SILVER SULFADIAZENE- silver sulfadiazine cream

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Actavis Pharma, Inc.

Designación común internacional (DCI):

SILVER SULFADIAZINE

Composición:

SILVER SULFADIAZINE 10 g in 1000 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Silver Sulfadiazine Cream 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 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 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:

Silver Sulfadiazine Cream USP 1%: white to off-white cream. 50 gram jar                      400 gram jar                     25 gram tube                      85 gram tube                      Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured for Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by Dr. Reddy's Laboratories Louisiana, LLC Shreveport, LA 71106 R05/08       110960-02

Estado de Autorización:

New Drug Application

Ficha técnica

SILVER SULFADIAZENE- SILVER SULFADIAZINE CREAM
ACTAVIS PHARMA, INC.
----------
SILVER SULFADIAZINE CREAM USP 1%
DESCRPITION
Silver Sulfadiazine Cream is a topical antibacterial preparation which
has its active antimicrobial
ingredient silver sulfadiazine. The active moiety is contained within
an opaque, white, water miscible
cream base.
Each 1000 grams of Silver Sulfadiazine Cream contains 10 grams of
silver sulfadiazine.
INACTIVE INGREDIANTS: cetyl alcohol, isopropyl myristate, polyoxyl 40
stearate, propylene glycol,
purified water, stearyl alcohol, sodium hydroxide, sorbitan
monooleate, white petrolatum; with 0.3%
methyl paraben, as a preservative.
Silver sulfadiazine has an emprical formula of C
H AgN O S, molecular weight of 357.14 and
structural formula as shown:
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 µg/mL 100 µ/mL
Pseudomonas aeruginosa
130/130
130/130
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
10
9
4
2
Morganella morganii
10/10
10/10
Providencia