This medication is used alone or with other medications to help prevent and treat wound infections in patients with severe burns. Mafenide is a drug applied to the skin that belongs to a class of drugs known as sulfa antibiotics. It works by killing bacteria that may infect an open wound. Killing bacteria helps to promote wound healing and to decrease the risk of the bacteria spreading to surrounding skin or to the blood, thereby helping to prevent a serious blood infection (sepsis).

Wash hands before and after using this medication. Use this medication on the skin only. After cleaning the affected area, wear a clean pair of medical gloves (such as latex, vinyl) and apply this medication to the wound as directed by your doctor, usually once or twice daily. The layer of cream should be about one-sixteenth of an inch (1 to 2 millimeters) thick. The wound should be covered with this medication at all times. Bandages do not need to be used to cover the wound. If some of the cream rubs off the wound, re-apply it right away. Length of treatment is based on your medical condition and response to treatment.

Do not stop using this medication until told to do so by your doctor.

If possible, bathe at least once a day to help remove the dead skin from the wound to allow healing to occur. Be sure to re-apply this medication after bathing.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Tell your doctor if your condition lasts or gets worse or if you notice increasing redness/tenderness of the skin around the wound.

Pain, burning, or redness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including:

• blisters
• bleeding
• fast breathing
• nausea
• vomiting
• diarrhea
• headache
• change in alertness
• shaking (tremors)
• seizures
• weakness
• dark urine
• stomach/abdominal pain
• arm/leg/back pain
• fast heartbeat

A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

Before using mafenide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (including preservatives such as parabens, sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• lung problems (such as asthma)
• kidney disease
• metabolism problems (such as glucose-6-phosphate dehydrogenase deficiency-G6PD)
• blood disorders

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms following swallowing may include: diarrhea.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later on other wounds unless told to do so by your doctor. A different medication may be necessary in that case.

Lab and/or medical tests (such as wound cultures, acid-base balance, complete blood counts) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.