SULFAMYLON- mafenide acetate powder, for solution
Mylan Institutional Inc.
DESCRIPTION
Mafenide acetate, USP is a synthetic antimicrobial agent designated chemically as ?-amino-p -toluenesulfonamide monoacetate.
C7 H10 N2 O2 S?C2 H4 O2 M.W. 246.29
Mafenide acetate, USP is a white, crystalline powder which is freely soluble in water.
SULFAMYLON� for 5% Topical Solution is provided in packets containing 50 g of sterile mafenide acetate to be reconstituted in 1000 mL of Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. After mixing, the solution contains 5% w/v of mafenide acetate. The solution is an antimicrobial preparation suitable for topical administration. The solution is not for injection. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20� to 25�C (68� to 77�F). Limited storage periods at 15� to 30�C (59� to 86�F) are acceptable.
CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of mafenide is not known, but is different from that of the sulfonamides. Mafenide is not antagonized by pABA, serum, pus or tissue exudates, and there is no correlation between bacterial sensitivities to mafenide and to the sulfonamides. Its activity is not altered by changes in the acidity of the environment. The osmolality of the 5% topical solution is approximately 340 mOsm/kg.
INDICATIONS AND USAGE
SULFAMYLON� for 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
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.
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.
OVERDOSAGE
Single oral doses of 2000 mg/kg of mafenide acetate as a 5% solution did not cause mortality or clinical symptoms of toxicity in rats.
DOSAGE AND ADMINISTRATION
SULFAMYLON� for 5% Topical Solution
Directions for Preparation of the Solution
SULFAMYLON� (mafenide acetate) for 5% Topical Solution is supplied as a sterile powder and is to be reconstituted with Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. Aseptic techniques should be observed during preparation of the solution. Premeasured quantities of 50 g of mafenide acetate powder are provided in sterile packets. The entire quantity of SULFAMYLON� should be emptied into a suitable container which contains 1000 mL of Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP and mixed until completely dissolved. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20� to 25�C (68� to 77�F). Limited storage periods at 15� to 30�C (59� to 86�F) are acceptable. Not for Injection � For Topical Use Only.
Directions for Use of the Solution
The grafted area should be covered with one layer of fine mesh gauze. An eight-ply burn dressing should be cut to the size of the graft and wetted with SULFAMYLON� for 5% Topical Solution using an irrigation syringe and/or irrigation tubing until leaking is noticeable. If irrigation tubing is used, the tubing should be placed over the burn dressing in contact with the wound and covered with a second piece of eight-ply dressing. The irrigation dressing should be secured with a bolster dressing and wrapped as appropriate. The gauze dressing should be kept wet. In clinical studies, this has been accomplished by irrigating with a syringe or injecting the solution into the irrigation tubing every 4 hours or as necessary. If irrigation tubing is not used, the gauze dressing may be moistened every 6-8 hours or as necessary to keep wet.
Wound dressings may be left undisturbed, except for the irrigations, for up to five days. Additional soaks may be initiated until graft take is complete. Maceration of skin may result from wet dressings applied for intervals as short as 24 hours. Treatment is usually continued until autograft vascularization occurs and healing is progressing (typically occurring in about 5 days). Safety and effectiveness have not been established for longer than 5 days for an individual grafting procedure.
If allergic manifestations occur during treatment with SULFAMYLON� for 5% Topical Solution, discontinuation of treatment should be considered. If acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing the soaks with the mafenide acetate solution for 24 to 48 hours may aid in restoring acid-base balance (see PRECAUTIONS section). Dressing changes and monitoring the site for bacterial growth during this interruption should be adjusted accordingly.
