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Mafenide Acetate Cream
TABLE OF CONTENTS
| 1. DESCRIPTION |  |
Mafenide Acetate Cream is a soft, white, nonstaining, water-miscible, anti-infective cream for topical administration to burn wounds. Mafenide Acetate Cream spreads, easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of Mafenide Acetate Cream contains mafenide acetate equivalent to 85 mg of the base. The cream vehicle consists of cetyl alcohol, steryl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate disodium as preservatives.
Chemically, mafenide acetate is a-Amino-ρ-toluenesulfonamide monoacetate and has the following structural formula:
| 2. INDICATIONS AND USAGE | |
Mafenide Acetate Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
| 3. 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 Mafenide Acetate 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 Mafenide Acetate 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.
The duration of therapy with Mafenide Acetate 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. Mafenide Acetate Cream should not be withdrawn from the therapeutic regimen while there is the possibility of infection. However, if allergic manifestations occur during treatment with Mafenide Acetate Cream, discontinuation of treatment should be considered.
If acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing therapy Mafenide Acetate Cream for 24 to 48 hours while continuing fluid therapy may aid in restoring acid-base balance.
| 4. CONTRAINDICATIONS | |
Mafenide Acetate Cream is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.
| 5. MECHANISM OF ACTION | |
Mafenide Acetate Cream, applied topically, produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns. Reduction in bacterial growth after application of Mafenide Acetate Cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to fullthickness. It should be noted, however, that delayed eschar separation has occurred in some cases.
| 6. USE IN SPECIFIC POPULATIONS | |
6.1 Usage in Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with Mafenide Acetate Cream. It is also not known whether Mafenide Acetate 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 Mafenide Acetate Cream is, in the physician's judgment, greater than the possible risk to the fetus.
6.2 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 Mafenide Acetate 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.
6.3 Pediatric Use
Same as for adults. (See DOSAGE AND ADMINISTRATION.)
| 7. WARNINGS AND PRECAUTIONS | |
WARNINGS
Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with Mafenide Acetate Cream.
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.
PRECAUTIONS
Mafenide acetate and its metabolite, r-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 mafenide acetate 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 Mafenide Acetate 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.
Mafenide Acetate Cream 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.
| 8. ADVERSE REACTIONS | |
It is frequently difficult to distinguish between an adverse reaction to Mafenide Acetate 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 Mafenide Acetate Cream. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6- phosphate dehydrogenase deficiency, has been reported following therapy with Mafenide Acetate 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 Mafenide Acetate Cream has been reported to cause diarrhea.
| 9. OVERDOSAGE | |
No cases of overdosage have been reported.
| 10. DRUG INTERACTIONS | |
No drug interaction studies have been performed.
| 11. PHARMACOKINETICS | |
No kinetics studies have been performed.
| 12. HOW SUPPLIED/STORAGE AND HANDLING | |
1) How Available:
a) Brand name: SULFAMYLON, by Mylan Bertek Pharmaceuticals.
b) Generic drugs: None.
2) How Supplied:
16 oz. Plastic Jar (453.6 g) - NDC 51079-623-83
4 oz. Tube (113.4 g) - NDC 51079-623-82
2 oz. Tube (56.7 g) - NDC 51079-623-81
3) Storage:
Avoid exposure to excessive heat (temperature above 104° F or 40° C).
Rx only
Rev 04/06
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