Sulfamylon® Cream is a topical antimicrobial cream for use as adjunctive antimicrobial therapy on patients with second- and third-degree burns.
• Helps prevent conversion of burn wounds from partial- to full-thickness
• Bacteriostatic action reduces risk of infection
• Aids healing in deep partial-thickness burns
• Spreads easily for simplified application
• Can be washed off readily with water
Sulfamylon® Cream is a topical agent indicated for use on adjunctive therapy of patients with second- and third- degree burns.
Sulfamylon® Cream is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross-sensitivity to other sulfonamides.
Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6- phosphate dehydrogenase deficiency, has been reported following Sulfamylon® Cream therapy.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Sulfamylon® Cream and its metabolite, p-carboxybenzenesulfonamide, inhibit carbonic anhydrase, which may result in metabolic acidosis, usually compensated by hyperventilation. In the presence of impaired renal function, high blood levels of Sulfamylon® Cream and its metabolite may exaggerate the carbonic anhydrase inhibition. Therefore, close monitoring of acid-base balance is necessary, particularly in patients with extensive second- degree or partial-thickness burns and in those with pulmonary or renal dysfunction. Some burn patients treated with Sulfamylon® Cream Cream have also been reported to manifest an unexplained syndrome of marked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pCO2, and decreased total CO2); change in arterial pO2 is variable. The etiology and significance of these findings are unknown.
Mafenide acetate cream should be used with caution in burn patients with acute renal failure.
This product should be administered with caution to patients with history of hypersensitivity to mafenide. It is not known whether there is cross-sensitivity to other sulfonamides.
Fungal colonization in and below eschar may occur concomitantly with reduction of bacterial growth in the burn wound. However, fungal dissemination through the infected burn wound is rare.
Carcinogenesis, Mutagenesis, Impairment of Fertility- No long-term animal studies have been performed to evaluate the drug's potential in these areas.
Pregnancy Category C- Animal reproduction studies have not been conducted with Sulfamylon® Cream. It is also not known whether Sulfamylon® Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, the preparation is not recommended for the treatment of a women of childbearing potential, unless the burned area covers more than 20% of the total body surface, or the need for the therapeutic benefit of the product is, in the physician's judgment, greater than the possible risk to the fetus.
Nursing Mothers- It is not known whether mafenide acetate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reaction in nursing infants from Sulfamylon® Cream, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
It is frequently difficult to distinguish between an adverse reaction to Sulfamylon® Cream and the effect of a severe burn. 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.
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. Accidental ingestion of Sulfamylon® Cream has been reported to cause diarrhea.
Avoid exposure to excessive heat (temperature above 104°F or 40°C).
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Prompt institution of appropriate measures for controlling shock and pain is of prime importance. Cleanse and debride, and apply Sulfamylon® Cream with a sterile gloved hand. Apply once or twice daily, to a thickness of approximately 1/16 inch; thicker application is not recommended. Covered burned areas with Sulfamylon® Cream at all times. Whenever necessary, reapplied to any areas from which it has been removed (e.g., by patient activity).
Patient should be bathed daily to aid in debridement.
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.
If acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing therapy Sulfamylon® Cream Cream for 24 to 48 hours while continuing fluid therapy may aid in restoring acid-base balance.
Dressings usually are not required. If individual patient demands make them necessary, however, only a thin layer of dressings should be used.
Mylan is a distributor of burn and wound care products and medical devices, emphasizing quality of products, customer service and improvement of patient care.