Drugs Details

Drugs Info of Carac, Efudex, Efudex Occlusion Pack, Fluoroplex
Drugs Details
  • Drugs Type  : Multum
  • Date : 4th Feb 2015 03:39 am
  • Brand Name : Carac, Efudex, Efudex Occlusion Pack, Fluoroplex
  • Generic Name : fluorouracil topical (Pronunciation: flore oh YER a sill)
Descriptions

Efudex (fluorouracil) Solutions and Cream are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.

Efudex Solution consists of 2% or 5% fluorouracil on a weight/weight basis, compounded with propylene glycol, tris (hydroxymethyl) aminomethane, hydroxypropyl cellulose, parabens (methyl and propyl) and disodium edetate.

Efudex Cream contains 5% fluorouracil in a vanishing cream base consisting of white petrolatum, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl).

Chemically, fluorouracil is 5-fluoro-2,4(1H,3H)-pyrimidinedione. It is a white to practically white, crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is:

Efudex (fluorouracil) structural formula illustration

What are the possible side effects of fluorouracil topical (Carac, Efudex, Efudex Occlusion Pack, 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...

Read All Potential Side Effects and See Pictures of Efudex »

What are the precautions when taking fluorouracil (Efudex)?

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 Efudex »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Efudex (fluorouracil) is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.

The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Efudex (fluorouracil) Cream and Solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

Dosage Administration

When Efudex (fluorouracil) is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.

Efudex (fluorouracil) should be applied preferably with a nonmetal applicator or suitable glove. If Efudex (fluorouracil) is applied with the fingers, the hands should be washed immediately afterward.

Actinic or Solar Keratosis: Apply cream or solution twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Efudex (fluorouracil) therapy.

Superficial Basal Cell Carcinomas: Only the 5% strength is recommended. Apply cream or solution twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.

How Supplied

Efudex (fluorouracil) Solution is available in 10-mLdrop dispensers containing either 2% (NDC 0187-3202-10) or 5% (NDC 0187-3203-10) fluorouracil and 25-mLdrop dispensers containing either 2% (NDC 0187-3202-02) or 5% (NDC 0187-3203-02) fluorouracil on a weight/weight basis compounded with propylene glycol, tris (hydroxymethyl) aminomethane, hydroxypropyl cellulose, parabens (methyl and propyl) and disodium edetate.

Efudex Cream is available in 40-gm tubes containing 5% fluorouracil (NDC 0187-3204-47) in a vanishing cream base consisting of white petrolatum, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl).

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

Valeant Pharmaceuticals North America, Costa Mesa, CA 92626. U.S.A. Rev. September 2005. FDA Rev date: 5/10/2006

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The most frequent adverse reactions to Efudex (fluorouracil) occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, pain, photosensitivity, pruritus, scarring, rash, soreness and ulceration. Ulcerations, other local reactions, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Efudex (fluorouracil) was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect.

Although a causal relationship is remote, other adverse reactions which have been reported infrequently are:

Central Nervous System: Emotional upset, insomnia, irritability

Gastrointestinal: Medicinal taste, stomatitis.

Hematological: Eosinophilia, thrombocytopenia, toxic granulation.

Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash.

Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation.

Miscellaneous: Herpes simplex.

Read the Efudex (fluorouracil) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

Read the Efudex Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Efudex (fluorouracil) was applied to mucous membrane areas during pregnancy.

Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations. If any occlusive dressing is used in treatment of basal cell carcinoma, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin. A porous gauze dressing may be applied for cosmetic reasons without increase in reaction.

Exposure to ultraviolet rays should be minimized during and immediately following treatment with Efudex (fluorouracil) because the intensity of the reaction may be increased.

Patients should discontinue therapy with Efudex (fluorouracil) if symptoms of DPD enzyme deficiency develop (see CONTRAINDICATIONS section).

Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. One case of life-threatening systemic toxicity has been reported with the topical use of Efudex (fluorouracil) in a patient with DPD enzyme deficiency. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil.

Precautions

General: There is a possibility of increased absorption through ulcerated or inflamed skin.

Laboratory Tests: Solar keratoses which do not respond should be biopsied to confirm the diagnosis. Follow-up biopsies should be performed as indicated in the management of superficial basal cell carcinoma.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. Studies with the active ingredient of Efudex (fluorouracil) , 5-fluorouracil, have shown positive effects in in vitro tests for mutagenicity and on impairment of fertility.

