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Levolet 500 mg No. 10 tablet p.o.

Instructions for medical use of the drug Levolet Trade name Levolet International nonproprietary name Levofloxacin Dosage form Film-coated tablets 250 and 500 mg Composition One tablet contains the active substance - levofloxacin hemihydrate 256.233 mg and 512.466 mg excipients: microcrystalline cellulose (Avicel RN 101), cellulose a microcrystalline (Avicel RN 102), corn starch, crospovidone, hypromellose 15 cps, colloidal silicon dioxide (Aerosil 200), magnesium stearate, shell composition: white opadry OY 58900, hypromellose 5 cp, titanium dioxide E 171, macrogol/PEG 400, water purified Description White, capsule-shaped, film-coated tablets with a biconvex surface engraved “DRY” on one side and “279” on the other (for a dosage of 250 mg). White, capsule-shaped, film-coated tablets with a biconvex surface engraved “DRY” on one side and “280” on the other (for a dosage of 500 mg). Pharmacotherapeutic group Antimicrobial drugs – quinolone derivatives. Fluoroquinolones. Levofloxacin. ATC code J01MA12 Pharmacological properties Pharmacokinetics Absorption. Levofloxacin, when taken orally, is quickly and almost completely absorbed; food intake has little effect on the speed and completeness of absorption; food intake has little effect on its absorption. Absolute bioavailability when taken orally is 99–100%. After a single dose of levofloxacin, Cmax in blood plasma is reached within 1–2 hours and is (2.8 ± 1.2) mcg/ml for a dosage of 250 mg and (5.2 ± 1.2) mcg/ml for 500 mg. The pharmacokinetics of levofloxacin is linear in the dose range from 50 to 1000 mg. Css of levofloxacin in blood plasma when taking 500 mg of levofloxacin 1 or 2 times a day is achieved within 48 hours. On the 10th day of taking levofloxacin 500 mg 1 time per day, Cmax of levofloxacin in blood plasma is (5.7 ± 1.4) mcg/ml, and the Cmin of levofloxacin (concentration before taking the next dose) in the blood plasma was (0.5 ± 0.2) mcg/ml. On the 10th day of oral administration of levofloxacin 500 mg 2 times a day, the Cmax of levofloxacin in plasma is (7.8 ± 1.1) μg/ml, and Cmin is (3 ± 0.9) μg/ml. Distribution. The binding to serum proteins is 30–40%. After a single and repeated dose of 500 mg of levofloxacin, Vd is on average approximately 100 l, which indicates good penetration of levofloxacin into organs and tissues of the human body. Penetration into the bronchial mucosa, epithelial lining fluid, alveolar macrophages. After a single oral dose of 500 mg of levofloxacin, Cmax of levofloxacin in the bronchial mucosa and epithelial lining fluid was reached within 1 to 4 hours and amounted to 8.3 mcg/g and 10.8 mcg/ml, respectively, with penetration coefficients into the bronchial mucosa and fluid epithelial lining compared to plasma concentrations of 1.1–1.8 and 0.8–3, respectively. After 5 days of oral administration of 500 mg levofloxacin, the mean concentrations of levofloxacin 4 hours after the last dose in the epithelial lining fluid were 9.94 μg/ml and in alveolar macrophages - 97.9 μg/ml. Penetration into lung tissue. Cmax in lung tissue after oral administration of 500 mg of levofloxacin was approximately 11.3 mcg/g and was achieved 4-6 hours after dosing with penetration coefficients of 2-5 compared to plasma concentrations. Penetration into alveolar fluid. After 3 days of taking 500 mg of levofloxacin 1 time or 2 times a day, the Cmax of levofloxacin in the alveolar fluid was 4 and 6.7 μg/ml, respectively, and was achieved 2–4 hours after dosing with a penetration coefficient of 1 compared with plasma concentrations blood. Penetration into bone tissue. Levofloxacin penetrates well into cortical and cancellous bone tissue, both in the proximal and distal parts of the femur with a penetration coefficient (bone tissue/blood plasma) of 0.1–3. Cmax of levofloxacin in the cancellous bone tissue of the proximal femur after taking 500 mg of the drug orally was approximately 15.1 mcg/g (2 hours after dosing). Penetration into the cerebrospinal fluid. Levofloxacin penetrates poorly into the cerebrospinal fluid. Penetration into prostate tissue. After oral administration of 500 mg levofloxacin once daily for 3 days, the average concentration of levofloxacin in prostate tissue was 8.7 mcg/g, the average prostate/blood plasma concentration ratio was 1.84. Concentrations in urine. Mean urinary concentrations 8 to 12 hours after oral doses of 150, 300, and 600 mg of levofloxacin were 44, 91, and 162 mcg/mL, respectively. Metabolism. Levofloxacin is metabolized to a small extent (5% of the dose taken). Its metabolites are demethyllevofloxacin and N-oxidelevofloxacin, which are excreted by the kidneys. Levofloxacin is stereochemically stable and does not undergo chiral transformations. Excretion. After oral administration, levofloxacin is eliminated from the blood plasma relatively slowly (T1/2 - 6-8 hours). Excretion is primarily through the kidneys (more than 85% of the dose taken). The