Mafenide: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Topical/Cutaneous
Adjunct in the treatment of infection in second degree burn, Adjunct in the treatment of infection in third degree burn

Adult: As 8.5% cream: Apply approx ¹/₁₆ inch thickness layer 1-2 times daily using a sterile-gloved hand. Thicker application is not recommended. Cover the burned areas with the cream at all times. Continue therapy until wound healing progresses well or the burn site is ready for grafting. If possible, the patient must be bathed daily to aid in debridement (e.g. whirlpool bath, shower).
Child: As 8.5% cream: Same as adult dose.

Topical/Cutaneous
Prophylaxis of burn wound infection

Adult: Adjunct to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds: As 5% topical solution: Wet an 8-ply burn dressing with the 5% topical solution and cover the graft area. Keep dressing wet by using a syringe or irrigation tubing 4 hourly (or as necessary) or by moistening the dressing 6-8 hourly (or as necessary). Continue therapy until autograft vascularisation occurs and wound healing progresses. Wound dressing may be left in place for up to 5 days.
Child: As 5% topical solution: ≥3 months Same as adult dose.

Reconstitution

Powder for topical solution: Reconstitute 50 g of mafenide with 1,000 mL of sterile water for irrigation or NaCl 0.9% for irrigation to provide a 5% w/v topical solution. Mix until dissolved.

Contraindications

Hypersensitivity to mafenide or other sulfonamides.

Special Precautions

Patient with G6PD deficiency and pulmonary dysfunction. Discontinue therapy for 24-48 hours to aid acid-base balance restoration if acidosis occurs and becomes difficult to control (particularly in patients with pulmonary dysfunction). Renal impairment. Children. Pregnancy and lactation.

Adverse Reactions

Significant: Metabolic acidosis, marked hyperventilation with resulting respiratory alkalosis; delayed eschar separation; bacterial or fungal superinfection, including Clostridium difficile-associated diarrhoea and pseudomembranous colitis (prolonged use).
Blood and lymphatic system disorders: Eosinophilia.
General disorders and administration site conditions: Pain or burning sensation on application; facial oedema.
Investigations: Decreased partial pressure of carbon dioxide (pCO₂).
Metabolism and nutrition disorders: Hyperchloraemia.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, tachypnoea.
Skin and subcutaneous tissue disorders: Rash, pruritus, swelling, urticaria, erythema, blisters, excoriation of new skin, skin bleeding; skin maceration (topical solution).
Potentially Fatal: Haemolytic anaemia with disseminated intravascular coagulation, which may be related to G6PD deficiency.

Pregnancy Category (US FDA)

Topical: C

Monitoring Parameters

Closely monitor acid-base balance, especially in patients with extensive 2nd degree or partial thickness burns and those with pulmonary or renal dysfunction. Assess for signs of infection and healing.

Action

Description:
Mechanism of Action: Mafenide is a short-acting sulfonamide topical antibacterial agent that is not antagonised by p-aminobenzoic acid (PABA), pus, serum or tissue exudates. The mechanism of action is unknown; however, it appears to interfere with bacterial folic acid synthesis by competitive inhibition of PABA. Its spectrum of activity encompasses both Gram-positive and Gram-negative organisms, including Pseudomonas aeruginosa and some anaerobes.
Pharmacokinetics:
Absorption: Diffuses through devascularised areas; rapidly absorbed from the burned surface into the circulation. Time to peak plasma concentration: 2 hours (11% cream); 4 hours (5% topical solution).
Metabolism: Rapidly metabolised into p-carboxybenzenesulfonamide (inactive metabolite), a weak carbonic anhydrase inhibitor.
Excretion: Via urine, as metabolites.

Chemical Structure

Storage

Cream: Store below 40°C. Protect from excessive heat. Powder for topical solution: Store between 15-30°C. Reconstituted solutions may be stored in unopened containers for up to 28 days. Once the container is opened, discard any unused portion within 48 hours.

MIMS Class

Topical Antibiotics

ATC Classification

D06BA03 - mafenide ; Belongs to the class of topical sulfonamides used in the treatment of dermatological diseases.

References

Anon. Mafenide Acetate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/03/2023.

Anon. Mafenide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/03/2023.

Buckingham R (ed). Mafenide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/03/2023.

Mafenide Acetate Powder, for Solution (Ingenus Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/03/2023.

Sulfamylon 5% Topical Solution (Bertek Pharmaceuticals, Inc.). U.S. FDA. https://www.fda.gov. Accessed 15/03/2023.

Sulfamylon Cream (Rising Pharma Holdings, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/03/2023.

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