Levomederm (Ointment) Instructions for Use

Marketing Authorization Holder

Formula-FR, 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 registered by WHO)

Dioxomethyltetrahydropyrimidine (Grouping name)

Dosage Form

Levomederm

Ointment for external use 40 mg+7.5 mg/1 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

Dosage Form, Packaging, and Composition

Ointment for external use is homogeneous, white or white with a yellowish tint.

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

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

Clinical-Pharmacological Group

Drug with antimicrobial and drying action for external use

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antibiotics for topical use; other antibiotics for topical use

Pharmacological Action

A combined medicinal product for topical use, it has anti-inflammatory (dehydrating) and antimicrobial action, and 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.

The 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 exerts 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 topically only.

Use for the treatment of purulent wounds in the first phase of the wound process.

Thoroughly cleanse and debride the wound area before application.

Impregnate sterile gauze napkins with the ointment.

Loosely fill the wound cavity with the medicated napkins.

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

Apply once daily or as directed by a physician.

Change dressings daily or as indicated by the clinical situation and amount of exudate.

Duration of treatment depends on the severity of the condition and the rate of wound cleansing.

Discontinue use and consult a physician if no improvement is observed within 3-5 days.

Avoid application to very large body surface areas for prolonged periods.

Perform a clinical blood test during long-term 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 (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 15°C (59°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.