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

Excipients: potato starch - 0.01700 g or 0.03400 g, povidone (low molecular weight medical polyvinylpyrrolidone 12600 ± 2700) 0.00525 g or 0.01050 g, stearic acid 0.00275 g or 0.00550 g.

Description:Tablets white or white with a weak yellowish hue of a color of 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:

Bacteriostatic antibiotic of a wide spectrum of action, disrupts the process of protein synthesis in a microbial cell. It is effective against strains of bacteria that are resistant to penicillin, tetracycline, sulfonamides. It is active against many Gram-positive and Gram-negative bacteria: Escherichia coli. Shigella dysenteria, Shigella flexneri spp .. Shigella boydii spp., Shigella sonnei spp .. 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 canis, Bacteroides fragilis, Klebsiella pneumoniae, Haemophilus influenzae. He acts on acid-fast bacteria (incl. Mycobacterium tuberculosis). Pseudomonas aeruginosa spp., Clostridium spp. methicillin-resistant strains Staphylococcus spp., Acinetobacter spp., Enterobacter spp., Serratia marcescens, indol-positive strains Proteus 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. Therapeutic concentration at blood is retained 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 inwards and can reach 21-50% of the maximum concentration in uninflated meninges at plasma and 45-89% at inflamed meninges. Goes throughplacental barrier, concentrations in 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 for 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 period in children - from 1 month to 16 years - 3-6.5 hours. It is slightly subjected to hemodialysis.

Indications:Infectious-inflammatory diseases caused by sensitive microorganisms, urinary tract infections, bile duct infections.

Contraindications:

Individual hypersensitivity to the components of the drug, oppression of bone marrow hematopoiesis, acute intermittent porphyria, skin diseases (psoriasis, eczema, fungal lesions), pregnancy and lactation period, children under 3 years of age and / or body weight less than 20 kg, liver and / or kidney, a deficiency of glucose-6-phosphate dehydrogenase.

Carefully:

With caution appoint chloramphenicol patients who received previous treatment with cytostatic drugs or radiation therapy.

Dosing and Administration:

Inside 30 minutes before meals.

Adults - 250-500 mg 3-4 times a day. The daily dose is 2000 mg. In case of severe forms of infections in a hospital, it is possible to increase the dose to 3000-4000 mg / day (the maximum daily dose for adults, under strict control of blood and liver and kidney function).

Children with 3 years and / or body weight more than 20 kg - 25 mg / kg every 12 hours. In severe infection, up to 75 mg / kg / day. Average duration of treatment -8-10 days.

Side effects:

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

On the part of the organs of hematopoiesis: 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 acuity and hearing, headache.

Allergic reactions: skin rash, angioedema.

Other: secondary fungal infection.

Overdose:

There are no data on overdose in adults.

Interaction:

With simultaneous use with phenobarbital, phenytoin. indirect anticoagulants there is a weakening of the metabolism of these drugs, slowing down the excretion and increasing their concentration in the plasma (suppresses the enzymatic system of cytochrome R₄₅₀).

With simultaneous use with drugs that inhibit bone marrow hematopoiesis, with radiation therapy, the risk of side effects increases.

With simultaneous use with erythromycin, clindamycin, lincomycin, there is a mutual weakening of action due to the fact that levomycetin can displace these drugs from the bound state or prevent their binding to the subunitof 50S bacterial ribosomes.

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

Reduces the antibacterial effect of penicillins and cephalosporins. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

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

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.

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

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

Form release / dosage:Tablets 250 mg and 500 mg.

Packaging:

For 10 tablets in contour non-cellular package of paper with polyethylene coating.

2 contour non-jawed packages of 10 tablets together with instructions for use are placed in a pack of cardboard boxes, or contour non-jammed packages with the same number of instructions for use are placed in a group package (for inpatient).

10 tablets per contour cell pack.By 1 or 2 contour mesh packages together with the instruction for use are placed in a pack of cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008191/08

Date of registration:16.10.2008 / 31.03.2017

Expiration Date:Unlimited

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

Manufacturer: & nbsp

ORGANICS, JSC Russia

Information update date: & nbsp07.03.2018

Illustrated instructions

Instructions

Levomycetin (Levomycetin)