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

Excipients: starch potato - 33.5 mg; povidone low molecular weight (polyvinylpyrrolidone low molecular weight medical) - 11 mg; calcium stearate - 5.5 mg.

Description:

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

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, pathogens of purulent infections, typhoid fever, dysentery, meningococcal infection, hemophilic bacteria, Escherichia coli, Shigella dysenteria spp., 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, a number of strains Proteus spp., Pseudomonas 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, clostridia, methicillin-resistant strains of staphylococcus, Acinetobacter, Enterobacter, 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%, in preterm infants - 32%. 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 is maintained for 4-5 hours after administration.

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 spinal fluid is determined 4-5 hours after a single injection inwards and can reach 21-50% of the maximum plasma concentration and 45-89% in case of inflamed meninges in uninflammated cerebral membranes.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% in unchanged form, 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, in newborns from 1 to 2 days - 24 hours or more ( especially in children with a low birth weight), 10-16 days -10 hours. Weakly undergoes hemodialysis.

Indications:

Urinary and bile duct infection caused by chloramphenicol-sensitive microorganisms.

Contraindications:

Hypersensitivity, 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 2 years.

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:

Inside (30 minutes before meals, and with the development of nausea and vomiting - 1 hour after meals, 3-4 times a day).

Single dose for adults - 0.25-0.5 g, daily - 2 g / day. In severe forms of infection (including typhoid fever, peritonitis), in hospital conditions, an increase in the dose to 3-4 g / day is possible.

Children are prescribed controlled serum concentrations of the drug in 12.5 mg / kg (base) every 6 hours or 25 mg / kg (base) every 12 hours, with severe infections (bekteriemia, meningitis) to 75-100 mg / kg ( basis) / day. 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 with admission after 1 hour after eating), diarrhea, irritation of the mucous membrane of the mouth and throat, dermatitis (including perianal dermatitis - for rectal administration), dysbacteriosis (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, collapse (in children under 1 year).

Overdose:

Symptoms: "gray syndrome" in premature and newborns with high doses (the cause of the development is the accumulation of chloramphenicol, due to the immaturity of liver enzymes, and its direct toxic effect on the myocardium) - bluish-gray skin color, low body temperature, irregular breathing, cardiovascular insufficiency. Mortality - up to 40%.

Treatment: hemosorption, symptomatic therapy.

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 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 chloramphenicope may dislodge these drugs of bound state or to prevent 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 with phenobarbital, phenytoin, indirect anticoagulants, there is a weakening of the metabolism of these drugs, a slowdown

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.

The fetus and newborns are not sufficiently developed to bind the liver chloramphenicol, and the drug can accumulate in toxic concentrations and lead to the development of a "gray syndrome," so children in the first months of life, the drug is prescribed only for life indications.

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, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets of 0.5 g.

Packaging:

For 10 tablets in contour cell packaging. 10 tablets per contour without packing.

1 or 2 contour mesh or non-jawed packages together with instructions for use are placed in a pack of cardboard.

Outlined Valium Valium or packaging together with an equal number of instructions for use are placed in multipacks.

Storage conditions:In the dark place at a temperature ofnot more than 25 ° C. Keep out of the reach of children.

Shelf life:

5 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001979

Date of registration:09.07.2010 / 03.12.2014

Expiration Date:Unlimited

The owner of the registration certificate:PHARMSTANDART-TOMSKHIMFARM, OJSC PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Information update date: & nbsp10.03.2018

Illustrated instructions

Instructions

Levomycetin (Levomycetin)