Levomekol

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LЕVOMECOLUM (LAEVOMECOLUM)

Composition:

Active substances: chloramphenicol (levomycetin), methyluracil;

1 g of ointment contains chloramphenicol (levomycetin) 7.5 mg, methyluracil 40 mg;

Excipients: polyethylene glycol 400, polyethylene glycol 1500.

Pharmaceutical form. Ointment.

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

Pharmacotherapeutic group.

Preparations promoting wound healing (scar formation). ATC code D03A X.

Pharmacological properties.

Pharmacodynamics.

A combined medicinal product for topical use with antimicrobial, reparative, and anti-inflammatory effects. Chloramphenicol (levomycetin) included in the formulation exerts an antimicrobial action, the mechanism of which is associated with inhibition of microbial protein synthesis. It acts bacteriostatically and is active against gram-positive and gram-negative microorganisms (Staphylococcus, Streptococcus, Pseudomonas aeruginosa, and Escherichia coli). Methyluracil accelerates cellular regeneration processes, promotes wound healing, and exerts anti-inflammatory effects.

Pharmacokinetics.

The polyethylene oxide base absorbs wound exudate and enhances the activity of active substances. The preparation easily penetrates into tissues without damaging biological membranes; however, the extent of systemic absorption following application to the skin, wounds, and mucous membranes is unknown.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug; psoriasis, eczema, fungal skin infections.

Interaction with other medicinal products and other forms of interactions.

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

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

Special precautions for use

The use of topical antibacterial agents may lead to skin sensitization, resulting in hypersensitivity reactions upon subsequent topical or systemic administration of this drug.

The antibacterial activity of the drug is preserved in the presence of pus or necrotic material. Avoid contact of the ointment with the mucous membranes of the eyes.

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

The recommended application guidelines for the medicinal product must not be violated.

Use during pregnancy or breastfeeding

The use of the medicinal product during pregnancy or breastfeeding is justified only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction rate when driving or operating machinery

Has no effect.

Method of Administration and Dosage.

Levomekol is intended for external use in adults and children aged 3 years and older. Sterile gauze pads are soaked 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 such cases, Levomekol should be preheated to 35–36 °C. Dressings should be performed daily until complete clearance of wounds from purulent-necrotic material and until the beginning of granulation. When large wound surfaces are involved, the daily dose of ointment, calculated as chloramphenicol (levomycetin), must not exceed 3 g.

The ointment should be applied starting from the first day of injury, for up to 4 days. Hyperosmolar ointment Levomekol should not be used for prolonged periods, 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 injured tissue integrity.

Children.

The drug may be used in children aged 3 years and older.

Overdose.

Prolonged (more than 5–7 days) external use often leads to contact sensitization, resulting in hypersensitivity reactions upon subsequent topical or systemic administration of the drug. Treatment is symptomatic.

Side effects.

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

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C; do not allow freezing. Keep out of reach of children.

Packaging.

25 g in containers. 20 g, 30 g, or 40 g in aluminum or laminated tubes, in a carton or without a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.