Levotek
Levotek: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application 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 in pharmacies
Latin name: Levotech
ATX code: J01MA12
Active ingredient: Levofloxacin (Levofloxacin)
Manufacturer: Protekh Biosystems Pvt. Ltd. (Protech Biosystems Pvt. Ltd.) (India)
Description and photo updated: 30.11.2018
Levotek is an antimicrobial agent.
Release form and composition
- film-coated tablets: biconvex, oval (500 mg) or round (250 mg), scored on one side (250 mg), almost white or white (10 pcs. in a blister / contour package, 1 or 10 blisters / contour packs in a cardboard box; for hospitals 50 or 100 blisters / contour packs in cardboard boxes (boxes) - in bulk);
- solution for infusion: transparent pale yellow or yellowish green (100 ml in a polyethylene bottle, in a cardboard box 1 bottle in a polypropylene bag).
Each pack also contains instructions for the use of Levoteka.
1 tablet contains:
- active substance: levofloxacin hemihydrate (in terms of anhydrous levofloxacin) - 250 or 500 mg;
- additional components: corn starch, microcrystalline cellulose, sodium carboxymethyl starch, povidone K-30, purified talc, magnesium stearate, croscarmellose sodium, colloidal silicon dioxide;
- film shell: titanium dioxide, hypromellose, purified talc, macrogol 600.
1 ml of solution contains:
- active substance: levofloxacin hemihydrate (in terms of levofloxacin) - 5 mg;
- additional components: water for injection, sodium hydroxide, anhydrous dextrose, hydrochloric acid.
Pharmacological properties
Pharmacodynamics
Levotek is an antimicrobial drug with bactericidal action; fluoroquinolone. Its active substance - levofloxacin, blocking DNA gyrase (topoisomerase II) and topoisomerase IV, leads to disruption of supercoiling and stitching of DNA breaks, interferes with DNA synthesis, initiates deep morphological changes in the cell wall, cytoplasm and bacterial membranes.
Levotek demonstrates activity against the following microorganisms:
- gram-positive bacteria: Listeria monocytogenes, Enterococcus spp. (including Enterococcus faecalis), Corynebacterium diphtheriae, Staphylococcus spp. coagulase-negative and methicillin-sensitive (including moderately sensitive), including Staphylococcus aureus (methicillin-sensitive), Streptococcus spp. (groups C and G), Staphylococcus epidermidis (methicillin-sensitive), Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus viridans (penicillin-sensitive, moderately sensitive, resistant), Streptococcus pneumoniae (penicillin-resistant, moderately sensitive)
- gram-negative bacteria: Actinobacillus actinomycetemcomitans, Acinetobacter spp. (including Acinetobacter baumanii), Eikenella corrodens, Citrobacter freundii, Enterobacter spp. (including Enterobacter cloacae, Enterobacter agglomerans, Enterobacter aerogenes), Haemophilus ducreyi, Gardnerella vaginalis, Escherichia coli, Haemophilus influenzae (ampicillin-sensitive and resistant), Helicobacter pylori, Haemophilus s parainella (including Klebsiella pneumoniae, Klebsiella oxytoca), Moraxella catarrhalis (producing and not producing beta-lactamase), Neisseria meningitidis, Neisseria gonorrhoeae (penicillin-susceptible, moderately sensitive, resistant), Morganella mirabilis s. (including Pasteurella canis, Pasteurella multocida, Pasteurella dagmatis), Pseudomonas spp. (incl. Pseudomonas aeruginosa), Providencia spp. (including Providencia stuartii, Providencia rettgeri), Proteus vulgaris, Serratia spp. (including Serratia marcescens), Salmonella spp.;
- anaerobes: Fusobacterium spp., Bacteroides fragilis, Clostridium perfringens, Bifidobacterium spp., Veillonella spp., Propionibacterium spp., Peptostreptococcus spp.;
- other microorganisms: Chlamydia trachomatis, Chlamydia psittaci, Chlamydia pneumoniae, Bartonella spp., Legionella spp. (including Legionella pneumophila), Mycoplasma hominis, Mycobacterium spp. (including Mycobacterium tuberculosis, Mycobacterium leprae), Rickettsia spp., Mycoplasma pneumoniae, Ureaplasma urealyticum.
