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Silvadev, 1 % cream

Drug formSoft

ATC categoryAntibacterials

ATC subcategorySulfanilamides for external use

Brand nameSilvadev

Generic nameSilver sulfadiazine

Composition

Each gram contains:

active ingredient: silver sulfadiazine – 10 mg;
excipients: cetostearyl alcohol, liquid parafin heavy, propylene glycol, glyceryl stearate, polysorbate 80, methylparaben, water purified.

Pharmacological group and ATC code
Antimicrobial preparation for topical use; D06BA01.

Pharmacology

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.

Pharmacokinetics
Silver sulfadiazine impregnates necrotic tissue and exudate. This effect has of great importance because the antibiotics which are used to treat general, do not act on the bacterias inside the burn of necrotic tissue as the latter is off from the blood circulation.

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.

Uses
– Processing of fresh burn surfaces for the prevention of infection development.

– 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.

Dosage and administration
Treatment is carried out after antishock therapy and regulation of water-electrolyte balance. After debridement and removal of necrotic tissue cream is applied to the damaged area with a thin layer (2-4 mm) under the band or open. The band should be changed 1-2 times / day or less. Before each re-applying the cream the wound should be well cleaned with an antiseptic solution to provide the best effect of the cream on the burn surface. Old cream and a large effusion can be easily removed with a jet of water or washing with disinfectant solution.

The cream application is painless. Does not stain on the clothing and bedding.

Contraindications
– Lack of the enzyme glucose-6-phosphate dehydrogenase.

– 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.

Adverse effects

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.

Precautions

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.

Drug interactions

With simultaneous use with other antimicrobial agents amplifies antimicrobial action (this combination is used for the prevention and suppression of infection in burns).

Presentation

40 g of cream is filled into aluminum tubes ,which tubes are packed and inserted with the leaflet into cardboard boxes .

Expiry date

3 years. Do not use after the expiration date.

Prescription status

To be dispensed without prescription.

Storage conditions

Store at a room temperature, in a dry place, out of the reach of children. Protect from light.