Levolet R
Levolet R: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Instructions for use P: method and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price P in pharmacies
Latin name: Levolet R
ATX code: J01MA12
Active ingredient: Levofloxacin (Levofloxacinum)
Manufacturer: Dr. Reddy`s laboratories, LTD (India)
Description and photo update: 2018-23-10
Prices in pharmacies: from 351 rubles.
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Levolet R is an antimicrobial agent, fluoroquinolone.
Release form and composition
- film-coated tablets: biconvex, capsular, white or almost white; 250 and 500 mg each - with RDY engraving on one side and “279” (for 250 mg tablets) or “280” (for 500 mg tablets) - on the other (in a blister of 10 tablets, 1 blister in a cardboard box);
- solution for infusion 5 mg / ml: transparent or slightly opalescent liquid of pale yellow color (100 ml in a translucent bottle made of low density polyethylene with a graduation scale and a loop on the bottom, 1 bottle in a cardboard box).
Composition of 1 tablet (250/500/750 mg):
- active substance: levofloxacin hemihydrate - 256.233 / 512.466 / 768.7 mg (which corresponds to 250/500/750 mg of levofloxacin);
- auxiliary components: microcrystalline cellulose (Avicel PH 101 and Avicel PH 102), corn starch, colloidal silicon dioxide, crospovidone, hypromellose (15 cps), magnesium stearate;
- film casing: white opadry OY 58900 (hypromellose 5 cP, titanium dioxide, macrogol 400).
Composition of 100 ml solution:
- active substance: levofloxacin hemihydrate - 512 mg (which corresponds to 500 mg of levofloxacin);
- auxiliary components: dextrose, hydrochloric acid, sodium hydroxide, water for injection.
Pharmacological properties
Pharmacodynamics
Levofloxacin belongs to fluoroquinolones, has a broad spectrum of action, antimicrobial and bactericidal properties. Blocks topoisomerase IV and DNA gyrase, and also disrupts supercoiling and stitching of DNA breaks (deoxyribonucleic acid), inhibits the synthesis of a DNA molecule, causes deep morphological changes in the cell wall, cytoplasm, and bacterial membranes.
The drug is effective both in vitro and in vivo against anaerobic (Bacteroides fragilis, Veillonella spp., Etc.), aerobic gram-positive (Staphylococcus spp., Corynebacterium diphtheriae, etc.) and gram-negative (Escherichia coli, Morganella morganii.) microorganisms.
Pharmacokinetics
The pharmacokinetics of the active substance, levofloxacin, is linear in both single and multiple administration of the drug. When taken orally, it is absorbed quickly and almost completely, regardless of meals. Bioavailability is 99%. The tablet form of Levolet R acts similarly to a solution for infusion, and therefore oral and intravenous methods of taking the drug are considered interchangeable. The average volume of distribution after intravenous administration at a dose of 500 mg is from 89 to 112 liters (both single and multiple). The connection of levofloxacin with plasma proteins varies within 30–40%. After i.v. infusion of 500 mg of levofloxacin for 1 hour, the maximum concentration of the substance (C max) was 6.2 ± 1 μg / ml, while taking the tablet form of the drug at a dose of 250 and 500 mg - 2.8 and 5.2 μg / ml, respectively. T max solution - 1 ± 0.1 h, T max tablets - 1–2 h.
Levofloxacin penetrates into the tissues of internal organs in a short period of time.
After a single intravenous administration of Levolet P 500 mg, the half-life (T 1/2) is 6.4 ± 0.7 hours. When the drug is taken in the form of tablets, T 1/2 is 6-8 hours. In small amounts, levofloxacin is metabolized and / or oxidized in the liver. It is excreted mainly by the kidneys by glomerular filtration and tubular secretion. 70% of the total clearance is renal clearance. Less than 5% is excreted as metabolites. In the urine after a day, 70% is found unchanged, after two days - 87% of the administered dose. In feces, after three days, 4% of the administered dose is detected.
