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Levomycetin 3% 25ml solution for external use in alcohol

pharmachologic effect

Levomycetin alcohol solution is an antimicrobial drug for topical use. The drug contains the active component - chloramphenicol - a synthetic substance with pronounced bacteriostatic activity. Gram-positive and gram-negative bacteria are sensitive to the action of the drug, including the drug is active against microorganisms resistant to the action of other antimicrobial agents (penicillin, tetracycline, sulfonamides). The mechanism of action of the drug is based on its ability to inhibit protein synthesis in microbial cells through interaction with the 50S ribosomal subunit. In patients with trophic ulcers and burns, the use of the drug leads to an acceleration of the processes of epithelization and tissue regeneration. When applied externally, the absorption of chloramphenicol into the systemic circulation is negligible. After a single application, the local bacteriostatic effect of the drug lasts about 6-12 hours.

Composition and release form Levomycetin 3% 25ml solution for external use in alcohol

Solution - 1 ml:

Active ingredient: Chloramphenicol – 2.5 mg;
Excipients: boric acid – 18.0 mg; sodium tetraborate decahydrate – 3.0 mg; water for injection – up to 1 ml.

Eye drops, 0.25%.

1 ml, 1.5 ml, 2 ml in a dropper tube with a valve or 5 ml, 10 ml in a dropper tube with a screw neck made of polyethylene.

Dropper tubes with a screw neck are sealed with screw-on caps made of polymer materials.

2 dropper tubes of 1 ml, 1.5 ml, 2 ml or 5 dropper tubes of 1 ml, 2 ml, or 1 dropper tube of 5 ml, 10 ml with instructions for use are placed in a cardboard pack.

Description of the dosage form

Transparent colorless or slightly yellowish liquid.

Directions for use and doses

Locally. For adults and children - instill 1-2 drops into the conjunctival sac every 1-4 hours. The recommended course of treatment is 7-10 days. Extension of the course of treatment is possible as prescribed by a doctor.

Pharmacodynamics

A bacteriostatic antibiotic with a broad spectrum of action, it disrupts the process of protein synthesis in the microbial cell (possessing fat solubility, it penetrates the bacterial cell membrane and reversibly binds to the 50S subunit of bacterial ribosomes, in which the movement of amino acids to growing peptide chains is delayed, which leads to disruption of protein synthesis).

Effective against strains of bacteria resistant to penicillin, tetracyclines, and sulfonamides. Active against Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, some species of Enterobacter and Neisseria, Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus haemolyticus), Moraxella lacunata, rickettsia and mycoplasma.

Not effective against acid-fast bacteria, anaerobes, Acinetobacter spp., Pseudomonas aeruginosa, Serratia marcescens.

Pharmacokinetics

When the drug is instilled into the conjunctival sac, therapeutic concentrations are created in the aqueous humor of the eye, cornea, iris, and vitreous body; does not penetrate the lens.

Partially enters the systemic circulation. It is excreted mainly by the kidneys in the form of inactive metabolites, and partially by the intestines.

Indications for use Levomycetin 3% 25ml solution for external use in alcohol

Bacterial eye infections caused by sensitive microflora:

conjunctivitis;
keratitis;
blepharitis;
blepharoconjunctivitis;
keratoconjunctivitis;
neuroparalytic keratitis in the presence of a secondary bacterial infection.

Contraindications

Increased individual sensitivity to the components of the drug; inhibition of bone marrow hematopoiesis; acute intermittent porphyria; deficiency of glucose-6-phosphate dehydrogenase; liver and/or kidney failure; pregnancy, lactation period; neonatal period (up to 4 weeks).

Carefully:

Skin diseases (psoriasis, eczema, fungal infections); early childhood; patients who have previously received treatment with cytotoxic drugs or radiation therapy.

Application of Levomycetin 3% 25ml solution for external use in alcohol during pregnancy and breastfeeding

The use of the drug is contraindicated during pregnancy and breastfeeding.

special instructions

There is some information about the development of bone marrow hypoplasia after the use of ophthalmic forms (systematic monitoring of the peripheral blood picture is necessary during treatment).

Impact on the ability to drive vehicles. Wed and fur.:

If the patient's visual clarity temporarily decreases after using the drug, until it is restored, it is not recommended to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

There is no data on drug overdose.

Side effects Levomycetin 3% 25ml solution for external use in alcohol

Local allergic reactions. With long-term use: reticulocytopenia, leukopenia, granulocytopenia, thrombocytopenia, erythrocytopenia; rarely – aplastic anemia, agranulocytosis; secondary fungal infection.

Drug interactions

Simultaneous administration with drugs that inhibit hematopoiesis (sulfonamides, cytostatics), affecting metabolism in the liver, or radiation therapy increases the risk of side effects.

When used simultaneously with erythromycin, clindamycin, lincomycin, a mutual weakening of the effect is observed due to the fact that chloramphenicol can displace these drugs from the bound state or prevent their binding to the 50S subunit of bacterial ribosomes. When prescribed with oral hypoglycemic drugs, their effect is enhanced by suppressing metabolism in the liver and increasing their concentration in plasma. Chloramphenicol inhibits the cytochrome P450 enzyme system, therefore, when used simultaneously with phenobarbital, phenytoin, and indirect anticoagulants, a weakening of the metabolism of these drugs, a slower elimination and an increase in their concentration in plasma are observed. Reduces the antibacterial effect of penicillins and cephalosporins.

Levomycetin alcohol solution 1% 25ml

Dosage form

Alcohol solution for external use

Compound:

Active substance

Chloramphenicol (chloramphenicol) – 0.25 g; 1 g; 3 g; 5 g

Excipients

Ethanol (ethyl alcohol) 70% up to 100 ml

Description

Transparent, colorless or yellowish liquid with a characteristic odor of alcohol.

Pharmacotherapeutic group

Antibiotic

ATX code

: D06AX02

Pharmacological properties

The active ingredient of the drug is chloramphenicol, a broad-spectrum antibiotic with high antibacterial activity against pathogens of wound infections and various forms of purulent-inflammatory processes. Chloramphenicol is a bacteriostatic antibiotic that disrupts the process of protein synthesis in the microbial cell (having good lipophilicity, it penetrates the bacterial cell membrane and reversibly binds to the 50S subunit of bacterial ribosomes, in which the movement of amino acids to growing peptide chains is delayed, which leads to disruption of protein synthesis). Active against most strains of gram-positive and gram-negative microorganisms resistant to penicillin, tetracyclines and sulfonamides. Promotes cleansing and healing of burn wounds and trophic ulcers, accelerates epithelization. Not effective against acid-fast bacteria, anaerobes, Acinetobacter spp., Serratia marcescens.

Indications for use

Bacterial skin infections caused by sensitive microorganisms, incl. infected burns (superficial and limited deep), bedsores, trophic ulcers, wounds, boils.

Contraindications

Hypersensitivity to any of the components of the drug, inhibition of bone marrow hematopoiesis, acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency, liver failure, renal failure, uninfected skin diseases, neonatal period (up to 4 weeks), pregnancy, breastfeeding.

Carefully

Early childhood, previous treatment with cytotoxic drugs or radiation therapy.

Use during pregnancy and breastfeeding

Use during pregnancy and breastfeeding is contraindicated.

Directions for use and doses

Externally. The affected areas are treated with a cotton swab soaked in the drug solution 2-3 times a day. The duration of treatment is as indicated, depending on the nature and location of the affected area. If there is no improvement after treatment, or symptoms worsen, or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, method of administration and in the doses indicated in the instructions.

Side effect

Allergic reactions (skin rash, angioedema).

From the hematopoietic organs: thrombocytopenia, erythropenia, leukopenia, aplastic anemia, reticulocytopenia, granulocytopenia, agranulocytosis.

If you experience the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

When using the drug in accordance with the instructions for use, an overdose is unlikely. To date, there have been no reports of cases of overdose when using the drug.

Interaction with other drugs

When used simultaneously with erythromycin, clindamycin, lincomycin, a mutual weakening of the effect is observed due to the fact that chloramphenicol can displace these drugs from the bound state or prevent their binding to the 50S subunit of bacterial ribosomes. Reduces the antibacterial effect of penicillins and cephalosporins. Simultaneous use with drugs that inhibit bone marrow hematopoiesis (sulfonamides, cytostatics) and radiation therapy increases the risk of side effects. If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Levomycetin.

special instructions

During treatment, systematic monitoring of peripheral blood patterns is necessary. When applied to large surfaces with simultaneous intake of ethanol, the development of disulfiram-like reactions (skin hyperemia, tachycardia, nausea, vomiting, reflex cough, convulsions) is possible.

Impact on the ability to drive vehicles and machinery

The use of the drug does not affect the performance of potentially hazardous activities that require special attention and quick reactions (driving vehicles, working with moving mechanisms).

Release form

Alcohol solution for external use 0.25%, 1%, 3%, 5%.

25, 40 ml of the drug in orange glass bottles with a screw neck, sealed with polymer stoppers and polymer screw caps.

25, 40 ml in bottles made of polyethylene terephthalate, sealed with polymer screw caps.

Each bottle, along with instructions for use, is placed in a cardboard pack.

It is allowed to place bottles in group packaging with an equal number of instructions for use

Storage conditions

In a place protected from light at a temperature not exceeding 25°C.

Keep out of the reach of children.

Best before date

2 years. Do not use after the expiration date.

Vacation conditions

Available without a prescription.