ATC subcategorySulfanilamides for external use
Generic nameSilver sulfadiazine
Each gram contains:
active ingredient: silver sulfadiazine – 10 mg;
excipients: cetostearyl alcohol, liquid parafin heavy, propylene glycol, glyceryl stearate, polysorbate 80, methylparaben, water purified.
Antimicrobial preparation has broad antimicrobial activity against Gram-positive and Gram-negative bacteria,as well as Candida fungi and dermatophytes. Silvadev has a bactericidal action; in contrast to sulfadiazine, the silver salt acts primarily on the cell membrane and cell wall and its action is not antagonised by p-aminobenzoic acid. Resistance to sulfadiazine silver has been reported and may develop during therapy.
Bactericidal activity of silver ions is supplemented with bacteriostatic effect of sulfadiazine (also released during dissociation of silver sulfadiazine). Silvadev is characterized by moderate osmotic activity and has no nekrolitic properties.
In the wound silver sulfadiazine dissociates moderately. Silver ion releases uniformly and slowly , therefore, does not bind rapidly and widely with chlorine ions, proteins and other components of body fluids. For this reason, electrolyte balance disorder using Silvadev does not observed.
Silver amount absorption is insignificantly and probably does not exceed 1%. Sulfadiazine can be absorbed up to 10%. The greatest concentration in the plasma can be detected during the third to seventh day of application in small-area burns and from the third to eleventh day of use in case of extensive and deep burns. Sulfadiazine excretes with the urine.
– Treatment of wound and burn surfaces in the first phase of the wound exudation process.
– Treatment of wounds and burns I-IIIA degree in the second and third phase of wound process.
– Treatment of venous ulcers, pressure ulcers, nonhealing wounds (including wounds cults) process.
The cream application is painless. Does not stain on the clothing and bedding.
– Deep festering wounds and burns with exudation.
– Pregnancy and breastfeeding.
– Hypersensitivity to sulfonamides.
– Silvadev can not be used in premature and newborn infants up to 2 months.
Local reactions: in rare cases – transient stinging or pain (going alone after 5-10 min); erythema multiforme, Stevens Johnson syndrome, skin necrosis (with prolonged use); allergic reactions can be (skin rash, burning, redness covers).
Systemic reactions: long-term use of cream on extensive burns surfaces systemic side effects characteristic of sulfonamides may develop _ (8-12%).
Since such side effects are possible (hemolytic anemia, agranulocytosis, thrombocytopenia, leukopenia, from the gastrointestinal tract – hepatitis), so the application of this preparation it is necessary to control the concentration of sulfonamide in the serum.
During therapy with SILVADEV , patients should receive SILVADEV rich alkaline water. Precaution is necessary for hypersensitive individuals to sulfonamides because of possible allergic reactions, patients with congenital deficiency of glucose-6-phosphate dehydrogenaseas, because after applying the cream on a large surface hemolysis may occur.
With long-term application of a preparation or cream applied over extensive surfaces of the skin should monitor renal , liver function, peripheral blood picture.
With simultaneous use with other antimicrobial agents amplifies antimicrobial action (this combination is used for the prevention and suppression of infection in burns).
40 g of cream is filled into aluminum tubes ,which tubes are packed and inserted with the leaflet into cardboard boxes .
3 years. Do not use after the expiration date.
To be dispensed without prescription.
Store at a room temperature, in a dry place, out of the reach of children. Protect from light.