for up to 6 weeks. Treated skin may have an undesirable appearance as it heals, which may take several weeks.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine container tightly closed when not in use. Keep out of the reach of children and pets.

Do not use fluorouracil topical to treat a skin condition that has not been checked by your doctor.

Usual Adult Dose for Keratosis:

0.5% cream (microsphere formulation): Apply to the affected area once a day where actinic keratosis lesions appear, using enough to cover the entire area with a thin film
-Duration of therapy: Apply for up to 4 weeks as tolerated; continued treatment up to 4 weeks results in greater lesion reduction; local irritation is not markedly increased by extending treatment from 2 to 4 weeks, and is generally resolved within 2 weeks of cessation of therapy

1%, 2%, 5% cream or 2%, 5% solution: Apply 2 times a day in an amount enough to cover the lesions; continue until the inflammatory response reaches the erosion stage, then discontinue use
-Duration of therapy: 2 to 4 weeks; complete healing of the lesions may not be evident for 1 to 2 months following cessation of therapy

Comments:
-Response starts with erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.
-This drug should not be applied near the eyes, nostrils, or mouth.
-Apply 10 minutes after washing, rinsing, and drying the entire area.
-This drug may be applied using the fingertips.
-Immediately after application, the hands should be thoroughly washed.
-Solar keratoses which do not respond to treatment should be biopsied to confirm the diagnosis.

Use: For the topical treatment of multiple actinic or solar keratoses

Usual Adult Dose for Basal Cell Carcinoma:

5% cream or solution:
-Apply 2 times a day in an amount sufficient to cover the lesions; continue until the inflammatory response reaches the erosion stage, then discontinue use
-Duration of therapy: 3 to 6 weeks; however, therapy may be required for as long as 10 to 12 weeks before lesions are obliterated

Comments:
-Only the 5% cream or solution is recommended to treat superficial basal cell carcinoma.
-Response starts with erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.

Use: To treat superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites

You should not use fluorouracil topical if you are allergic to fluorouracil, or if you have:

• a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency.

Do not use fluorouracil topical if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

You should not breastfeed while using fluorouracil topical.

Fluorouracil topical is not approved for use by anyone younger than 18 years old.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Do not use fluorouracil topical on your eyelids or in your eyes, nose, or mouth. Rinse with water or saline if this medicine gets in your eyes.

Do not let fluorouracil topical build up in the skin folds around your mouth, nose, or eyes. Use caution when applying the medicine around these areas.

Avoid using other medications on the areas you treat with fluorouracil unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Fluorouracil topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Fluorouracil topical may cause serious side effects. Stop using fluorouracil topical and call your doctor at once if you have:

• severe pain or swelling of treated skin;

• severe itching, burning, or irritation;

• new or worsening skin sores;

• fever, chills; or

• severe stomach pain, bloody diarrhea, vomiting.

Before your skin begins to heal it will become red, dry, tender, and crusty. This is a normal skin reaction, even if these symptoms get worse for a short time. Gradually, the dead skin will begin to shed off and you'll see raw skin appear. Ask your doctor when to stop using the medicine after you notice signs of healing.

Common side effects of fluorouracil topical may include:

• skin pain, itching, burning, or irritation;

• skin darkening or scarring;

• skin redness and swelling; or

• small blood vessels under the skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.