MAFENIDE (Topical)

Some commonly used brand names are:

In the U.S.?

• Sulfamylon

In Canada?

• Sulfamylon

Category

• Antibacterial, topical
• Antifungal, topical

Description

Mafenide (MA-fe-nide),a sulfa medicine, is used to prevent and treat bacterial or fungus infections.It works by preventing growth of the fungus or bacteria.

Mafenide cream is applied to the skin and/or burned area(s) to preventand treat bacterial or fungus infections that may occur in burns.

Other medicines are used along with this medicine for burns. Patients withsevere burns or burns over a large area of the body must be treated in a hospital.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Topical
• Cream (U.S. and Canada)
• Powder for solution (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For mafenide, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to mafenide, acetazolamide (e.g., Diamox), oral antidiabetics(diabetes medicine you take by mouth), dichlorphenamide (e.g., Daranide),furosemide (e.g., Lasix), methazolamide (e.g., Neptazane), other sulfa medicines,or thiazide diuretics (water pills). Also tell your health care professionalif you are allergic to any other substances, such as preservatives or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. However, use is not recommended in women duringtheir child-bearing years unless the burn area covers more than 20% of thetotal body surface. In addition, sulfa medicines may increase the chance ofliver problems in newborn infants and should not be used near the due dateof the pregnancy.

Breast-feeding?Mafenide, when used on skin and/or burns, is absorbedinto the mother's body. It is not known whether this medicine passes intobreast milk. Sulfa medicines given by mouth do pass into the breast milk,and may cause liver problems, anemia (iron-poor blood), and other unwantedeffects in nursing babies, especially those with glucose-6-phosphate dehydrogenasedeficiency (lack of G6PD enzyme). Be sure you have discussed the risks andbenefits of mafenide with your doctor.

Children?Use of mafenide is not recommended in premature ornewborn infants up to 2 months of age. Sulfa medicines may causeliver problems in these infants.

Older adults?Many medicines have not been tested in older people.Therefore, it may not be known whether they work exactly the same way theydo in younger adults or if they cause different side effects or problems inolder people. There is no specific information comparing use of mafenide inthe elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of mafenide. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Blood problems?Use of mafenide may make the condition worse

• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)?Useof mafenide in persons with this condition may result in hemolytic anemia

• Kidney problems or
• Lung problems or
• Metabolic acidosis?Use of mafenide in persons with any of theseconditions may increase the risk of a side effect called metabolic acidosis

Proper Use of This Medicine

To use:

• Before applying this medicine, cleanse the affected area(s). Removedead or burned skin and other debris.
• Wear a sterile glove to apply this medicine. For the topical cream,apply a thin layer (about 1/16 inch) of mafenide to the affected area(s).For the topical solution, the solution is applied to the dressing coveringthe affected area(s). Keep the affected area(s) covered with the medicineat all times.
• If this medicine is rubbed off the affected area(s) by moving aroundor if it is washed off during bathing, showering, or the use of a whirlpoolbath, reapply the medicine.
• After this medicine has been applied, the treated area(s) may becovered with a dressing or left uncovered as desired.

To help clear up your skin and/or burn infection completely, keep using mafenide for the full time of treatment. You should keepusing this medicine until the burn area has healed or is ready for skin grafting. Do not miss any doses.

Dosing?The dose of topical mafenide will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of topical mafenide. If your dose isdifferent, do not change it unless your doctor tells you to do so.

• For topical dosage form (cream):
  • For bacterial or fungus infection:
    • Adults and children 2 months of age and over?Use one or twotimes a day.
    • Infants and children up to 2 months of age?Use is not recommended.
• For topical dosage form (solution):
  • For bacterial or fungus infection:
    • Adults and children 3 months of age and over?Use every 4 to8 hours each day as needed to keep the dressing wet.
    • Infants and children up to 3 months of age?Use is not recommended.

Missed dose?If you miss a dose of this medicine, apply it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It isimportant that your doctor check your progress at regular visits.

If your skin infection or burn does not improve within a few days or ifyour more serious burns or burns over larger areas do not improve within afew weeks, or if they become worse, check with your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctor immediately if any ofthe following side effects occur:

Less common

Itching; skin rash or redness; swelling of face or skin; wheezing ortroubled breathing

Rare

Bleeding or oozing of skin; drowsiness; fast, deep breathing; nausea

Not known

black, tarry stools; chest pain; chills; cough or hoarseness; dark urine; dizziness; fever; fluid-filled skin blisters; light-colored stools; lower back orside pain; numbness to feet, hands and around mouth; painful or difficult urination; rapid shallow breathing; sensitivity to the sun; shortness of breath; skin thinness; sore throat; sores, ulcers, or whitespots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusualtiredness or weakness; yellow eyes or skin

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Pain or burning feeling on treated area(s)

Not known

Blisters; flushing; raised red swellings on the skin, lips, tongue, or in the throat; redness of skin; skin rash; softening of the skin; swelling; unusually warm skin

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.