Sulfamylon

Sulfamylon

INDICATIONS

SULFAMYLON® (mafenide acetate) 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.

DOSAGE AND ADMINISTRATION

SULFAMYLON® (mafenide acetate) For 5% Topical Solution: Directions for Preparation of the Solution: SULFAMYLON® (mafenide acetate) (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. Pre- measured quantities of 50 g of mafenide acetate powder are provided in sterile packets. The entire quantity of SULFAMYLON® (mafenide acetate) 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 bum dressing should be cut to the size of the graft and wetted with SULFAMYLON® (mafenide acetate) 5% 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 bum 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 maybe 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® (mafenide acetate) 5% 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.

HOW SUPPLIED

SULFAMYLON® (mafenide acetate, USP) For 5% Topical Solution is available in packets (NDC 51079-624-84) containing 50 g of sterile mafenide acetate to be prepared using 1000 mL Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. (See DOSAGE AND ADMINISTRATION: SULFAMYLON® (mafenide acetate) For 5% Topical Solution: Directions for Preparation of the Solution.) The packets are supplied as follows:

Carton of five 50 g packets

NDC 51079-624-85

Recommended Storage:

Packets - Store PACKETS in a dry place at room temperature 15° to 30°C (59° to 86°F).

Prepared Solution - Store SOLUTION at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

The solution may be held for up to 28 days if stored in unopened containers.

ONCE A CONTAINER IS OPENED, ANY UNUSED SOLUTION MUST BE DISCARDED WITHIN 48 HOURS.

Distributed By: UDL Laboratories, Inc. Rockford, IL 61103. REVISED APRIL 2006. FDA rev date: 12/18/2002

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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