Levomycetin-LekT - 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, pathogens of purulent, intestinal infections, meningococcal infection: Escherichia coli ,.Shigella dysenteria, Shigella flexneri spp., Shigella boydii spp., Shigella sonnei, Salmonella spp. (including Salmonella typhi, Salmonella paratyphi), Staphylococcus spp, Streptocjccus spp. (including Streptocjccus pneumonia), Neisseria meningitides, Neisseria gonorrhoeae, a number of strains of Proteus spp., Burkholderia pseudomallei, Rickettsia spp., Treponema spp., Leptospira spp, Chlamydia spp. (including Chlamydia trachomatis), Coxiella burnetii, Ehrlicha canis, Bacteroides fragilis, Klebsiella pneumonia, Haemophilus influenza.

He acts; on acid-fast bacteria (incl. Mycobacterium tuberculosis), anaerobes, methicilin-resistant strains of staphylococci, Acinetobacter, Enterobacter, Serratia marcescent, indole-positive strains of Proteus spp., Pseudomonas aeruginosa spp., protozoa and fungi.

Stability of microorganisms develops slowly.

Pharmacokinetics:Absorption - 90 % (fast and almost complete). Bioavailability - 80% after oral administration and 70% after intravenous administration. The connection with plasma proteins is 50-60%, in preterm infants - 32%. TC max after oral administration - 1-3 hours, after intravenous administration - 1-1.5 hours. Distribution volume 0.6-1 l / kg. The therapeutic concentration in the blood is maintained for 4-5 hours after administration, when used in tablets with prolonged action - for 12 hours.

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. From max to CSF is determined 4-5 hours after a single oral intake and can reach 21-50% of C max in plasma and 45-89% in the presence of inflammation of the meninges in the absence of inflammation of the meninges. Passes through the placental barrier, the concentrations 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.

Listed in for 24 hours kidneys - 90% (by glomerular filtration - 5-10% in unchanged form, through 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. The half-life in children from 3 to 16 years is 3-6.5 hours. It is weakly excreted during hemodialysis.

Indications:

Urinary and biliary tract infections caused by sensitive microorganisms. Diseases caused by sensitive microorganisms, incl. typhoid fever, bacterial meningitis, brain abscess, generalized forms of salmonella, rickettsiosis: Ku fever, spotted fever of the Rocky Mountains, typhus; intra-abdominal infections, infections of the pelvic organs, gas gangrene. With all of the listed infections chloramphenicol is considered as a drug of the II series.

Contraindications:

Hypersensitivity to chloramphenicol or 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, lactation, 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 in pregnancy and during breastfeeding.

Dosing and Administration:

In / m, in / in or inside (30 minutes before meals, and with the development of nausea and vomiting 1 hour after eating), tablets and capsules 3-4 times a day.

Single dose for adults 250 - 500 mg, daily - 2000 mg. With severe forms of infections in a hospital, it is possible to increase the dose to 3000-4000 mg / day.

If it is not possible to use inward (persistent vomiting), prescribe rectally, 4 times a day in a dose exceeding 1.5 times the dose shown to the patient for oral administration.

Children are prescribed controlled concentrations of the drug in the blood serum, depending on the age: children over 3 years old - 12.5 mg / kg (base) every 6 hours or 25 mg / kg (base) every 12 hours, with severe infections (bacteremia, meningitis) - up to 75-100 mg / kg (base) / day.

The average duration of treatment is 8-10 days.

Side effects:On the part of the digestive system: dyspepsia, nausea, vomiting (the likelihood of development decreases with admission after 1 hour after eating), diarrhea, irritation of the oral mucosa and throat, dermatitis (for rectal administration), dysbacteriosis (suppression of normal microflora).

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

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

Allergic reactions: skin rash, angioedema.

Other: secondary fungal infection.

Overdose:

Symptoms: oppression of bone marrow hematopoiesis, gastrointestinal disorders, liver and kidney damage, neuropathy (including the optic nerve) and retinopathy;

Treatment: hemosorption, symptomatic therapy.

Interaction:

Suppresses the enzymatic system of cytochrome P450,therefore, with simultaneous use with phenobarbital, phenytoin, indirect anticoagulants, there is a weakening of the metabolism of these drugs, slowing down and increasing their concentration in 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 SOS subunit of bacterial ribosomes. Simultaneous appointment with drugs that oppress hemopoiesis (sulfonamides, cytostatics), affecting liver metabolism, with radiotherapy, increases the risk of side effects. In the appointment with oral hypoglycemic drugs, their effect is noted (due to the suppression of metabolism, in the liver and increase in their concentration in the plasma).

Myelotoxic drugs increase the manifestation of the drug's genotoxicity.

Special instructions:

With the simultaneous use of alcohol may develop disulfiramovoy reaction (hyperemia - skin, tachycardia, nausea, vomiting, reflex cough, convulsions

During the treatment, systematic monitoring of the peripheral blood pattern is necessary.

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

During the treatment period, care must be taken when administering vehicles and employment by other potentially dangerous kinds of activity demanding the raised concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets 500 mg.

Packaging:

For 10 tablets in a contour non-jawed package, according to10 tablets in a planar cell package. 2, 3, 5 contour mesh or contour non-jawed packages together with the instruction for use are placed in a bundle. It is allowed to place contour non-cellular packages directly in a group package with a corresponding number of instructions for use.

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 expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001070

Date of registration:27.10.2011

Expiration Date:Unlimited

The owner of the registration certificate:Tyumen Chemical - Pharmaceutical Plant, OJSC Tyumen Chemical - Pharmaceutical Plant, OJSC Russia

Manufacturer: & nbsp

Tyumen Chemical - Pharmaceutical Plant, OJSC Russia

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Levomycetin-LekT (Levomycetin-LekT)