Mafenide

Mafenide is a prescription medication indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

• Mafenide is available under the following different brand names: Sulfamylon

Common side effects of Mafenide include:

• skin rash
• redness
• itching
• pain
• burning
• redness of the treated skin areas

Serious side effects of Mafenide include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• pale or yellowed skin
• dark colored urine
• fever
• confusion
• weakness
• rapid breathing
• skin rash
• bruising
• severe tingling
• numbness
• pain
• muscle weakness
• severe skin irritation where the medicine is applied

Rare side effects of Mafenide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Burn Treatment

• Adult dosage
• Cream
  • Apply to cleaned, debrided area once a day or every 12 hours at a thickness of approximately 1/16 inch
  • Ensure the burned area is covered with cream at all times — reapply as needed
• Topical solution
  • Cover the grafted area with 1 layer of gauze
  • Wet 8-ply burn dressing with the solution until leakage is observed; apply, secure, and wrap as necessary
  • With irrigation tubing: keep gauze dressing wet by irrigating with a syringe or injecting a solution into irrigation tubing every 4 hours or as needed
  • Not using irrigation tubing: moisten gauze every 6-8 hours or as needed
  • Wound dressings may be left undisturbed for up to 5 days
• Pediatric dosage
• Cream
  • Children younger than 2 years: Safety and efficacy not established
  • Children older than 2 years: Apply to clean, debrided area once a day or every 12 hours at thickness approximately 1/16 inch; ensure burned area covered with cream at all times — reapply as needed
• Topical solution
  • Cover the grafted area with 1 layer of gauze
  • Wet 8-ply burn dressing with the solution until leakage is observed; apply, secure, and wrap as necessary
  • With irrigation tubing: keep gauze dressing wet by irrigating with a syringe or injecting a solution into irrigation tubing every 4 hours or as needed
  • Not using irrigation tubing: moisten gauze every 6-8 hours or as needed
  • Wound dressings may be left undisturbed for up to 5 days

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Mafenide has severe interactions with no other drugs
• Mafenide has serious interactions with the following drug:
  • allogeneic cultured keratinocytes and fibroblasts
• Mafenide has moderate interactions with the following drug:
  • dichlorphenamide
• Mafenide has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to mafenide or any component of the formulation

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Mafenide?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Mafenide?"

Cautions

• Hypersensitivity
• Use extreme caution in patients with sulfonamide allergy
• E coli and proteus species appear to be less sensitive
• Prolonged use may result in fungal or bacterial superinfection including Clostridium difficile–associated diarrhea and pseudomembranous colitis
• Pregnancy/women of childbearing potential: not recommended in women of childbearing potential unless the burned area is more than 20% of the body surface area or benefits justify possible risks to the fetus
• G-6-PD deficiency; may result in hemolytic anemia

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Not known whether distributed into breast milk; discontinue the drug or do not nurse