Topical (Burns)

Silver sulfadiazine (ssd ® , silvadene ®)

Mafenide acetate (sulfamylon ®)

CLINICAL PHARMACOLOGY
SULFAMYLON Cream, applied topically, produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns. Reduction in bacterial growth after application of SULFAMYLON Cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to full-thickness. It should be noted, however, that delayed eschar separation has occurred in some cases.

Absorption and Metabolism
Applied topically, SULFAMYLON Cream diffuses through devascularized areas, is absorbed, and rapidly converted to a metabolite (?-carboxybenzenesulfonamide) which is cleared through the kidneys. SULFAMYLON is active in the presence of pus and serum, and its activity is not altered by changes in the acidity of the environment.

Antibacterial Activity
SULFAMYLON exerts bacteriostatic action against many gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and certain strains of anaerobes.

INDICATIONS AND USAGE
SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.

CONTRAINDICATIONS
SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.

WARNINGS
Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people

Dosing:
Children and Adults: Topical: Apply once or twice daily with a sterile gloved hand; apply to a thickness of approximately 16 mm; the burned area should be covered with cream at all times

Supplied
Cream, topical, as acetate: 85 mg/g (60 g, 120 g, 454 g) [contains sodium metabisulfite]
Powder, for topical solution: 5% (5s) [50 g/packet]

Silver sulfadiazine (ssd ® , silvadene ®)

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.

INDICATIONS AND USAGE
SILVADENE Cream 1% (silver sulfadiazine) 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.

CONTRAINDICATIONS
SILVADENE Cream 1% (silver sulfadiazine) 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, SILVADENE Cream 1% 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.

WARNINGS
There is 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 SILVADENE Cream 1% (silver sulfadiazine) in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

Dosing
Children and Adults: Topical: Apply once or twice daily with a sterile-gloved hand; apply to a thickness of 1 /16"; burned area should be covered with cream at all times

Supplied
Cream, topical: 1% [10 mg/g] (25 g, 85 g, 400 g)
Silvadene®, Thermazene®: 1% (20 g, 50 g, 85 g, 400 g, 1000 g)
SSD®: 1% (25 g, 50 g, 85 g, 400 g)
SSD AF®: 1% (50 g, 400 g)

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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