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

Excipients: povidone (kollidon 90 F) - 0.0066 g, potato starch - 0.0079 g, sodium carboxymethyl starch (primogel) - 0.0330 g, magnesium stearate - 0.0025 g.

Description:

Tablets white or white with a weak yellowish hue of color, flat-cylindrical shape with a facet and a risk.

Pharmacotherapeutic group:Antibiotic

ATX: & nbsp

D.06.A.X.02 Chloramphenicol

S.01.A.A.01 Chloramphenicol

J.01.B.A.01 Chloramphenicol

Pharmacodynamics:

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. (incl. Streptococcus pneumoniae), Neisseria meningitidis.Neisseria gonorrhoeae, a number of strains Proteus spp., Burkholderia pseudomallei, Rickettsia spp. Treponema spp., Leptospira spp., Chlamydia spp. (incl. Chlamydia trachomatis), Coxiella burnetii, Ehrlichia cards, Klebsiella pneumoniae, Haemophilus influenzae.

Does not affect acid-fast bacteria (incl. Mycobacterium tuberculosis), anaerobes, methicillin-resistant strains of staphylococci, Acinetobacter spp., Enterobacter spp., Serratia marcescens, indol-positive 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%. The time to reach the maximum concentration after oral administration is 1-3 hours. The volume of distribution is 0.6-1.0 l / kg. The therapeutic concentration in the blood persists for 4-5 hours after admission.

It penetrates well into body fluids and tissues. The 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, concentrations in the fetal blood serum can be 30-80% of the concentration in the mother's blood. Penetrates into breast milk. The majority (90%) is metabolized in the liver.In the intestines, under the action 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% 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. The half-life of children under 16 years is 3-6.5 hours. It is poorly excreted during hemodialysis.

Indications:

Urinary and biliary tract infections caused by sensitive microorganisms.

Contraindications:Hypersensitivity to chloramphenicol, other components of the drug, oppression of bone marrow hematopoiesis, acute intermittent porphyria, deficiency of glucose-6-phosphate dehydrogenase, hepatic and / or renal failure, skin diseases (psoriasis, eczema, fungal lesions), pregnancy, lactation, children under 3 years and with a body weight of less than 20 kg.

Carefully:

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

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 / day.In severe forms of infections, in hospital conditions, an increase in the dose to 3-4 g / day is possible.

Children over 3 years of age and a body weight of more than 20 kg are prescribed controlled concentrations of the drug in the blood serum, depending on age: 12.5 mg / kg (base) every 6 hours or 25 mg / kg (base) every 12 hours .

The average duration of the course 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 visual acuity and hearing.

Treatment: symptomatic therapy, hemosorption.

Interaction:

Simultaneous administration with drugs that oppress hemopoiesis (sulfonamides, cytostatics) that affect liver metabolism with radiation therapy increases the risk of side effects.

With the simultaneous administration of ethanol, the development of a disulfiramic reaction is possible.

When administered with oral hypoglycemic drugs, their effect is noted (by suppressing the metabolism in the liver and increasing their concentration in the plasma).

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 interfere with their binding to the subunit 50S bacterial ribosomes.

Reduces the antibacterial effect of penicillins and cephalosporins.

Chloramphenicol suppresses the enzymatic system of cytochrome P450, so when used simultaneously with phenobarbital, phenytoin,indirect anticoagulants marked by a weakening of the metabolism of these drugs, slowing the excretion and increasing their concentration in the plasma.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

Due to the high toxicity, it is not recommended without resorting to banal infections, colds, flu, pharyngitis, bacteriocarriers for treatment and prevention. Severe complications from the hematopoietic system, as a rule, are associated with the use of large doses (more than 4 g / day) for a long time.

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

With the simultaneous administration of ethanol, the development of a disulfiram reaction (hyperemia of the skin, tachycardia, nausea, vomiting, reflex cough, convulsions) is possible.

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

During the period of drug treatment, special care must be taken when driving vehicles and occupation other potentially hazardous activities. requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 500 mg.

Packaging:

For 10 tablets in a contiguous cell-free or contiguous cell package.

1, 2 contoured cell packs together with instructions for use are placed in a pack of cardboard.

Contour non-cellular or contiguous cell packs, together with an equal number of instructions for use, should be placed directly in the group package.

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-002613

Date of registration:30.12.2011

Expiration Date:Unlimited

The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia

Manufacturer: & nbsp

TATHIMFARMPREPARATY, JSC Russia

Information update date: & nbsp11.03.2018

Illustrated instructions

Instructions

Levomycetin (Levomycetin)