The decrease in drug clearance and its excretion by the kidneys in patients with renal insufficiency depends on the level of creatinine clearance.
Indications for use
Pills
Levolet R is indicated for mild and moderate infectious and inflammatory lesions caused by microorganisms that are sensitive to the drug: infections of the lower respiratory tract (community-acquired pneumonia, exacerbation of chronic bronchitis), skin and soft tissues, ENT organs, intra-abdominal infections, uncomplicated and complicated infections of the kidneys and urinary tract (including pyelonephritis), drug-resistant forms of tuberculosis (in combination with other drugs), prostatitis, as well as septicemia and bacteremia associated with these diseases.
Solution for infusion
Levolet R is indicated for mild and moderate infectious and inflammatory lesions caused by microorganisms that are sensitive to the drug: uncomplicated and complicated infections of the kidneys and urinary tract (including pyelonephritis), intra-abdominal infections, community-acquired pneumonia, drug-resistant forms of tuberculosis (in combination with other drugs), bacterial prostatitis, as well as septicemia and bacteremia associated with these diseases.
Contraindications
Absolute:
- epilepsy;
- age up to 18 years;
- pregnancy and the period of breastfeeding;
- tendon lesions during previous therapy with quinolones;
- increased sensitivity to the components of Levolet R, as well as to other quinolones.
Additionally for tablets 750 mg: impaired renal function with CC <20 ml / min.
Relative:
- old age (due to the high likelihood of a concomitant age-related decrease in renal function);
- deficiency of glucose-6-phosphate dehydrogenase.
Additionally for 750 mg tablets:
- diseases of the central nervous system that reduce the threshold of seizure activity of the brain;
- joint administration with drugs that reduce the threshold of convulsive readiness of the brain;
- a history of psychosis and psychiatric illness;
- impaired renal function, with CC 20-50 ml / min (monitoring of renal function is necessary, as well as dose adjustment of the drug);
- the presence of risk factors for prolongation of the QT interval [syndrome of congenital prolongation of the QT interval, electrolyte disturbances (uncorrected), heart disease, concomitant use of drugs that can prolong the QT interval, advanced age];
- diabetes mellitus with the use of oral hypoglycemic drugs or insulin;
- the presence of severe side effects when taking other fluoroquinolones.
Instructions for use of Levolet R: method and dosage
Pills
Levolet R is taken orally before meals or in between meals. The tablet is swallowed whole with a sufficient amount of liquid.
Recommended dosage for normal renal function (CC> 50 ml / min):
- infectious lesions of the skin and soft tissues: 500 mg per day for 1 or 2 doses, in the case of complicated infections, the dose can be increased to 750 mg per day, the duration of use is 7-14 days;
- sinusitis: 500 mg per day for 1 dose, duration of use - 10-14 days; in the case of acute bacterial sinusitis - 750 mg per day for 1 dose, duration of use - 5 days;
- tuberculosis (drug-resistant forms): 500-1000 mg per day per dose, duration of use - up to 90 days;
- chronic bronchitis in the exacerbation phase: 250-500 mg per day for 1 dose, duration of use - 10-14 days;
- pneumonia (community-acquired): 500 mg 1-2 times a day, duration of use - 7-14 days; or 750 mg 1 time per day, the duration of treatment is 5 days;
- urinary tract infections (uncomplicated): 250 mg per day for 1 dose, duration of use - 3 days;
- complicated urinary tract infections (including pyelonephritis): 250 mg per day for 1 dose, duration of use - 7-10 days; in cases of severe infection - 750 mg per day for 1 dose, duration of use - 5 days;
- intra-abdominal infection: 500 mg per day for 1 dose, duration of use - 7-14 days (as part of combination therapy with antibacterial drugs acting on the anaerobic flora);
- prostatitis: 500 mg per day for 1 dose, duration of use - 28 days;
- septicemia / bacteremia: 500 mg 1-2 times a day, duration of use - 10-14 days.
