Sulfamylon

SULFAMYLON®
(mafenide acetate, USP)

FOR 5% TOPICAL SOLUTION

DRUG DESCRIPTION

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

SULFAMYLON (mafenide acetate) structural formula illustration

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.

What are the possible side effects of mafenide (Sulfamylon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have a serious side effect such as:

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • chest pain, fast or pounding heartbeats, headache, confusion;
  • nausea, vomiting, stomach pain, appetite changes, muscle weakness, bone pain, and weight loss;
  • rapid breathing, gasping, or feeling short of breath; or
  • severe skin rash,...

Read All Potential Side Effects and See Pictures of Sulfamylon »

What are the precautions when taking mafenide acetate (Sulfamylon)?

Before using mafenide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung problems (e.g., asthma), kidney disease, metabolism problems (e.g., glucose-6-phosphate dehydrogenase deficiency-G6PD), blood disorders.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Sulfamylon »

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

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.