Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 17 February 2017


INDICATIONS AND USAGE Thermazene® 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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Advisory information

CONTRAINDICATIONS Thermazene® 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® 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.
Special warnings and precautions


If hepatic and renal functions become impaired and elimination of the drug decreases accumulation may occur.

Discontinuation of Thermazene® should be weighed against the therapeutic benefit being achieved.

In considering the use of topical proteolytic enzymes in conjunction with Thermazene® the possibility should be noted that silver may inactivate such enzymes.

Laboratory Tests.

In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12 mg %).

Therefore, in these patients it would be advisable to monitor serum sulfa concentrations.

Renal function should be carefully monitored and the urine should be checked for sulfa crystals.

Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

Adverse reactions

ADVERSE REACTIONS Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy.1,2, 3 Leukopenia 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.

An increased 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.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION 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® is then applied under sterile conditions.

The burn areas should be covered with Thermazene® 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 by 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® 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.

Pregnancy and lactation

Nursing Mothers.

It is not known whether Thermazene® is excreted in human milk.

However, sulfonamides are known to be excreted in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus.

Because of the possibility for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

More information

Category Value
Authorisation number NDA018810
Agency product number W46JY43EJR
Orphan designation No
Product NDC 53097-101
Date Last Revised 15-01-2015
RXCUI 106351
Marketing authorisation holder The Pharma Network LLC