Instructions Argosulfan cream 2% tube 15 g
Composition
active ingredient: silver sulphathiazole;
1 g of the drug contains 20 mg of silver sulfathiazole;
excipients: liquid paraffin, cetostearyl alcohol, white soft paraffin, sodium lauryl sulfate, glycerin, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), potassium dihydrogen phosphate, sodium hydrogen phosphate dodecahydrate, water for injections.
Dosage form
Cream.
Main physicochemical properties: white or white with a pink to light gray tint, homogeneous emulsion mass.
Pharmacotherapeutic group
Chemotherapeutic agents for topical use. Sulfonamides. ATX code D06B A02.
Pharmacological properties
Pharmacodynamics
The mechanism of antimicrobial action of sulfathiazole includes inhibition of the growth and reproduction of microorganisms, it is associated with competitive antagonism with para-aminobenzoic acid and inhibition of dihydropteroate synthetase, which leads to disruption of the synthesis of dihydrofolic acid and, ultimately, its active metabolite - tetrahydrofolic acid, necessary for the synthesis of purines and pyrimidines of the microbial cell.
Silver sulfathiazole has a broad spectrum of antibacterial activity against mixed flora (gram-positive and gram-negative microorganisms), including Pseudomonas aeruginosa.
Inactivates and significantly reduces the infectious capacity of herpes viruses outside the cell and herpes zoster virus.
The drug effectively protects the wound from infection, forms a protective layer on the wound surface, maintains adequate moisture and promotes wound healing.
Pharmacokinetics
Silver sulfathiazole has the lowest solubility among other silver salts of the sulfonamide group, as well as high stability. The low solubility and high stability of silver sulfathiazole allows it to remain on the surface of the affected skin and reduce absorption into the blood. Absorbed sulfathiazole is acetylated in the liver, after which it is excreted in the urine as inactive metabolites and partially unchanged. Absorption of sulfathiazole increases after application of the drug to large areas of affected skin.
Indication
Argosulfan® is used topically to treat infections in cases such as:
Skin burns of all degrees (including radiation); pressure sores; trophic ulcers of the lower leg.
Contraindication
Hypersensitivity to sulfathiazole, to other sulfonamides or to excipients.
Argosulfan® should not be used:
breastfeeding women; premature newborns and infants under two months of age due to the risk of subcutaneous jaundice (kernicterus); patients with congenital glucose-6-phosphate dehydrogenase deficiency due to the risk of hemolytic anemia.
Interaction with other medicinal products and other types of interactions
The drug is not recommended for use simultaneously with other topical medications to prevent their interaction.
When used systemically, folic acid or p-aminosalicylic acid derivatives (e.g. procaine) may weaken the antibacterial effect of silver sulfathiazole.
The development of the above interactions is possible, but unlikely, since silver salts of sulfonamides act mainly on the cell membrane, and not on metabolic processes (but such an effect cannot be excluded).
Leukopenia may develop during concomitant treatment with cimetidine (leukopenia is observed 20 times more often when used with sulfadiazine).
Application features
Cross-hypersensitivity to sulfonylurea derivatives, benzothiazines and p-aminosalicylic acid is possible. In each case, a careful allergic history should be taken, especially to sulfonamides. Avoid contact of the drug with eyes and mucous membranes. In case of accidental contact, rinse with plenty of water. It is also possible to develop undesirable and systemic side effects characteristic of sulfonamides.
Use the drug with caution in patients in shock after significant burns and in patients after burns that are difficult to contact. Cumulation of the drug and the occurrence of adverse reactions in patients with impaired liver and kidney function are possible. Against the background of prolonged use on large areas of skin, the level of sulfathiazole in the blood serum should be monitored, especially in cases of kidney and liver diseases, as well as the level of leukocytes, since the development of agranulocytosis or anemia is possible.
Do not use other topical medications.
Prolonged use should be avoided.
Argosulfan® contains excipients including cetostearyl alcohol, propyl parahydroxybenzoate and methyl parahydroxybenzoate. Due to the content of cetostearyl alcohol, the medicinal product may cause local skin reactions (e.g. contact dermatitis). Due to the content of propyl parahydroxybenzoate and methyl parahydroxybenzoate, the medicinal product may cause allergic reactions (possible delayed reactions).
Ability to influence reaction speed when driving vehicles or other mechanisms
Argosulfan® does not affect the ability to drive or operate other mechanisms.
Use during pregnancy or breastfeeding
The safety of using the drug Argosulfan® during pregnancy has not been studied.
Animal studies on the effects of silver sulfathiazole on fetal development have not been conducted. Controlled studies on the effects of topical application of the drug on fetal development have not been conducted. The drug is not recommended for use during pregnancy, except in cases where the expected benefit to the woman outweighs the potential risk to the fetus.
Lactation (breastfeeding).
It is not known whether silver sulfathiazole or its metabolites are excreted in human milk. Oral sulfonamides are known to pass into breast milk and cause jaundice in infants.
It is not recommended to use the drug during breastfeeding.
Fertility.
Data is missing.
Method of administration and doses
Use for burns.
The drug is intended for topical use both in an open manner and with the use of occlusive dressings. Argosulfan® does not cause darkening of the skin and linen.
After cleaning and surgical treatment of the wound, the cream is applied in a 2-3 mm layer, observing sterile conditions. All affected skin areas should be covered with the cream throughout the entire treatment period. If for some reason part of the wound is not covered with the cream, a thin layer of the drug should always be applied additionally. There is no need to apply an occlusive dressing to the wound, except in cases where there are indications for the use of a dressing. The cream should be applied until the wound is completely healed or until the wound surface is prepared for skin grafting (surgical interventions).
Treatment of bedsores and trophic ulcers of the lower leg.
Apply the drug in a thin layer to the affected areas of the skin 2-3 times a day.
When applying the drug to infected wounds, exudate may appear. In such cases, before applying the cream, the wound should be washed with a 0.1% aqueous solution of chlorhexidine, a 3% aqueous solution of boric acid or another antiseptic. For adults, dosage control is not required.
Patients with renal failure
Due to the lack of clinical trials, caution should be exercised when using Argosulfan® in patients with renal insufficiency. In patients with severe renal impairment, the concentration of sulfonamide in the blood serum should be monitored.
Patients with liver dysfunction
Due to the lack of clinical trials, the drug should be used with caution in patients with impaired liver function.
Application method
The drug is intended for use on the skin both openly and with the use of occlusive dressings.
Children
The drug can be used in children from 3 months of age.
Overdose
The drug can be absorbed through damaged skin. There is no data on overdose.
Adverse reactions
The very low solubility and poor absorption of silver sulfathiazole by damaged skin reduce the potential for side effects when using the drug.
With prolonged use, there is a risk of general adverse reactions of sulfonamides, including kidney or liver damage, agranulocytosis, hemorrhagic diathesis, aplastic and hemolytic anemia, leukopenia, dermatological reactions and hypersensitivity, such as Stevens-Johnson syndrome, exfoliative dermatitis.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze.
Packaging
Cream in 15 g tubes.
Vacation category
Without a prescription.
Producer
Pharmaceutical factory Elfa A.T.
Location of the manufacturer and its business address
58-500 m. Jelenia Góra, ul. Vincentego. Pola, 21, Poland.
