mafenide acetate
Drug Details
- Generic Name
- mafenide acetate
- Brand Names
- SULFAMYLON
- Application Number
- NDA016763
- Sponsor
- Rising Pharma Holdings, Inc.
- NDC Codes
- 1
- Dosage Forms
- CREAM
- Routes
- TOPICAL
- Active Ingredients
- MAFENIDE ACETATE
Indications and Usage
INDICATIONS AND USAGE SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
Warnings
WARNINGS Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON 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.