Silver Sulfadiazene
SILVER SULFADIAZENE- silver sulfadiazine cream
Unit Dose Services
DESCRPITION
Silver Sulfadiazine Cream is a topical antibacterial preparation which has its active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base.
Each 1000 grams of Silver Sulfadiazine Cream contains 10 grams of silver sulfadiazine.
Inactive Ingrediants: cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative.
Silver sulfadiazine has an emprical formula of C10 H9 AgN4 O2 S, molecular weight of 357.14 and structural formula as shown:
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 wall to produce its bactericidal effect.
Results of In Vitro Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine
Number of Sensitive Strains / Total Number of Strains Tested
Genus and Species | 50 µg/mL | 100 µ/mL |
Pseudomonas aeruginosa | 130/130 | 130/130 |
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 | 101/101 |
Staphylococcus epidermidis | 51/51 | 51/51 |
β -Hemolytic Streptococcus | 4/4 | 4/4 |
Enterococcus species | 52/53 | 53/53 |
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.
INDICATIONS AND USAGE
Silver Sulfadiazine Cream 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 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 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 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 in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.
PRECAUTION
General
If hepatic and renal functions become impaired and elimination of the drug decreases, accumulation may occur and discontinuation of Silver Sulfadiazine Cream should be weighed against the therapeutic benefit being achieved.
In considering the use of topical proteolytic enzymes in conjunction with Silver Sulfadiazine Cream, the possibility should be noted that silver may inactivate such enzymes.
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