Levodex 500mg 6 tablets

Form

tableti saghech i

Dosage mg

500

Pack

6

Instructions for Use LEVODEX Trade Name LEVODEX International Nonproprietary Name Levofloxacin Active Ingredient Levofloxacin / Levofloxacin Composition of the Medicinal Product LEVODEX 500 One film-coated tablet contains: Levofloxacin hemihydrate, equivalent to 500 mg of Levofloxacin. Properties Levofloxacin is a broad-spectrum bactericidal antibacterial agent from the quinolone group (fluoroquinolone). Levofloxacin is the L-isomer of ofloxacin. Levofloxacin blocks topoisomerase IV and DNA gyrase (topoisomerase II), inhibits DNA supercoiling and ligation of broken DNA fragments, inhibits DNA synthesis, causing profound morphological changes in the cytoplasm, cell wall, and membrane of microorganisms. Levofloxacin is active in vitro and in vivo against many strains of microorganisms. Aerobic Gram-positive microorganisms: Corynebacterium diphtheriae; Enterococcus faecalis; Listeria monocytogenes; Staphylococcus spp. (coagulase-negative, methicillin-susceptible / moderately susceptible strains), including Staphylococcus aureus, epidermidis (methicillin-susceptible strains); Streptococcus pyogenes, agalactiae, pneumoniae (penicillin-susceptible / moderately susceptible / resistant strains), Streptococcus (groups C, G), Viridans group streptococci (penicillin-susceptible / resistant strains); 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 (ampicillin-susceptible / resistant strains), Haemophilus parainfluenzae; Helicobacter pylori; Klebsiella spp., including Klebsiella oxytoca, pneumoniae; Moraxella catarrhalis; Morganella morganii; Neisseria gonorrhoeae (including penicillinase-producing strains), Neisseria meningitidis; Pasteurella spp., including Pasteurella canis, dagmatis, multocida; Proteus mirabilis, vulgaris; 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.; Peptostreptococcus; 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. Pharmacokinetics: After oral administration, levofloxacin is rapidly and almost completely absorbed. Food has little effect on the rate and completeness of absorption. Bioavailability is approximately 99% after administration of 500 mg of levofloxacin. After a single dose of 250 mg of levofloxacin, Cmax is 2.8±0.4 mcg/mL, Tmax is 1.6±1.0 h, and half-life is 7.3±0.9 h. The pharmacokinetic characteristics after administration of 500 mg of levofloxacin are respectively: Cmax is 5.1±0.8 mcg/mL, Tmax is 1.8±0.6 h, and half-life is 6.3±0.6 h. After a 60-minute intravenous infusion of 500 mg of levofloxacin in healthy volunteers, the mean peak plasma concentration was 6.2 mcg/mL. The pharmacokinetic characteristics after a single intravenous administration of 500 mg of levofloxacin are respectively: Cmax is 6.2±1.0 mcg/mL, Tmax is 1.0±0.1 h, and half-life is 6.4±0.7 h. The pharmacokinetics of levofloxacin are linear and predictable with single and multiple dosing. The plasma concentration profile after intravenous administration of levofloxacin is analogous to that of tablets, making oral and intravenous routes interchangeable. The volume of distribution after single and multiple intravenous administrations of 500 mg of levofloxacin is 89-112 L. It is bound to plasma proteins by 30-40%. The mean half-life of levofloxacin with single or multiple use is 6-8 h. Levofloxacin is well distributed into organs and tissues: lungs, bronchial mucosa, sputum, reproductive organs, including the prostate gland, bone tissue, cerebrospinal fluid, polymorphonuclear leukocytes, alveolar macrophages. Levofloxacin is excreted unchanged in the urine. A small portion is metabolized in the liver by oxidation and/or deacetylation. Approximately 87% of the dose is excreted unchanged in the urine within 48 hours after oral administration. Less than 4% is found in feces after 72 hours. Indications Infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin: intra-abdominal infections; exacerbation of chronic bronchitis; community-acquired pneumonia; prostatitis; acute sinusitis; uncomplicated urinary tract infections; bacteremia/septicemia (associated with indications); complicated urinary tract infections (including pyelonephritis); soft