Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3365
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rdfs:label |
Silvadene (Cream)
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dailymed-instance:dosage |
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, and SILVADENE Cream
1% (silver sulfadiazine) is applied under sterile conditions. The burn areas
should be covered with SILVADENE Cream 1% at all times. The cream should be
applied once to twice daily to a thickness of approximately 1/16 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 SILVADENE
Cream 1% 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 The drug should not be withdrawn from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.
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dailymed-instance:descripti... |
SILVADENE Cream 1% is a soft, white, water-miscible cream
containing the antimicrobial agent silver sulfadiazine in micronized form,
which has the following structural formula: Each gram of
SILVADENE Cream 1% contains 10 mg of micronized silver sulfadiazine. The cream
vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate,
sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with
methylparaben 0.3% as a preservative. SILVADENE Cream 1% (silver sulfadiazine)
spreads easily and can be washed off readily with water.
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dailymed-instance:clinicalP... |
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 membrane and cell wall to produce its bactericidal effect. Silver sulfadiazine is not a carbonic anhydrase inhibitor
and may be useful in situations where such agents are contraindicated.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
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.
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dailymed-instance:supply |
SILVADENE Cream 1% (silver sulfadiazine) is available in
jars containing 50 g (NDC 61570-131-50), 400 g (NDC 61570-131-40), and 1000
g (NDC 61570-131-98) and tubes containing 20 g (NDC 61570-131-20) and 85 g
(NDC 61570-131-85).
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dailymed-instance:genericDr... | |
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
General: If hepatic and renal functions become impaired and elimination
of drug decreases, accumulation may occur and discontinuation of SILVADENE
Cream 1% (silver sulfadiazine) should be weighed against the therapeutic benefit
being achieved. In considering the use of topical proteolytic
enzymes in conjunction with SILVADENE Cream 1%, the possibility should be
noted that silver may inactivate such enzymes.<br/>Laboratory Tests: In the treatment of burn wounds involving extensive areas
of the body, the serum sulfa concentrations may approach adult therapeutic
levels (8 mg% to 12 mg%). Therefore, in these patients it would be advisable
to monitor serum sulfa concentrations. Renal function should be carefully
monitored and the urineshould 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.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term dermal toxicity studies of 24 months' duration
in rats and 18 months' in mice with concentrations of silver sulfadiazine
three to ten times the concentration in SILVADENE Cream 1% revealed no evidence
of carcinogenicity.<br/>Pregnancy:<br/>Teratogenic Effects.: Pregnancy Category B. A reproductive study has been performed
in rabbits at doses up to three to ten times the concentration of silver sulfadiazine
in SILVADENE Cream 1% and has revealed no evidence of harm to the fetus due
to silver sulfadiazine. There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproduction studies are not always
predictive of human response, this drug should be used during pregnancy only
if clearly justified, especially in pregnant women approaching or at term.<br/>Nursing Mothers: It is not known whether silver sulfadiazine is excreted in
human milk. However, sulfonamides are known to be excreted in human milk,
and all sulfonamide 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.<br/>Geriatric Use: Of the total number of subjects in clinical studies of Silvadene
Cream 1%, seven percent were 65 years of age and over. No overall differences
in safety or effectiveness were observed between these subjects and younger
subjects, and other reported clinical experience has not identified differences
in responses between the elderly and younger patients, but greater sensitivity
of some older individuals cannot be ruled out.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been
established.
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dailymed-instance:genericMe... |
silver sulfadiazine
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dailymed-instance:fullName |
Silvadene (Cream)
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dailymed-instance:adverseRe... |
Several cases of transient leukopenia have been reported
in patients receiving silver sulfadiazine therapy.Leukopenia
associated with silver sulfadiazine administration is primarily characterized
by decreased neutrophil count. Maximal white blood cell depression occurs
within 2 to 4 days of initiation of therapy. Rebound to normal leukocyte levels
follows onset within 2 to 3 days. Recovery is not influenced by continuation
of silver sulfadiazine therapy. An increased incidence of leukopenia has been
reported 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 including agranulocytosis, aplastic anemia, thrombocytopenia,
leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including
Stevens-Johnson syndrome and exfoliative dermatitis; gastrointestinal reactions;
hepatitis and hepatocellular necrosis; CNSreactions; and toxic nephrosis.
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dailymed-instance:warning |
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.
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dailymed-instance:indicatio... |
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.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Silvadene
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