THERMAZENE SILVER SULFADIAZINE- silver sulfadiazine cream

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Silver Sulfadiazine (UNII: W46JY43EJR) (SILVER CATION - UNII:57N7B0K90A)

Disponible depuis:

Preferred Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

Silver Sulfadiazine

Composition:

Silver Sulfadiazine 10 mg in 1 g

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

     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, but greater s

Descriptif du produit:

Silver sulfadiazine cream, USP 1% - white to off-white cream 50 Gram jar - 68788-0600-5 25 Gram Tube – 68788-0600-2

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

THERMAZENE SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM
PREFERRED PHARMACEUTICALS, 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 wall to
produce its bactericidal effect.
Results of _In Vitro_ Testing With Silver Sulfadiazine Cream, 1%
Concentration of Silver
Sulfadiazine
Number of Sensitive Strains / Total Number of Strains Tested
Genus and Species 50 micrograms/mL 100 micrograms/mL
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
Proteus Vulgaris 2/2 2/2
Providencia Species 1/1