Levomycetin Reneval, 500 mg 10 pcs.

Pharmacotherapeutic group: antibiotic.

ATX code: J01BA01

Pharmacological properties.

Pharmacodynamics

A broad-spectrum bacteriostatic antibiotic, disrupts protein synthesis in the microbial cell at the stage of transfer of t-RNA amino acids to ribosomes.

It is effective against strains of bacteria resistant to penicillins, tetracyclines, sulfonamides.

Active against the following microorganisms: Escherichia coli, Shigella dysenteriae, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella spp. (including Salmonella typhi, Salmonella paratyphi), Staphylococcus spp, Streptococcus spp. (including Streptococcus pneumoniae), Neisseria meningitidis, Neisseria gonorrhoeae, several strains of Proteus spp., Burkholderia pseudomallei, Rickettsia spp, Treponema spp., Leptospira spp, Chlamydia spp. (including Chlamydia trachomatis), Coxiella burnetii, Ehrlichia canis, Bacteroides fragilis, Klebsiella pneumoniae, Haemophilus influenzae.

It has no effect on acid-fast bacteria (including Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter spp., Enterobacter spp., Serratia marcescens, indole-positive strains of Proteus spp., Pseudomonas aeruginosa, protozoa and fungi.

The resistance of microorganisms develops slowly.

Pharmacokinetics

Absorption – 90% (fast and almost complete). Bioavailability – 80% after oral administration and 70% after intramuscular administration. Binding with plasma proteins – 50-60 %. Time to reach maximum concentration (T_max) after oral administration – 1-3 hours. Volume of distribution is 0.6-1 l/kg. Therapeutic concentration in blood is maintained for 4-5 hours after ingestion.

It penetrates well into body fluids and tissues. Its highest concentrations are created in the liver and kidneys. Up to 30% of the administered dose is found in the bile. Maximal concentration (С_max) in cerebrospinal fluid (CSF) is determined 4-5 hours after a single oral administration and may reach 21-50% of С_max in plasma and 45-89% in case of cerebrospinal fluid inflammation. Passes through the placental barrier, fetal serum concentrations may be 30-80% of that in the mother’s blood. It penetrates into breast milk.

The main amount (90%) is metabolized in the liver. In the intestine it is hydrolyzed under the influence of intestinal bacteria with the formation of inactive metabolites.

Extracted during 24 hours by kidneys – 90% (by glomerular filtration – 5-10% of unchanged form, by renal secretion as inactive metabolites – 80%), through the intestines – 1-3%. Half-life period (T½) in adults is 1.5-3.5 hours, with impaired renal function – 3-11 hours. The elimination half-life in children from 3 to 16 years old is 3-6.5 hours. Weakly excreted during hemodialysis.

Indications

Active ingredient

Composition

How to take, the dosage

Orally (30 minutes before a meal, and 1 hour after a meal if nausea and vomiting develop), 3-4 times a day.

The single dose for adults is 250-500 mg, the daily dose is 2000 mg.

Children over 3 years of age and with a body weight of more than 20 kg are prescribed 12.5 mg/kg every 6 hours or 25 mg/kg every 12 hours.

The average duration of treatment is 8-10 days.

Interaction

Inhibits the cytochrome P450 enzyme system, therefore concomitant use with phenobarbital, phenytoin, indirect anticoagulants, impaired metabolism of these drugs, slower excretion and increased plasma concentrations of these drugs are noted.

Decreases the antibacterial effect of penicillins and cephalosporins.

In concomitant use with erythromycin, clindamycin, lincomycin mutual weakening of action is noted due to the fact that chloramphenicol may displace these drugs from their bound state or prevent their binding to the 50S subunit of bacterial ribosomes.

The concomitant use with drugs that inhibit hematopoiesis (sulfonamides, cytostatics), which affect metabolism in the liver, with radiation therapy increases the risk of side effects.

The simultaneous use of ethanol may cause a disulfiram-like reaction.

When administered with oral hypoglycemic agents, an increase in their effect has been noted (due to the suppression of metabolism in the liver and an increase in their plasma concentrations).

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special Instructions

The simultaneous use of ethanol may cause disulfiram-like reactions (skin hyperemia, tachycardia, nausea, vomiting, reflex cough, seizures).

The peripheral blood count must be monitored systematically during treatment.

Influence on driving and operating machinery

At the time of treatment, caution must be exercised while driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Cautious

Patients who have previously received cytostatic drugs or radiation therapy.

Side effects

Gastrointestinal tract disorders:dyspepsia, nausea, vomiting (possibility of development is reduced when taken 1 hour after a meal), diarrhea, irritation of the mucous membrane of the mouth and throat, dermatitis, dysbacteriosis (suppression of normal microflora).

Blood and lymphatic system disorders:reticulocytopenia, leukopenia, granulocytopenia, thrombocytopenia, erythrocytopenia, aplastic anemia, agranulocytosis.

Nervous system disorders: psychomotor disorders, depression, confusion, peripheral neuritis, visual and auditory hallucinations, headache.

Immune system disorders:skin rash, angioedema.

Visual organ disorders: optic neuritis, decreased visual acuity.

Hearing organ and labyrinth disorders: decreased hearing.

Infectious and parasitic diseases: secondary fungal infection.

Overdose

Symptoms: suppression of medullary hematopoiesis, gastrointestinal disorders, liver and kidney damage, neuropathy (including optic nerve) and retinopathy.

Treatment:hemosorption, symptomatic therapy.

Pregnancy use

Similarities