Fluorouracil topical

Storage

Topical

Cream 0.5%: 20–25°C.e

Cream 1%: Tight containers at 15–30°C; avoid freezing.a c

Cream and solutions 2 and 5%: 25°C (may be exposed to 15–30°C);b g avoid freezing.a

• Interferes with DNA synthesis and, to a lesser extent, the formation of RNA by inhibiting the methylation of deoxyuridylic acid to thymidylic acid, a DNA precursor.a b e g

• Since DNA and RNA are essential for cell division and growth, may create a thymine deficiency, which provokes unbalanced growth and death of the cell.b e g

• Effects of DNA and RNA deprivation are most marked on cells that grow more rapidly.e g

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:

• Redness and swelling of normal skin

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:

• Burning feeling where medicine is applied
• increased sensitivity of skin to sunlight
• itching
• oozing
• skin rash
• soreness or tenderness of skin

• Darkening of skin
• scaling
• watery eyes

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Fever or chills.
• Belly pain.
• Bloody loose stools (diarrhea).
• Throwing up.
• Very loose stools (diarrhea).
• Change in eyesight, eye pain, or very bad eye irritation.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

You should not use fluorouracil topical if you are allergic to it.

To make sure fluorouracil topical is safe for you, tell your doctor if you have:

• dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

Fluorouracil topical can harm an unborn baby or cause birth defects. Do not use if you are pregnant. If you become pregnant, stop using the medicine and tell your doctor right away. Use effective birth control to avoid pregnancy during treatment. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether fluorouracil topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

Do not use this medicine 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 topical 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.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Usual Adult Dose for Keratosis:

0.5% cream (microsphere formulation): Apply to the affected area once a day

1%, 2%, 5% cream or 2%, 5% 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: 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.
-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

This medication is used on the skin to treat pre-cancerous and cancerous skin growths. Fluorouracil belongs to a class of medications known as anti-metabolites. It works by blocking the growth of abnormal cells that cause the skin condition.

How to use Fluorouracil Cream

Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Use this medication as directed by your doctor. Before you apply this medication to the skin, clean the affected area and dry well. Wait 10 minutes, then apply a small amount of medication to the affected skin, using just enough to cover the area with a thin film. Wash your hands immediately after applying this medication, even if you have used gloves.

The treated area may become unsightly during treatment and in some cases for several weeks after treatment. Do not cover the area with tight dressings or plastic bandages. Check with your doctor whether you may cover the treated area loosely with gauze.

Avoid applying this medication in or around the eyes or eyelids. Also, do not apply this medication inside the nose or mouth. If you do get the medication in these areas, rinse with plenty of water.

Use this medication exactly as prescribed. Do not stop using this medication without consulting your doctor. Do not increase your dose or use it more often than directed. Your condition will not clear faster, but side effects will be increased.

If your condition worsens or does not improve, consult your doctor or pharmacist promptly.

Applies to fluorouracil topical: topical cream, topical solution

Along with its needed effects, fluorouracil topical 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 while taking fluorouracil topical:

• Redness and swelling of normal skin

Some side effects of fluorouracil topical 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:

• Burning feeling where medicine is applied
• increased sensitivity of skin to sunlight
• itching
• oozing
• skin rash
• soreness or tenderness of skin

• Darkening of skin
• scaling
• watery eyes

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

Data not available