Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
SILVER SULFADIAZINE (UNII: W46JY43EJR) (SULFADIAZINE - UNII:0N7609K889)
The Pharma Network LLC
SILVER SULFADIAZINE
SILVER SULFADIAZINE 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Thermazene® 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® 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® 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 sensitivity of some older individuals cannot be ruled out. Pediatric Use. Saf
Thermazene® - white to off-white cream NDC No. Size 53097-101-20 20g tube 53097-101-25 25g tube 53097-101-50 50g tube 53097-101-85 85g tube 53097-101-05 50g jar 53097-101-40 400g jar 53097-101-10 1000g jar Store at room temperature. 15°-30°C (56°-86°F). Manufactured for: ThePharmaNetwork, LLC 180 Summit Avenue Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Product information: 1-800-272-7901 ® Registered Trademark of Coviden AG or an affiliate P1852.01
New Drug Application
THERMAZENE - SILVER SULFADIAZINE CREAM THE PHARMA NETWORK LLC ---------- DESCRIPTION Thermazene 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_ 2/2 2/2 _Proteus vulgaris_ 2/2 2/2 _P Izlasiet visu dokumentu