SILVER SULFADIAZINE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

SILVER SULFADIAZINE

Composition:

SILVER SULFADIAZINE 10 g in 1000 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Silver sulfadiazine 1% 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 1% 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 1% 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.

Product summary:

Silver sulfadiazine 1% creamis supplied by Keltman Pharmaceuticals Inc. as follows:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SILVER SULFADIAZINE - SILVER SULFADIAZINE CREAM
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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SILVER SULFADIAZINE 1% CREAM
DESCRIPTION
Silver sulfadiazine 1% cream is a soft, white, water-miscible cream
containing the antimicrobial agent
silver sulfadiazine in micronized form, which has the following
structural formula:
Each gram of silver sulfadiazine 1% cream contains 10 mg of micronized
silver sulfadiazine. The
cream vehicle consists of CETYL ALCOHOL, ISOPROPYL MYRISTATE, POLYOXYL
40
STEARATE, PROPYLENE GLYCOL, WATER, STEARYL ALCOHOL, SODIUM HYDROXIDE,
SORBITAN MONOOLEATE, PETROLATUM, METHYLPARABEN. SILVADENE Cream 1%
(silver sulfadiazine) spreads easily and can be washed off readily
with water.
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 SILVADENE
CREAM 1% (SILVER SULFADIAZINE) CONCENTRATION OF
SILVER SULFADIAZINE NUMBER OF SENSITIVE
STRAINS/TOTAL NUMBER OF STRAINS TESTED
Genus & 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
10/1