Pharmacokinetics
After oral administration, levofloxacin is almost completely rapidly absorbed from the gastrointestinal tract (GIT). The maximum concentration (C max) of the substance in the serum is noted after 1–2 hours, the average value of C max after ingestion of 250 and 500 mg is 2.8 and 5.2 μg / ml, respectively.
After intravenous (intravenous) administration, Levoteka at a dose of 500 mg C max reaches a value of 6.2 μg / ml. The pharmacokinetics of the active substance is linear, its level in blood plasma after oral administration and intravenous infusion of equivalent doses is identical. With a single injection of levofloxacin in a dose of 500 mg intravenously for 60 minutes, T max (time to reach C max) reaches 1.0 ± 0.1 hours, T 1/2 (half-life) - 6.4 ± 0.7 hours.
The substance is well distributed in tissues and body fluids, such as lungs, bronchial mucosa, bone tissue, cerebrospinal fluid, sputum, polymorphonuclear leukocytes (anti-endotoxin defense system), alveolar macrophages, as well as in the organs of the genitourinary system. In the lung tissue, the level of levofloxacin exceeds that in the blood plasma. After a single and multiple oral and intravenous administration of Levoteca at a dose of 500 mg, the average volume of distribution (Vd) can vary from 89 to 112 liters. It binds to blood plasma proteins by 24-38%, insignificant cumulation is recorded only when using levofloxacin 2 times a day, 500 mg.
A small part of the drug undergoes hepatic metabolism (oxidized and / or deacetylated), excreted mostly by the kidneys, approximately 87% - unchanged and 5% - in the form of inactive metabolites for 48 hours. Less than 4% is excreted through the intestines within 72 hours.
Indications for use
The antibiotic Levotek is recommended for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin:
- lower respiratory tract infections (community-acquired pneumonia, period of exacerbation of chronic bronchitis);
- diseases of the ENT organs (including acute sinusitis);
- urinary tract and kidney infections (including acute pyelonephritis);
- genital infections (including urogenital chlamydia) - for solution;
- bacterial prostatitis - for pills;
- intra-abdominal infections;
- infections of soft tissues and skin (abscess, suppurating atheroma, furunculosis);
- septicemia / bacteremia - for solution;
- drug-resistant forms of tuberculosis (as part of combination therapy).
Contraindications
Absolute:
- age up to 18 years;
- pregnancy and lactation;
- epilepsy;
- damage to the tendons against the background of previous treatment with quinolones;
- hypersensitivity to any of the constituents of the drug or other fluoroquinolones.
Relative (use the antibiotic Levotek with caution):
- deficiency of glucose-6-phosphate dehydrogenase (due to an increased risk of hemolysis);
- elderly age.
Levotek, instructions for use: method and dosage
Levotek film-coated tablets are taken orally, without chewing or breaking, with a sufficient amount of liquid, before meals or between meals.
Levotek solution is administered intravenously, drip slowly over at least 60 minutes at a dose of 500 mg (100 ml) 1-2 times a day. A few days after the start of the course, taking into account the patient's condition, it may be recommended to switch to oral administration of the drug in the same dose.
The doctor determines the optimal dosage regimen. The duration of therapy with Levotek depends on the type of disease and the severity of its course, the course can vary from 7 to 14 days. After normalization of temperature and decrease in the severity of symptoms of acute inflammation, drug treatment continues for at least 48-72 hours.
