Sulfargin 50.0 ointment

Dosage form

Ointment white or almost white, with a characteristic odor.

Structure

1 g of ointment contains:

active substance: 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.

general description

Antimicrobial agent, sulfonamide

Special conditions

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 atmospheric oxygen, metals and other chemical components, especially when catalyzed by heat, darken, so the drug should be stored in a closed container and away from heat sources.

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

When using the drug, avoid contact with the eyes.

Do not dispose of unused product and packaging with waste water or household waste.

The release of drugs into the environment should be minimized.

Influence on the ability to drive vehicles, mechanisms

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

Drug interactions

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

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 Escherichia coli, Proteus spp., Staphylococcus spp., Klebsiella spp.

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 sulfadiazine salt

the release of silver ions is gradual (moderate dissociation), ensuring the constancy of the 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 has no necrolytic properties.

Pharmokinetics

When applied to the wound surface, about 10% sulfadiazine and 1% 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 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 prevention of their infection.

Contraindications

Pregnancy, lactation, children under 1 year of age

severe deficiency of glucose-6-phosphate dehydrogenase and hypersensitivity to sulfa drugs.

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

Carefully

Renal / hepatic failure, deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis).

In the case of the presence of these diseases, before using the drug, you must consult a doctor.

Application during pregnancy and during breastfeeding

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

Overdose

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

Treatment is symptomatic.

Side effects

The incidence of adverse reactions is classified according to the recommendations of the World Health Organization: very often (> 1/10), often (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1 / 10000, < 1/1000), very rare, including individual messages (< 1/10000).

Blood and lymphatic system disorders

Uncommon: leukopenia, which is characterized mainly by a decrease in the number of neutrophils.

The maximum decrease in the number of leukocytes is observed 2-4 days after the start of treatment

the normalization of the number of leukocytes is observed for 2-4 days, while the continuation of treatment with the drug does not affect the process of restoring the number of leukocytes.

Skin and subcutaneous tissue disorders

Rarely: allergic skin reactions, skin pigmentation disorders.

General disorders and disorders at the injection site Very rare: burning and itching at the site of application.

With prolonged use on large wound surfaces: systemic side effects characteristic of sulfa drugs.

Immune system disorders Rare: allergic reactions.

Blood and lymphatic system disorders

Rarely: hematopoiesis disorder (agranulocytosis, aplastic and hemolytic anemia, thrombocytopenia, leukopenia).

Disorders from the gastrointestinal tract Often: dyspepsia.

Liver and biliary tract disorders Rarely: hepatitis, hepatocellular necrosis.

Renal and urinary system disorders Rare: toxic nephrosis.

There are isolated reports of central nervous system dysfunctions, kidney and urinary system disorders (interstitial nephritis), skin and subcutaneous tissue disorders (skin necrosis, erythema multiforme, Stevens-Johnson syndrome and exfoliative dermatitis).

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

If you experience side effects that are not described in these instructions, you should stop taking the drug and inform your doctor about it.

Special storage conditions

Do not freeze.

Dosage

1% x 50g

Indications

Treatment of infected burn wounds, bedsores, abrasions, skin ulcers, transplanted skin areas

as well as prevention of their infection.

Wounds (including long-term non-healing), trophic ulcers, bedsores, burns with mild exudation.

Storage conditions and periods

At a temperature not higher than 25 degrees.

(do not freeze).

Expiration date: 2 years

Contraindications

Pregnancy, lactation, children under 1 year of age

severe deficiency of glucose-6-phosphate dehydrogenase, hypersensitivity to sulfonamides.

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

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

INN / Active ingredient

Sulfadiazine

Specifications

Category

Wound healing

,

Scarring

,

Regenerating agents

Scope of the medicinal product

Leather

Release form

Ointment

Manufacturer country

Estonia

Package quantity, pcs

one

Vacation conditions

Without recipe

Brand name

Grindex

The amount of the dosage form in the primary package

50 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antimicrobial agent - sulfonamide

Anatomical and therapeutic characteristics

D06BA01 Silver sulfadiazine

Dosage form

Ointment for external use

Expiration date in days

730

Package weight, g

75

Information on technical characteristics, delivery set, country of manufacture