Thermazene

THERMAZENE- silver sulfadiazine cream
COVIDIEN INC.

DESCRIPTION

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.

This active agent has the following structural formula:

Structural Formula
(click image for full-size original)

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.

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 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

Proteus vulgaris

2/2

2/2

Providencia species

1/1

1/1

Citrobacter species

10/10

10/10

Acinetobacter calcoaceticus

10/11

11/11

Stahylococcus aureus

100/101

101/101

Staphylococcus epidermidis

51/51

51/51

B-Hemolytic streptococcus

4/4

4/4

Enterococcus species

52/53

53/53

Corynebacterium diphtheriae

2/2

2/2

Clostridium perfringens

0/2

2/2

Candida albicans

43/50

50/50

Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

INDICATIONS AND USAGE

Thermazene 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.

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