The recommended dosing regimen of Levoteka in patients with normal renal activity, with creatinine clearance (CC) above 50 ml / min:
- acute sinusitis: orally once a day, 500 mg, 10-14 days;
- exacerbation of chronic bronchitis: orally once a day, 250-500 mg, 7-10 days;
- community-acquired pneumonia: intravenously or orally 1–2 times a day, 500 mg, 7–14 days;
- bacterial prostatitis: orally once a day, 500 mg, 28 days;
- urinary tract infections: uncomplicated - orally once a day, 250 mg, 3 days; complicated (including pyelonephritis) - in / in or orally once a day, 250 mg (in case of severe disease, the dose should be increased), 7-10 days;
- intra-abdominal infection: intravenous or orally once a day, 500 mg, 7-14 days (when used in combination with antibacterial drugs acting on the anaerobic flora);
- infections of soft tissues and skin: orally - 250-500 mg 2 times a day, intravenous - 500 mg 2 times a day, 7-14 days;
- septicemia / bacteremia: intravenously, 1–2 times a day, 500 mg, 10–14 days;
- drug-resistant forms of tuberculosis (as part of complex therapy): orally 1-2 times a day, 500 mg, course - up to 3 months.
Dosage of Levoteka in patients with functional impairment of the kidneys with CC below 50 ml / min (doses in mg):
- CC - 50–20 ml / min: initial dose 250/24 hours - then 125/24 hours; the initial dose is 500/24 or 500/12 hours - then 250/24 or 250/12 hours, respectively;
- CC - 19-10 ml / min: initial dose 250/24 hours - then 125/48 hours; initial dose of 500/24 or 500/12 hours - then 125/24 or 125/12 hours, respectively;
- CC - below 10 ml / min, including with continuous outpatient peritoneal dialysis (CAPD) and hemodialysis: initial dose 250/24 hours - then 125/48 hours; initial dose of 500/24 or 500/12 hours - then 125/24 hours. After hemodialysis or CAPD, the appointment of additional doses of Levoteca is not required.
Side effects
- cardiovascular system: lowering blood pressure (BP), tachycardia, vascular collapse, prolongation of the QT interval; extremely rare - atrial fibrillation;
- digestive system: decreased appetite, vomiting, nausea, abdominal pain, diarrhea, dysbiosis, hyperbilirubinemia, increased activity of hepatic transaminases, hepatitis, pseudomembranous colitis;
- metabolism: hypoglycemia (concomitant symptoms: sweating, increased appetite, tremors, nervousness);
- sense organs: hearing impairment, vision, smell, tactile and gustatory sensitivity;
- nervous system: drowsiness / insomnia, weakness, dizziness, headache, fear, anxiety, depression, movement disorders, paresthesias, convulsions, confusion, hallucinations;
- hematopoietic organs: hemolytic anemia, neutropenia, leukopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis, hemorrhages;
- musculoskeletal system: myalgia, arthralgia, myasthenia gravis, tendinitis, tendon rupture, rhabdomyolysis;
- allergic reactions: edema of the skin and mucous membranes, itching, urticaria, bronchospasm, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock, vasculitis, allergic pneumonitis;
- urinary system: interstitial nephritis, hypercreatininemia;
- local reactions: redness, pain at the site of administration of the solution, phlebitis;
- others: persistent fever, photosensitivity, exacerbation of porphyria, development of superinfection.
Overdose
Symptoms of an overdose of Leveteca may include nausea, erosive defects of the gastrointestinal mucosa, dizziness, confusion, changes in the QT interval, convulsions.
If this condition is suspected, symptomatic therapy is prescribed, there is no specific antidote, dialysis is ineffective.
special instructions
During the period of use of Levoteka, solar and artificial ultraviolet radiation should be avoided due to the risk of possible damage to the skin (photosensitization).
If there is a history of brain damage (severe trauma, stroke) during treatment, the threat of seizures increases.