tissue and skin infections. Dosage and Administration LEVODEX tablets are taken orally during meals or between meals. The daily dose can be divided into 2 doses. Tablets should be swallowed whole. Drink with 0.5-1 glass of water. Levofloxacin is administered intravenously by drip infusion (0.5 g twice daily, depending on the severity of symptoms). The dosage regimen depends on the severity of the disease, the sensitivity of microorganisms, and the course of the pathological process. In adults with normal or slightly reduced renal function (creatinine clearance ≤ 50 mL/min), the following therapeutic regimen is used: Sinusitis - 500 mg once daily, duration of treatment is 10-14 days; Community-acquired pneumonia - 500 mg once or twice daily; duration of treatment is 7-14 days; Exacerbation of chronic bronchitis - 250 mg once daily, duration of treatment is 7-14 days; Prostatitis - 500 mg once daily; duration of treatment is 28 days; Complicated urinary tract infections (including pyelonephritis) - 250 mg once daily, duration of treatment is 7-10 days; Uncomplicated urinary tract infections - 250 mg once daily; duration of treatment is 3 days; Bacteremia or septicemia - treatment begins with intravenous infusion of levofloxacin and continues with oral forms: 500 mg or 250 mg levofloxacin once or twice daily, course of treatment is 1-2 weeks; Skin and soft tissue infections - 250 mg once daily for 1-2 weeks or 500 mg once or twice daily for 1-2 weeks; Intra-abdominal infections - 500 mg or 250 mg once daily, course of treatment is 1-2 weeks; Other antimicrobial agents with activity against anaerobic pathogens should be administered additionally during treatment. When taking the drug, the rule that applies to all antibacterial agents should be considered: tablet intake should continue for at least 48-72 hours after confirmed elimination of the pathogen and normalization of temperature. The dosage of the drug changes if the patient has impaired renal function. Creatinine clearance 20-50 mL/min: 250 mg once daily: initial dose is 250 mg once daily, then 125 mg; or 500 mg once daily: initial dose is 500 mg once daily, then 250 mg; or daily dose of 1 g in two divided doses: initial dose is 500 mg, then 250 mg; Creatinine clearance 10-19 mL/min: 250 mg once daily: initial dose is 250 mg once daily, then 125 mg every 48 hours; 500 mg once daily: initial dose is 500 mg once daily, then 125 mg once daily; daily dose of 1 g in two divided doses: initial dose is 500 mg, then 125 mg every 12 hours; Creatinine clearance < 10 mL/min and patients on dialysis (including continuous ambulatory peritoneal dialysis): 250 mg once daily: initial dose is 250 mg once daily, then 125 mg every 48 hours; 500 mg once daily: initial dose is 500 mg once daily, then 125 mg once daily; daily dose of 1 g in two divided doses: initial dose is 500 mg, then 125 mg once daily. Additional levofloxacin doses are not required after continuous ambulatory peritoneal dialysis or hemodialysis. Dose adjustment is not necessary in elderly patients, except in cases of reduced creatinine clearance. No special dose selection or regimen is required in case of impaired liver function, as levofloxacin hemihydrate is only metabolized to a small extent in the liver. Overdose: Symptoms of levofloxacin overdose develop on the part of the central nervous system (confusion, dizziness, impaired consciousness, and seizures). In addition, gastrointestinal disorders (e.g., nausea) and mucosal lesions are observed; QT interval prolongation (observed in studies using doses higher than therapeutic). Symptomatic treatment. Levofloxacin is not removed by hemodialysis and peritoneal dialysis. There is no specific antidote. Contraindications: Individual intolerance to levofloxacin or other quinolones (including hypersensitivity in history); epilepsy; tendon damage during previous treatment with quinolones; children or adolescents in the growth stage (up to 18 years), due to possible damage to articular cartilage; pregnancy; breastfeeding period. Pregnancy: Levofloxacin is not prescribed during pregnancy and breastfeeding. Side Effects: Skin reactions and general hypersensitivity