5-Fluorouracil was positive in three in vitro cell neoplastic transformation assays. In the C3H/10T12 clone 8 mouse embryo cell system, the resulting morphologically transformed cells formed tumors when inoculated into immunosuppressed syngeneic mice.

While no evidence for mutagenic activity was observed in the Ames test (3 studies), fluorouracil has been shown to be mutagenic in the survival count rec-assay with Bacillus subtilis and in the Drosophila wing-hair spot test. Fluorouracil produced petite mutations in Saccharomyces cerevisiae and was positive in the micronucleus test (bone marrow cells of male mice).

Fluorouracil was clastogenic in vitro (ie, chromatid gaps, breaks and exchanges) in Chinese hamster fibroblasts at concentrations of 1.0 and 2.0 ug/mL and has been shown to increase sister chromatid exchange in vitro in human lymphocytes. In addition, 5-fluorouracil has been reported to produce an increase in numerical and structural chromosome aberrations in peripheral lymphocytes of patients treated with this product.

Doses of 125 to 250 mg/kg, administered intraperitoneally have been shown to induce chromosomal aberrations and changes in chromosome organization of spermatogonia in rats. Spermatogonial differentiation was also inhibited by fluorouracil, resulting in transient infertility. However, in studies with a strain of mouse which is sensitive to the induction of sperm head abnormalities after exposure to a range of chemical mutagens and carcinogens, fluorouracil was inactive at oral doses of 5 to 80 mg/kg/day. In female rats, fluorouracil administered intraperitoneally at doses of 25 and 50 mg/kg during the preovulatory phase of oogenesis significantly reduced the incidence of fertile matings, delayed the development of preimplantation and postimplantation embryos, increased the incidence of preimplantation lethality and induced chromosomal anomalies in these embryos. Single dose intravenous and intraperitoneal injections of 5-fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes (at 500 mg/kg) and to produce abnormalities in spermatids (at 50 mg/kg) in mice.

Pregnancy: Teratogenic Effects: Pregnancy Category X: See CONTRAINDICATIONS section

Nursing Mothers: It is not known whether Efudex (fluorouracil) is excreted in human milk. Because there is some systemic absorption of fluorouracil after topical administration (see CLINICAL PHARMACOLOGY), because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue use of the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in children have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

There have been no reports of overdosage with Efudex (fluorouracil) .

The oral LD50 for the 5% topical cream was 234 mg/kg in rats and 39 mg/kg in dogs. These doses represented 11.7 and 1.95 mg/kg of fluorouracil, respectively. Studies with a 5% topical solution yielded an oral LD50 of 214 mg/kg in rats and 28.5 mg/kg in dogs, corresponding to 10.7 and 1.43 mg/kg of fluorouracil, respectively. The topical application of the 5% cream to rats yielded an LD50 of greater than 500 mg/kg.

ContrainDications

Efudex (fluorouracil) may cause fetal harm when administered to a pregnant woman.

There are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. One birth defect (cleft lip and palate) has been reported in the newborn of a patient using Efudex (fluorouracil) as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when Efudex (fluorouracil) was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil.

Animal reproduction studies have not been conducted with Efudex. Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats, and hamsters when given at doses equivalent to the usual human intravenous dose; however, the amount of fluorouracil absorbed systemically after topical administration to actinic keratoses is minimal (see CLINICAL PHARMACOLOGY). Fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on Day 10 or 12 of gestation. Similarly, intraperitoneal doses of 12 to 37 mg/kg given to rats between Days 9 and 12 of gestation and intramuscular doses of 3 to 9 mg/kg given to hamsters between Days 8 and 11 of gestation were teratogenic and/or embryotoxic (ie, resulted in increased resorptions or embryolethality). In monkeys, divided doses of 40 mg/kg given between Days 20 and 24 of gestation were not teratogenic. Doses higher than 40 mg/kg resulted in abortion.

Efudex (fluorouracil) should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. A large percentage of fluorouracil is catabolized by the DPD enzyme. DPD enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities.

Efudex (fluorouracil) is contraindicated in women who are or may become pregnant during therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus.

Efudex (fluorouracil) is also contraindicated in patients with known hypersensitivity to any of its components.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency which provokes unbalanced growth and death of the cell. The effects of DNA and RNA deprivation are most marked on those cells which grow more rapidly and take up fluorouracil at a more rapid rate. The catabolic metabolism of fluorouracil results in degradation products (eg, CO, urea, a-fluoro-|3-alanine) which are inactive.

