INDICATIONS AND USAGE Silver sulfadiazine cream, USP 1% 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 Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage.

Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur.

Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]; gastrointestinal reactions, hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis.

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, USP 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

ADVERSE REACTIONS Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy.

1,2,3 Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count.

Maximal white blood cell depression occurs within two to four days of initiation of therapy.

Rebound to normal leukocyte levels follows onset within two to three days.

Recovery is not influenced by continuation of silver sulfadiazine therapy.

An increased incidence has been seen in patients treated concurrently with cimetidine.

Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis.

Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis.

However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.