Mafenide (Topical Route)

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.

This product is available in the following dosage forms:

• Powder for Suspension


• Powder for Solution


• Cream

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Pregnancy

Breastfeeding

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

Drug Interactions

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problemsa€”Use of mafenide may make the condition worse.

• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)a€”Use of mafenide in persons with this condition may result in hemolytic anemia.

• Kidney problems or


• Lung problems or


• Metabolic acidosisa€”Use of mafenide in persons with any of these conditions may increase the risk of a side effect called metabolic acidosis.

Proper Use

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 overa€”Use one or two times a day.
    
    
    • Infants and children up to 2 months of agea€”Use is not recommended .
    
    
    
    
  
  
  
  


• For topical dosage form (solution):
  
  
  
  • For bacterial or fungus infection:
    
    
    
    • Adults and children 3 months of age and overa€”Use every 4 to 8 hours each day as needed to keep the dressing wet.
    
    
    • Infants and children up to 3 months of agea€”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.

Precautions

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

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:

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.