Source: Medicines Authority (MT) Revision Year: 2021 Publisher: Laboratorio ALDO-UNIÓN, S.L., Baronesa de Maldá, 73, 08950 Esplugues de Llobrega, BARCELONA (SPAIN)
Pharmacotherapeutic group: Topical chemotherapeutics. Sulphonamides
Code ATC: D06BA
Silver sulfadiazine has a wide activity spectrum, it is bactericidal for the majority of grampositive and gram-negative germs and it is also effective against yeasts and fungi.
It is particularly effective against Pseudomonas aeruginosa, Enterobacter species., Klebsiella species., Escherichia coli, Proteus mirabilis, Proteus vulgaris, Providencia species., Staphylococcus aureus, Clostridium perfringens and Candida albicans.
It can inhibit bacteria resistant to other antimicrobial agents and its effectiveness is greater than sulfadiazine’s.
Studies carried out using radioactive micronised silver sulfadiazine, electronic microscopy and biochemical techniques have proved that the mechanism of action on microorganisms is different from the mechanism of action of silver sulfadiazine or sodium sulfadiazine. Its antimicrobial activity is the result of an exclusive action on the membrane and cellular wall.
Silver sulfadiazine is not absorbed when the skin remains intact. Sulfadiazine canbe absorbed in a systemic way from the site of application when it is applied to second and third degree burns or after a prolonged application. When it is appliedto extensive burns, serum concentrations of about 12 mg/ml are detected. The absorption of sulfadiazine can be approximately a 10%, whereas only a 1% of free silver is absorbed.
With the application of 5 to 10 g of silver sulfadiazine at 1%, haematic concentrations of 1 to 2 mg/ml of sulfadiazine are detected.
The maximum serum levels are detectable between the third and eleventh day after the daily application.
Once it is absorbed, sulfadiazine is distributed to the majority of the tissues and it freely goes through the cellular membranes.
About a 95% is detected in the epidermal layers 20 hours after its application.
Its metabolism is carried out at hepatic level and it is transformed into N-acetyl derivatives, glucuronides, and other metabolites that are excreted in urine together with the unaltered drug. Its elimination half-life is 10 hours.
Within the first 72 hours, about 60 to 80% of the absorbed drug can be found in urine as unaltered drug or its metabolites.
Long term dermal toxicity studies of 24 months of duration in rats and of 18 months of duration in mice with silver sulfadiazine concentrations of three to ten times the concentration in SILVEDERMA cream, revealed no evidence of carcinogenicity.
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