Systemic absorption studies of topically applied fluorouracil have been performed on patients with actinic keratoses using tracer amounts of 14C-labeled fluorouracil added to a 5% preparation. All patients had been receiving nonlabeled fluorouracil until the peak of the inflammatory reaction occurred (2 to 3 weeks), ensuring that the time of maximum absorption was used for measurement. One gram of labeled preparation was applied to the entire face and neck and left in place for 12 hours. Urine samples were collected. At the end of 3 days, the total recovery ranged between 0.48% and 0.94% with an average of 0.76%, indicating that approximately 5.98% of the topical dose was absorbed systemically. If applied twice daily this would indicate systemic absorption of topical fluorouracil to be in the range of 5 to 6 mg per daily dose of 100 mg. In an additional study, negligible amounts of labeled material were found in plasma, urine and expired CO2 after 3 days of treatment with topically applied 14C-labeled fluorouracil.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be forewarned that the reaction in the treated areas may be unsightly during therapy and, usually, for several weeks following cessation of therapy. Patients should be instructed to avoid exposure to ultraviolet rays during and immediately following treatment with Efudex (fluorouracil) because the intensity of the reaction may be increased. If Efudex (fluorouracil) is applied with the fingers, the hands should be washed immediately afterward. Efudex (fluorouracil) should not be applied on the eyelids or directly into the eyes, nose or mouth because irritation may occur.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

FLUOROURACIL - TOPICAL

 

(flewr-oh-YOUR-uh-sill)

 

COMMON BRAND NAME(S): Efudex, Fluoroplex

 

USES: 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: 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.

Consumer Overview Side Effect

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.

 

Read the Efudex (fluorouracil) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication must be used under close medical supervision. Be sure to keep all your medical appointments so your doctor can monitor your progress or any side effects.

Discard any unused medication when the treatment is finished. Do not use it for any other skin conditions unless directed to do so by your doctor.

There are different brands and forms of this medication available. Not all have identical effects. Do not change brands or forms without consulting your doctor or pharmacist.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Carac, Efudex, Efudex Occlusion Pack, Fluoroplex

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

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

What is fluorouracil topical (Efudex)?

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 (Efudex)?

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.

Read the Efudex (fluorouracil) Side Effects Center for a complete guide to possible side effects

Learn More »

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

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.

Side Effects Centers
  • Carac
  • Efudex
  • Fluoroplex

Patient Detailed How Take

What should I discuss with my healthcare provider before using fluorouracil topical (Efudex)?

Before using fluorouracil topical, tell your doctor if you:

  • have ever had an allergic reaction to another form of fluorouracil topical (Carac, Efudex, Fluoroplex) or injectable fluorouracil (Adrucil, 5-FU); or
  • have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

You may not be able to use fluorouracil topical, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

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.

It is not known whether fluorouracil topical passes into breast milk. Do not use fluorouracil topical without first talking to your doctor if you are breast-feeding a baby.

The safety and effectiveness of fluorouracil topical in patients younger than 18 years of age have not been established.

How should I use fluorouracil topical (Efudex)?

Use fluorouracil topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

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.

Clean the area where you will apply fluorouracil topical. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.

Wash your hands before and immediately after applying this medication, unless it is being used to treat a hand condition.

Apply fluorouracil topical to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.

Fluorouracil topical should not be applied on the eyelids or in the eyes, nose, or mouth. Use caution when applying fluorouracil topical around the eyes, nose, or mouth.

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.

Do not cover the area after applying fluorouracil topical. This could cause too much medicine to be absorbed by the body and could be harmful. If a covering is needed, ask your doctor if a porous gauze dressing may be used.

A moisturizer or sun screen may be applied 2 hours after fluorouracil topical has been applied. Do not use any other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor.

The reaction of the skin treated with fluorouracil topical may be unsightly during treatment, and sometimes, for several weeks after completion of therapy.

Store fluorouracil topical at room temperature away from moisture and heat.

Side Effects Centers
  • Carac
  • Efudex
  • Fluoroplex

Patient Detailed Avoid Taking

What happens if I miss a dose (Efudex)?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.

What happens if I overdose (Efudex)?

An overdose of fluorouracil topical is unlikely to occur. If you do suspect an overdose, or if fluorouracil topical has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using fluorouracil topical (Efudex)?

Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with the treatment or increase irritation of the skin.

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.

What other drugs will affect fluorouracil topical (Efudex)?

Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with treatment or increase irritation to the skin.

Drugs other than those listed here may also interact with fluorouracil topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about fluorouracil topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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