Silver sulfadiazine warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Warnings
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.
Precaution
General
If hepatic and renal functions become impaired and elimination of the drug decreases, accumulation may occur and discontinuation of Silver Sulfadiazine Cream should be weighed against the therapeutic benefit being achieved.
In considering the use of topical proteolytic enzymes in conjunction with Silver Sulfadiazine Cream, the possibility should be noted that silver may inactivate such enzymes.
Laboratory Tests
In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12 mg %). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals.
Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in Silver Sulfadiazine Cream revealed no evidence of carcinogenicity.
Pregnancy
Pregnancy category B. A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in Silver Sulfadiazine Cream and has revealed no evidence of harm to the fetus due to silver sulfadiazine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term (See CONTRAINDICATIONS).
Nursing Mothers
It is not known whether Silver Sulfadiazine Cream is excreted in human milk. However, sulfonamides are known to be excreted in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus. Because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children have not been established (See CONTRAINDICATIONS).[1]
References
Adapted from the FDA Package Insert.