Fluoroplex

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Injectable:

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Topical:

• Cream
  • Use fluorouracil once a day as instructed by your doctor. Use it only on your skin.
    • Clean the area where you will apply fluorouracil. Rinse well and dry the area with a towel and wait 10 minutes before applying fluorouracil.
    • Use enough to cover the affected area of skin.
    • Avoid contact with your eyes, nostrils, and mouth.
    • Wash your hands as soon as you finish putting the fluorouracil on your skin.
    • Do not use any other skin products including creams, lotions, medications or cosmetics unless instructed by your doctor.
• Topical solution
  • Apply solution preferably with a nonmetal applicator or suitable glove. If applied with the fingers, the hands should be washed immediately afterward.
• What you should avoid while using fluorouracil cream or topical solution:
  • Avoid sunlight or other ultraviolet light (such as tanning booths) as much as possible while using fluorouracil. Sunlight may increase your side effects. When exposed to sunlight, wear a hat and use sunscreen.
  • Do not cover the treated skin with a dressing.
  • Do not breast feed or become pregnant while using fluorouracil. If you do become pregnant, stop using fluorouracil and tell your doctor right away.

Injectable:

• Store at room temperature 15° to 30°C (59° to 86°F).
• Protect from light.
• Retain in carton until time of use.

Topical:

• Keep this medicine at room temperature (68–77° F/ 20–25° C). Throw away unused medicine.
• Keep this medicine out of the reach of children.
• Medicines are sometimes prescribed for conditions that are not described in patient information leaflets. Do not use it for a condition for which it was not prescribed. This medicine is for your use only. Never give it to other people. It may harm them even if their skin problem appears to be the same as yours. Do not use Carac after the expiration date on the tube.

Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

Fluorouracil topical (for the skin) is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.

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

This medication can harm an unborn baby or cause birth defects. Do not use fluorouracil topical if you are pregnant.

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

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

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;

• open skin sores; or

• shedding of dead skin.

Common side effects may include:

• skin redness, followed by dryness, tenderness, and crusting;

• skin peeling or flaking;

• skin darkening or scarring;

• small blood vessels under the skin;

• mild rash; or

• mild irritation where the medicine was applied.

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.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Fluoroplex by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Wait 10 minutes after washing affected part before putting drug on skin.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Do not put on cuts, scrapes, eczema, or damaged skin.
• Do not put on healthy skin.
• Do not let the skin where this medicine was used touch anyone else's skin after you have used Fluoroplex (fluorouracil (topical)).
• If you get this medicine in the eyes, flush right away with cool water and get medical help.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

There exists the potential for a delayed hypersensitivity reaction to fluorouracil. Patch testing to prove hypersensitivity may be inconclusive1.

If an occlusive dressing is used, there may be an increase in the incidence of inflammatory reactions in the adjacent normal skin.

The patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment with Fluoroplex® Cream, as the intensity of the reaction may be increased.

Fluoroplex® (fluorouracil) 1% Topical Cream is available in 30 g tubes (NDC 16110-812-30)

NOTE: Avoid freezing. Store at 15° - 30°C (59° - 86°F) in tight containers.

Rx Only