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Common Name:

fluorouracil topical (Tolak)


How does Tolak work? What will it do for me?

Fluorouracil topical cream belongs to the class of medications called antineoplastics. It is used topically to treat a skin condition known as actinic keratosison the face, ears, and scalp.Actinic keratosis is a rough, crusty, or scaly growth on the top layer of skin. Actinic keratosis lesions may lead to skin cancer if they are not treated. This medication works by stopping the growth of the abnormal skin cells.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does Tolak come in?

Each gram of cream contains 40 mg of fluorouracil as fluorouracil sodium. Nonmedicinal ingredients: arlacel-165, butylated hydroxytoluene, cetyl alcohol, anhydrous citric acid, glycerin, isopropyl myristate, methyl gluceth-10, methylparaben, peanut oil, propylparaben, purified water, sodium hydroxide, stearic acid, and stearyl alcohol.

How should I use Tolak?

Fluorouracil topical cream is applied to the skin lesions and the area surrounding the lesions in a thin layer, once daily, for 4 weeks, unless otherwise directed by your doctor.

Wash the area to be treated and thoroughly pat the area dry. Once a day, apply a thin layer, but enough to cover the entire affected area of skin. Gently massage the cream into the skin. Wash your hands well with soap and water immediately after applying the cream.

Avoid contact with the eyes, eyelids, corners of the nose, mouth, or other areas that are easily irritated. Do not apply the cream to areas that are not affected by the lesions. Do not cover the treated area with an airtight dressing. Avoid transferring this medication from your body to other people.

This medication will cause the skin to become severely inflamed and irritated, but continue to use it for the length of time recommended by your doctor. Complete healing of the treated area may take 4 weeks after stopping treatment. If the area becomes severely irritated or does not heal, contact your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take Tolak?

Do not take this medication if you:

  • are allergic to fluorouracil or any ingredients of the medication
  • are or may become pregnant
  • have dihydropyrimidine dehydrogenase (DPD) deficiency

What side effects are possible with Tolak?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • difficulty sleeping
  • increased sensitivity to the sun
  • skin reactions where the cream is applied (e.g., redness, scaling, dryness, swelling, crusting, skin breakdown, burning or stinking, itching)

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • eye irritation
  • eye swelling
  • redness and swelling of normal skin

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe itchiness or red rash (on treated areas or on areas not treated)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Tolak?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reaction: Skin irritation and redness are expected effects of fluorouracil. Some people will experience a delayed reaction to this medication that results in eczema or severe itchiness at the treatment site or another site on the body. If you experience any prolonged skin reaction after using fluorouracil topical cream, let your doctor know.

Dihydropyrimidine Dehydrogenase (DPD) deficiency: People who are deficient in the enzyme DPD do not have the ability to effectively break down and get rid of fluorouracil from the body. If you have this condition, you may develop serious side effects due to increased levels of fluorouracil in your body. If you experience fever or chills, vomiting, abdominal pain, or bloody diarrhea contact your doctor immediately.

Peanut allergy: This medication contains peanut oil. If you have a peanut allergy, you should not use this medication.

Sunlight: This medication can increase your sensitivity to the sun and sensitivity reactions including severe sunburn can occur. You should minimize your exposure to sunlight while using this medication. Sun lamps and tanning beds should be avoided.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Women who may become pregnant should use effective birth control while using this medication and for at least 1 month after stopping treatment.

Breast-feeding: It is not known if fluorouracil passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with Tolak?

There may be an interaction between fluorouracil topical and any of the following:

  • capecitabine
  • fosphenytoin
  • gemcitabine
  • leucovorin
  • phenytoin
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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