Tendonitis that sometimes occurs during treatment (mainly Achilles tendon inflammation) can cause tendon rupture. If signs of tendinitis appear, Levotek therapy should be terminated immediately and the affected tendon should be treated appropriately, ensuring that it is at rest.
During the use of Levetek, if you suspect the occurrence of pseudomembranous colitis, you must immediately stop using the drug and begin appropriate treatment. Medicines that inhibit intestinal motility cannot be used in such cases.
During therapy with quinolones (including levofloxacin), immediate-type hypersensitivity reactions (HHT), up to anaphylaxis, were recorded in rare cases. If, after using levofloxacin, signs of GNT appear (including skin itching), treatment should be urgently canceled.
Influence on the ability to drive vehicles and complex mechanisms
In view of the possible development of drowsiness, dizziness and visual disturbances during therapy with Levotek, patients receiving the drug are advised to refrain from driving complex mechanisms, including vehicles.
Application during pregnancy and lactation
During pregnancy and lactation, the use of Leveteca is contraindicated.
Pediatric use
For patients under 18 years of age, therapy with Levotek is contraindicated.
With impaired renal function
Levotec is not eliminated from the body by hemodialysis or long-term ambulatory peritoneal dialysis.
In patients with impaired renal activity, T 1/2 of levofloxacin from plasma increases, as a result of which dose adjustment may be required to avoid antibiotic accumulation.
For violations of liver function
Functional liver disorders do not significantly affect the metabolism of levofloxacin. Patients with impaired liver function do not require Leveteka dose adjustment.
Use in the elderly
Elderly patients should use Levotek with caution, due to the high risk of concomitant deterioration of renal function. In addition, patients in this age group are more prone to the development of tendinitis, which should be taken into account when combined therapy with GCS, against which the threat of tendon rupture increases.
Drug interactions
- cyclosporin: T 1/2 of this substance increases;
- drugs that inhibit tubular secretion (including cimetidine): the elimination of levofloxacin slows down;
- glucocorticosteroids (GCS): the threat of tendon rupture is aggravated;
- non-steroidal anti-inflammatory drugs (NSAIDs) and theophylline: the seizure threshold decreases;
- vitamin K antagonists: it is required to control the blood coagulation system;
- hypoglycemic agents: the likelihood of developing hyper- and hypoglycemia increases, and therefore, with this combination, blood glucose levels should be carefully monitored;
- heparin or solutions with an alkaline reaction (for example, sodium bicarbonate solution): these drugs cannot be mixed with levofloxacin solution for infusion;
- sodium chloride solution 0.9%, dextrose solution 5%, Ringer's solution with dextrose 2.5%, combined solutions for parenteral nutrition: the compatibility of these funds with Levotek solution is noted;
- drugs that suppress intestinal motility, antacids containing magnesium / aluminum, sucralfate, iron and zinc salts: the effectiveness of levofloxacin decreases, the interval between taking it with these drugs should be at least 2 hours.
Analogs
The analogues of Levoteka are: Haileflox Levoflox, Glevo, Levoximed, Levostar, Eleflox, Levofloxacin, Tavanik, Tanflomed, Leflobact, etc.
Terms and conditions of storage
Store in a place protected from moisture (for tablets) and light, out of the reach of children, at a temperature not exceeding 25 ° C. The solution must not be frozen.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Levotek
According to a few reviews, Levotek is an effective broad-spectrum antimicrobial agent. According to patients, the drug has proven itself well in the treatment of infections of the urinary tract, lower respiratory tract, skin and soft tissues.
However, there are quite a few complaints about the development of negative side effects, sometimes quite pronounced, because of which, in some cases, patients were forced to refuse treatment with the drug.
The price of Levotek in pharmacies
There is no reliable data on the price of Levotek tablets and solution, since the drug is not currently sold in pharmacies. The cost of an analogue of the drug, Levofloxacin (500 mg film-coated tablets) can be 400–650 rubles. per package containing 10 pcs.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
