Sulfargin, ointment 50 g

Pharmacotherapeutic group

Antimicrobial agent, sulfonamide.

ATC code: D06BA01

Pharmacodynamics

Sulfadiazine is a broad spectrum antimicrobial bactericidal agent belonging to the sulfonamide group. The drug is active against Gram-positive and Gram-negative bacteria Escherichiacoli, Proteusspp., Staphylococcusspp., Klebsiellaspp.

The bactericidal properties of the ointment are due to the activity of silver ions, which are released in the wound as a result of dissociation of the silver salt of sulfadiazine; the release of silver ions is gradual (moderate dissociation), providing a constant antimicrobial effect. Bactericidal activity of silver ions is complemented by bacteriostatic effect of sulfadiazine (also released during dissociation of silver salt of sulfadiazine).

The drug has moderate osmotic activity and no necrolytic properties.

Pharmacokinetics

About 10% sulfadiazine and 1% silver are absorbed into the peripheral and systemic bloodstream when applied to the wound surface. Application to an extensive wound surface is accompanied by increase of sulfadiazine concentration in blood up to 10-20 µg/ml.

Indications

Treatment of infected superficial wounds and burn surfaces with weak exudation, bedsores, abrasions, skin ulcers, transplanted skin areas; as well as preventing their infection.

Pharmacological effect

PHARMACOTHERAPEUTIC GROUP

Antimicrobial agent, sulfonamide.

ATX code: D06BA01

PHARMACODYNAMICS

Sulfadiazine is a broad-spectrum antimicrobial bactericidal agent belonging to the group of sulfonamides. The drug is active against gram-positive and gram-negative bacteria Escherichiacoli, Proteus spp., Staphylococcus spp., Klebsiellaspp.

The bactericidal properties of the 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 a constant antimicrobial effect. 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).

The drug is characterized by moderate osmotic activity and does not have necrolytic properties.

PHARMACOKINETICS

When applied to the wound surface, about 10% of sulfadiazine and 1% of silver are absorbed into the peripheral and systemic bloodstream. Application to a large wound surface is accompanied by an increase in the concentration of sulfadiazine in the blood to 10-20 mcg/ml.

Special instructions

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

It is recommended to protect parts of the body treated with the drug from direct sunlight.

When applying the ointment on a large surface, the functional state of the kidneys, liver and the content of blood cells should be monitored; patients should be prescribed plenty of alkaline drinks.

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

Active ingredient

Sulfadiazine

Composition

1 g of ointment for external use contains:
active ingredient: silver sulfadiazine – 10 mg;
excipients: liquid paraffin – 230 mg; propylene glycol – 100 mg; cetostearyl alcohol – 60 mg; glyceryl monostearate 40-55 – 30 mg; polysorbate-80 – 20 mg; methyl parahydroxybenzoate – 0.80 mg; propyl parahydroxybenzoate – 0.20 mg; purified water – up to 1 g.

Pregnancy

The use of the drug during pregnancy and breastfeeding is contraindicated.

Contraindications

Pregnancy, lactation, children under 1 year of age; severe deficiency of glucose-6-phosphate dehydrogenase and increased sensitivity to sulfonamide drugs.

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

WITH CAUTION
Renal/liver failure, glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis).
If you have these diseases, you should consult your doctor before using the drug.

Side Effects

Uncommon: leukopenia, which is characterized mainly by a decrease in the number of neutrophils. Rarely: allergic skin reactions, skin pigmentation disorders. Very rare: burning and itching at the site of application. With long-term use on large wound surfaces: systemic side effects characteristic of sulfonamide drugs. Rarely: allergic reactions. Disorders of the blood and lymphatic system. Rarely: hematopoietic disorders (agranulocytosis, aplastic and hemolytic anemia, thrombocytopenia, leukopenia). Common: dyspepsia. Rarely: hepatitis, hepatocellular necrosis. Rare: toxic nephrosis.

Interaction

The active ingredient in the ointment, silver sulfadiazine, can inactivate enzyme preparations used to cleanse the wound, so the simultaneous use of these drugs is undesirable.

Overdose

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

Functional features

The bactericidal properties of the 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 a constant antimicrobial effect. 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).
The drug is characterized by moderate osmotic activity and does not have necrolytic properties.

Storage conditions

Store at a temperature not exceeding 25 °C. Do not freeze. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiration date stated on the package.

Manufacturer

Tallinn Pharmaceutical Plant, Estonia