Mafenide Topical

In the U.S.

• Sulfamylon

Available Dosage Forms:

• Powder for Suspension
• Powder for Solution
• Cream

Therapeutic Class: Antibacterial

Chemical Class: Sulfonamide

Mafenide, 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 mafenide for burns. Patients with severe burns or burns over a large area of the body must be treated in a hospital.

mafenide is available only with your doctor's prescription.

You should not use this medicine if you are allergic to mafenide.

To make sure mafenide topical is safe for you, tell your doctor if you have:

• kidney disease;

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency;

• asthma or sulfite allergy; or

• if you are allergic to sulfa drugs.

FDA pregnancy category C. It is not known whether mafenide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether mafenide topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

It is not likely that other drugs you take orally or inject will have an effect on topically applied mafenide. 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.

Pain, burning, or redness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: blisters, fast breathing, nausea, vomiting, diarrhea, headache, change in alertness, shaking (tremors), seizures.

Tell your doctor right away if any of these rare but very serious side effects occur: weakness, dark urine, stomach/abdominal pain, arm/leg/back pain, fast heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Applies to mafenide topical: topical cream, topical powder for solution, topical powder for suspension

Along with its needed effects, mafenide topical 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 mafenide topical:

• Itching
• skin rash or redness
• swelling of face or skin
• wheezing or troubled breathing

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

• 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 of mafenide 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:

• Pain or burning feeling on treated area(s)

• 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

Acute renal failure: Use with caution.

Data not available