Glevo coated pills 500mg N5
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Active ingredients
Levofloxacin
Release form
Pills
Composition
Levofloxacin (levofloxacin) 500 mg
Pharmacological effect
Antibacterial drug group fluoroquinolone broad-spectrum. Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, violates the supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes of microorganisms. . (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative, including methicillin-sensitive / methicillin-moderately sensitive strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive / moderately sensitive / resistant strains), Streptococcus pyogenes, Streptococcus viridans (penicillin-moderately sensitive / resistant strains); aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive / resistant strains), Haemophilus parainfluenzae, in-the-art, in-the-art, resistant, resistant strains, in-place, in-place, in-place, in-place, in Haemophilus influenzae (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-producing β-lactamases), Morganella morganii, Neisseria gonorrhoeae (producing and non-producing penicillinase), Neisseria meningiideisitisideis izide idiis, itidus iecide, itidazide, itimenthiote, iis, and nepherosis (Klebsiella pneumoniae pneumoniae) (including Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Salmonella spp., Serratia spp. (including Serratia marcescens); anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veilonella spp .; other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.
Pharmacokinetics
AbsorptionWhen ingestion is quickly and almost completely absorbed. Food intake has little effect on the speed and completeness of absorption. Bioavailability - 99%. Tmax - 1-2 hours. When taking the drug in doses of 250 mg and 500 mg Cmax is 2.8 mcg / ml and 5.2 mcg / ml, respectively. The distributionBinding to plasma proteins is 30-40%. It penetrates well into organs and tissues (lungs, bronchial mucosa, sputum, organs of the urogenital system, polymorphonuclear leukocytes, alveolar macrophages). Metabolism In the liver, a small part of the drug is oxidized and / or deacetylated. Injection The kidney clearance is 70% of the total clearance. T1 / 2 - 6-8 h. Excreted mainly by the kidneys by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites.After ingestion, about 70% of the dose is excreted in the urine in unchanged form within 24 hours, about 87% of the dose - within 48 hours; less than 4% - with feces within 72 hours
Indications
Levofloxacin-sensitive bacterial infections in adults: - acute sinusitis; - exacerbation of chronic bronchitis; - community-acquired pneumonia; - uncomplicated urinary tract infections; - complicated urinary tract infections (including pyelonephritis); - chronic bacterial prostatitis; - skin infections and infections of the urinary tract; tissues; - septicemia / bacteremia associated with the above indications; - infections of the abdominal cavity; - for the integrated treatment of drug-resistant forms of tuberculosis.
Contraindications
Hypersensitivity to levofloxacin and other fluoroquinolones, epilepsy, affection of the tendons with the previously conducted treatment with quinolones, pregnancy, lactation, children and adolescents (under 18).
Precautionary measures
The drug should be prescribed with caution to elderly patients (due to the high probability of the presence of a concomitant reduction in renal function), with a deficiency of glucose-6-phosphate dehydrogenase.
Use during pregnancy and lactation
The use of the drug is contraindicated in pregnancy and lactation.
Dosage and administration
The drug is taken orally once or twice a day. Tablets should be swallowed whole, without chewing and washing down with enough liquid (from 0.5 to 1 cup). The drug can be taken before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. Patients with normal or moderately reduced kidney function (creatine clearance> 50 ml / min) are recommended the following dosage regimen: Sinusitis: 500 mg 1 time per day - 10-14 days Exacerbation of chronic bronchitis: 250 mg or 500 mg 1 per day - 7-10 days. Community-acquired pneumonia: 500 mg 1-2 times per day - 7-14 days. Uncomplicated urinary tract infections: 250 mg 1 time per day - 3 days. Prostatitis - 500 mg 1 time per day - 28 days. Complicated urinary tract infections, including pyelonephritis - 250 mg 1 time per day - 7-10 days. Infections of the skin and soft tissues: 250-500 mg 1-2 times in day - 7-14 days. Intraabdominal infection: 500 mg 1 time per day - 7-14 days (in combination with antibacterial drugs,acting on anaerobic flora). Dosing regimen for patients with impaired renal function: Creatine clearance 250 mg / 24h 500mg / 24h 500mg / 12h first dose: 250mg first dose: 500mg first dose: 500mg50 - 20 ml / min then: 125mg / 24h after : at 250mg / 24h then: at 250mg / 12h19 - 10 ml / min then: at 125mg / 48h then: at 125mg / 24h then: at 125mg / 12h <10 ml / min (including hemodialysis and CAPD) then: at 125mg / 48h then: at 125mg / 24h then: at 125mg / 24hAfter hemodialysis or permanent ambulatory peritoneal dialysis (CAPD), no additional doses are required. If there is no abnormal liver function for special dose selection, since levofloxacin is metabolized in the liver only to a very minor extent. Elderly patients do not need to change the dosing regimen, except in cases of low creatinine clearance. As with other antibiotics, Glevo pills are film-coated, 250mg and 500mg is recommended to continue for at least 48-78 hours after normalization of body temperature or after reliable eradication of the pathogen. If you miss the drug, you should as soon as possible Do not take a pill until the time of the next intake is near. Then continue to take the drug according to the scheme.
