SSD CREAM- silver sulfadiazine cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Silver Sulfadiazine (UNII: W46JY43EJR) (Sulfadiazine - UNII:0N7609K889)

Tillgänglig från:

Dr Reddys Laboratories Inc

INN (International namn):

Silver Sulfadiazine

Sammansättning:

Silver Sulfadiazine 10 g in 1000 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain.  The burn wounds are then cleansed and debrided; Silver Sulfadiazine Cream is then applied u

Produktsammanfattning:

SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram jar                     NDC 43598-210-55 400 gram jar                     NDC 43598-210-40 25 gram tube                     NDC 43598-210-25 50 gram tube                     NDC 43598-210-50 85 gram tube                     NDC 43598-210-85 SSD AF™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram jar                     NDC 43598-211-55 400 gram jar                      NDC 43598-211-40 Store at controlled room temperature 15° - 30°C (59° - 86°F) SSD is a trademark of Dr. Reddy's Laboratories, Inc. Manufactured by: Dr. Reddy's Laboratories Louisiana LLC Shreveport, LA 71106 USA Revised, June 2013

Bemyndigande status:

New Drug Application

Produktens egenskaper

SSD CREAM- SILVER SULFADIAZINE CREAM
DR REDDYS LABORATORIES INC
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SSD™ (1% SILVER SULFADIAZINE CREAM)
SSD AF™ (1% SILVER SULFADIAZINE CREAM)
DESCRPITION
SSD™ (1% Silver Sulfadiazine Cream) and SSD AF™ (1% Silver
Sulfadiazine Cream), 1% 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 INGREDIANTS: 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 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 5