silver sulfadiazine

FDA Drug Profile — SILVADENE, SILVER SULFADIAZINE

Drug Details

Generic Name
silver sulfadiazine
Brand Names
SILVADENE, SILVER SULFADIAZINE
Application Number
NDA017381
Sponsor
A-S Medication Solutions
NDC Codes
4
Dosage Forms
CREAM, POWDER
Routes
TOPICAL
Active Ingredients
SILVER SULFADIAZINE

Indications and Usage

INDICATIONS AND USAGE Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.

Warnings

WARNING There is a potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction. Fungal proliferation in and below the eschar may occur. However, the incidence of clinically reported fungal superinfection is low. The use of Silver Sulfadiazine Cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.