Solution for infusion
Levolet R is administered intravenously.
The dose of the drug depends on the nature and severity of the infection, as well as on the sensitivity of the alleged pathogen.
Recommended dosage:
- community-acquired pneumonia: 500 or 1000 mg per day for 1 or 2 doses, duration of use - 7-14 days;
- tuberculosis (drug-resistant forms): 500 or 1000 mg per day for 1 or 2 doses, depending on the severity of the disease and the treatment regimen used, the duration of use can be up to 90 days;
- bacterial prostatitis: 500 mg per day for 1 dose, duration of use - 28 days;
- uncomplicated urinary tract infections: 250 mg per day for 1 dose, duration of use - 3 days;
- complicated urinary tract infections (including pyelonephritis): 250 mg per day for 1 dose (in case of severe infection, the dose may be increased), duration of use - 7-10 days;
- intra-abdominal infection: 500 mg per day for 1 dose, duration of use - 7-14 days (as part of combination therapy with antibacterial drugs acting on the anaerobic flora);
- septicemia / bacteremia: 500 or 1000 mg per day for 1 or 2 doses, duration of use - 10-14 days.
The solution is injected intravenously, slowly. The introduction of Levolet R 500 mg (100 ml of solution) should last at least 1 hour. The following solutions are recommended for use as solvents for the drug: sodium chloride 0.9%, Ringer's solution with dextrose 2.5%, dextrose 5%, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).
Levofloxacin should not be mixed with heparin, as well as solutions that are alkaline (for example, sodium bicarbonate solution).
After starting therapy with an infusion solution, in case of positive dynamics of the patient's condition, you can switch to oral administration of the drug.
After reliable eradication of the pathogen or after normalization of temperature, therapy should be continued for at least 48–72 hours.
Side effects
- hematopoietic organs and circulatory system: leukopenia, eosinophilia, thrombocytopenia, neutropenia, pronounced agranulocytosis, hemolytic anemia, pancytopenia;
- digestive system: nausea, diarrhea, increased activity of ALT, AST, dysbiosis, vomiting, abdominal pain, loss of appetite, increased serum bilirubin levels, digestive disorders, diarrhea mixed with blood (which may indicate inflammation in the intestine or pseudomembranous colitis), hepatitis;
- cardiovascular system: decreased blood pressure, tachycardia, vascular collapse, prolongation of the QT interval;
- central and peripheral nervous system: headache, drowsiness, dizziness, stiffness of movements, sleep disturbances, paresthesia in the hands, a state of fear, anxiety, tremors, confusion, convulsions, psychotic reactions (hallucinations, depression), movement disorders;
- sense organs: disturbances of smell, hearing, vision, taste and tactile sensitivity;
- metabolism: hypoglycemia (a sharp increase in appetite, perspiration, tremors), exacerbation of existing porphyria;
- urinary system: hypercreatininemia, decreased renal function up to acute renal failure (for example, due to an allergic reaction - interstitial nephritis);
- musculoskeletal system: tendon damage (including tendonitis), muscle and joint pain, rupture of the Achilles tendon (can appear within 2 days after the start of treatment and be bilateral), muscle weakness (especially in patients with myasthenia gravis), rhabdomyolysis;
- allergic reactions: skin redness, itching, anaphylactic and anaphylactoid reactions (symptoms: bronchospasm with possible severe suffocation, urticaria, rarely - swelling of the face, larynx), sudden decrease in blood pressure, Stevens-Johnson syndrome, anaphylactic shock, toxic epidermal necrolysis, allergic pneumonitis exudative erythema multiforme, vasculitis;
- skin and subcutaneous fat: photosensitivity;
- other: asthenia, persistent fever, development of superinfection.
When using Levolet R solution for infusion, the following local reactions may occur: pain, redness, phlebitis.
Overdose
Symptoms of an overdose of Levolet R: nausea, dizziness, confusion, erosive lesions of the gastrointestinal mucosa, convulsions, prolongation of the QT interval.
