Country: United States
Language: English
Source: NLM (National Library of Medicine)
Silver Sulfadiazine (UNII: W46JY43EJR) (Silver Sulfadiazine - UNII:W46JY43EJR)
Rebel Distributors Corp
Silver Sulfadiazine
Silver Sulfadiazine 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Thermazene® (Silver Sulfadiazine) Cream, 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. Thermazene Cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. Because sulfonamide therapy is known to increase the possibility of kernicterus, Thermazene Cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.
Silver Sulfadiazine Cream USP 1% white to off-white cream NDC Number Size 21695-182-20 20 gram tube 21695-182-25 25 gram tube 21695-182-50 50 gram tube 21695-182-85 85 gram tube 21695-182-40 400 gram tube Store at controlled room temperature 15o - 30o C (59o - 86o F)
New Drug Application
THERMAZENE SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM REBEL DISTRIBUTORS CORP ---------- ASCEND LABORATORIES, LLC THERMAZENE SILVER SULFADIAZINE CREAM Thermazene (silver sulfadiazine Cream, 1% is a soft, water dispersible cream containing silver sulfadiazine in micronized form for topical application. Each gram of Thermazene contains 10mg of micronized silver sulfadiazine. Thermazene contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol NF, white petrolatum USP, polyoxyl 40 stearate NF, propylene glycol USP, isopropyl myristate NF, and sorbitan monooleate NF with 0.3% methylparaben NF as a preservative. 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 wall to produce its bactericidal effect. Results of in Vitro Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains / Total Number of Strains Tested Genus and Species 50 micrograms/mL 100 micrograms/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 Proteus Vulgaris 2/2 2/2 Providencia Species 1/1 1/1 Citrobacter Species 10/10 Read the complete document