Silver Sulfadiazine

SILVER SULFADIAZINE- silver sulfadiazine cream
Medsource Pharmaceuticals

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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:

Structural Formula
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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.

CLINICAL PHARMACOLOGY

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.

Results of in Vitro Testing With Silver Sulfadiazine Cream, USP 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains / Total Number of Strains Tested
Genus and Species 50 µg/mL 100 µg/mL
Pseudomonas aeruginosa 130/130 130/130
Xanthomonas (Pseudomonas) Maltophilia 7/7 7/7
Enterobacter species 48/50 50/50
Enterobacter cloacae 24/24 24/24
Klebsiella species 53/54 54/54
Escherichia coli 63/63 63/63
Serratia species 27/28 28/28
Proteus mirabilis 53/53 53/53
Morganella morganii 10/10 10/10
Providencia rettgeri 2/2 2/2
Proteus vulgaris 2/2 2/2
Providencia species 1/1 1/1
Citrobacter species 10/10 10/10
Acinetobacter calcoaceticus 10/11 11/11
Stahylococcus aureus 100/101 100/101
Staphylococcus epidermidis 51/51 51/51
β-Hemolytic Streptococcus 4/4 4/4
Enterococcus species 52/53 52/53
Corynebacterium diphtheriae 2/2 2/2
Clostridium perfringens 0/2 2/2
Candida albicans 43/50 50/50

Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

Silver Sulfadiazine 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.

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

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

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.

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