Levofenax (Ointment) Instructions for Use

Marketing Authorization Holder

Vita Line, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

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

Active Substances

Chloramphenicol (Rec.INN)

Dioxomethyltetrahydropyrimidine (Grouping name)

Dosage Form

Levofenax

Ointment for external use: 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g tubes; 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g jars

Dosage Form, Packaging, and Composition

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

Excipients: macrogol 1500 – 19.05 g, macrogol 400 – 76.2 g.

15 g – tubes (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
15 g – jars (1) – cardboard packs.
20 g – jars (1) – cardboard packs.
25 g – jars (1) – cardboard packs.
30 g – jars (1) – cardboard packs.
35 g – jars (1) – cardboard packs.
40 g – jars (1) – cardboard packs.
50 g – jars (1) – cardboard packs.
60 g – jars (1) – cardboard packs.
70 g – jars (1) – cardboard packs.
80 g – jars (1) – cardboard packs.
90 g – jars (1) – cardboard packs.
100 g – jars (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

Combined medicinal product for topical use, has anti-inflammatory (dehydrating) and antimicrobial action, is 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.

Antibacterial action is preserved in the presence of pus and necrotic masses. Dioxomethyltetrahydropyrimidine, by normalizing nucleic acid metabolism, stimulates regeneration processes in wounds, tissue growth and granulation maturation, epithelialization, and has an anti-inflammatory (dehydrating) effect.

Indications

Purulent wounds (including those infected with mixed microflora) in the first (purulent-necrotic) phase of the wound process.

ICD codes

Dosage Regimen

Apply the ointment topically only.

Use the medicinal product to impregnate sterile gauze napkins.

Loosely fill the purulent wound cavity with the impregnated napkins.

Alternatively, introduce the ointment into purulent cavities through a catheter or drainage tube using a syringe.

Apply dressings daily or change them as directed by a physician based on the wound’s condition.

Ensure the wound is appropriately cleansed before each new application.

The duration of treatment is determined by the rate of wound cleansing and the appearance of granulation tissue.

Discontinue use upon the transition of the wound process to the second phase.

Avoid applying to large body surface areas for extended periods without medical supervision.

Perform a clinical blood test during prolonged therapy or when treating extensive wounds.

Adverse Reactions

Allergic reactions skin rashes.

Contraindications

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

With caution

Pregnancy, lactation period (breastfeeding).

Use in Pregnancy and Lactation

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

During lactation, either the use of the medicinal product should be discontinued or breastfeeding should be stopped.

Pediatric Use

Use is contraindicated in children under 1 year of age (in newborns, the biotransformation of chloramphenicol occurs more slowly than in adults).

Special Precautions

When applied to large areas of the skin and during long courses of treatment, a clinical blood test should be performed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.