Fluoroplex

What is Fluoroplex?

• Fluoroplex (Fluorouracil (Topical)) is an antineoplastic/antimetabolite product used as a cream to treat actinic keratosis (a skin condition that may become cancer).

Fluorouracil

Fluorouracil3DanZ

What are the uses of this medicine?

• Fluoroplex (Fluorouracil (Topical)) cream is a prescription medicine used on the skin to treat multiple actinic (solar) keratosis.

How does this medicine work?

Fluorouracil mechanism

• Fluorouracil (or its metabolites) blocks the methylation reaction of deoxyuridylic acid to thymidylic acid.
• In this fashion, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA).

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who are or may become pregnant
• are allergic to any of its components

What drug interactions can this medicine cause?

• Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Is this medicine FDA approved?

• Fluorouracil was patented in 1956 and came into medical use in 1962.

How should this medicine be used?

Recommended dosage:

• Apply medication twice daily with fingertips and wash hands afterwards.
• A treatment period of 2-6 weeks is usually required.
• Increasing the frequency of application and a longer period of administration with Fluoroplex Cream may be required on areas other than the head and neck.

Administration:

• Fluoroplex Cream is usually applied 2 times a day for 2 to 6 weeks.
• Use your fingertips to apply enough Fluoroplex Cream to cover the areas to be treated on your face or other affected areas, as instructed by your healthcare provider.
• Skin reactions are expected when you use Fluoroplex Cream. These skin reactions begin with redness, usually followed by dryness or tenderness and crusting of your skin. Before you see any healing of your skin, these skin reactions continue to progress. Stop using Fluoroplex Cream when you see raw areas (erosion and ulcers) and shedding of dead skin (sloughing). Be sure to follow your healthcare provider’s instructions about when to stop using Fluoroplex Cream.
• If your skin reaction bothers you or is severe, or if you are not sure what to do, call your healthcare provider for instructions.
• Avoid letting Fluoroplex Cream build up in the skin folds around your eyes, nose or mouth.
• Wash your hands right away after you apply Fluoroplex Cream. If you accidentally get Fluoroplex Cream in your eyes, flush your eyes with water or normal saline.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As fluorouracil 1% Topical Cream

This medicine is available in fallowing brand namesː

• Fluoroplex

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain
• itching
• burning
• irritation
• redness and swelling
• small blood vessels that can be seen under the skin
• darkening of the skin
• scarring

What special precautions should I follow?

• 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.
• There is a possibility of increased absorption through ulcerated or inflamed skin.
• The medication should be applied with care near the eyes, nose, and mouth. Excessive reaction in these areas may occur due to irritation from accumulation of drug.
• Fluorouracil, including Fluoroplex Cream may be fatal if ingested by pets. Avoid allowing pets to contact the Fluoroplex Cream container or the skin where Fluoroplex® Cream has been applied.
• Fluorouracil may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Overdosage will not cause acute problems.
• If Fluoroplex Cream accidentally comes in contact with the eye(s), flush the eyes(s) with water or normal saline.

Management of overdosage:

• If Fluoroplex Cream is accidentally ingested, induce emesis and gastric lavage.
• Administer symptomatic and supportive care as needed.

Can this medicine be used in pregnancy?

• Fluorouracil may cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: fluorouracil
• Inactive ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide.

Who manufactures and distributes this medicine?

Manufactured by:

• Almirall, LLC, Exton, PA U.S.A.
• Made in Germany

What should I know about storage and disposal of this medication?

• Do not freeze Fluoroplex Cream.
• Store Fluoroplex Cream between 59°F to 86°F (15°C to 30°C) in tight containers.

• Dailymed label info on Fluoroplex
• FDA Fluoroplex

Fluoroplex Resources
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