Levomekol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LEVOMECOL (Laevomecol)

Composition:

Active substances: chloramphenicol, methyluracil;

1 g of ointment contains: chloramphenicol 7.5 mg, methyluracil 40 mg;

Excipients: polyethylene glycol 400, polyethylene glycol 1500.

Pharmaceutical form. Ointment.

Main physicochemical properties: white ointment or white with a yellowish tint.

Pharmacotherapeutic group.

Agent for the treatment of wounds and ulcerative lesions.

ATC code D03AX.

Pharmacological properties.

Pharmacodynamics.

A combined preparation for topical use. Exerts anti-inflammatory and antimicrobial effects, active against Gram-positive and Gram-negative microorganisms (staphylococci, Escherichia coli).

The medicinal product contains methyluracil and chloramphenicol.

Chloramphenicol has a broad spectrum of antimicrobial activity against Gram-positive and Gram-negative microorganisms, including staphylococci, Pseudomonas aeruginosa, and Escherichia coli, providing antibacterial effect by inhibiting microbial protein synthesis.

Methyluracil accelerates cellular regeneration processes, promotes wound healing, and exerts anti-inflammatory action.

The preparation easily penetrates tissues without damaging biological membranes. Its antibacterial activity is preserved in the presence of pus and necrotic masses.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Purulent wounds (including those infected with mixed microflora) during the first phase (suppurative-necrotic phase) of the wound process, trophic ulcers, pressure sores, infected burns, furuncles, carbuncles.

Contraindications.

Individual hypersensitivity to the components of the drug. Psoriasis, eczema, fungal skin infections.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with hematopoiesis-suppressing agents is not recommended: sulfonamides, cytostatics, pyrazoline derivatives; diphenyl, barbiturates, ethanol.

Concomitant use with erythromycin, oleandomycin, nystatin, and levorin enhances the antibacterial activity of Levomekol ointment, whereas concomitant use with benzylpenicillin salts reduces it.

Special precautions for use.

The use of Levomekol ointment may lead to skin sensitization, which can cause hypersensitivity reactions upon subsequent topical or systemic administration of medicinal products.

The antibacterial activity of the drug is preserved in the presence of pus or necrotic masses.

Peripheral blood picture should be monitored during prolonged treatment (longer than 1 month).

Avoid contact of the ointment with eyes and mucous membranes.

The instructions for use of the medicinal product must not be violated.

Use during pregnancy or breastfeeding.

The use of the medicinal product during pregnancy or breastfeeding is possible if, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Method of Administration and Dosage

The ointment is intended for external use in adults and children aged 3 years and older. Sterile gauze dressings are saturated with the ointment and used to fill the wound. The ointment may also be introduced into purulent cavities through a catheter (drainage tube) using a syringe. In this case, the ointment should be pre-warmed to 35–36 °C. Dressings should be changed daily until the wound is completely cleared of pus and necrotic material. In cases of extensive wound surfaces, the daily dose of ointment, calculated as chloramphenicol, must not exceed 3 g.

The ointment should be applied from the first day of injury for up to 4 days. Hyperosmolar Levomekol ointment is not recommended for prolonged use, as it may cause osmotic shock in undamaged cells. On days 5–7 of treatment, it is recommended to switch to medications that promote tissue integrity restoration.

Children

For use in children aged 3 years and older.

Overdose

In case of overdose, adverse effects of the drug may be intensified. Prolonged (more than 5–7 days) topical use often leads to contact sensitization, resulting in hypersensitivity reactions upon subsequent topical or systemic administration of the drug.

Symptomatic therapy is recommended.

Side effects.

Allergic reactions may occur during the use of the medication, including skin rashes, itching, burning sensation, local swelling, hyperemia, angioneurotic edema, urticaria, dermatitis; general weakness is also possible. In such cases, the use of the ointment must be discontinued and medical advice should be sought.

Shelf life.

2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

40 g in a tube.

1 tube in a cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

JSC "CHIMFARMZAVOD "CHERVONA ZIRKA".

Manufacturer's address and place of business.

Ukraine, 61010, Kharkiv region, Kharkiv, Gorodyenkovskaya street, building 1.