Active substanceChloramphenicolChloramphenicol
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  • Dosage form: & nbsppills
    Composition:

    for 1 tablet:

    Active substance: Chloramphenicol (Levomycetin) in terms of 100% substance - 0.5 g.

    Excipients: potato starch - 0,0349 g, povidone (low molecular weight polyvinylpyrrolidone (12600 ± 2700) - 0.0096 g, calcium stearate - 0.0055 g.

    Description:Tablets white or white with a yellowish tinge colors, plane-cylindrical shape with a risk on one side and a facet.
    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 (protein synthesis in a microbial cell at the stage of amino acid transfer by transport ribonucleic acids to the ribosomes.) Effective against strains of bacteria resistant to penicillin, tetracyclines, sulfonamides.

    It is active against the following microorganisms: Escherichia coli, Shigella dysenteriae, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella spp. (incl.Salmonella typhi, Salmonella paratyphi). Staphylococcus spp., Streptococcus spp. (Including Streptococcus pneumoniae), Neisseria meningitidis, Neisseria gonorrhoeae, a number of strains of Proteus spp., Burkholderia pseudomallei, Rickettsia spp., Treponema spp., Leptospira spp., Chlamidia spp., (Including Chlamydia trachomatis) , Coxiella burnetii, Ehrlichia canis, Klebsiella pneumoniae, Haemophilus influenzae.

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

    Stability of microorganisms develops slowly.

    Pharmacokinetics:

    When ingested quickly absorbed. Absorption - 90% (fast and almost complete).

    Bioavailability - 80%. The connection with plasma proteins is 50-60%. The time to reach the maximum concentration is 1-3 hours. The therapeutic concentration in the blood is preserved 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 cerebrospinal fluid is determined after 4-5 p after a single dose and can reach in the absence of inflammation of the meninges 21-50% of the maximum plasma concentration and 45-89% - in the presence of an 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 for 24 hours by kidneys: 90% by glomerular filtration, of which 5-10% in unchanged form, 80% by tubular secretion in the form of inactive metabolites, 1-3% through the intestine. The half-life in adults is 1.5-3.5 hours, with renal dysfunction 3-11 hours. It is weakly excreted during hemodialysis.

    Indications:

    Infections urinary tract and bile ducts caused by chloramphenicol-sensitive microorganisms.

    Contraindications:

    Hypersensitivity to the drug, oppression of bone marrow hematopoiesis, acute intermittent porphyria, deficiency of glucose-6-phosphate dehydrogenase, hepatic and / or renal insufficiency. Childhood.

    Carefully:

    Assign to patients who received previous treatment with cytostatic drugs or radiation therapy.

    Pregnancy and lactation:

    The use of the drug is contraindicated.

    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.

    A single dose for adults - 0.25-0.5 grams, daily - 2 g. In severe forms of infections in hospital conditions, an increase in the dose to 3-4 g / day (under the control of blood, kidney and liver function) is possible.

    The average duration 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: nausea, vomiting, increased dose-dependent side effects.

    Treatment: hemosorption, symptomatic therapy.

    Interaction:

    Inhibits microsomal enzymes of the liver, therefore, while using with phenobarbital, phenytoin, indirect anticoagulants, there is a weakening of the metabolism of these drugs, slowing the excretion and increasing their concentration in the 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 interfere with their binding to the 50S subunit of bacterial ribosomes.

    Simultaneous use with drugs that depress hemopoiesis (sulfonamides, cytostatics), affecting metabolism, with radiation therapy increases the risk of side effects.

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

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    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.

    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 treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Tablets 500 mg.
    Packaging:

    10 tablets into a contiguous, non-jawed package or into a contourcell package. 1, 2 or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard. Contour non-cellular packages, together with an equal number of instructions for use, are placed in a group package (for hospitals).

    Storage conditions:

    In a dry, dark place at a temperature of 5 to 30 ° C.

    Keep out of the reach of children.

    Shelf life:5 years.Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000509
    Date of registration:21.06.2010 / 18.05.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.03.2018
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