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

Pharmacodynamics:It is active against gram-positive and gram-negative bacteria: Escherichia coli, Shigella dysenteria, Shigella flexneri spp., Shigella boydii spp., Shigella sonnei, Salmonella spp (incl. Salmonella typhi, Salmonella paratyphy), 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.

Pharmacokinetics:

When ingested quickly absorbed. Absorption - 90% (fast and almost complete). Bioavailability after oral administration - 80%. The connection with plasma proteins is 50-60%.

Time to reach the maximum concentration (Tc_max) after oral administration -1-3 hours.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 of it are created in the liver and kidneys. In bile, up to 30% of the administered dose is detected.

The maximum concentration (C_mOh) in the cerebrospinal fluid (CSF) is determined 4-5 hours after a single injection inwards and can reach 21-50% of C in the absence of inflammation of the meninges_max in the plasma 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 % from 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, of which 5-10% unchanged, 80 % - by tubular secretion in the form of inactive metabolites. Through the intestine, 1-3% is excreted.

Half-life (T_1/2) in adults - 1,5 - 3,5 h, with a violation of the kidneys - 3-11 h. T_1/2 in children from 1 month to 16 years - 3-6.5 hours. It is weakly excreted during hemodialysis.

Indications:

Infectious-inflammatory diseases caused by sensitive microorganisms, including.urinary tract infection, bile duct infection.

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

Carefully:

Assign chloramphenicol 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. Dosing regimen is individual.

Single dose for adults - 250 - 500 mg; daily - 2000 mg. With severe forms of infections, in hospital conditions, an increase in the dose to 3000-4000 mg / day (under strict control of blood and liver and kidney function) is possible. The daily dose is divided into 3-4 doses.

Children older than 3 years and / or body weight of more than 20 kg prescribed - 25 mg / kg (base) every 12 hours, with severe infections - up to 75-100 mg / kg (basis) / day.

The average duration of treatment is 8-10 days.

Side effects:

From the gastrointestinal tract: 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; 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:

Symptoms: nausea, vomiting, increased other side effects.

Treatment: hemosorption, symptomatic treatment.

Interaction:

Suppresses the enzymatic system of cytochrome P450. With simultaneous use with phenobarbital, phenytoin, indirect anticoagulants, there is a weakening of metaboliteslysis of these drugs, delay in excretion and increase in their concentration in plasma.

Reduces the antibacterial effect of penicillins and cephalosporins.

With erythromycin, clindamycin, lincomycin - mutual weakening of action 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. With sulfonamides, cytostatics, drugs that depress hemopoiesis and affect metabolism in the liver, with radiation therapy, the risk of side effects increases.

With oral hypoglycemic drugs, there is an increase in their effect (due to the suppression of metabolism in the liver).

Special instructions:

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 peripheral blood parameters is necessary.

Form release / dosage:The tablets covered with a cover, on 500 mg.

Packaging:

10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil or packaging material.

1, 2 contour mesh packages together with instructions for use in a cardboard box. For 200, 300, 400 or 500 packs with contour mesh packaging in a group box of cardboard.

400, 500, 600, 800 or 1000 contour mesh packages together with instructions for use in group packaging from cardboard (for inpatient).

Storage conditions:In dry, sheltered from light place at a temperature not higher 25 ° C. Keep out of the reach of children's place.

Shelf life:5 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-003069/07

Date of registration:09.10.2007

Expiration Date:Unlimited

The owner of the registration certificate: Mapichem AG Mapichem AG Switzerland

Manufacturer: & nbsp

MAPICHEM, AG Switzerland

Representation: & nbspMapichem AGMapichem AG

Information update date: & nbsp07.03.2018

Illustrated instructions

Instructions

Levomycetin (Levomycetin)