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|Sulfamylon Topical

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 prevent and treat bacterial or fungus infections that may occur in burns.

Other medicines are used along with this medicine for burns. Patients with severe 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 the following 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 will do. This is a decision you and your doctor will make. For mafenide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic 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 professional if you are allergic to any other substances, such as preservatives or dyes.

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

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

Children—Use of mafenide is not recommended in premature or newborn infants up to 2 months of age. Sulfa medicines may cause liver 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 they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mafenide in the elderly with use in other age groups.

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

Other medical problems—The presence of other medical problems may affect the use of mafenide. Make sure you tell your doctor if you 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)—Use of 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 these conditions 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). Remove dead 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 covering the affected area(s). Keep the affected area(s) covered with the medicine at all times.
• If this medicine is rubbed off the affected area(s) by moving around or if it is washed off during bathing, showering, or the use of a whirlpool bath, reapply the medicine.
• After this medicine has been applied, the treated area(s) may be covered 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 keep using 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 different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of topical mafenide. If your dose is different, 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 two times 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 to 8 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 as soon as possible. However, if it is almost time for your next dose, skip the missed 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 sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits.

If your skin infection or burn does not improve within a few days or if your more serious burns or burns over larger areas do not improve within a few 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 may need medical attention.

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

Other side effects may occur that usually do not need medical attention. These side effects may 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 are bothersome:

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

Revised: 09/29/2005

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