SILVER SULFADIAZINE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SILVER SULFADIAZINE (UNII: W46JY43EJR) (SILVER CATION - UNII:57N7B0K90A)

Tillgänglig från:

DIRECT RX

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.

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

SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM
DIRECT RX
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SILVER SULFADIAZINE
DESCRIPTION SECTION
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 C10H9AgN4O2S, molecular
weight of
357.14 and structural formula as shown:
CLINICAL PHARMACOLOGY SECTION
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