THERMAZENE SILVER SULFADIAZINE- 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:

Rebel Distributors Corp

INN (International Name):

Silver Sulfadiazine

Composition:

Silver Sulfadiazine 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Thermazene® (Silver Sulfadiazine) Cream, 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. Thermazene 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, Thermazene 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 Cream USP 1% white to off-white cream NDC Number                           Size 21695-182-20                       20 gram tube 21695-182-25 25 gram tube 21695-182-50                       50 gram tube 21695-182-85                       85 gram tube 21695-182-40                       400 gram tube Store at controlled room temperature 15o - 30o C (59o - 86o F)

Authorization status:

New Drug Application

Summary of Product characteristics

THERMAZENE SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM
REBEL DISTRIBUTORS CORP
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ASCEND LABORATORIES, LLC THERMAZENE SILVER SULFADIAZINE CREAM
Thermazene (silver sulfadiazine Cream, 1% is a soft, water dispersible
cream containing silver
sulfadiazine in micronized form for topical application. Each gram of
Thermazene contains 10mg of
micronized silver sulfadiazine. Thermazene contains 1% w/w silver
sulfadiazine. The vehicle in which
the active ingredient is dispersed consists of water, stearyl alcohol
NF, white petrolatum USP,
polyoxyl 40 stearate NF, propylene glycol USP, isopropyl myristate NF,
and sorbitan monooleate NF
with 0.3% methylparaben NF as a preservative.
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
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
Proteus Vulgaris 2/2 2/2
Providencia Species 1/1 1/1
Citrobacter Species 10/10