reactions. Sometimes: itching and skin hyperemia. Rarely: general hypersensitivity reactions (anaphylactic and anaphylactoid reactions), including urticaria, bronchospasm and difficulty breathing, as well as - in rare cases - swelling of the skin and mucous membranes (e.g., in the face and throat area). Very rarely: sudden decrease in blood pressure and shock; increased sensitivity to sunlight and ultraviolet radiation. In some cases: severe skin rash with blistering, e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema. General hypersensitivity reactions are sometimes preceded by mild skin reactions. The reactions listed above can develop with the very first dose of levofloxacin, within minutes or hours. Effects on the gastrointestinal tract and metabolism. Often: nausea, diarrhea. Sometimes: loss of appetite, vomiting, abdominal pain, indigestion. Rarely: bloody diarrhea, which in very rare cases may be a symptom of intestinal inflammation and/or pseudomembranous colitis. Very rarely: decrease in blood glucose levels (hypoglycemia), which is particularly important for patients with diabetes; possible signs of hypoglycemia: "wolf hunger", nervousness, sweating, tremor. Experience with other quinolones indicates that they can cause exacerbation of porphyria in patients already suffering from this disease. A similar effect cannot be ruled out with levofloxacin. Effects on the nervous system. Sometimes: headache, dizziness or/and tightness, drowsiness, sleep disturbances. Rarely: unpleasant sensations (e.g., paresthesia in the limbs), tremor, anxiety, fear, seizures, and impaired cognition. Very rarely: disturbances of vision, hearing, taste, and smell, decreased tactile sensitivity, psychotic reactions in the form of hallucinations and depression, as well as movement disorders, including gait disturbances. Effects on the cardiovascular system. Rarely: increased heart rate, decreased blood pressure. Very rarely: vascular collapse (shock-like). Effects on muscles, tendons, and bones. Rarely: tendon damage (including tendinitis), joint and muscle pain. Very rarely: tendon rupture (e.g., Achilles tendon); this side effect can develop within 48 hours of starting treatment and be bilateral; muscle weakness, which is particularly important for patients with myasthenia gravis. In some cases: muscle damage (rhabdomyolysis). Effects on the liver and kidneys. Often: increased activity of liver enzymes (e.g., alanine aminotransferase and aspartate aminotransferase). Sometimes: increased levels of bilirubin and creatinine in serum (sign of impaired liver or kidney function). Very rarely: liver reactions (e.g., hepatitis); impaired kidney function up to the development of acute renal failure, e.g., as a result of allergic reactions (interstitial nephritis). Hematopoietic system. Sometimes: increased number of certain blood cells (eosinophilia), decreased number of white blood cells (leukopenia). Rarely: decreased number of certain types of white blood cells (neutropenia); decreased number of platelets (thrombocytopenia), which can increase the risk of bruising or bleeding. Very rarely: acute decrease in the number of certain types of white blood cells (agranulocytosis), which contributes to the development of severe symptoms of the disease (persistent or recurrent increase in body temperature, sore throat, and deterioration of health). In some cases: decreased number of red blood cells due to their hemolysis (hemolytic anemia); decreased number of all types of blood cells (pancytopenia). Other side effects. Sometimes general weakness (asthenia). Very rarely: fever, allergic reactions in the lungs (allergic pneumonia) or at the level of small blood vessels (vasculitis). Any antibacterial therapy can cause changes in the normal microflora (bacteria and fungi) in the human body. As a result, resistant bacteria and fungi (secondary infection) may develop against the antibiotic used, which in rare cases may require additional treatment. Special Instructions and Precautions: Levofloxacin is not used in children and adolescents due to the high risk of damage to articular cartilage. When used in elderly patients, it should be considered that