Methyluracil + Levomycetin (Ointment) Instructions for Use

Marketing Authorization Holder

Dalkhimpharm, JSC (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

Methyluracil + Levomycetin

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

Dosage Form, Packaging, and Composition

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

Excipients: macrogol 400 (polyethylene glycol 400) – 762 mg, macrogol 1500 (polyethylene glycol 1500) – 190.5 mg.

30 g – tubes (1) – cardboard packs (1).
40 g – tubes (1) – cardboard packs (1).
50 g – tubes (1) – cardboard packs (1).

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Combined antimicrobial agent

Pharmacological Action

This is a combined medicinal product for topical use that has anti-inflammatory (dehydrating) and antimicrobial action. It 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) action.

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

Impregnate sterile gauze napkins with the ointment and use them to loosely fill the wound cavity.

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

Change dressings daily or as directed by a physician, based on the severity of suppuration and the rate of wound cleansing.

Prior to application, perform surgical treatment of the wound, removing necrotic tissue and pus.

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

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

For applications on extensive skin areas or during prolonged treatment, monitor hematological parameters via clinical blood tests.

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 extensive areas of the skin and during prolonged courses of treatment, it is necessary to perform a clinical blood test.

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.