LEVOMEKOL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LEVOMEKOL (Laevomekol)

Composition:

Active substances: 1 g of the preparation contains: chloramphenicol (calculated as 100% dry substance) 7.5 mg, 6-methyluracil (calculated as 100% dry substance) 40 mg;

Excipients: polyethylene glycol 400, polyethylene glycol 1500.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of white or white with a slightly yellowish tint, of uniform consistency.

Pharmacotherapeutic group. Agents promoting wound healing (scar formation). ATC code D03A X.

Pharmacological Properties

Pharmacodynamics

A combined medication for topical use with antimicrobial, regenerative, and anti-inflammatory effects. Chloramphenicol, one of the components of the drug, exerts an antimicrobial action by inhibiting microbial protein synthesis. It acts bacteriostatically and is active against both gram-positive and gram-negative microorganisms (staphylococci, streptococci, Pseudomonas aeruginosa, Escherichia coli). Methyluracil accelerates cellular regeneration, promotes wound healing, and exerts anti-inflammatory effects.

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

Pharmacokinetics

Not studied.

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, boils, carbuncles.

Contraindications.

• Hypersensitivity to the active substances or to other components of the medicinal product;
• 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, pyrazolone derivatives; with diphenyl, barbiturates, ethanol.

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

Special precautions for use.

The use of topical antibacterial agents may lead to skin sensitization, accompanied by the development of 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 tissue. Avoid contact of the ointment with the mucous membrane of the eyes.

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

The recommended instructions for using the medicinal product must not be violated.

Use during pregnancy or breastfeeding.

The use of the drug 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.

Does not affect.

Dosage and Administration.

Levomekol is intended for topical use in adults and children aged 3 years and older. The ointment should be used to saturate sterile gauze dressings, which should then be applied to fill the wound. It is possible to administer the ointment 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 changed daily until complete removal of purulent-necrotic material from the wound and until the beginning of granulation. When treating large wound surface areas, the daily dose of ointment, calculated as chloramphenicol, should not exceed 3 g.

The ointment should be applied from the first day of injury for up to 4 days. Prolonged use of the hyperosmolar ointment Levomekol is not recommended, as it may cause osmotic shock in undamaged cells. On days 5–7 of treatment, it is recommended to replace the ointment with agents promoting restoration of damaged tissue integrity.

Children.

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

Overdose.

There have been no reports of overdose. However, prolonged (more than 5–7 days) topical use often leads to contact sensitization, resulting in hypersensitivity reactions upon subsequent topical or systemic use of the drug. When Levomekol is used according to the recommendations provided, overdose is not possible. Treatment is symptomatic.

Adverse reactions.

Allergic reactions (skin rashes), dermatitis, burning sensation, itching, local swelling, hyperemia, angioneurotic edema, urticaria may occur; general weakness is possible. In such cases, the use of the ointment should be discontinued.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report any suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://аіsf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. In the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 30 g or 40 g in a tube, 1 tube per carton.

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

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchahivskiy Chemical and Pharmaceutical Plant".

Manufacturer's address and location of business activity.

17, Miru Street, Kyiv, 03134, Ukraine.