Novomikol^® (Ointment) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Moscow Pharmaceutical Factory CJS (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

Novomikol®

Ointment for external use 40 mg+7.5 mg/1 g: jars 25 g, tubes 30 g, 40 g, or 50 g

Dosage Form, Packaging, and Composition

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

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

25 g – dark glass jars (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial and tissue regeneration-improving 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 drug for topical use that has anti-inflammatory (dehydrating) and antimicrobial effects. 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. Cholecalciferol, by normalizing nucleic acid metabolism, stimulates regeneration processes in wounds, tissue growth and granulation maturation, and 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 for purulent wounds in the first phase of the wound process.

Cleanse the wound surface from necrotic masses and purulent exudate before application.

Impregnate sterile gauze napkins with the ointment. Loosely fill the wound cavity with the impregnated napkins.

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

Apply a sterile bandage over the treated area. Change dressings daily or every other day, depending on the clinical picture.

The frequency of changes is determined by the degree of suppuration and the rate of cleansing. Continue treatment until the wound is clean and granulation tissue appears.

Avoid applying the drug to large skin areas for prolonged periods. Monitor the patient’s condition throughout the therapy.

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 drug 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.