Mafenide Acetate

Mafenide acetate, USP is a synthetic antimicrobial agent designated chemically as a-amino-p- toluenesulfonamide monoacetate. It has the following structural formula:

C7H10N2O2S • C2H4O2
M.W. 246.29

Mafenide acetate, USP is a white, crystalline powder which is freely soluble in water.

SULFAMYLON® (mafenide acetate) 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.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with mafenide.

In the clinical setting of severe bums, it is often difficult to distinguish between an adverse reaction to mafenide acetate and bum sequelae. In a clinical study of pediatric patients with acute bums requiring autografts who received SULFAMYLON® (mafenide acetate) 5% SOLUTION in addition to double antibiotic solution (DAB) wound therapy (neomycin sulfate 40 mg and polymyxin B 200,000 units/liter), the incidence of rash (4.6%) and itching (2.8%) in the group which received SULFAMYLON® (mafenide acetate) 5% Solution was not different from that experienced with (DAB) dressings alone (5.7% and 1.3%, respectively).

From other clinical settings, a single case of bone marrow depression and a single case of an acute attack of porphyria have been reported following therapy with mafenide acetate. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with mafenide acetate. The following adverse reactions have been reported with topical mafenide acetate therapy:

Dermatologlc and Allergic: Pain or burning sensation, rash and pruritus (often localized to the area covered by the wound dressing), erythema, skin maceration from prolonged wet dressings, facial edema, swelling, hives, blisters, eosinophilia.

Respiratory or Metabolic: Tachypnea, hyperventilation, decrease in pCOa, metabolic acidosis, increase in serum chloride.

Read the entire FDA prescribing information for Sulfamylon (Mafenide Acetate)

• Burns (First Aid)

© Sulfamylon Patient Information is supplied by Cerner Multum, Inc. and Sulfamylon Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Synthetic anti-infective agent.a

• Importance of understanding that mafenide preparations are for external topical use only.a b c

• Importance of informing clinician if any signs or symptoms of an allergic reaction occur (e.g., rash, itching, facial or other swelling, blisters, redness).b c

• Importance of informing clinicians of existing concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., kidney or lung disease).b c

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b c

• Importance of informing patients of other important precautionary information. (See Cautions.)