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:

Medsource Pharmaceuticals

Designació comuna internacional (DCI):

SILVER SULFADIAZINE

Composición:

SILVER SULFADIAZINE 10 mg in 1 g

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

New Drug Application

Fitxa tècnica

SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM
MEDSOURCE PHARMACEUTICALS
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DESCRIPTION
Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible
cream containing the antimicrobial
agent silver sulfadiazine in micronized form for topical application.
Each gram of silver sulfadiazine
cream contains 10mg of micronized silver sulfadiazine.
This active agent has the following structural formula:
Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The
vehicle in which the active
ingredient is dispersed consists of water, stearyl alcohol, white
petrolatum, polyoxyl 40 stearate,
propylene glycol, isopropyl myristate, and sorbitan monooleate with
0.3% methylparaben as a
preservative.
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
SILVER SULFADIAZINE CREAM, USP 1% CONCENTRATION
OF SILVER SULFADIAZINE NUMBER OF SENSITIVE
STRAINS / TOTAL NUMBER OF STRAINS TESTED
GENUS AND 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/