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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.
Tolak (for the skin) is used to treat scaly overgrowths of skin (actinic or solar keratoses). This medicine may also be used in the treatment of superficial basal cell carcinoma.
Tolak 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 Tolak if you are pregnant.
You should not use Tolak if you are allergic to it.
To make sure Tolak is safe for you, tell your doctor if you have:
dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
Tolak can harm an unborn baby or cause birth defects. Do not use if you are pregnant. If you become pregnant, stop using the medicine and tell your doctor right away. Use effective birth control to avoid pregnancy during treatment. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.
It is not known whether fluorouracil topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Tolak.
Tolak is not approved for use by anyone younger than 18 years old.
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Do not take by mouth. Topical medicine is for use only on the skin.
Clean the area where you will apply Tolak. 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 medicine, unless it is being used to treat a hand condition.
Apply Tolak 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.
Caregivers who apply this medicine should wear rubber gloves.
Do not use Tolak on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using this medicine.
Do not cover the treated skin area unless your doctor tells you to.
A moisturizer or sun screen may be applied 2 hours after Tolak has been applied.
Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine container tightly closed when not in use.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Do not use Tolak on your eyelids or in your eyes, nose, or mouth. Rinse with water or saline if this medicine gets in your eyes.
Do not let Tolak build up in the skin folds around your mouth, nose, or eyes. Use caution when applying the medicine around these areas.
Avoid using other medications on the areas you treat with Tolak unless your doctor tells you to.
Avoid exposure to sunlight or tanning beds. Tolak can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
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 Tolak 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.
It is not likely that other drugs you take orally or inject will have an effect on topically applied fluorouracil. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.
Further informationRemember, 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Tolak (www.drugs.com/mtm/tolak.html).
Note: This document contains side effect information about fluorouracil topical. Some of the dosage forms listed on this page may not apply to the brand name Tolak.
For the ConsumerApplies to fluorouracil topical: topical cream, topical solution
Along with its needed effects, fluorouracil topical (the active ingredient contained in Tolak) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fluorouracil topical:
Some side effects of fluorouracil topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common or rare
For Healthcare Professionals
Applies to fluorouracil topical: topical cream, topical kit, topical solution
DermatologicVery rare (less than 0.01%): Pruritus, urticaria, rash (local or generalized), erythema (i.e., erythema multiforme), burning sensation, exfoliation, swelling, ulceration, allergic contact dermatitis, eczema, blistering, alopecia, pain
Frequency not reported: Hyperpigmentation, crusting, irritation, photosensitivity, scarring, bullous pemphigoid, ichthyosis, scaling, suppuration, telangiectasia, tenderness, herpes simplex
GastrointestinalVery rare (less than 0.01%): Diarrhea, vomiting, abdominal pain, stomatitis, mucosal inflammation
Frequency not reported: Nausea, medicinal taste
HematologicFrequency not reported: Leukocytosis, eosinophilia, thrombocytopenia, toxic granulation
HypersensitivityVery rare (less than 0.01%): Hypersensitivity
Nervous systemFrequency not reported: Dysgeusia, headache, dizziness
OcularFrequency not reported: Conjunctival irritation, corneal reaction, keratitis, increased lacrimation
OtherVery rare (less than 0.01%): Pyrexia, chills
RespiratoryFrequency not reported: Nasal irritation
PsychiatricFrequency not reported: Emotional upset, irritability, insomnia
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Tolak (www.drugs.com/mtm/tolak.html).
December 16, 2020
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