Levomecol^® (Ointment) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

D06C (Antibiotics and chemotherapeutic agents in combination with other drugs)

Active Substances

Chloramphenicol (Rec.INN WHO registered)

Dioxomethyltetrahydropyrimidine (Grouping name)

Dosage Form

Levomecol®

Ointment for external use 40 mg+7.5 mg/1 g: tubes 10 g, 20 g, 30 g, 40 g, or 50 g

Dosage Form, Packaging, and Composition

Ointment for external use white or white with a yellowish tint.

Excipients: macrogol 1500 – 190.5 mg, macrogol 400 – 762 mg.

10 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
10 g – laminated polyethylene tubes (1) – cardboard packs.
20 g – laminated polyethylene tubes (1) – cardboard packs.
30 g – laminated polyethylene tubes (1) – cardboard packs.
40 g – laminated polyethylene tubes (1) – cardboard packs.
50 g – laminated polyethylene tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial and tissue regeneration-improving action for external use

Pharmacotherapeutic Group

Combined antimicrobial agent

Pharmacological Action

A combined drug for topical use, has anti-inflammatory (dehydrating) and antimicrobial action, active against gram-positive and gram-negative microorganisms (staphylococci, Pseudomonas aeruginosa and Escherichia coli).

It easily penetrates deep into tissues without damaging biological membranes and stimulates regeneration processes. The antibacterial action is preserved in the presence of pus and necrotic masses.

Indications

• Infected wounds (including cuts and abrasions) of various locations (including those infected with mixed microflora) in the first phase of the wound process.

ICD codes

Dosage Regimen

Topically. Sterile gauze napkins are soaked with the drug and used to loosely fill the wound. It is possible to introduce it into purulent cavities through a catheter (drainage tube) using a syringe. In this case, the ointment is preheated to 35-36°C (95-96.8°F). Dressings are changed daily, once a day, until the wound is completely cleansed of purulent-necrotic masses.

For large wound surfaces, the daily dose of the ointment in terms of Chloramphenicol should not exceed 3 g.

The duration of treatment depends on the severity and course of the disease.

Adverse Reactions

Allergic reactions (skin rashes).

Contraindications

• Hypersensitivity to the components of the drug;
• Children under 1 year of age (in newborns, the biotransformation of chloramphenicol occurs more slowly than in adults).

Use in Pregnancy and Lactation

Use during pregnancy is only possible if the benefit to the mother outweighs the risk to the fetus.

During breastfeeding, either the use of the drug should be discontinued or breastfeeding should be stopped.

Pediatric Use

The use of the drug is contraindicated in children under 1 year of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

No effect.

Overdose

No cases of overdose with Levomecol^® ointment have been reported.

Drug Interactions

Cases of interaction or incompatibility with other drugs have not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years 6 months.

Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.