SILVADENE- silver sulfadiazine cream

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Designació comuna internacional (DCI):

SILVER SULFADIAZINE

Composición:

SILVER SULFADIAZINE 10 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

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) and 85 g (NDC 61570-131-85).

Estat d'Autorització:

New Drug Application

Fitxa tècnica

SILVADENE- SILVER SULFADIAZINE CREAM
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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
®
®
_Providen