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Argedin (Cream) Instructions for Use

Marketing Authorization Holder

Bosnalijek, JSC (Bosnia And Herzegovina)

ATC Code

D06BA01 (Sulfadiazine silver)

Active Substance

Sulfadiazine silver (Rec.INN WHO registered modified name)

Dosage Form

Bottle Rx Icon Argedin Cream for external use 10 mg/g: tubes 40 g

Dosage Form, Packaging, and Composition

Cream for external use 1 g
Sulfadiazine silver 10 mg

40 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

Antimicrobial agent, sulfonamide

Pharmacological Action

A sulfonamide drug for external use. It has a broad spectrum of antibacterial action, which includes almost all gram-positive and gram-negative microorganisms, including Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Staphylococcus spp., Streptococcus spp., Enterobacter spp. and Klebsiella spp.; it is also active against some species of fungi and yeasts.

When applied to damaged skin, it dissociates with the release of silver ions and sulfonamide, interacts with the sulfhydryl groups of the bacterial cell enzymes and reduces their activity, while not having a damaging effect on tissue cells. It penetrates into necrotic tissue. It acts bacteriostatically.

Pharmacokinetics

When applied to a wound surface, about 10% of sulfadiazine and 1% of silver are absorbed into the peripheral and systemic circulation. Application to an extensive wound surface is accompanied by an increase in the concentration of sulfadiazine in the blood to 10-20 µg/ml. T1/2 is 10 hours.

Indications

  • Infected, superficial wounds and burns with weak exudation;
  • Bedsores;
  • Trophic and long-term non-healing ulcers (including stump wounds);
  • Abrasions;
  • Skin grafting.

ICD codes

ICD-10 code Indication
I83.2 Varicose veins of lower extremities with ulcer and inflammation
L89 Decubitus ulcer and pressure area
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
Z94 Presence of transplanted organs and tissues
ICD-11 code Indication
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
EH90.Z Pressure ulcer of unspecified degree
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
ND56.0 Superficial injury of unspecified body region
NE11 Burn of unspecified body region
NF0A.3 Posttraumatic wound infection, not elsewhere classified
QB63.Z Presence of transplanted organ or tissue, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Externally.

For adults and children over 2 years of age, the damaged surface is lubricated with a layer of cream 2 mm thick twice a day after cleaning the wound; large damaged skin surfaces are covered with a sterile bandage, changed twice a day, in serious cases up to 4 times.

No pain effects are observed during dressing changes. Before each re-application, the previous layer of the drug must be removed with a stream of water or an antiseptic solution. The course of treatment should be continued until healing.

Adverse Reactions

Burning, itching, brownish-gray discoloration of the skin, skin allergic reactions (skin rash, photosensitivity); with prolonged use on large wound surfaces – systemic side effects (leukopenia, headache, dyspepsia).

Contraindications

  • Allergic reactions to the components of the drug;
  • Suppression of bone marrow hematopoiesis;
  • Glucose-6-phosphate dehydrogenase deficiency;
  • Renal/hepatic insufficiency;
  • Porphyria;
  • Deep purulent wounds and burns with pronounced exudation;
  • Children under 2 years of age.

Use in Pregnancy and Lactation

Use during pregnancy is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. In such cases, the use of the drug should be as short as possible and limited to small areas of the skin.

If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

Silver salts, reacting with atmospheric oxygen, metals and other chemical components, especially under catalytic thermal influence, darken, so the drug should be stored in a closed container and away from heat sources. Body parts treated with the drug are recommended to be protected from direct sunlight.

Effect on the ability to drive vehicles and mechanisms

No effect.

Drug Interactions

Cimetidine – the risk of leukopenia increases.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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