For adults, adolescents, children, and infants 2 months of age and older:
- After cleaning and debridement, silver sulfadiazine may be applied to the affected area(s) to a thickness of approximately 1.6 mm (1/16 of an inch) once or twice daily.
- The cream may be reapplied whenever necessary to affected area(s) if it is removed by activity or washing.
- Silver sulfadiazine is not recommended for use in premature neonates or neonates < 2 months of age.
- Silver sulfadiazine reduces the effect of collagenase (Santyl) ointment which is used for treating dermal ulcers.
- No significant drug interactions with oral medications have been reported with silver sulfadiazine use.
PREGNANCY AND BREASTFEEDING SAFETY:
- Use of topical silver sulfadiazine has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, silver sulfadiazine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Silver sulfadiazine is classified as FDA pregnancy risk category B (animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women).
- It is not known if silver sulfadiazine is excreted in breast milk. However, silver sulfadiazine is a sulfonamide and oral sulfonamides are excreted into breast milk and increase the risk of kernicterus, a rare type of brain damage in newborns caused by very high levels of bilirubin. Therefore, use of silver sulfadiazine in females who are breastfeeding is not recommended.
PREPARATIONS: 1% topical cream
STORAGE: Cream should be stored at room temperature between 15 C to 30 C (59 F to 86 F).
How does silver sulfadiazine work?
- Silver sulfadiazine is a topical (applied to the skin) antimicrobial agent used to treat and prevent skin infections caused by second or third degree burns.
- Silver sulfadiazine kills bacteria by damaging the bacterial cell membrane. Silver sulfadiazine has activity against a broad spectrum of gram-positive and gram-negative bacteria including Pseudomonas aeruginosa, Xanthomonas maltophilia, Enterobacter species, Klebsiella species, Escherichia coli, Serratia species, Proteus mirabilis, Morganella morganii, Providencia rettgeri, Proteus vulgaris, Providencia species, Citrobacter species, Acinetobacter calcoaceticus, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus species, Candida albicans, Corynebacterium diphtheriae, and Clostridium perfringens. Additionally, silver sulfadiazine has demonstrated activity against yeast.
- Silver sulfadiazine was approved by the FDA in 1973.
REFERENCE: FDA Prescribing Information.
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