total clearance of levofloxacin after a single dose of 500 mg was (175±29.2) ml/min. There are no significant differences in the pharmacokinetics of levofloxacin when administered intravenously and orally, which confirms that oral administration and intravenous administration are interchangeable. Pharmacokinetics in certain groups of patients. The pharmacokinetics of levofloxacin do not differ between men and women. Pharmacokinetics in elderly patients do not differ from those in younger patients, with the exception of differences in pharmacokinetics associated with differences in creatinine clearance. In renal failure, the pharmacokinetics of levofloxacin changes. As renal function declines, renal excretion and renal clearance are reduced and the half-life is prolonged. Pharmacokinetic parameters for renal failure after a single oral dose of 500 mg of Tavanic® are presented in the table. Creatinine Cl, ml/min <20 20–49 50–80 Renal clearance, ml/min 13 26 57 T1/2, h 35 27 9 Pharmacodynamics Levolet is a broad-spectrum antibiotic from the group of fluoroquinolones. It is a levorotatory isomer of ofloxacin, blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes of microorganisms. Levolet is active against most strains of microorganisms: - aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Listeria monocytogenes, Staphylococcus spp., including Staphylococcus aureus, epidermidis, Streptococcus pyogenes, agalactiae, pneumoniae, Streptococcus (groups C, G), Viridans group streptococci — aerobic gram-negative microorganisms: Acinetobacter spp., including Acinetobacter anitratus, baumannii, calcoaceticus, Actinobacillus actinomycetemcomitans, Bordetella pertussis, Citrobacter freundii, diversus, Eikenella corrodens, Enterobacter spp., including Enterobacter aerogenes, agglomerans, cloacae, sakazakii, Escherichia coli, Gardnerella vaginalis , Haemophilus ducreyi, influenzae, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp., including Klebsiella oxytoca, pneumoniae, Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitides, Pasteurella spp., including Pasteurella canis, dagmatis, multocida, Proteus mirabilis, v ulgaris , Providencia spp., including Providencia rettgeri, stuartii, Pseudomonas spp., including Pseudomonas aeruginosa, fluorescens, Salmonella spp., Serratia spp., including Serratia marcescens - anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., P eptostreptococcus , Propionibacterium spp., Veillonella spp - other microorganisms: Bartonella spp., Chlamydia pneumoniae, psittaci, trachomatis, Legionella spp., including Legionella pneumophila, Mycobacterium spp., including Mycobacterium leprae, tuberculosis, Mycoplasma pneumoniae; Rickettsia spp., Ureaplasma urealyticum Indications for use - infections of the ENT organs (sinusitis, otitis media) - inflammation of the lower respiratory tract: exacerbation of chronic bronchitis, community-acquired pneumonia - uncomplicated and complicated urinary tract infections (including pyelonephritis), prostatitis - genital infections ( including urogenital chlamydia) - infections of the skin and soft tissues (festering atheromas, abscesses, boils) - septicemia associated with the above indications Method of administration and dosage Levolet tablets are taken orally, before meals or in between meals, without chewing, with a sufficient amount of liquid. For sinusitis - 500 mg 1 time per day; for exacerbation of chronic bronchitis - 250 - 500 mg 1 time per day. For pneumonia - 250 - 500 mg 1 - 2 times a day (500 - 1000 mg/day). For urinary tract infections - 500 mg once a day. For chronic prostatitis - 500 mg once a day for 28 days. For infections of the skin and soft tissues - 250 - 500 mg orally 1 - 2 times a day. For kidney diseases, the dose is reduced in accordance with the degree of dysfunction: with creatinine clearance 20 - 50 ml/min - 125 - 250 mg 1 - 2 times a day; at 10 - 19 ml/min - 125 mg 1 time every 12 - 48 hours; less than 10 ml/min - 125 mg after 24 or 48 hours. Duration of treatment - 7 - 10 (up to 14) days Side effects often - nausea, vomiting, loss of appetite, - increased activity of liver enzymes (ALAT, AST), increased levels of bilirubin and creatinine in the blood serum, hepatic reactions - eosinophilia, leukopenia in some cases - headache, dizziness, stupor, drowsiness, sleep disturbance, - abdominal pain, diarrhea, indigestion - hemolytic anemia, pancytopenia - muscle damage (rhabdomyolysis) - itching, redness of the skin, increased sensitivity to solar and ultraviolet radiation (syndrome) Stevens-Johnson), toxic epidermal necrolysis (Lyell's syndrome), exudative erythema multiforme rarely - colitis, including pseudomembranous (manifested by hemorrhagic diarrhea) - paresthesia in the hands, trembling, anxiety, states of fear, seizures, confusion - tachycardia, drop in blood pressure, vascular collapse - tendon lesions (including tendinitis), muscle weakness, joint and muscle pain, tendon rupture - neutropenia, thrombocytopenia (tendency to hemorrhage or