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Pharmacological properties

argedin bosnalek cream - an antibacterial drug for external use, promotes wound healing, provides effective protection of wounds from infection, reduces the duration of treatment.

The active substance of the cream is silver sulfadiazine - a chemotherapeutic agent for topical application with antimicrobial action. It has a wide spectrum of antibacterial action, is active against gram-positive and gram-negative bacteria, as well as Candida albicans and herpes virus. The antibacterial effect is mainly due to the binding of membranes and walls of microbial cells. Sulfadiazine silver is a combination of sulfadiazine acid and silver nitrate. Sulfadiazine refers to sulfonamides, antimicrobial bacteriostatic agents. The silver ions in the preparation inhibit the growth and division of bacteria by binding bacterial enzymes to the microbial cell DNA and sulfhydryl groups. As a result, damage to skin cells and subcutaneous tissues is reduced and wound healing is accelerated. Sulfadiazine and silver ions mutually enhance the antibacterial effect of each. Silver sulfadiazine penetrates into necrotic tissues and exudate, which is very important, since systemic drugs are ineffective against the bacterial flora in necrotic tissues.

Pharmacokinetics With topical application, especially in large areas of affected skin and / or with prolonged use, sulfadiazine can be absorbed and enter the general bloodstream (up to 10%). Accumulation of sulfadiazine in the body is possible in patients with significant burns, in children, in patients with significant impaired renal function, with dehydration. Absorbed sulfadiazine is excreted in the urine, T½ - 10 hours. Silver ions are generally not absorbed.

Indications

Treatment for infected burns, pressure sores, ulcers, superficial wounds with weak exudation; prevention of infection with these injuries, wounds, abrasions, small cuts, as well as with skin transplantation.

Application

The drug is intended for topical use. after cleansing the surface of the burn or other wound, argedin bosnalek is applied to it (or to a sterile gauze cloth, which is applied to the affected surface) with a layer of approximately 2-3 mm thick with a sterile spatula or gloved hand. cream is usually applied to affected surfaces 1-2 times a day, in severe cases - up to 4 times a day. it is important that the affected areas of the skin are always covered with a layer of cream.

Before each subsequent application of the cream, the burned surface must be washed with 0.9% sodium chloride solution or an antiseptic solution to remove the remaining cream and wound exudate. You can apply a bandage. The cream is used until the wound is completely healed or until the wound surface is prepared for appropriate surgical intervention.

Contraindications

Hypersensitivity to sulfonamides, silver or another component of the drug, porphyria.

Side effects

When taken in recommended doses, the drug is usually well tolerated. but in some cases, adverse reactions may occur.

From the blood system: leukopenia.

On the part of the skin and subcutaneous tissues: skin irritation, burning, pain when applied, rash, photosensitivity, hyperpigmentation, skin discoloration, erythema multiforme, hypersensitivity skin reactions with hyperemia, itching, very rarely - skin necrosis. In some cases, argyria is possible (skin color in gray, caused by the deposition of silver).

When applying the cream to large surfaces (high doses), especially after severe burns, there have been reports of adverse reactions similar to those of oral administration of sulfadiazine, such as nausea, vomiting, diarrhea, glossitis, joint pain, headache, confusion, cramps , anemia, thrombocytopenia, eosinophilia, agranulocytosis, drug fever, impaired liver and / or kidney function, hepatitis, liver necrosis, crystalluria, interstitial nephritis, toxic nephrosis, Stevens-Johnson syndrome, exfoliative dermis um.

special instructions

Topical use of silver sulfadiazine requires caution in such cases:

patients with congenital glucose-6-phosphate dehydrogenase deficiency due to the risk of hemolysis, especially when applied to large areas of affected skin;

patients with impaired renal and / or liver function (cumulation is possible, for such patients control of the level of sulfonamide in the blood plasma is necessary).

With prolonged treatment with silver sulfadiazine of lesions with a large area, the risk of exceeding the therapeutic concentration of sulfonamides in the blood plasma with the appearance of characteristic side effects increases. To prevent this, clinical blood counts, plasma sulfadiazine concentration and its possible presence in urine, liver and kidney function should be monitored. If skin or hematological reactions occur, discontinue use of the drug. An exception is the possible occurrence of transient leukopenia on the 2nd – 3rd day from the start of treatment for burns, which disappears after a few days without stopping treatment with silver sulfadiazine. Blood monitoring is recommended.

Topical application of the cream can cause porphyria.

As with other antimicrobials, superinfection may develop.

Very rarely, an increase in body temperature is possible, which is associated with undesirable side effects.

The cream contains methyl parahydroxybenzoate, which can cause an allergic reaction, and propylene glycol, which can cause skin irritation.

Avoid contact with the eyes.

The cream does not stain clothes and bedding.

During pregnancy and breastfeeding. Do not use in late pregnancy. Topical use of silver sulfadiazine in the third trimester of pregnancy can cause the occurrence of neonatal hemolysis and methemoglobinemia. The safety of silver sulfadiazine during pregnancy has not been established, therefore, the drug should not be used during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus. If you need to use the cream during lactation, you should switch to alternative feeding the baby.

Children. The drug is not used in children under the age of 3 months.

The ability to influence the reaction rate when driving vehicles and working with other mechanisms. Does not affect.

Interactions

Silver sulfadiazine can inactivate preparations for enzymatic cleansing of the wound when used together.

PABA or similar substances do not impair the effect of silver sulfadiazine.

If silver sulfadiazine due to absorption appears in the blood plasma in a significant amount, interactions with drugs characteristic of systemic sulfonamides are possible. It was noted that the simultaneous use of cimetidine can increase the incidence of leukopenia.

Overdose

An increase in the severity of adverse reactions can be expected with prolonged treatment of burn wounds that cover a large surface of the skin (see side effects). in patients with severe burns with prolonged treatment, a significant increase in the osmolarity of blood plasma was noted. the reason for this may be increased resorption of propylene glycol, which is part of the drug, through the affected dermis.

Treatment is symptomatic. A large volume of fluid is prescribed inside (it is recommended to maintain daily diuresis at the level of 1200-1500 ml or more). If necessary, kidney function and blood counts should be monitored. Sulfadiazine, absorbed systemically, is easily excreted by hemo- and peritoneal dialysis. Hemodialysis and blood transfusion reduce the plasma concentration of silver.

Storage conditions

At a temperature not exceeding 25 ° C.

Tags: Silver sulfadiazine