Classes
DEA Class; Rx
Common Brand Names; Sulfamylon
- Antibacterials, Topical
Description
Synthetic topical sulfonamide.
Used adjunctively to prevent infections in patients with 2nd- and 3rd-degree burns.
Bacteriostatic against many gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa and several anaerobic strains.
Indications
Indicated for wound management including the treatment of second or third degree burns or burn wound infection prophylaxis as an adjunct.
Contraindications
Hypersensitivity to mafenide or any component of the formulation
Adverse Effects
- Application site reactions
- Edema
- Facial edema
- Diarrhea
- Excoriation
- Pain
- Blisters
- Burning sensation
- Hypersensitivity
- Bone marrow suppression
- Anemia
- Eosinophilia
- Porphyria
- Hyperventilation
- Hemolytic anemia
- Allergic reactions
- Systemic acidosis with tachypnea
Warnings
Hypersensitivity
Use extreme caution in patients with sulfonamide allergy
E. coli & Proteus spp. appear to be less sensitive
Prolonged use may result in fungal or bacterial superinfection including C. difficile-associated diarrhea and pseudomembranous colitis
Pregnancy/women of childbearing potential-not recommended in women of childbearing potential unless burned area >20% BSA or benefits justify possible risks to the fetus
G-6-PD deficiency; may result in hemolytic anemia
Pregnancy and Lactation
Pregnancy Category: C
Lactation: Not known whether distributed into breast milk, discontinue drug or do not nurse
Maximum Dosage
Safety and efficacy of solution have not been established beyond 5 days for an individual grafting procedure; no maximum dosing information available for cream.
Safety and efficacy of solution have not been established beyond 5 days for an individual grafting procedure; no maximum dosing information available for cream.
Safety and efficacy of solution have not been established beyond 5 days for an individual grafting procedure; no maximum dosing information available for cream.
Safety and efficacy of solution have not been established beyond 5 days for an individual grafting procedure; no maximum dosing information available for cream.
3 months and older: Safety and efficacy of solution have not been established beyond 5 days for an individual grafting procedure; no maximum dosing information available for cream.
Less than 3 months: Safety and efficacy of solution have not been established; no maximum dosing information available for cream.
Use not recommended.
How supplied
Mafenide Acetate/Sulfamylon Topical Pwd F/Recon: 5%
Sulfamylon Topical Cream: 1g, 85mg
