Mafenide (Sulfamylon) is a broad-spectrum antibiotic with activity against gram-positive and gram-negative bacteria including Pseudomonas aeruginosa. It is used as a topical solution or cream in patients with second or third-degree burns.

Mafenide (Sulfamylon) Uses:

• Burn treatment:

  • It is used as an adjunctive treatment in patients with second-degree or third-degree burns as a topical antimicrobial cream to control bacterial infection.
  • It is used over meshed autografts on excised burn wounds (powder for solution) under moist dressings.

Mafenide (Sulfamylon) Dose in Adults:

Mafenide (Sulfamylon) Dose in the treatment of Burn: Topical:

• Cream:
  • Apply the cream with a sterile-gloved hand once or twice a day.
  • Apply as a thin layer over the burned area.
  • Cover the burned area at all times until healing or the burned site is ready for grafting.
• Powder for solution:
  • Cover the graft area with an 8-ply burn dressing soaked in the solution.
  • The dressings should be kept wet using an irrigation tubing or a syringe every four hours as necessary.
  • The treatment should be continued until revascularization of the autograft occurs and healing is progressing.
  • The dressing may be kept in place not exceeding five days.

Mafenide (Sulfamylon) Dose in the treatment of Burns: Topical:

• Infants, Children, and Adolescents:

  • Cream:
    • Apply the cream with a sterile-gloved hand once or twice a day.
    • Apply as a thin layer that covers the burned surface at all times.

• Infants ≥3 months, Children, and Adolescents:

  • Solution (5%):
    • The burned area should be covered with a layer of meshed gauze piece.
    • The graft area should be covered with an 8-ply burn dressing soaked in the solution.
    • The dressing should be kept wet using an irrigation tubing or a wet syringe every four hours or as necessary.
    • The dressing may be kept in place not exceeding five days and should be secured and wrapped with bolster dressing as appropriate.

Pregnancy Risk Category: C

• Animal reproduction studies did not show any adverse reactions when the drug was given orally.
• The cream should not be used by women under the age of 20 years.

Use Mafenide while breastfeeding

• It is unknown if the drug will be excreted into breastmilk.
• The manufacturer suggests that infants not be breastfed due to the potential for serious adverse drug reactions.

Mafenide (Sulfamylon) Dose in Kidney Disease:

• In the manufacturer's labeling, there are no contraindications mentioned.
• It should, however, be used with caution in patients with renal failure because of drug accumulation and metabolic acidosis.

Mafenide (Sulfamylon) Dose in Liver disease:

In the manufacturer's labeling, there are no contraindications mentioned.

Side effects of Mafenide (Sulfamylon):

• Cardiovascular:

  • Edema
  • Facial Edema

• Dermatologic:

  • Erythema
  • Maceration
  • Pruritus
  • Rash
  • Urticaria

• Endocrine & Metabolic:

  • Hyperchloremia
  • Metabolic Acidosis

• Gastrointestinal:

  • Diarrhea (Following Accidental Ingestion)

• Hematologic:

  • Bleeding
  • Bone Marrow Suppression
  • DIC
  • Eosinophilia
  • Hemolytic Anemia
  • Porphyria

• Local:

  • Blisters
  • Burning Sensation,
  • Excoriation
  • Pain

• Respiratory:

  • Dyspnea
  • Hyperventilation
  • Pco Decreased
  • Tachypnea

• Miscellaneous:

  • Hypersensitivity

Contraindications to Mafenide (Sulfamylon):

Allergy to mafenide, or any component of this formulation

Warnings and precautions

• Acid-base imbalance

  • The inhibitory effect of the drug upon the enzyme carbonic anihydrase may cause metabolic acidosis.
  • Patients with impaired renal function may experience metabolic acidosis more often.
  • Metabolic acidosis symptoms are subtle and may manifest only as an increase of the respiratory rate (due compensatory hyperventilation).
  • Patients with severe burns and patients with renal dysfunction or pulmonary dysfunction should be closely monitored for venous or arterial PH.

• Allergy to sulfonamide

  • Patients who are allergic to sulfonamides or sulfonylureas, thiazide diuretics, thiazide diuretics or loop diuretics (except for ethacrynic acids), should not use it.
  • Patients who have had an allergic reaction in the past should not use the drug.

• Superinfection

  • Long-term use of the drug can lead to superinfection, including serious bacterial or fungal infections.
  • The risk of antibiotic-associated pseudomembranous colitis may occur as later as two months after the last dose of antibiotics.

• G6PD deficiency:

  • G6PD deficiency can lead to acute hemolytic crises and DIC (disseminated intravascular coagulation), which may prove fatal.
  • These patients should use it with caution.

• Renal impairment

  • Patients with acute renal impairment should not be given the drug.
  • Due to drug accumulation and carbonic anhydrase inhibitor, the risk of metabolic acidosis could increase.

Mafenide: Drug Interaction

Monitoring parameters:

• Acid base balance
• Monitor for superimposed infections and healing

How to administer Topical Mafenide (Sulfamylon)?

Cream:

• It is intended for topical (external) use only. The burn area should be covered with the medicated cream at all times.
• Dressings are not required but a thin layer of dressings may be used.
• The cream should be applied using a sterile gloved hand to a clean area that has been debrided. A thin layer of the drug should be applied.
• If the possibility of infection persists, treatment must not be discontinued. To help in the debridement of the wound, the patient should be bathed daily.

Powder for solution:

• It is intended for external use only.
• The graft area should be covered with one layer of fine mesh gauze.
• An 8-ply burn dressing should be soaked with the solution until leaking is noticeable and the graft area should be covered with it.
• The dressings should be kept wet using a syringe or irrigation tubing or by moistening dressing.
• Irrigation tubing should be placed over the burn dressing in contact with the wound;
• An additional 8-ply dressing should be used to cover the area.
• The irrigation dressing should be secured with bolster dressing and wrapped as appropriate.

Mechanism of action of Mafenide (Sulfamylon):

• It is a sulfonamide anti-biotic that competes against para-aminobenzoic acids and interferes with bacterial folic acid synthesis.
• It is effective against both gram positive and gram negative organisms, including pseudomonas Aeruginosa as well as anaerobic and anaerobic diseases.

Absorption:

• It absorbs quickly from the burnt surface and diffuses through devascularized areas.

Metabolism:

• It is metabolized to para-carboxybenzene sulfonamide.
• Mafenide and metabolite are carbonic anhydrase inhibitors

The time to peak serum concentration:

• Cream 11%: 2 to 4 hours
• Burn tissue:
  • Cream 11%: 2 hours,
  • Solution 5%: 4 hours

Excretion:

• Urine (as metabolites)

International Brands of Mafenide:

• Sulfamylon
• Homonal
• Mafatate
• Mefede
• Sulfamylon
• Sulfomyl

Mafenide Brands Names in Pakistan:

No Brands Available in Pakistan.