Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
SILVER SULFADIAZINE (UNII: W46JY43EJR) (SILVER SULFADIAZINE - UNII:W46JY43EJR)
H.J. Harkins Company, Inc.
SILVER SULFADIAZINE
SILVER SULFADIAZINE 10 g in 1000 g
TOPICAL
PRESCRIPTION DRUG
Silver Sulfadiazine Cream 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 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 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.
SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream. SSD AF™ (1% Silver Sulfadiazine) Cream : white to off-white cream. Store at controlled room temperature 15° - 30°C (59° - 86°F) SSD is a trademark of Dr. Reddy's Laboratories Louisiana, LLC Manufactured for Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Manufactured by Dr. Reddy's Laboratories Louisiana, LLC Shreveport, LA 71106 Repacked by H.J. Harkins Company, Inc. Nipomo, CA 93444 Aug 2011
New Drug Application
SILVER SULFADIAZINE - SILVER SULFADIAZINE CREAM H.J. HARKINS COMPANY, INC. ---------- SSD™ (1% SILVER SULFADIAZINE CREAM) SSD AF™ (1% SILVER SULFADIAZINE CREAM) DESCRIPTION SSD (1% Silver Sulfadiazine) Cream and SSD AF (1% Silver Sulfadiazine) Cream are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine INACTIVE INGREDIENTS: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C H AgN O S, molecular weight of 357.14 and structural formula as shown: 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 wall to produce its bactericidal effect. RESULTS OF IN VITRO TESTING 1% CONCENTRATION OF SILVER SULFADIAZINENUMBER OF SENSITIVE STRAINS / TOTAL NUMBER OF STRAINS TESTED GENUS AND SPECIES 50 _UG_/ML 100 _UG_/ML Pseudomonas aeruginosa 130/130 130/130 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 28/2 Přečtěte si celý dokument