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One tablet with a film covering can contain 500 or 750 mg of active agent of a levofloksatsin (in the form of a gemigidrat).
MKTs, gipromeloza, krospovidon, the sodium stearylfumarating — are used as auxiliary connections. The Opadry Y17000 White covering consists of a gipromeloza, titanium dioxide (E 171) and polyethyleneglycol 400.
Tablets Lebel are packed into blisters on 7 tablets. Each blister is sealed in a cardboard pack and completed with the medical application instruction.
Antimicrobic, antibacterial wide range.
Pharmacodynamics and pharmacokinetics
Lebel 500 and 750 are synthetic drugs of group of ftorkhinolon. The mechanism of effect of active agent is based on ability to block DNK-girazu (tetramer at prokariot — topoisomerase II), and also a target of hinolon is topoisomerase IV. At the same time superspiralling and a stitching of ruptures of DNA is broken, synthesis of DNA is suppressed that leads to profound morphological changes in membranes, cytoplasm and a cell wall of bacteria.
In the researches in vitro it is established that drug is active in relation to such microorganisms (are sensitive when using minimum suppressing concentration from 2 mg/l):
Among aerobic gram-positive microorganisms:
- Corynebacterium diphtheria;
- Enterococcus spp. and faecalis;
- Staphylococcus spp., aureus and epidermidis;
- Listeria monocytogenes;
- Streptococcus of group C and G, viridians, agalactiae, pneumonia, pyogenes.
Among aerobic gram-negative microorganisms:
- Actinobacillus actinomycetemcomitans;
- Citrobacter freundii;
- Acinetobacter spp.baumannii;
- Enterobacter spp, cloacae, aerogenes and agglomerans;
- Eikenella corrodens;
- Escherichia coli;
- Haemophilus ducreyi, parainfluenzae and influenza;
- Gardnerella vaginalis;
- Klebsiella spp, oxytoca and pneumoniae;
- Helicobacter pylori;
- Neisseria gonorrhoeae, meningitidis;
- Morganella morganii;
- Pasteurella spp., canis, dagmatis and multocida;
- Providencia spp., rettgeri and stuartii;
- Proteus mirabilis and vulgaris;
- Pseudomonas spp. And aeruginosa;
- Salmonella spp.;
- Moraxella catarrhalis;
- Serratia spp. and marcescens.
Other sensitive bacteria:
- Bifidobacterium spp;
- Bacteroides fragilis, thetaiotaomicron, ovatus and vulgates;
- Legionella spp. and pneumophila;
- Chlamydia pneumoniae, psittaci, trachomatis;
- Mycobacterium spp., leprae, tuberculosis and hominis;
- And also: Fusobacterium spp., Clostridium perfringens, Propionibacterium spp., Ureaplasma urealyticum, Veilonella spp., Bartonella spp., Peptostreptococcus spp., Rickettsia spp, Mycoplasma pneumonia.
- Absorption process: at oral administration levofloxacin quickly enough and practically all is soaked up from a gastrointestinal tract and the food almost does not influence absorption (bioavailability of 100%), achievement of peak concentration requires 60 min.
- Distribution: about 30-40% of a dose of a levofloksatsin contact blood serum proteins. Drug is capable to get well into bodies and body tissues, the insignificant cumulative effect is observed only when using 1000 mg a day.
- Metabolism: limited, in a liver by oxidation and/or a dezatsetilirovaniye. To 5% of the accepted dose it will be transformed to metabolites: desmetil-and N-oxide.
- Removal: occurs mainly kidneys (more than 85% of a dose) on the way of glomerular filtering together with canalicular secretion (at this T1/2 for a levofloksatsin – about 6-8 hours), 4% are removed by intestines in 72 hours.
Indications to use
Drug is effective at such infectious and inflammatory diseases which are caused by microorganisms sensitive to a levofloksatsin:
- at infectious diseases of lower parts of respiratory tracts, including pneumonia and an exacerbation of bronchitis;
- at infections of urinary tract and kidneys, for example, acute pyelonephritis;
- at acute bacterial sinusitis;
- at skin infections and defeats of soft tissues, for example, abscess, furuncles, nagnoivshiyesya atheromas;
- at chronic prostatitis of a bacterial etiology;
- at an intraabdominal infection (as a part of a combination therapy with the antibacterial drugs influencing anaerobic microflora);
- at tuberculosis (as a part of a combination therapy).
- existence in the anamnesis of damages of the sinews caused by therapy of a hinolonama;
- children's and teenage group (18 is younger), pregnant women and the feeding patients;
- hyper sensitivity to active ingredient to a levofloksatsin and ftorkhinolona, and also to other components of Lebel.
With caution it is recommended to take
- at deficit glyukozo-6-fosfatdegidrogenazy;
- to elderly patients in connection with high probability of depression of function of an urinary system.
