SILVADENE- silver sulfadiazine cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

SILVER SULFADIAZINE (UNII: W46JY43EJR) (SULFADIAZINE - UNII:0N7609K889)

Tilgængelig fra:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

SILVER SULFADIAZINE

Sammensætning:

SILVER SULFADIAZINE 10 mg in 1 g

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

SILVADENE Cream 1% (silver sulfadiazine) 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. SILVADENE Cream 1% (silver sulfadiazine) 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, SILVADENE Cream 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.

Produkt oversigt:

SILVADENE Cream 1% (silver sulfadiazine) is available in jars containing 50 g (NDC 61570-131-50), 400 g (NDC 61570-131-40), and 1000 g (NDC 61570-131-98) and tubes containing 20 g (NDC 61570-131-20) , 25 g (NDC 61570-131-25), 50 g (NDC 61570-131-55) and 85 g (NDC 61570-131-85). Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).

Autorisation status:

New Drug Application

Produktets egenskaber

SILVADENE- SILVER SULFADIAZINE CREAM
PFIZER LABORATORIES DIV PFIZER INC
----------
SILVADENE CREAM 1%
(SILVER SULFADIAZINE)
DESCRIPTION
SILVADENE Cream 1% is a soft, white, water-miscible cream containing
the antimicrobial
agent silver sulfadiazine in micronized form, which has the following
structural formula:
Each gram of SILVADENE Cream 1% contains 10 mg of micronized silver
sulfadiazine.
The cream vehicle consists of white petrolatum, stearyl alcohol,
isopropyl myristate,
sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and
water, with
methylparaben 0.3% as a preservative. SILVADENE Cream 1% (silver
sulfadiazine)
spreads easily and can be washed off readily with water.
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 SILVADENE
CREAM 1% (SILVER SULFADIAZINE) CONCENTRATION OF
SILVER SULFADIAZINE NUMBER OF SENSITIVE
STRAINS/TOTAL NUMBER OF STRAINS TESTED
Genus & 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
_Providen