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.
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.
SULFAMYLON is contraindicated in patients who are hypersensitive to it.
It is not known whether there is cross sensitivity to other
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
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.
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.
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
National Institutes of Health, U.S. National Library of Medicine,
DailyMed Database. Provides access to the latest drug monographs submitted to the
Food and Drug Administration (FDA). Please review the latest applicable package insert for
additional information and possible updates. A local search
option of this data can be found here.
Listed dosages are for - Adult patients ONLY. PLEASE READ THE
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