bleeding) very rarely - anaphylactic and anaphylactoid reactions (urticaria, bronchospasm, Quincke's edema ) - agranulocytosis, hemolytic anemia (considered in case of diabetes mellitus) - visual and hearing impairment, impaired taste and smell, decreased tactile sensitivity, psychotic reactions such as hallucinations and depression, movement disorders, including walking - exacerbation of porphyria - deterioration of kidney function up to acute renal failure Other side effects; in isolated cases, asthenia very rarely - fever, allergic pneumonitis, vasculitis Contraindications - hypersensitivity to levofloxacin or other quinolones - epilepsy - tendon damage during previous treatment with quinolones - pregnancy and lactation - childhood and adolescence under 18 years of age Drug interactions Levolet, reduces the effect of drugs that inhibit intestinal motility, sucralfate, magnesium- and aluminum-containing antacids and iron salts, the drug should be taken at least 2 hours before or after taking these drugs. The combined use of the drug Levolet and non-steroidal anti-inflammatory drugs, theophylline increases convulsive readiness. Cimetidine and drugs that block tubular secretion slow down the elimination of Levolet. Levolet increases the half-life of cyclosporine. When combining the drug Levolet with vitamin K antagonists, control over the blood coagulation system is necessary. Glucocorticoids increase the risk of tendon rupture. Alcohol may increase central nervous system side effects (dizziness or stupor, drowsiness, visual disturbances), impairing reactivity and concentration. Drugs that cause QT prolongation Levofloxacin, like other fluoroquinolones, should be used with caution in patients taking drugs that cause prolongation of the QT interval (for example, antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics) (see “Special Instructions” Prolongation of the QT interval). In pharmacokinetic interaction studies, levofloxacin had no effect on the pharmacokinetics of theophylline (a marker substrate of CYP1A2), indicating that levofloxacin is not an inhibitor of CYP1A2. Other interactions Food No clinically significant interactions with food were noted. Thus, Levolet tablets can be taken regardless of food intake. Special instructions During treatment, it is necessary to avoid strong solar and artificial ultraviolet irradiation to avoid photosensitization. If pseudomembranous colitis is suspected, Levolet should be discontinued immediately and appropriate treatment should be initiated. If signs of tendinitis appear, Levolet should be discontinued immediately. It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), seizures may develop; with glucose-6-phosphate dehydrogenase deficiency, there is a risk of hemolysis. In this regard, treatment of such patients with Levolet should be carried out with great caution. When prescribing Levolet to patients with diabetes, the possibility of hypoglycemia must be taken into account. Use in patients with impaired liver and kidney function The drug should be used with caution in patients with impaired renal function, since in such patients the half-life of the drug Levolet increases. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms During the period of treatment, you must refrain from activities potentially hazardous activities that require increased concentration and psychomotor speed Prolongation of the QT interval Fluoroquinolones, including levofloxacin, should be used with caution in patients who have known risk factors for prolongation of the QT interval, such as: - congenital long QT interval syndrome - concomitant use drugs known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) - uncorrected electrolyte imbalance (eg, hypokalemia, hypomagnesemia) - heart disease (eg, heart failure, myocardial infarction, bradycardia) . Elderly patients and women may be more sensitive to drugs that cause QT prolongation. Therefore, fluoroquinolones, including levofloxacin, should be used with caution in these groups of patients (see “Dosage and Administration”, Elderly Patients, “Drug Interactions”, “Side Effects”, “Overdose”). Overdose Symptoms: confusion, dizziness, disturbances of consciousness, seizures; gastrointestinal disorders, lesions of the mucous membranes; prolongation of the QT interval Treatment: symptomatic, there is no specific antidote. Levolet is not excreted by hemodialysis and peritoneal dialysis. Release form and packaging 10 tablets are packaged in a blister pack made of polyvinyl chloride film and aluminum foil. 1 contour package together with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life: 2 years After the expiration date, do not apply Conditions for dispensing from pharmacies By prescription, INDIA ADDRESS OF THE ORGANIZATION RECEIVING CLAIMS FROM CONSUMERS FOR PRODUCT QUALITY IN THE TERRITORY OF THE REPUBLIC OF KAZAKHSTAN REPRESENTATIVE OFFICE IN THE REPUBLIC OF KAZAKHSTAN, 050057 ALMATY, ST. . 22 LINE, 45, POST BOX 7, TEL: 8(701)7633805, FAX: 8(727)3941294