Label: 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. 

This active agent has the following structural formula:

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

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

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.

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.

There is a potential cross-sensitivity between silver sulfadiazine and other sulfonamides.  If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction. 

Fungal proliferation in and below the eschar may occur.  However, the incidence of clinically reported fungal superinfection is low.

The use of Thermazene Cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

Several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy.  Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count.  Maximal white blood cell depression occurs within two to four days of initiation of therapy.  Rebound to normal leukocyte levels follows onset within two to three days.  Recovery is not influenced by continuation of silver sulfadiazine therapy.  The incidence of leucopenia in various reports averages about 20%.  A higher incidence has been seen in patients treated concurrently with cimetidine.

Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. 

Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis.  However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage.  Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur.  Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia, hemolytic anemia, dermatologic reactions, allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.

Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain.  The burn wounds are then cleansed and debrided; Thermazene Cream is then applied under sterile conditions.  The burn areas should be covered with Thermazene Cream at all times.  The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch.  Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity.  Administration may be accomplished in minimal time because dressings are not required.  However, if individual patient requirements make dressings necessary, they may be used. 

Reapply immediately after hydrotherapy.  Treatment with Thermazene Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting.  The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Store at controlled room temperature 15° - 30°C (59° - 86°F)

*Trademark of Sherwood Services AG

THE KENDALL COMPANY
MANSFIELD, MA 02048
MADE IN U.S.A.
©1999 KENDALL ALL RIGHTS RESERVED. 991206
IN U.S. 1-800-962-9888
www.kendallhq.com

A tyco INTERNATIONAL LTD. COMPANY
017-0799

Reorder
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473800

KENDALL
THERMAZENE*
(Silver Sulfadiazine) Cream, 1%

NET WT. 35oz (1000g)

For Topical Use Only

NDC 8880-9505-10