Levomycetin alcohol solution 1 %

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORAMPHENICOL ALCOHOLIC SOLUTION 1%

Composition:

active substance: chloramphenicin;

1 ml of solution contains chloramphenicol 0.01 g;

excipient: ethanol 70%.

Pharmaceutical form.

Alcoholic solution for topical use.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with a smell of alcohol.

Pharmacotherapeutic group.

Antibiotics for local use. ATC code D06AX02.

Pharmacological properties.

Pharmacodynamics.

The drug exerts an antimicrobial, predominantly bacteriostatic effect when applied locally against most Gram-positive and Gram-negative bacteria by interfering with protein synthesis. It is active against pathogens resistant to penicillin-group antibiotics, streptomycin, and sulfonamides. Resistance to chloramphenicol develops slowly.

Pharmacokinetics.

When applied externally, chloramphenicol poorly penetrates intact skin and mucous membranes; therefore, its systemic absorption is weak. On average, the antimicrobial effect lasts for 6–12 hours.

Clinical characteristics.

Indications.

Topical use – for burns, cuts, skin fissures, and skin diseases accompanied by purulent-inflammatory lesions.

Contraindications.

Hypersensitivity to the components of the drug, glucose-6-phosphate dehydrogenase deficiency, acute intermittent porphyria, skin diseases (psoriasis, eczema, fungal infections), pregnancy or breastfeeding period.

Special precautions.

Use of the drug may lead to skin sensitization, resulting in hypersensitivity reactions upon subsequent topical or systemic administration of this drug.

Antibacterial activity of the drug is preserved in the presence of purulent or necrotic material.

During prolonged treatment (longer than 1 month), monitoring of peripheral blood status is required.

Avoid contact with eyes and mucous membranes.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with drugs that suppress hematopoiesis (sulfonamides, cytostatics, pyrazolone derivatives) is undesirable.

Usage notes.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery. Not studied.

Method of Administration and Dosage

For use in adults and children aged 1 year and older. Apply to affected areas of the skin (can be used under an occlusive dressing). For the treatment of wounds and burns, apply the medication to affected skin areas 4–5 times daily.

The duration of treatment depends on the course of the pathological process, its severity, and the therapeutic effect achieved.

Children.

Do not use in children under 1 year of age.

Overdose.

In case of overdose, skin and mucous membrane irritation may occur, as well as local allergic reactions such as rash, itching, redness, tissue swelling, or exacerbation of other adverse reactions. Treatment is symptomatic.

Side effects.

Allergic reactions may occur during the use of the drug, including skin rashes, itching, dermatitis, burning, hyperemia, angioneurotic edema, urticaria. In such cases, the drug should be discontinued.

Shelf life. 2 years.

Storage conditions.

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

Packaging.

25 ml in glass bottles sealed with stoppers or dropper stoppers and caps. One bottle per carton or without carton.

25 ml in polymer bottles sealed with dropper stoppers and caps. One bottle per carton or without carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Avenue, Zaporizhzhia, Ukraine, 69063.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Avenue, Zaporizhzhia, Ukraine, 69063.