Some undesirable side reactions from the following systems of a human body were registered:
- Nervous system: dizziness and weakness, a headache, drowsiness, sleeplessness, can arise concern, confusion of consciousness, a tremor, paresthesia, sensation of fear, hallucinations, a depression; disturbances of sense of smell, sight, hearing, flavoring and tactile sensitivity; motive frustration, and also spasms (in particular: at patients with damages of a brain and at the persons who endured a stroke).
- Cardiovascular system: clinically significant lowering of the ABP, tachycardia, a ciliary arrhythmia, a vascular collapse, lengthening on QT interval ECG.
- Alimentary system: diarrhea, nausea, vomiting and other disturbances of digestion, abdominal pain, loss of appetite, superactivity of transaminases of a liver, development of pseudomembranous colitis, hyperbilirubinemia, hepatitis, dysbacteriosis.
- Musculoskeletal system: an arthralgia, a mialgiya, rabdomioliz, the tendinitis, muscular weakness, is possible a rupture of sinews.
- Urinary system: intersticial nephrite, giperkreatininemiya, acute insufficiency of function of kidneys.
- System of a hemopoiesis: agranulocytosis, eosinophilia, leukopenia, neutropenia, hemolitic anemia, hemorrhages, thrombocytopenia, pancytopenia.
- Immune system: itch, hyperemia of integuments, hypostases, urticaria, malignant form of an exudative erythema, Lyell's disease, vasculitis, acute anaphylaxis, bronchospasm, allergic pneumonitis.
- Others: hypoglycemia, photosensitization, porphyria aggravation, fever, superinfection.
Lebel, application instruction (Way and dosage)
Take a pill inside before meal or in breaks between them. It is not necessary to chew! It is recommended to wash down with enough clear water.
The scheme of treatment and dosage at various diseases
- at hospital pneumonia the daily dose makes 750 mg, duration of therapy of 7-14 days;
- at community-acquired pneumonia the daily dose makes on 500 mg 1 or 2 times, therapy duration also 7-14 days;
- at an exacerbation of chronic bronchitis a daily dose – 500 mg within 1 week;
- at acute bacterial sinusitis there are two options of therapy: the first – on 500 mg every day for 10-14 days, the second — on 7500 mg every day for 5 days;
- at uncomplicated infections of urinary tract a daily dose – 250 mg within 3 days;
- at the complicated infections of urinary tract, including acute pyelonephritis the scheme of treatment differs depending on the activator: if Enterococcus cloacae, Enterococcus faecalis, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli is caused, appoint a one-time dose of 250 mg if Escherichia coli, Proteus mirabilis Klebsiella pneumoniae, Escherichia coli with the accompanying bacteremia is a cause of illness, it is recommended to accept a one-time dose in the amount of 750 mg;
- at uncomplicated infections of epidermis and hypodermic fabrics – on 500 mg of 7-10 days;
- at the complicated infections of epidermis and hypodermic fabrics – on 7500 mg of 10-14 days;
- at chronic bacterial prostatitis it is necessary to accept on 500 mg within 28 days;
- at intraabdominal infections (as a part of a combination therapy with the antibacterial drugs influencing anaerobic microorganisms) — on 500 mg for 7-14 days;
- at tuberculosis appoint 500 mg 1 or 2 times per day to an extent of 3 months, therapy addition with drug resistant forms is possible.
If you have a clearance of creatinine less than 49 ml a minute, then it is necessary to see a doctor behind correction of a dosage.
Dizziness, nausea, erosive defeat mucous a gastrointestinal tract, confusion of consciousness, are possible spasms, and on an ECG lengthening of QT is observed.
Effective is a symptomatic treatment and a gastric lavage.
- The concomitant use of a levofloksatsin with Cyclosporine leads to lengthening of an elimination half-life of the last whereas Cimetidinum due to blocking of canalicular secretion slows down removal of a levofloksatsin.
- Action of a levofloksatsin is suppressed with the medicines oppressing motility of intestines, and also sukralfaty, aluminum - and magniysoderzhashchy antiacid means and iron preparations (therefore it is necessary to maintain an interval not less than 2 hours).
- Simultaneous therapy of NPVP, Theophylline and Lebel increases risk of spasms (at patients with predisposition) whereas GKS increase probability of a rupture of sinews.
- Lebel with hypoglycemic drugs causes change of concentration of glucose in a blood-groove and therefore there can be a hyperglycemia or a hypoglycemia.
- Levofloxacin exponentiates anticoagulating influence of Warfarin.
Terms of sale
Before Lebel's acquisition it is necessary to see the attending physician to receive the recipe.
The protected from light, dry place, at a temperature up to +25 °C.
Period of validity
No more than 24 months can be stored.
As development of a photosensitization is possible, during therapy and 5 days after end it is recommended not to get under solar and artificial ultra-violet radiation.
At the first signs of phototoxicity, and also a tendinitis, pseudomembranous colitis stop administration of drug and see a doctor.
Coincidence on the ATH code of the 4th level:
- Levofloxacin in tablets, the price is from 77 rub;
- Levofloksatsin-Tev in tablets, the price is from 440 rub;
- Glevo's tablets from 190 rub;
- Elefloks from 825 rub.
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