In case of overdose, symptomatic treatment is recommended. Dialysis is ineffective.
special instructions
During the period of therapy with Levolet R, solar and artificial UV irradiation should be avoided due to the risk of damage to the skin.
At the first sign of tendinitis, the administration of levofloxacin should be stopped immediately.
In the presence of a history of brain lesions, such as stroke, severe trauma, there is a risk of seizures, in case of glucose-6-phosphate dehydrogenase deficiency - the risk of hemolysis.
Influence on the ability to drive vehicles and complex mechanisms
During the period of therapy with Levolet R, care should be taken when driving vehicles, as well as in other types of activities that require increased concentration of attention and speed of psychomotor reactions.
Application during pregnancy and lactation
According to the instructions, Levolet R is contraindicated in pregnancy.
If necessary, the use of the drug during lactation is recommended to stop breastfeeding.
Pediatric use
Levolet R is contraindicated for use in persons under the age of 18 years.
With impaired renal function
In case of impaired renal function, dose adjustment of Levolet R is required depending on the CC value. Doses for oral administration / intravenous administration - 250 mg / day, 500 mg / day, 500 mg / 12 h. The further dosing regimen depends on the nature and severity of the infection, as well as on the sensitivity of the alleged pathogen.
Recommended dosage for impaired renal function [250 mg / day (first dose - 250 mg), 500 mg / day, 500 mg / 12 h (first dose - 500 mg)]:
- CC <10 (including hemodialysis and continuous ambulatory peritoneal dialysis): 125 mg / 48 h, 125 mg / day, 125 mg / day;
- CC 10-19 ml / min: 125 mg / 48 h, 125 mg / day, 125 mg / 12 h;
- CC 20-50 ml / min: 125 mg / day, 250 mg / day, 250 mg / 12 hours.
The introduction of additional doses of Levolet R after continuous outpatient dialysis or hemodialysis is not required.
For violations of liver function
Levofloxacin is slightly metabolized in the liver, and therefore, if its function is impaired, the drug can be taken in normal doses.
Use in the elderly
Elderly patients should use Levolet R with caution due to the high likelihood of concomitant renal dysfunction.
Drug interactions
When taken together, levofloxacin increases T 1/2 of cyclosporin.
The following drugs reduce the effectiveness of levofloxacin when taken simultaneously: drugs that inhibit intestinal motility, magnesium- and aluminum-containing antacids, sucralfate, iron salts (the interval between doses should be at least 2 hours).
Concomitant use with non-steroidal anti-inflammatory drugs (NSAIDs), as well as theophylline, increases convulsive readiness; with glucocorticosteroids (GCS) - increases the risk of tendon rupture.
Cimetidine and drugs that block calcium secretion reduce the rate of excretion of levofloxacin.
When taking levofloxacin and indirect anticoagulants (including warfarin) together, blood clotting control is necessary.
Analogs
Analogs of Levolet R are: Tanflomed, Glevo, Levofloxabol, OD Levox, Leflobact, Remedia, Levoflox, Ivacin, Ekolevid, Flexid.
Terms and conditions of storage
Store away from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Do not freeze the solution!
Shelf life: tablets - 3 years, solution for infusion - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Levolet R
Reviews about Levolet R are quite contradictory. Of the advantages of the drug, patients in most cases note its relatively low cost, while negative reviews are mainly associated with an impressive list of side effects.
Price for Levolet R in pharmacies
The approximate price for Levolet R is: solution (100 ml) - 430 rubles, tablets (10 pcs. In a package) at a dose of 250 mg - 210 rubles, at a dose of 500 mg - 400 rubles, at a dose of 750 mg - 510 R.
Levolet R: prices in online pharmacies
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Drug name Price Pharmacy |
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Levolet R 500 mg film-coated tablets 10 pcs. 351 r Buy |
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Levolet R 750 mg film-coated tablets 10 pcs. 458 r Buy |
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Levolet R tablets p.p. 750mg 10 pcs. 574 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
