Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
SILVER SULFADIAZINE (UNII: W46JY43EJR) (SULFADIAZINE - UNII:0N7609K889)
NuCare Pharmaceuticals,Inc.
TOPICAL
PRESCRIPTION DRUG
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. Silver sulfadiazine cream, USP 1% 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, silver sulfadiazine cream, USP 1% 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. Geriatric Use. Of the total number of subjects in clinical studies of silver sulfadiazine cream, USP 1% seven percent were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater se
66267-943-50 50g jar Store at room temperature. 15°-30°C (56°-86°F). Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Product information: 1-877-272-7901 P1840.01
New Drug Application
SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM NUCARE PHARMACEUTICALS,INC. ---------- DESCRIPTION Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula: Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative. 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 SILVER SULFADIAZINE CREAM, USP 1% CONCENTRATION OF SILVER SULFADIAZINE NUMBER OF SENSITIVE STRAINS / TOTAL NUMBER OF STRAINS TESTED GENUS AND 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/ Läs hela dokumentet