Silver Sulfadiazene

SILVER SULFADIAZENE- silver sulfadiazine cream
Rebel Distributors Corp

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:

structural formula of silver sulfadiazine

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.

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 12 mg %). 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.

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