Sulfargin^® (Ointment) Instructions for Use

ATC Code

D06BA01 (Sulfadiazine silver)

Active Substance

Sulfadiazine silver (Rec.INN Mod. registered by WHO, modified name)

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

Antimicrobial agent, sulfonamide

Pharmacological Action

A broad-spectrum antimicrobial agent, a sulfonamide. It has a bactericidal effect.

The drug is active against gram-positive and gram-negative bacteria (Escherichia coli, Proteus spp., Staphylococcus spp., Klebsiella spp.).

The bactericidal properties of Sulfargin^® ointment are due to the activity of silver ions, which are released in the wound as a result of the dissociation of the silver salt of sulfadiazine; the release of silver ions occurs gradually (moderate dissociation), ensuring the constancy of the antimicrobial action. The bactericidal activity of silver ions is complemented by the bacteriostatic effect of sulfadiazine (also released during the dissociation of the silver salt of sulfadiazine).

Sulfargin^® is characterized by moderate osmotic activity and does not possess necrolytic properties.

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.

Indications

• Treatment of infected burn wounds, bedsores, abrasions, skin ulcers, transplanted skin areas; as well as for the prevention of their infection.

ICD codes

Dosage Regimen

Ointment

For external use.

After surgical treatment of the wound and removal of necrotic tissues, the ointment is applied to the damaged surface in a thin layer of 2-4 mm (under a bandage or by the open method) 1-2 times/day. The maximum single dose is 300 g. The duration of treatment is set individually, depends on the nature of the disease and the effectiveness of the treatment used, and is usually up to 3 weeks.

If the application of the drug was missed, the ointment should be applied as soon as possible and continue application at the usual time, without doubling the dose.

If the patient feels that the effect of the drug is too strong or too weak, they should inform the doctor or pharmacist.

Adverse Reactions

Local reactions: burning and itching at the application site, skin pigmentation disorder, skin allergic reactions, skin necrosis.

Systemic reactions: erythema multiforme, interstitial nephritis, leukopenia, which is mainly characterized by a decrease in the number of neutrophils. The maximum decrease in the number of leukocytes is observed on days 2-4 after the start of treatment; normalization of the leukocyte count is observed on days 2-4, and continuation of treatment with the drug does not affect the process of leukocyte count recovery.

With long-term use on large wound surfaces: systemic side effects characteristic of sulfonamides, including hematopoiesis disorders (agranulocytosis, aplastic and hemolytic anemia, thrombocytopenia, leukopenia), skin and allergic reactions, including Stevens-Johnson syndrome and exfoliative dermatitis; dyspepsia, hepatitis, hepatocellular necrosis, impaired CNS function and toxic nephrosis.

The degree of absorption of the drug depends on the size of the burn surface and the degree of tissue damage.

Contraindications

• Pregnancy;
• Lactation period;
• Marked deficiency of glucose-6-phosphate dehydrogenase;
• Children under 1 year of age;
• Hypersensitivity to sulfonamides.

The drug should not be used to treat deep purulent wounds and burn surfaces with abundant exudation.

With caution: renal/hepatic insufficiency, glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis).

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

When applying the ointment to an extensive surface, the functional state of the liver should be monitored.

Use in Renal Impairment

When applying the ointment to an extensive surface, the functional state of the kidneys should be monitored.

Pediatric Use

The drug is contraindicated in children under 1 year of age.

Special Precautions

When treating patients with hepatic and/or renal insufficiency, it is necessary to regularly monitor the concentration of sulfonamides in plasma.

Silver salts, reacting with oxygen in the air, metals and other chemical components, especially under catalyzing 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.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

With prolonged treatment of extensive burn surfaces, sulfonamides can reach the same plasma concentrations as with systemic treatment, which determines the symptoms of overdose: nausea, impaired liver function, crystalluria, impaired renal function, leukopenia.

Treatment: symptomatic therapy.

Drug Interactions

Sulfadiazine silver may inactivate enzyme preparations used for wound cleansing, so the simultaneous use of these drugs is undesirable.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is available without a 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.