Sulfamylon

Name: Sulfamylon

What happens if I miss a dose?

Because you will receive mafenide topical in a clinical setting, you are not likely to miss a dose.

Uses for Sulfamylon

Treatment and Prevention of Burn Infections

Mafenide acetate cream is used topically as adjunctive therapy in second- and third-degree burns to prevent septicemia caused by susceptible organisms, especially Pseudomonas aeruginosa.a b

Control of bacterial growth may prevent conversion of second-degree (partial-thickness) wounds to third-degree (full-thickness) wounds; however, delayed eschar separation reported.a b

Although controlled, comparative studies are lacking, mafenide and silver sulfadiazine are considered by many clinicians to be among the topical anti-infective agents of choice in burn patients.d e g h i

Mafenide appears to penetrate burn eschar better than silver sulfadiazine and may be more effective in minimizing the growth of bacteria and early treatment of wound sepsis.d i Unlike mafenide, silver sulfadiazine does not alter acid-base balance and does not have a limited duration of therapy and area of topical application; softening action of silver sulfadiazine cream may aid in eschar removal and preparation of wound for grafting.d f

Alternative therapies include wet dressings of 0.5% silver nitrate; appears to be of equal efficacy as mafenide cream; mafenide cream may cause more pain on application.a

Mafenide acetate solution is used topically as adjunctive therapy to control bacterial infections under moist dressings over meshed autografts on excised burn wounds.c

Cautions for Sulfamylon

Contraindications

  • Known hypersensitivity to mafenide or any ingredient in the formulation.a b Unknown if cross-sensitivity to other sulfonamides occurs.b c (See Sensitivity Reactions under Cautions.)

Warnings/Precautions

Warnings

Hemolytic Anemia

Fatal hemolytic anemia with disseminated intravascular coagulation reported, presumably related to glucose-6-phosphate dehydrogenase deficiency.a b c

Sensitivity Reactions

Hypersensitivity

Hypersensitivity reactions (e.g., rash, pruritus, facial edema, swelling, urticaria, blisters, erythema, eosinophilia) reported 10–14 days after initiation of therapy.a

If hypersensitivity reaction occurs, consider discontinuing mafenide therapy temporarily or initiating concomitant antihistamine therapy.a

Potential for cross-sensitivity with other sulfonamides is unknown.b c

Sulfite Sensitivity

Cream contains a sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.b j k l m n o p q

Major Toxicities

Systemic Acidosis

May cause systemic acidosis (tachypnea or hyperventilation, increased serum chloride concentration, and decreased arterial pCO2).a b c Closely monitor acid-base balance in patients with extensive second-degree (partial-thickness) burns, pulmonary dysfunction, or renal impairment.b c (See Dosage Modification for Toxicity under Dosage and Administration and see Pulmonary Dysfunction and also Renal Impairment under Cautions.)

Syndrome of marked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pCO2, decreased total CO2) has been reported; change in arterial pO2 is variable.a b c Etiology and significance unknown.a b c

General Precautions

Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi, both in and below burn eschar.a

Fungal colonization in wound and in and below burn eschar may occur concomitantly with reduction of bacterial growth; however, systemic fungal infection via dissemination through the burn wound is rare.a b c

Pulmonary Dysfunction

Closely monitor acid-base balance in pulmonary dysfunction.a b c (See Systemic Acidosis under Cautions.)

Specific Populations

Pregnancy

Category C.b c

Not recommended for women of childbearing potential unless the burned area covers >20% of total body surface area or the therapeutic benefits justify the possible risks to the fetus.a b c

Lactation

Not known whether mafenide is distributed into milk.a b c Discontinue nursing or the drug.a b c

Pediatric Use

Safety and efficacy of topical solution not established in infants <3 months of age.c

Renal Impairment

Increased risk for metabolic acidosis in renal impairment due to substantial carbonic anhydrase inhibition.a b c Closely monitor acid-base balance.a b c (See Systemic Acidosis under Cautions.)

Use with caution in acute renal failure.a b c

Common Adverse Effects

Pain on application, burning sensation. a b c

Contraindications

Sulfamylon® for 5% Topical Solution is contraindicated in patients who are hypersensitive to mafenide acetate. It is not known whether there is cross sensitivity to other sulfonamides.

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