Levomycetin - instructions for use, dose, side effects, contraindications

A bacteriostatic broad-spectrum antibiotic disrupts the process of protein synthesis in a microbial cell at the stage of transfer of t-RNA amino acids to ribosomes. Effective against strains of bacteria resistant to penicillin, tetracyclines, sulfonamides.

It is active against many Gram-positive and Gram-negative bacteria: Escherichia, coli, Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella spp. (incl.Salmonella typhi, Salmonella paratyphi), Staphylococcus spp., Streptococcus spp. (including Streptococcus pneumoniae), Neisseria meningitidis, Neisseria gonorrhoeae, a number of 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.

He acts on acid-fast bacteria (incl. Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter spp., Enterobacter spp., Serratia marcescens, andpositive strains Proteus spp., Pseudomonas aeruginosa spp., protozoa and fungi.

Stability of microorganisms develops slowly.

Pharmacokinetics:

Absorption - 90% (fast and almost complete). Bioavailability - 80%. The connection with plasma proteins is 50-60%, in preterm infants - 32%. The time of concentration of maximum concentration after administration is 1-3 hours. The volume of distribution is 0.6-1 l / kg. The therapeutic concentration in the blood is maintained for 4-5 hours after administration. It penetrates well into body fluids and tissues. Its greatest concentrations are created in the liver and kidneys. In bile, up to 30% of the administered dose is detected. The maximum concentration in the cerebrospinal fluid is determined 4-5 hours after a single injection inside and can reach 21-50% of the maximum plasma concentration 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 fetal blood serum can be 30-80% of that in the mother's blood. Penetrates into breast milk.

The majority (90%) is metabolized in the liver.In the intestines, under the influence of intestinal bacteria, it hydrolyses with the formation of inactive metabolites.

It is excreted within 24 hours by kidneys - 90% (by glomerular filtration - 5-10% in unchanged, by tubular secretion in the form of inactive metabolites - 80 %), through the intestine - 1-3%. The half-life in adults is 1.5-3.5 hours, with renal dysfunction 3-11 hours. Half-life in children from 3 up to 16 years - 3-6.5 hours. Poorly inferred during hemodialysis.

Indications:Urinary and biliary tract infections caused by sensitive microorganisms.

Contraindications:

Hypersensitivity to chloramphenicol and other components of the drug, oppression of bone marrow hematopoiesis, acute intermittent porphyria, deficiency of glucose-6-phosphate dehydrogenase, hepatic and / or renal failure, pregnancy, breastfeeding period, children under 3 years of age and body weight less than 20 kg .

Carefully:

Patients who received previous treatment with cytostatic drugs or radiation therapy.

Pregnancy and lactation:The drug is contraindicated during pregnancy and during breastfeeding.

Dosing and Administration:

Inside (30 minutes before meals, and with the development of nausea and vomiting - 1 hour after eating) 3-4 times a day. Single dose for adults-0.25-0.5 g, daily-2 g.

Children from 3 years of age are prescribed controlled concentrations of the drug in the blood serum at 12.5 mg / kg (base) every 6 hours or 25 mg / kg (base) every 12 hours. The average duration of treatment is 8-10 days.

Side effects:

From the digestive system: dyspepsia, nausea, vomiting (the probability of development decreases when taking 1 hour after eating), diarrhea, irritation of the mucous membrane of the mouth and throat, dermatitis, dysbiosis (suppression of normal microflora).

On the part of the organs of hematopoiesis: reticulocytopenia, leukopenia, granulocytopenia, thrombocytopenia, erythrocytopenia; aplastic anemia, agranulocytosis.

From the nervous system: psychomotor disorders, depression, confusion, peripheral neuritis, optic neuritis, visual and auditory hallucinations, decreased visual acuity and hearing, headache.

Allergic reactions: skin rash, angioedema.

Other: secondary fungal infection.

Overdose:

Symptoms: psychomotor disorders, confusion, visual and auditory hallucinations, decreased hearing and visual acuity.

Treatment: hemosorption, symptomatic therapy.

Interaction:

Suppresses the enzymatic system of cytochrome P 450, so when used simultaneouslywith phenobarbital, phenytoin, indirect anticoagulants, there is a weakening of the metabolism of these drugs, a slowing down of the excretion and an increase in their concentration in the plasma. Reduces the antibacterial effect of penicillins and cephalosporins. With simultaneous use with erythromycin, clindamycin, lincomycin, there is a mutual weakening of the effect due to the fact that chloramphenicol can displace these drugs from the bound state or prevent their binding to the 50 S subunit of bacterial ribosomes. Simultaneous prescribing with drugs that oppress hemopoiesis (sulfonamides, cytostatics) that affect liver metabolism with radiation therapy increases the risk of side effects. When administered with oral hypoglycemic drugs, their effect is noted (by suppressing metabolism in the liver and increasing their concentration in the plasma).

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

Treatment with the drug should be carried out under the control of the blood picture and the functional state of the liver and kidneys of the patient. With oppression of hematopoiesis, the abolition of the drug is mandatory.

With the simultaneous administration of ethanol, a disulfiram-like reaction may develop (facial hyperemia, stomach and stomach spasms, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).

Effect on the ability to drive transp. cf. and fur:

During the treatment period, it is necessary to refrain from driving vehicles and other potentially hazardous activities requiring increasedconcentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 500 mg.

Packaging:

For 10 tablets in cans of orange glass, in polymer cans, in contoured cell packaging from polyvinylchloride film and foil of aluminum printed lacquered or paper with polyethylene coating, in contour non-cellular package made of paper with polyethylene coating.

1 bank or 1, 2 contour mesh packages with instructions for use are placed in a cardboard pack.

For 100 contour non-jammed packages with an equal number of instructions for use are placed in a group package - a box of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:5 years. Do not use after the expiry date printed on the package

Terms of leave from pharmacies:On prescription

Registration number:LS-002212

Date of registration:03.10.2011

Expiration Date:Unlimited

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp11.03.2018

Illustrated instructions

Instructions

Levomycetin (Levomycetin)