SILVER SULFADIAZINE cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aidarex Pharmaceuticals LLC

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

     Silver sulfadiazine cream, USP 1% 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, USP 1% 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, USP 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.

leaflet_short:

Silver sulfadiazine cream, USP 1% - white to off-white cream 25g tube Store at room temperature. 15°-30°C (59°-86°F). Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880 Manufactured for: Ascend Laboratories, LLC Parsippany, NJ 07054 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Product information: 1-877-272-7901                                     Revised: SEPT 2016                                                         P1840.03

מצב אישור:

New Drug Application

מאפייני מוצר

SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM
AIDAREX PHARMACEUTICALS LLC
----------
SILVER-SULFADIAZINE
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
_Provide