Fluoroplex

DRUG DESCRIPTION

FLUOROPLEX® (fluorouracil) 1% Topical Cream is an antineoplastic/antimetabolite product for dermatological use. Fluorouracil has the empirical formula C4H3FN2O2 and a molecular weight of 130.08. It is sparingly soluble in water and slightly soluble in alcohol. The pH is approximately 8.5.

Structural Formula:

FLUOROPLEX® (fluorouracil) Structural Formula illustration

fluorouracil

Chemical Name:

2,4(1H,3H)-Pyrimidinedione, 5-fluoro-.

FLUOROPLEX (fluorouracil topical cream) ® 1% Topical Cream contains:

Active Ingredient: fluorouracil 1.0%

Inactive Ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide .

What are the possible side effects of fluorouracil topical (Carac, Efudex, Fluoroplex)?

Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side...

Read All Potential Side Effects and See Pictures of Fluoroplex »

What are the precautions when taking fluorouracil topical cream (Fluoroplex )?

Before using fluorouracil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain enzyme deficiency (dihydropyrimidine dehydrogenase - DPD).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: red/irritated/infected/open sores on skin.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective...

Read All Potential Precautions of Fluoroplex »


Fluoroplex Consumer (continued)

SIDE EFFECTS: Skin irritation, burning, redness, dryness, pain, swelling, tenderness, or changes in skin color may occur at the site of application. Eye irritation (e.g., stinging, watering), trouble sleeping, irritability, temporary hair loss, or abnormal taste in the mouth may also occur.

If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: stomach/abdominal pain, bloody diarrhea, vomiting, signs of infection (e.g., fever, chills, persistent sore throat), easy bruising/bleeding, mouth sores.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fluorouracil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain enzyme deficiency (dihydropyrimidine dehydrogenase - DPD).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: red/irritated/infected/open sores on skin.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. After using fluorouracil cream, wait 2 hours before applying sunscreen or moisturizer to the treated area. Do not use other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor to do so.

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control.

It is not known if this medication passes into breast milk. Due to the potential risk to a nursing infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Fluoroplex Patient Information Including Side Effects

Brand Names: Carac, Efudex, Fluoroplex

Generic Name: fluorouracil topical (Pronunciation: flore oh YER a sill)

  • What is fluorouracil topical (Fluoroplex)?
  • What are the possible side effects of fluorouracil topical (Fluoroplex)?
  • What is the most important information I should know about fluorouracil topical (Fluoroplex)?
  • What should I discuss with my healthcare provider before using fluorouracil topical (Fluoroplex)?
  • How should I use fluorouracil topical (Fluoroplex)?
  • What happens if I miss a dose (Fluoroplex)?
  • What happens if I overdose (Fluoroplex)?
  • What should I avoid while using fluorouracil topical (Fluoroplex)?
  • What other drugs will affect fluorouracil topical (Fluoroplex)?
  • Where can I get more information?

What is fluorouracil topical (Fluoroplex)?

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 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 other than those listed in this medication guide.

What are the possible side effects of fluorouracil topical (Fluoroplex)?

Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluorouracil topical (Fluoroplex)?

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

Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

Related Drug Centers
  • Carac
  • Efudex
  • Fluoroplex


Related Drugs Index: