Description
Pharmacological action
Pharmacodynamics Bacteriostatic broad-spectrum antibiotic disrupts the process of protein synthesis in a microbial cell at the stage of transfer of amino acids by transport ribonucleic acids (t-RNAs) to ribosomes. Effective against strains of bacteria resistant to penicillin, 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, Klebsiella pneumoniae, Haemophilus influenzae. Does not affect acid-resistant bacteria (including Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter spp., Enterobacter spp., Serratia marcescens, indole-positive strains of Proteus spp., Pseudomonas aerugosa simple. The resistance of microorganisms develops slowly. Pharmacokinetics Absorption – 90% (fast and almost complete). After oral administration, bioavailability is 80%. Communication with plasma proteins – 50-60%. The time to reach maximum concentration after oral administration (TCmax) is 1-3 hours. Distribution volume is 0.6-1 l / kg. The therapeutic concentration in the blood persists for 4-5 hours after administration. It penetrates well into body fluids and tissues. Its highest concentrations are created in the liver and kidneys. In bile, up to 30% of the dose taken is detected. The maximum concentration (Cmax) in the cerebrospinal fluid (CSF) is determined 4-5 hours after a single ingestion and can reach 21-50% of plasma Cmax in the absence of inflammation of the meninges and 45-89% in the presence of inflammation of the meninges. Passes through the placental barrier, the concentration in the blood serum of the fetus can be 30-80% of that in the blood of the mother. Penetrates into breast milk. The main amount (90%) is metabolized in the liver. In the intestine, under the influence of intestinal bacteria, it hydrolyzes with the formation of inactive metabolites. It is excreted within 24 hours by the kidneys – 90% (by glomerular filtration – 5-10% unchanged, by tubular secretion in the form of inactive metabolites – 80%), by the intestines – 1-3%. The half-life (T ) In adults is 1.5-3.5 hours, in case of impaired renal function – 3-11 hours. It is poorly excreted during hemodialysis.
Indications
Urinary and biliary tract infections caused by susceptible microorganisms.
Contraindications
Hypersensitivity, inhibition of bone marrow hematopoiesis, acute intermittent porphyria, deficiency of glucose-6-phosphate dehydrogenase, hepatic and / or renal failure, pregnancy, lactation, children’s age.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Special instructions
Severe complications of the hematopoietic system are usually associated with the use of high doses of Levomycetin (more than 4 g / day) for a long time. In the process of treatment, systematic monitoring of the peripheral blood picture is necessary. With the simultaneous intake of ethanol, a disulfiram-like reaction is possible (hyperemia of the skin, tachycardia, nausea, vomiting, reflex cough, convulsions).
Composition
Active ingredient: levomycithin 500 mg
Excipients: potato starch, povidone (low molecular weight polyvinylpyrrolidone medical 12600 ± 2700), calcium stearate, talc, crospovidone (CL-M-Collidone).
Dosage and administration of
Inside (30 minutes before meals, and with the development of nausea and vomiting – 1 hour after eating) 3-4 times a day. A single dose for adults – 250-500 mg, daily – 2 g. In severe infections (in a hospital), it is possible to increase the dose to 3-4 g / day (under the control of the blood condition, kidney and liver function). The average duration of treatment is 8-10 days.
Side effects of the digestive system: dyspepsia, nausea, vomiting (the likelihood of developing when taken within 1 hour after eating), diarrhea, irritation of the mucous membrane of the oral cavity and pharynx, dermatitis, dysbiosis (suppression of normal microflora). From the hemopoietic organs: reticulocytopenia, leukopenia, granulocytopenia, thrombocytopenia, erythrocytopenia rarely – aplastic anemia, agranulocytosis. From the nervous system: psychomotor disorders, depression, confusion, peripheral neuritis, optic neuritis, visual and auditory hallucinations, decreased visual and hearing acuity, headache. Allergic reactions: skin rash, angioedema. Other: secondary fungal infection.
Drug interaction
Inhibits microsomal liver enzymes, therefore, when used together with phenobarbital, phenytoin, indirect anticoagulants, weakening of the metabolism of these drugs (drugs), a slowdown in excretion, and an increase in their concentration in plasma are noted. Reduces the antibacterial effect of penicillins and cephalosporins. With simultaneous use with erythromycin, clindamycin, lincomycin, a mutual weakening of action is noted 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. Simultaneous administration with drugs that inhibit hematopoiesis (sulfonamides, cytostatics), affecting the metabolism in the liver, with radiation therapy increases the risk of side effects. When prescribed with oral hypoglycemic drugs, an increase in their action is noted (due to the suppression of metabolism in the liver and an increase in their concentration in plasma). Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.
Overdose of
Symptoms: inhibition of bone marrow hematopoiesis, gastrointestinal disturbances, damage to the liver and kidneys, neuropathy (including optic nerve) and retinopathy. Treatment: symptomatic therapy, hemosorption.
Storage conditions
List B. In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
Term hodnosty
5 years
Active ee substances chloramphenicol
Form of Treatment
tablets
Appointment
Children over 3 years old, Prescribing children, Adult prescribers
Indications of
From intestinal infections, From infections of the biliary tract, From infections of the urinary tract
Possible product names
Levomycetin tablets 500 mg, 20 pcs.
