SILVADENE® CREAM 1%
(silver sulfadiazine)
DESCRIPTION
SILVADENE Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula:
Each gram of SILVADENE Cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. SILVADENE Cream 1% (silver sulfadiazine) spreads easily and can be washed off readily with water.
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CLINICAL PHARMACOLOGY
Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. Results from in vitro testing are listed below.
Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine.
Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell membrane and cell wall to produce its bactericidal effect.
Results of In Vitro Testing with SILVADENE® Cream 1% (silver sulfadiazine) Concentration of Silver Sulfadiazine Number of Sensitive Strains/Total Number of Strains Tested | Genus & Species | 50 μg/mL | 100 μg/mL |
| Pseudomonas | | |
| aeruginosa | 130/130 | 130/130 |
| Xanthomonas (Pseudomonas) | | |
| maltophilia | 7/7 | 7/7 |
| Enterobacter species | 48/50 | 50/50 |
| Enterobacter cloacae | 24/24 | 24/24 |
| Klebsiella species | 53/54 | 54/54 |
| Escherichia coli | 63/63 | 63/63 |
| Serratia species | 27/28 | 28/28 |
| Proteus mirabilis | 53/53 | 53/53 |
| Morganella morganii | 10/10 | 10/10 |
| Providencia rettgeri | 2/2 | 2/2 |
| Providencia species | 1/1 | 1/1 |
| Proteus vulgaris | 2/2 | 2/2 |
| Citrobacter species | 10/10 | 10/10 |
| Acinetobacter | | |
| calcoaceticus | 10/11 | 11/11 |
| Staphylococcus aureus | 100/101 | 100/101 |
| Staphylococcus | | |
| epidermidis | 51/51 | 51/51 |
| β-Hemolytic | | |
| Streptococcus | 4/4 | 4/4 |
| Enterococcus species | 52/53 | 53/53 |
| Corynebacterium- | | |
| diphtheriae | 2/2 | 2/2 |
| Clostridium perfringens | 0/2 | 2/2 |
| Candida albicans | 43/50 | 50/50 |
Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.
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