Pharmacological properties
Pharmacodynamics. Silver sulfadiazine has an antimicrobial effect on gram-positive and gram-negative microbes and fungi (candida, phycomycetes and aspergillus spp., dermatophytes). The activity of Sulfargin ointment is due to the high concentration of silver ions in the wound as a result of moderate dissociation of silver sulfadiazine, which achieves a long-lasting antimicrobial effect, which complements sulfadiazine (sulfanilamides). Silver ions are adsorbed on the surface of microbial cells and have the so-called oligodynamic bacteriostatic and bactericidal effect. The ointment does not have a necrolytic and mutagenic effect, is characterized by moderate osmotic activity.
Pharmacokinetics. When applied topically, up to 1% of silver ions and up to 10% of sulfadiazine from the total amount of ointment applied to the wound may be absorbed. Most of the absorbed silver is excreted in the bile. Absorbed sulfadiazine does not accumulate in the body and is rapidly excreted by the kidneys.
Indication
Treatment and prevention of infected burns, bedsores, ulcers, superficial wounds with low exudation, abrasions; skin transplantation.
Application
The ointment is intended for topical external use.
After removal of necrotic tissues, the ointment is applied in a thin layer (2-4 mm) to the damaged surface usually 1-2 times a day, under a sterile bandage or in an open way. In severe cases, the ointment is applied up to 4 times a day. It is important that the damaged skin areas are covered with a layer of ointment at all times.
Before each subsequent application of the ointment, the damaged surface must be washed with 0.9% sodium chloride solution or an antiseptic solution to remove ointment residues and wound exudate.
The ointment is used until the wound is completely healed or until the wound surface is prepared for appropriate surgical intervention.
The method of application and dose of the ointment do not depend on the patient's age, but depend on the size and depth of the wound surface lesion. The maximum single dose is 300 g.
When applying the ointment to a large surface, kidney and liver function and blood parameters (content of formed blood elements) should be monitored. The patient should be given plenty of alkaline fluids.
Contraindication
Hypersensitivity to silver sulfadiazine, sulfonamides or any of the excipients included in the ointment; genetic deficiency of glucose-6-phosphate dehydrogenase (hemolysis may occur when applied to large surfaces); purulent wounds and burn wounds with abundant exudation (not advisable); porphyria; premature infants, newborns and children under 3 months of age (due to the risk of kernicterus).
Side effects
Local reactions. Rarely, the ointment may have a local irritating effect (short-term burning, pain), which passes after 5-10 minutes. With increased sensitivity, allergic reactions may occur, including rash, burning, itching, redness, allergic rhinitis, allergic urticaria, photosensitivity, skin necrosis, hyperpigmentation, contact dermatitis. With prolonged treatment or treatment of large skin surfaces, argyria may occur - as a result of the accumulation of silver in the tissues, the skin may acquire a slightly grayish color.
Systemic reactions. With prolonged treatment of large burn surfaces, concentrations of sulfonamides in the blood plasma may occur that are comparable to those achieved with systemic use. Adverse reactions characteristic of sulfonamides may occur: nausea, vomiting, diarrhea, glossitis, joint pain, liver dysfunction and necrosis, headache, drug fever, confusion, convulsions, crystalluria, interstitial nephritis, leukopenia, thrombocytopenia, eosinophilia.
Special instructions
Avoid getting the ointment in the eyes.
It should be used with caution in:
hypersensitivity to sulfonamides (due to the possibility of allergic reactions); congenital deficiency of glucose-6-phosphate dehydrogenase (after applying the ointment to large surfaces, hemolysis is possible); impaired renal and hepatic function (cumulation may occur; for such patients, monitoring of sulfonamide levels in blood plasma is necessary).
The use of the ointment should be avoided in patients with porphyria.
As with the topical use of other antimicrobial drugs, superinfection may also develop when taking silver sulfadiazine.
The ointment's excipients, methylparaben (E218) and propylparaben (E216), may cause allergic reactions (including delayed type), and in some cases, bronchospasm.
Cetostearyl alcohol and propylene glycol may cause local skin reactions (e.g. contact dermatitis); propylene glycol may cause skin irritation.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. There are no data on the effect of the drug.
Use during pregnancy or breastfeeding. Should not be used during pregnancy or breastfeeding.
Sulfonamides are known to increase the risk of bilirubin encephalopathy in infants, so the use of the ointment is contraindicated during breastfeeding. If it is necessary to use the ointment during breastfeeding, you should switch to alternative feeding of the child.
Children: Due to the risk of kernicterus, silver sulfadiazine should not be used in premature infants, newborns, and infants under 3 months of age.
Silver sulfadiazine can inactivate enzymatic wound cleansing agents, so it is not recommended to use these drugs simultaneously.
Concomitant use of cimetidine may cause an increased incidence of leukopenia.
Overdose
In case of an overdose of the ointment, side effects associated with the systemic use of all sulfonamides may occur (see Side Effects).
In patients with severe burns, a significant increase in plasma osmolarity was observed with prolonged use. This may be due to increased resorption of propylene glycol, which is part of the drug, through the affected skin.
Treatment is symptomatic. If necessary, renal function and blood parameters should be monitored. Absorbed sulfadiazine is easily excreted by hemodialysis and peritoneal dialysis.
Storage conditions
At a temperature not exceeding 25 °C. Do not store in the refrigerator or freezer.
