Levomekol

Instructions for Medical Use of the Medicinal Product LEVOMECOL

Composition:

1 g of ointment contains:

Active substances: chloramphenicol (levomycetin) – 7.5 mg; methyluracil – 40 mg;

Excipients: polyethylene oxide 1500, polyethylene oxide 400.

Pharmaceutical form. Ointment.

Main physicochemical properties: homogeneous mass of white or white with a yellowish tint color, with a weak specific odor.

Pharmacotherapeutic group.

Agents for the treatment of wounds and ulcerative lesions. ATC code D03A X.

Pharmacological properties.

Pharmacodynamics.

A combined drug belonging to the group of reparative and antimicrobial agents. Levomekol ointment exerts reparative, antimicrobial, and anti-inflammatory effects; the preparation is active against gram-positive and gram-negative microorganisms.

The drug contains methyluracil and chloramphenicol (levomycetin). Chloramphenicol (levomycetin) 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, promotes wound healing, exerts anti-inflammatory action, enhances local immunity, induces interferonogenesis, stimulates cellular regeneration processes, and accelerates wound healing. In purulent wounds, polyethylene glycol 1500 actively binds inflammatory exudate and transfers it to the dressing, from which the fluid evaporates, while the freed polyethylene glycol 1500 molecules again bind accumulating exudate at the wound base. The smallest molecules of polyethylene glycol 400 are capable of penetrating into tissues. By forming a complex with the antibiotic, polyethylene glycol 400 delivers it into wound tissues where microbes are localized. Thus, during the use of the drug, perifocal edema is reduced and the wound is cleared of purulent-necrotic contents.

Pharmacokinetics.

The drug has predominantly local action and penetrates minimally through mucous membranes and skin. Therapeutic activity persists for 20–24 hours.

Clinical characteristics.

Indications. Treatment of purulent wounds (including those infected with mixed microflora) in the first phase of the wound process, trophic ulcers, pressure sores, infected burns, furuncles, carbuncles.

Contraindications.

Individual hypersensitivity to components of the medicinal product.

Psoriasis, eczema, fungal skin infections.

Special precautions.

Use of the drug may lead to skin sensitization, accompanied by development of hypersensitivity reactions upon subsequent topical or systemic administration of this drug.

Antibacterial activity of the drug is preserved in the presence of purulent or necrotic material.

During prolonged use (longer than 1 month), monitoring of peripheral blood picture is required.

Avoid contact of the ointment with eyes.

Interaction with other medicinal products and other types of interactions.

Concomitant use with drugs that suppress hematopoiesis (sulfonamides, cytostatics, pyrazoline derivatives), diphenyl, barbiturates, ethanol is not recommended.

Concomitant use of the drug with erythromycin, oleandomycin, nystatin, and levorin increases the antibacterial activity of the ointment, whereas concomitant use with benzylpenicillin salts decreases it.

Special precautions for use.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration.

Levomekol ointment is intended for external use in adults and children aged 3 years and older.

Soak sterile gauze pads with the ointment and apply them to the wound. The ointment may also be introduced into purulent cavities through a catheter (drainage tube) using a syringe. In such cases, Levomekol ointment should be pre-warmed to 35–36 °C.

Apply the ointment from the first day of injury for 4 days. Prolonged use of hyperosmolar Levomekol ointment is not recommended, as it may cause osmotic shock in undamaged cells. On days 5–7 of treatment, it is recommended to switch to medications promoting restoration of damaged tissue integrity.

Children.

Do not administer the drug to children under 3 years of age.

Overdose.

In case of overdose, adverse reactions of the drug may be intensified. Prolonged (more than 5–7 days) external use often leads to contact sensitization.

Treatment – symptomatic.

Side effects.

Allergic reactions are possible during the use of the medicinal product, including skin rashes, itching, burning sensation, local swelling, hyperemia, angioneurotic edema, urticaria, dermatitis; general weakness may also occur.

In such cases, the use of the ointment must be discontinued and medical advice should be sought.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 g, 40 g in tubes; 25 g, 40 g, 100 g in a tube, 1 tube per cardboard pack.

Supply category. Over-the-counter (without a prescription).

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

16 Barvinкова St., Lubny, Poltava region, 37500, Ukraine.