ARGOSULIFAN

Active material: Sulphathiazole silver
When ATH: D06BA02
CCF: The drug with antibacterial action for outdoor use
ICD-10 codes (testimony): A46, I73.1, I79.2, I83.2, L01, L23, L24, L30.3, L55, L89, T14.0, T30, T33, T79.3
When CSF: 06.16.03
Manufacturer: PHARMACEUTICAL WORKS JELFA S.A. (Poland)

Pharmaceutical form, composition and packaging

Cream for external application 2% in the form of white or white with a touch of pink to light gray homogeneous soft mass.

1 g
sulphathiazole silver20 mg

Excipients: Liquid paraffin, cetostearyl alcohol, vaseline, sodium lauryl, glycerol, propyl, metilgidroksiʙenzoat, potassium hydrogen phosphate, sodium dihydrogen, water d / and.

15 g – aluminum tuba (1) – packs cardboard.
40 g – aluminum tuba (1) – packs cardboard.
400 g – Polypropylene boxes.

 

Pharmacological action

The drug with antibacterial action for outdoor use. It promotes wound healing (incl. burn, trophic, purulent), provides effective protection against wound infection, relieves pain and burning in the wound, It reduces preparation time to transplant skin wounds, in many cases it leads to improvement, eliminates the need for transplantation.

Part of the drug sulfanilamide – sulphathiazole silver, antimicrobial bacteriostatic agent, It has a broad spectrum of activity against Gram-positive and Gram-negative bacteria. The mechanism of antimicrobial action sulphathiazole is the oppression of growth and reproduction of microorganisms as a result of competitive antagonism with parabens and oppression digidropteroatsintetazy, which leads to disruption of synthesis of dihydrofolic acid, ultimately, ff aktivnogo metabolite – tetrahydrofolic acid, necessary for the synthesis of purines and pyrimidines microbial cells.

Ions present in the formulation enhance the antibacterial effect of silver sulfanilamide – They inhibit the growth and division of bacteria by binding to the bacterial cell deoxyribonucleic acid. Besides, silver ions weaken the sensitizing properties of sulfanilamide.

Hydrophilic base cream, having an optimum pH value and containing a large amount of water, It provides local analgesic effect and moisturizing wounds, promoting good endurance, facilitate and accelerate the healing of wounds.

Due to the minimal resorption of the drug has no toxic effect.

 

Pharmacokinetics

Absorption

Contained in the preparation sulphathiazole silver has little solubility, whereby after topical application of the drug concentration in the wound permanently maintained at the same level. Absorption sulphathiazole silver increases with use of the drug in the vast wound surfaces.

Distribution and metabolism

Only a small amount of silver sulfathiazole is circulating, and then subjected to acetylation in the liver.

Deduction

Urine is in the form of inactive metabolites and partially unaltered.

 

Testimony

- Burns of all degrees of any etiology (incl. Thermal, solar, chemical, electrocution, ray);

- Frostbite;

- Sores;

- Small household injuries (cuts, Abrasions);

- Infected dermatitis (incl. a simple contact dermatitis, impetigo, Microbial eczema, stryeptostafilodyermiya);

- Bedsores;

- Leg sores of different genesis (incl. in chronic venous insufficiency, occlusive disease, angiopathy in diabetes, erysipelas).

 

Dosage regimen

The drug is applied topically as an open method, and in the form of occlusive dressings.

After cleansing and debridement under conditions of sterility of the drug is applied to the wound bed thickness 2-3 mm 2-3 times / day. The wound during treatment must be completely covered with cream. If part of the wound opens, must also apply the cream.

The cream is applied to the complete healing of wounds or until skin grafting.

If the result of applying the cream to the infected wound exudate appears, before re-applying the cream should wash the wound 0.1% an aqueous solution of chlorhexidine, 3% aqueous solution of boric acid or other antiseptic.

The maximum daily dose – 25 g. The maximum duration of treatment – 60 days.

 

Side effect

Maybe: allergic skin reactions (incl. burning, itch, dermahemia).

With prolonged use – leukopenia, deskvamatozny dermatitis.

 

Contraindications

- Congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase;

- Nedonoshennosty, infancy up 2 months (due to the risk of “nuclear” želtuhi);

- Hypersensitivity to the drug and other sulfonamides.

 

Pregnancy and lactation

Application Argosulfan during pregnancy and lactation is possible only in cases, when the surface is not more than the burn 20% the body surface and the expected benefit to the mother more than, than the potential risk to the fetus / baby.

 

Cautions

In hepatic and / or renal failure should monitor the concentration of sulfathiazole in serum.

Precautions should be prescribed to patients, in a state of shock, with extensive burns due to the inability to collect the full allergic history.

Effects on ability to drive vehicles and management mechanisms

The drug has no effect on employment in potentially hazardous activities, require high concentration and speed of psychomotor reactions (incl. driving).

 

Overdose

Currently, cases of drug overdose were reported Argosulfan.

 

Drug Interactions

Not recommended for use in conjunction with other local drugs.

Folic acid and its structural analogs can reduce the antimicrobial effect sulphathiazole.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C; Do not freeze. Shelf life – 2 year.

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