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Topical antibacterial (sulfonamide derivative) — deep burn wounds Pregnancy: Not stated — no pregnancy, lactation or reproductive-toxicity section was present in the fetched label sections (only DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS and ADVERSE REACTIONS were retrieved). Do not infer a pregnancy position from this bundle.

Mafenide Acetate 5%

Brand names: Sulfamylon

Mafenide acetate is a topical sulfonamide antimicrobial applied to burn wounds to control bacterial colonisation, valued for its ability to penetrate eschar and avascular tissue.

Adult dose

Dose: Apply the cream to a thickness of approximately 1/16 inch (thicker application is not recommended)
Route: Topical — to cleansed, debrided burn wounds, applied with a sterile gloved hand
Frequency: Once or twice daily; the burned areas should be covered with the cream at all times, so reapply to any areas from which it has been removed (e.g. by patient activity)
SCOPE: this covers the 5% CREAM only — the product this page is titled for ('Mafenide Acetate 5%'). The 0.5% solution for continuous wound irrigation that the page also lists is NOT in the fetched label and was not re-sourced; source it separately before publishing an irrigation regimen. Verbatim DOSAGE AND ADMINISTRATION: 'Prompt institution of appropriate measures for controlling shock and pain is of prime importance. The burn wounds are then cleansed and debrided, and SULFAMYLON Cream is applied with a sterile gloved hand. Satisfactory results can be achieved with application of the cream once or twice daily, to a thickness of approximately 1/16 inch; thicker application is not recommended. The burned areas should be covered with SULFAMYLON Cream at all times. Therefore, whenever necessary, the cream should be reapplied to any areas from which it has been removed (e.g., by patient activity). The routine of administration can be accomplished in minimal time, since dressings usually are not required, if individual patient demands make them necessary, however, only a thin layer of dressings should be used. When feasible, the patient should be bathed daily to aid in debridement. A whirlpool bath is particularly helpful, but the patient may be bathed in bed or in a shower.' DURATION, verbatim: 'The duration of therapy with SULFAMYLON Cream depends on each patient's requirements. Treatment is usually continued until healing is progressing well or until the burn site is ready for grafting. SULFAMYLON Cream should not be withdrawn from the therapeutic regimen while there is the possibility of infection. However, if allergic manifestations occur during treatment with SULFAMYLON Cream, discontinuation of treatment should be considered.' ACIDOSIS INTERRUPTION, verbatim: 'If acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing therapy SULFAMYLON Cream for 24 to 48 hours while continuing fluid therapy may aid in restoring acid-base balance.' No maximum quantity, body-surface-area limit or per-kg figure appears anywhere in the fetched label, so maxDose is left empty — the only quantitative ceiling given is the application thickness quoted in the dose. PAEDIATRIC: the fetched label contains NO paediatric section and no paediatric dosing statement of any kind. This is US labelling — confirm local burns-unit protocol before use.

Dose adjustments

Renal

Not stated — no renal-impairment statement appears in any fetched section of this label (DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, ADVERSE REACTIONS were the only sections retrieved).

Hepatic

Not stated — no hepatic-impairment statement appears in any fetched section of this label.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity — CONTRAINDICATIONS verbatim: 'SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.'

Side effects

  • Dermatologic — 'The most frequently reported reaction was pain on application or a burning sensation. Rare occurrences are excoriation of new skin and bleeding of skin.'
  • Allergic — 'Rash itching, facial edema, swelling, hive, blisters, erythema, and eosinophilia.'
  • Respiratory — 'Tachypnea or hyperventilation, decrease in arterial pCO2.'
  • Metabolic — 'Acidosis, increase in serum chloride.'
  • Serious but singly reported — 'A single case of bone marrow depression and a single case of acute attack of porphyria have been reported following therapy with SULFAMYLON Cream.'
  • 'Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.'
  • 'Accidental ingestion of SULFAMYLON Cream has been reported to cause diarrhea.'
  • General caveat from the label: 'It is frequently difficult to distinguish between an adverse reaction to SULFAMYLON Cream and the effect of a severe burn.'

Monitoring

  • Acid-base balance — the label instructs interrupting treatment for acidosis: 'If acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing therapy SULFAMYLON Cream for 24 to 48 hours while continuing fluid therapy may aid in restoring acid-base balance.'
  • Respiratory pattern and arterial blood gases — the label lists 'Tachypnea or hyperventilation, decrease in arterial pCO2' as respiratory adverse reactions
  • Serum chloride — listed under metabolic adverse reactions ('Acidosis, increase in serum chloride')
  • Allergic manifestations — 'if allergic manifestations occur during treatment with SULFAMYLON Cream, discontinuation of treatment should be considered'
  • Wound healing / readiness for grafting — treatment 'is usually continued until healing is progressing well or until the burn site is ready for grafting', and should not be withdrawn 'while there is the possibility of infection'
  • No laboratory monitoring schedule is specified anywhere in the fetched label

Clinical monograph

How it works

It is a topical antibacterial agent that diffuses through devascularised burn eschar to inhibit susceptible bacteria, broadening antimicrobial cover in deep or established burn wounds.

Prescribing in practice

  • Mafenide is a carbonic anhydrase inhibitor and can cause metabolic acidosis with compensatory hyperventilation, so monitor acid-base status during extensive use.
  • Application can be painful and hypersensitivity reactions occur, including in patients sensitive to sulfonamides.
  • Reserve for selected burn wounds under specialist burns care and follow current prescribing references, noting it is not routinely stocked in the UK.

Monitoring

Monitor acid-base balance, respiratory rate and local tolerance, particularly when treating large burn surface areas.

Counselling the patient

  • Warn that application to the burn may sting or be painful.
  • Advise the team to watch for rapid breathing or signs of acidosis with extensive use.
  • Report any rash or worsening wound appearance to the burns team.

Evidence & guidelines

Mafenide is a long-established topical burns antimicrobial; use and its acid-base effects are described in current prescribing references and burns care literature.

Reference: British Burns Association Guidelines; ABA Burns Treatment Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.