SILVER SULFADIAZINE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

SILVER SULFADIAZINE

Composition:

SILVER SULFADIAZINE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

     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.      Geriatric Use. Of the total number of subjects in clinical studies of silver sulfadiazine cream, USP 1% seven percent were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients,

Product summary:

Silver sulfadiazine cream, USP 1% - white to off-white cream NDC: 70518-0366-00 PACKAGING: 50 g in 1 TUBE, TYPE 0 Store at room temperature. 15°-30°C (59°-86°F). Risperidone tablets should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Protect from light and moisture. Keep out of reach of children. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application

Summary of Product characteristics

SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM
REMEDYREPACK INC.
----------
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
2/2
_Pro