impaired renal function is common in this group of patients. Levofloxacin may not provide optimal therapeutic effect in severe pneumonia caused by Streptococcus pneumoniae. Hospital infections caused by certain pathogens (Pseudomonas aeruginosa) may require combination therapy. Seizures may occur with levofloxacin in patients with a history of brain damage, e.g., after stroke or severe trauma. Convulsive readiness may increase with the simultaneous use of fenbufen, similar non-steroidal anti-inflammatory drugs, or theophylline. Although photosensitization (increased sensitivity to light with burn-like reactions) is very rare with levofloxacin, it is recommended to avoid excessive sun exposure or artificial UV radiation (e.g., sun exposure in the mountains or visiting a solarium). In case of suspected pseudomembranous colitis, levofloxacin should be discontinued and appropriate treatment initiated. In such cases, the use of intestinal motility-inhibiting agents is not allowed. Tendinitis, which rarely develops with levofloxacin, can lead to tendon rupture. The risk of tendinitis is higher in the elderly. Treatment with corticosteroids increases the risk of tendon rupture. In case of suspected tendinitis, levofloxacin should be discontinued and appropriate treatment initiated, e.g., by ensuring rest for the affected tendon (immobilization). In patients with glucose-6-phosphate dehydrogenase deficiency, lysis of red blood cells (hemolysis) may occur with the use of quinolones. Levofloxacin is prescribed with particular caution in such patients. In patients with diabetes, the possibility of developing hypoglycemia, with symptoms such as "wolf hunger", nervousness, sweating, tremor, should be considered when prescribing levofloxacin. Levofloxacin treatment should continue for at least 48-78 hours after temperature normalization and confirmed eradication of the pathogen. If a dose is missed, take the missed dose as soon as possible, then continue treatment according to the prescribed regimen. Effect of the drug on the ability to drive and operate machinery: Side effects of levofloxacin, such as dizziness, stupor, drowsiness, and visual disturbances, can impair concentration, which poses a particular risk in situations where this ability is particularly important (e.g., driving vehicles and operating machinery, performing work in unstable positions). This also applies to the interaction of levofloxacin with alcohol to some extent. Interaction with other medicinal products: The effect of levofloxacin is significantly reduced when co-administered with aluminum and magnesium antacids, sucralfate, and iron-containing preparations. Therefore, the interval between these preparations should be at least 2 hours. Like other quinolones, levofloxacin significantly reduces the threshold for convulsive readiness of anticonvulsant drugs. The threshold for convulsive readiness may also be reduced with the simultaneous use of fenbufen, similar non-steroidal anti-inflammatory drugs, or theophylline. Renal clearance of levofloxacin is reduced with the simultaneous use of probenecid and cimetidine. Clinically, this is only manifested if the patient has renal failure (prescribed with caution). The risk of tendon rupture is significantly increased with the use of glucocorticosteroids. The half-life of cyclosporine increases during the use of levofloxacin. Dosage Form 500 mg/100 ml infusion solution in a 100 ml vial containing 0.5 g of active ingredient. 250 mg and 500 mg tablets 6 tablets in a blister. Storage Conditions Tablets should be stored in a dry, light-protected place at a temperature not exceeding 25°C. Keep out of reach of children. Infusion solution should be stored in a dry, light-protected place at a temperature not exceeding 25°C. Keep out of reach of children. Do not use if the container is damaged. Expiration Date Tablets - 3 years; infusion solution - 3 years, provided storage conditions are met. Dispensing Rule Pharmaceutical product group II, dispensed by prescription N3. Manufacturer LLC "Ultra Laboratories" ULTRA LABORATORIES PVT. LTD Plot No 102-B & 102-B (P-1). SEZ Pharma, KIADB Industrial Estate Hassan -573201 Karnataka, India