INSTRUCTIONS FOR MEDICAL USE OF THE DRUG LEVOMYCETIN (LAEVOMYCETIN)

Composition:

Active substance: chloramphenicol;

1 ml of the preparation contains 2.5 mg of chloramphenicol;

Excipients: boric acid, purified water.

Pharmaceutical form. 0.25% eye drops.

Main physico-chemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Medicinal products used in ophthalmology. Antibiotics. Chloramphenicol. ATC code S01AA01.

Pharmacological properties.

Pharmacodynamics.

Chloramphenicol is a broad-spectrum antibiotic: effective against many Gram-positive and Gram-negative bacteria, rickettsiae, spirochetes, agents of trachoma, psittacosis, and venereal lymphogranuloma; active against bacterial strains resistant to penicillin, streptomycin, and sulfonamides. Weakly active against acid-resistant bacteria, Pseudomonas aeruginosa, protozoa, and Clostridia. Microbial resistance to chloramphenicol develops relatively slowly.

At usual doses, it exerts a bacteriostatic effect. The mechanism of antimicrobial action of chloramphenicol is associated with inhibition of protein synthesis in microorganisms.

Pharmacokinetics.

The drug penetrates well into tissues and body fluids; therapeutic concentrations of chloramphenicol are achieved in the vitreous body, cornea, iris, and aqueous humor of the eye when administered locally as eye drops; the drug does not penetrate into the lens.

Clinical characteristics.

Indications. Conjunctivitis, keratitis, blepharitis caused by microorganisms sensitive to the drug.

Contraindications. Individual hypersensitivity to the components of the drug. Skin diseases (psoriasis, eczema, fungal lesions).

Interaction with other medicinal products and other forms of interaction. Interaction with other drugs during topical administration of eye drops has not been established. If other local ophthalmic medicinal products are used concomitantly, an interval of at least 15 minutes between their applications should be maintained. Ophthalmic ointments should be applied last.

Special precautions.

Uncontrolled use of chloramphenicol is not allowed, especially in pediatric practice.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy. Breastfeeding should be discontinued for the duration of treatment with this drug.

Ability to affect reaction speed when driving vehicles or operating machinery.

For 1 hour after administration of the drug (until vision clears), driving vehicles or operating machinery should be avoided.

Dosage and Administration.

Instill 1 drop of the preparation into the conjunctival sac of both eyes 3 times daily using the dropper. The treatment course usually lasts 5–15 days (depending on the nature and severity of the disease, as well as the therapeutic effect achieved).

Children.

In children under 4 weeks of age, the drug should be administered only if clearly indicated.

Overdose.

Increased doses of chloramphenicol may lead to temporary reduction in visual acuity. In such cases, rinse the eyes with running water.

Side effects.

Immune system side effects: allergic reactions, including rash, itching, skin hyperemia, angioedema, urticaria.

Nervous system side effects: headache, dizziness.

Injection site reactions: local reactions, including eyelid swelling, itching, eye irritation, and tearing.

Shelf life. 2 years.

After opening the vial – 15 days.

Storage conditions. Store in the original packaging at a temperature not exceeding 25°C. Keep out of reach of children.

Packaging. 10 ml in a vial or in a vial and carton.

Prescription status. Prescription only.

Manufacturer. JSC "FITOPHARM".

Manufacturer's address and location of business activity.

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder. JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoi Rady Avenue, Kyiv, 02100, Ukraine, floor 3, room 18.