Mafenide (Topical)

Mafenide, a sulfa medicine, is used to prevent and treat infections caused by bacteria or fungus. It works by stopping the growth of the fungus or bacteria.

Mafenide cream is put on the skin and/or burned area(s) to prevent and treat infections that may happen in burns.

Other medicines are used alongside this medicine for burns. Patients with severe burns or burns covering a large area of the body must be treated in a hospital.

This medicine is available only with your doctor's prescription.

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

If your skin infection or burn does not get better within a few days, or if your more serious burns or burns covering larger areas do not improve within a few weeks, or if they get worse, contact your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Mafenide is not recommended for premature or newborn infants up to 2 months of age. Sulfa medicines may cause liver issues in these infants.

Geriatric

Many medicines have not been tested in older adults. Therefore, it may not be clear if they work the same way as they do in younger adults or if they cause different side effects or problems in older adults. There is no specific information comparing the use of mafenide in elderly patients to other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Methenamine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Methotrexate

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Aminolevulinic Acid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Blood problems—Using mafenide may worsen the condition.

• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)—Using mafenide in individuals with this condition may lead to hemolytic anemia.

• Kidney problems or
• Lung problems or
• Metabolic acidosis—Using mafenide in individuals with any of these conditions may increase the risk of a side effect called metabolic acidosis.

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

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

Less common

• Itching
• Skin rash or redness
• Swelling of face or skin
• Wheezing or troubled breathing

Rare

• Bleeding or oozing of skin
• Drowsiness
• Fast, deep breathing
• Nausea

Incidence unknown

• Black, tarry stools
• Chest pain
• Chills
• Cough or hoarseness
• Dark urine
• Dizziness
• Fever
• Fluid-filled skin blisters
• Light-colored stools
• Lower back or side 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 white spots on lips or in mouth
• Swollen glands
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Yellow eyes or skin

Some 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. 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

• Pain or burning feeling on treated area(s)

Incidence unknown

• 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Sulfamylon

Available Dosage Forms:

• Cream
• Powder for Solution

Therapeutic Class: Antibacterial

Chemical Class: Sulfonamide

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 creak, 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.