Name:
Argesin cream dnar.prim.10mg1g in tubes 50g in pack №1
Description:
Uniform cream of white or almost white color. Air bubbles are allowed. The main active ingredient Sulfadiazine Product form Cream Dosage 50g Pharmacological properties Silver sulfadiazine is a topical chemotherapeutic agent that prevents and suppresses the development of infection in burns and other wound processes, reduces the expansion of necrosis in depth and ensures healing of damaged surfaces. Pharmacodynamics The mechanism of antimicrobial action of silver sulfadiazine cream differs from the mechanism of action of other silver salts and the sulfonamides themselves. Silver sulfadiazine moderately dissociates in the wound, and thus silver ions are slowly and uniformly released at concentrations that are toxic to microorganisms but harmless to human skin and subcutaneous tissue cells. Silver ions bind to some components of the bacterial cell, among which the most important reaction for suppressing growth and reproduction is binding to RNA. Sulfadiazine is found at concentrations well below the MBC and therefore its direct effect on bacteria is negligible. This is supported by the fact that para-aminobenzoic acid (PABA) does not inhibit the antimicrobial action of silver sulfadiazine. Cream Argezin has a broad antimicrobial spectrum of action, covering all types of microorganisms that can be found in burn wounds. In vitro tests have shown that all strains of Pseudomonas aeruginosa, Proteus mirabilis and Escherichia coli are already sensitive to silver sulfadiazine at a concentration of 50 mg/ml. For Staphylococcus aureus, Klebsiella spp., Enterobacter, Candida albicans and some other fungi, MBC is 100 mg/ml. Silver sulfadiazine has been found to be 50 times more effective than sulfadiazine, mafenide acetate, and many other antimicrobial agents. This is due to its unique mechanism of antimicrobial action. Pharmacokinetics The pharmacologically active component of Argesin cream penetrates into necrotic tissue and exudate. This effect is especially important because systemic antibiotics commonly used in clinical practice do not reach microorganisms in the necrosis zone with impaired microcirculation. Silver sulfadiazine moderately dissociates in the wound, releasing silver ions evenly and slowly. Thus, rapid and massive binding of silver ions to chloride ions, proteins and other components of physiological fluids is prevented, and electrolyte imbalance does not occur. The amount of absorbed silver is very small and does not exceed 1%. Studies using silver isotopes have shown that it cannot be found in organs. The results of animal studies show that most of the absorbed silver is excreted in the bile. Sulfadiazine can be absorbed in amounts up to 10%, while plasma concentrations generally do not exceed 2.0 mg%. In the case of applying a large amount of cream to extensive burn wounds, plasma concentrations of sulfadiazine may, in exceptional cases, approach therapeutic values (8-12 mg%). Sulfadiazine is excreted in the urine. Indications for use Prevention of infection and treatment of infected burns, bedsores, ulcers, superficial wounds with weak exudation, abrasions. Prevention of infection during skin transplantation. Dosage and administration The drug is intended for external use. Select the appropriate treatment regimen after assessing the size and depth of the wound surface. After cleaning the surface of the burn or other wound, the cream is applied in a thin layer (2-4 mm) on the damaged surface (or on a sterile gauze napkin, which is applied to the wound surface). The cream is applied with a sterile spatula or a hand in a sterile glove, usually 1 time per day, in severe cases – twice a day. Before each subsequent application of the cream, the burn surface must be washed with a 0.9% solution of sodium chloride or an antiseptic solution to remove the remnants of the cream and wound exudate. You can apply a bandage. The method of administration and dose of the drug does not depend on the age of the patient. The drug should be used until the wound is completely healed or until the wound surface is prepared for the appropriate surgical intervention. If the drug is not used according to the doctor’s prescription, it is necessary to contact him for advice, or if after 7 days of treatment the patient’s condition has not improved or worsened. The cream does not leave stains on clothes and bed linen. Impaired kidney/liver function. When applying the cream on a large surface, kidney and liver function and blood counts (the content of blood cells) should be monitored. The patient should be given a plentiful alkaline drink. Use during pregnancy and lactation Given the limited experience and risks (sulfonamides, when used systemically, displace bilirubin from binding sites with albumin in the blood plasma, which can lead to hyperbilirubinemia and kernicterus in newborns), the drug should not be used during pregnancy. Silver sulfadiazine should be used with caution in women planning pregnancy. It is known that sulfonamides increase the risk of bilirubin encephalopathy in newborns, so the use of the cream is contraindicated during breastfeeding. Precautions Avoid getting the drug in the eyes. Cream Argezin should be used with caution: in case of hypersensitivity to sulfonamides (due to the possibility of allergic reactions); patients with congenital deficiency of glucose-6-phosphate dehydrogenase (in the treatment of minor superficial burns); patients with impaired renal or hepatic function (cumulation is possible, for such patients it is necessary to control the level of sulfonamide in the blood serum). Do not use in patients with porphyria (see section “Contraindications”). During treatment with sulfadiazide, dangerous skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. The greatest risk of such reactions exists in the first weeks of treatment. At the first manifestations of hypersensitivity (progressive skin rash often with blisters and mucosal lesions), the drug should be discontinued. Only with minor burns can the cream be used alone. Patients with deeper burns should always consult a doctor before starting treatment. Burns affecting 2% or more of the body surface area (approximately 1 patient’s palm corresponds to 1% of the patient’s body surface area), as well as burns affecting the eyes, ears, face, hands, legs and / or perineum, need medical evaluation. Consultation with a doctor is necessary for skin wounds containing foreign materials that cannot be removed; with deep stab wounds; animal bites; in wounds with significant redness, sudden development of edema and wounds accompanied by fever. If treatment involves prolonged use of Argesin cream on large areas of the skin, monitoring of blood counts is necessary, since leukopenia, thrombocytopenia and eosinophilia may occur. In the treatment of massive wounds, plasma concentrations of sulfadiazine can reach therapeutic levels. Systemic side effects of sulfonamides may develop. Therefore, it is recommended to monitor the concentration of sulfadiazine in the blood serum, kidney function, and also examine the urine. As with other topical antimicrobials, superinfection may develop during treatment. Very rarely, an increase in body temperature is possible, which is associated with undesirable side effects. Excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate can cause allergic reactions, including in some cases delayed bronchospasm. Propylene glycol, which is part of the drug, can cause skin irritation. Cetostearyl alcohol can also cause local skin reactions (eg contact dermatitis). Application in children Due to the risk of nuclear jaundice, silver sulfadiazine should not be used in premature babies, newborns and children under 3 months. Since the efficacy and safety of the drug in children over the age of 3 months have not been determined, it is recommended to prescribe to patients in this age group after consulting a doctor. Drug Interactions Silver sulfadiazine may inactivate wound cleansing enzyme preparations when used concomitantly. Simultaneous use of cimetidine may increase the incidence of leukopenia. In the treatment of extensive burns, when the concentration of silver sulfadiazine in the blood serum reaches therapeutic values, it should be borne in mind that the effect of drugs used systemically may change. Contraindications Hypersensitivity to silver sulfadiazine, sulfonamides or any other ingredient of the drug. Porfiry. Genetic deficiency of glucose-6-phosphate dehydrogenase (when used on large surfaces, hemolysis may occur). Purulent and burn wounds with abundant exudation (not advisable). Premature babies, newborns and children under 3 months (due to the risk of bilirubin encephalopathy). Composition 1 g of cream contains 10 mg of micronized silver sulfadiazine. Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, unrefined castor oil, macrogolglycerol hydroxystearate, macrogol cetostearyl ether, propylene glycol, cetostearyl alcohol, polysorbate 80, purified water. Overdose In case of an overdose of the cream, side effects associated with the systemic use of all sulfonamides may occur (see section “Side Effects”). Long-term use of high doses of silver sulfadiazine may cause an increase in serum silver levels. However, these levels return to normal upon discontinuation of treatment. In patients with severe burns during long-term treatment, a significant increase in serum osmolarity was observed. The reason for this may be increased resorption of propylene glycol, which is part of the drug, through the affected skin. Treatment is symptomatic. If necessary, kidney function and blood counts should be monitored. Absorbed sulfadiazine is easily excreted by hemo- and peritoneal dialysis. Side effect On the part of the blood: leukopenia, increased osmolarity of blood serum. Transient leukopenia usually does not require discontinuation of therapy or the use of other special measures. Monitoring of the patient’s blood counts is recommended. On the part of the skin and subcutaneous tissue: hypersensitivity reactions, irritation and redness of the skin, itching, burning, pain upon application, rash, discoloration of the skin to gray under the influence of sunlight (argyria – pigmentation caused by silver deposition), photosensitivity, skin necrosis, hyperpigmentation , contact dermatitis, runny nose and asthma of allergic origin. In long-term treatment of extensive burn surfaces, especially after severe burns, adverse reactions characteristic of oral sulfadiazine use have been reported, such as nausea, vomiting, diarrhea, glossitis, joint pain, headache, confusion, convulsions, anemia, leukopenia, thrombocytopenia , eosinophilia, drug fever, liver dysfunction and necrosis, interstitial nephritis, crystalluria, allergic reactions, skin reactions, erythema nodosum, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, cholestatic hepatosis, folic acid deficiency. Systemic absorption of silver sulfadiazine can very rarely cause adverse reactions associated with the systemic use of sulfonamides. If any side effect occurs or worsens, whether it is described in this section or not, you should contact your doctor immediately. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Argezin cream 10mg/1g 50g №1 Price for Argezin cream 10mg/1g 50g №1
INN | SULFATHIAZOL SILVER |
---|---|
The code | 69 634 |
Barcode | 4 810 183 006 111 |
Dosage | 10mg/1g 50g |
Active substance | Silver sulfadiazine |
Manufacturer | Pharmtekhnologiya LLC, Belarus |
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