Mafenide Acetate

Pronunciation: MAF-en-ide AS-e-tate
Class: Topical anti-infective

Trade Names

Sulfamylon
- Powder for solution, topical 5%
- Cream, topical 85 mg per gram

Pharmacology

Mechanism of action is unknown; however, it is different from sulfonamides.

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Pharmacokinetics

Absorption

Topical mafenide is delivered to burned tissue over a 4-h period following application. Peak concentrations of the cream and solution formulations in burned skin occur at 2 and 4 h, respectively. Following application of the cream, plasma C _max occurs in 2 h with levels ranging from 26 to 197 mcg/mL.

Metabolism

Once absorbed, mafenide is rapidly converted to an inactive metabolite.

Elimination

The metabolite is eliminated through the kidneys. Parent drug and the metabolite blood levels decrease to pretreatment levels within 24 h after application.

Indications and Usage

Use as adjunctive treatment of second- and third-degree burns.

Use as an adjunctive topical antimicrobial agent to control bacterial infections when used under moist dressings over meshed autografts or excised burn wounds.

Contraindications

Standard considerations. It is not known if there is cross-sensitivity to other sulfonamides.

Dosage and Administration

Topical

Apply 1 to 2 times daily, to a thickness of about 1/ 16 inch.

Cover grafted area with 1 layer of fine mesh. Cut an 8-ply burn dressing to the size of the graft and wet with mafenide acetate 5% solution using an irrigation syringe and/or irrigation tubing until leaking is noticeable. If irrigation tubing is not used, the gauze dressing may be moistened every 6 to 8 h as needed to keep it wet. Safety and efficacy have not been established for treatment longer than 5 days for an individual graft procedure.

General Advice

• Cream
• Apply with a sterile gloved hand.
• Keep burned area covered at all times, reapplying to any area from which the cream has been removed.
• Dressings usually are not required. However, if a dressing is necessary, apply only a thin layer of dressing.
• Patient should be bathed daily to aid in debridement.
• Continue treatment until healing is progressing well or until the burn site is ready for grafting.

• Solution
• If wetted with irrigation tubing, place the tubing over the burn dressing in contact with the wound and cover with a second piece of 8-ply dressing.
• Secure irrigation dressing with a bolster dressing.
• Keep gauze wet.
• Wound dressings may be left undisturbed, except for the irrigations, for up to 5 days. Additional soaks may be initiated until graft take is complete.
• Maceration of the skin may result from wet dressings applied for intervals as short as 24 h.

Storage/Stability

Store undiluted packets at 59° to 86°F. Store prepared solution at 59° to 86°F for up to 28 days in an unopened container. Once container is opened, any unused solution must be discarded within 48 h.

Avoid temperatures above 104°F. Protect from light.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Rash (5%); itching (3%); blisters; erythema; facial edema; hives; swelling.

Hematologic-Lymphatic

Bone marrow depression (rare); eosinophilia; fatal hemolytic anemia.

Local

Burning sensation; pain.

Metabolic-Nutritional

Decreased pCO ₂ ; increased serum chloride; metabolic acidosis.

Respiratory

Hyperventilation; tachypnea.

Miscellaneous

Acute porphyria (rare).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 3 mo of age.

Elderly

Safety and efficacy not established.

Hypersensitivity

If allergic reactions occur, consider discontinuing treatment.

Renal Function

Use with caution in patients with acute renal impairment.

Sulfite Sensitivity

Mafenide cream contains sodium metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or severe asthmatic episodes in susceptible people.

Acidosis

May occur. If acidosis becomes difficult to control, discontinuing the soaks for 24 to 48 h may aid in restoring acid-base balance.

Fungal colonization

May occur concurrently with reduction of bacterial growth in the burn wound. Systemic fungal infection through the burn wound is rare.

Hemolytic anemia

Fatal hemolytic anemia with DIC, presumably related to G-6-PD deficiency, has been reported.

Hyperventilation

Masked hyperventilation with resulting respiratory alkalosis has occurred.

Metabolic acidosis

May occur as a result of carbonic anhydrase inhibition, usually compensated by hyperventilation. The carbonic anhydrase inhibition may be exaggerated in patients with renal function impairment.

Overdosage

Symptoms

Data are lacking.

Patient Information

• Advise patients to notify their health care provider if condition worsens, if irritation occurs, or if hyperventilation occurs.
• Advise patients using mafenide cream to bathe burned area daily; a whirlpool bath is particularly helpful.

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