Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Silver Sulfadiazine
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: Silver Sulfadiazine
GENERIC: Silver Sulfadiazine
DOSAGE: CREAM
ADMINSTRATION: TOPICAL
NDC: 70518-1562-0
PACKAGING: 20 g in 1 TUBE
ACTIVE INGREDIENT(S):
- SILVER SULFADIAZINE 10mg in 1g
INACTIVE INGREDIENT(S):
- Water
- Stearyl Alcohol
- Petrolatum
- Polyoxyl 40 Stearate
- Propylene Glycol
- Isopropyl Myristate
- Sorbitan Monooleate
- Methylparaben
DESCRIPTION SECTION
DESCRIPTION
Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream
containing the antimicrobial agent silver sulfadiazine in micronized form for
topical application. Each gram of silver sulfadiazine cream contains 10mg of
micronized silver sulfadiazine.
This active agent has the following structural formula:
Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative.
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
Silver sulfadiazine cream, USP 1% 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.
DOSAGE & ADMINISTRATION SECTION
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; silver sulfadiazine cream, USP 1% is
then applied under sterile conditions. The burn areas should be covered with
silver sulfadiazine cream, USP 1% 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 silver sulfadiazine
cream, USP 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.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS
Silver sulfadiazine cream, USP 1% 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, silver sulfadiazine cream, USP 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 SECTION
WARNINGS
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 life-threatening cutaneous
reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]; gastrointestinal reactions, hepatitis and
hepatocellular necrosis; CNS reactions; and toxic nephrosis.
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 silver sulfadiazine cream, USP 1% in some cases of
glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as
hemolysis may occur.
PRECAUTIONS SECTION
PRECAUTIONS
** General.**If hepatic and renal functions become impaired and elimination
of the drug decreases accumulation may occur. Discontinuation of silver
sulfadiazine cream, USP 1% should be weighed against the therapeutic benefit
being achieved.
In considering the use of topical proteolytic enzymes in conjunction with
Silver sulfadiazine cream, USP 1% 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 12mg %). 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.
** 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 silver sulfadiazine cream, USP 1% revealed no evidence of carcinogenicity.
PREGNANCY SECTION
PREGNANCY:
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 silver sulfadiazine cream, USP 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. (See CONTRAINDICATIONS)
NURSING MOTHERS SECTION
** Nursing Mothers.**It is not known whether silver sulfadiazine cream, USP 1% 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.
GERIATRIC USE SECTION
** Geriatric Use.** Of the total number of subjects in clinical studies of silver sulfadiazine cream, USP 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.
PEDIATRIC USE SECTION
** Pediatric Use.** Safety and effectiveness in children have not been established. (See CONTRAINDICATIONS)
ADVERSE REACTIONS SECTION
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.
HOW SUPPLIED SECTION
HOW SUPPLIED
Silver sulfadiazine cream, USP 1% - white to off-white cream
NDC: 70518-1562-00
PACKAGING: 25 g in 1 TUBE, TYPE 0
Store at room temperature. 15°-30°C (59°-86°F).
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
REFERENCES SECTION
REFERENCES
- Caffee F, Bingham H. Leukopenia and silver sulfadiazine. J Trauma. 1982;22: 586–587.
- Jarret F, Ellerbe S, Demling R. Acute leukopenia during topical burn therapy with silver sulfadiazine. Amer J Surg. 1978;135: 818–819.
- Kiker RG, Carvajal HF, Micak RP, Larson DL. A controlled study of the effects of silver sulfadiazine on white blood cell counts in burned children. J Trauma. 1977;17: 835–836.