Side effects
The following side effects are presented in accordance with the following gradations of the frequency of their occurrence: very frequent (≥1 / 10), frequent (≥ 1/100, <1/10); infrequent (≥1 / 1000, <1/100); rare (≥1 / 10000, <1/1000; very rare (<1/10000) (including individual messages), unknown frequency (according to the available data, it is not possible to determine the frequency of occurrence). Data from clinical studies of levofloxacin Heart disordersRare: sinus tachycardia Unknown frequency: prolongation of the Q-T interval Disorders in the blood and lymphatic system Infrequent: leukopenia (decrease in the number of leukocytes in peripheral blood), eosinophilia (increase in the number of eosinophils in peripheral blood). Rare: neutro singing (reducing the number of neutrophils in the peripheral blood), thrombocytopenia (reducing the number of platelets in the peripheral blood). Unknown frequency: pancytopenia (reducing the number of all formed elements in the peripheral blood), agranulocytosis (absence or sharp decrease in the number of granulocytes in the peripheral blood), hemolytic anemia . Nervous system disorders: Frequent: headache, dizziness Mild: drowsiness, tremor, dysgeusia (taste perversion). Rare: paresthesia,convulsions Unknown frequency: peripheral sensory neuropathy, peripheral sensorimotor neuropathy, dyskinesia, extrapyramidal disorders, loss of taste, paromcia (disorder, sensation of smell, especially the subjective sensation of smell, which is objectively absent), including loss of smell, sight. as a vagueness of the visible image. Violations of the hearing and labyrinth disorders Infrequent: vertigo (feeling of deviation or whirling or with of the body or surrounding objects). Rare: tinnitus Unknown frequency: hearing loss Disruptions in the respiratory system, organs of the chest and mediastinum Frequent: dyspnea Unknown frequency: bronchospasm, allergic pneumonitis. abdominal dyspepsia. Unknown frequency: hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis. Kidney and urine disorders excretory tract. Particular: elevated serum creatinine concentration. Rare: acute renal failure (for example, due to the development of interstitial nephritis). Disorders of the skin and subcutaneous tissues. erythema, photosensitivity reactions (hypersensitivity to solar and ultraviolet radiation), leukocytoclastic vasculitis). Reactions from the skin and mucus sometimes even the first dose of the drug can develop. Disorders of the musculoskeletal system and connective tissue Infrequent: arthralgia, myalgia. Rare: tendon damage, including tendinitis (eg, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudo-paralytic myasthenia (myasthenia gravis). Unknown frequency: rhabdomyolysis, tendon rupture (for example, Achilles tendon). This side effect can occur within 48 hours after the start of treatment and can be bilateral. Disorders of metabolism and nutrition. Infrequent: anorexia. Rare: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: wolfish appetite, nervousness, perspiration. , tremors). Infectious and parasitic diseases Infrequent: fungal infections,development of resistance of pathogenic microorganisms. Vascular disorders Rare: decrease in blood pressure. General disorders Infrequent: astheniaRare: pyrexia (fever) Disorders of the immune system Rare: angioedema edema Unknown frequency: anaphylactic shock, anaphylacoididirophiopiopaea, anaphylacoididirophiosis, anaphylacoididistoxis, anaphylacoididistoxis, anaphylacoidid, anaphylacoididis, anaphylacoidid, anaphylacoidid, anephioplasty can sometimes develop even after taking the first dose of the drug. Violations of the liver and biliary tract Frequent: an increase in the activity of "hepatic x "enzymes in the blood (for example, alanine aminotransferase (AlAT), aspartate aminotransferase (AsAT)). Infrequent: elevated concentrations of bilirubin in the blood. Unknown frequency: severe hepatic failure, including cases of acute liver failure, especially in patients with severe underlying disease (eg in sepsis); Hepatitis. Psychiatric Disorders. Frequent: insomnia: Mild: anxiety, confusion. Rare: mental disorders (for example, with hallucinations), depression, agitation (arousal), sleep disturbances, nightmares. Unknown frequency: mental disorders with behavioral disturbances with self-harm, including suicidal thoughts and suicidal attempts. Other possible adverse effects related to all fluoroquinolones. Very rare: bouts of porphyria (a very rare metabolic disease) in patients already suffering from this disease. by the
Overdose
Symptoms: nausea, erosive lesions of the gastrointestinal mucosa, lengthening of the QT interval, confusion, dizziness, convulsions. Treatment: symptomatic therapy is carried out, dialysis is not effective.
Interaction with other drugs
With the simultaneous use of levofloxacin increases T1 / 2 cyclosporine. The drug reduces the effect of oppressing intestinal motility, sucralfate, aluminum / magnesium-containing antacid medicines and iron salts (a break between taking at least 2 hours is necessary). When using Glevo with NSAID, theophylline convulsive readiness increases. With simultaneous use of Glevo with GCS, the risk of tendon rupture increases. Tsimetidin and preparations that block tubular secretion, slow down the elimination of levoflok Satsina. With simultaneous use of hypoglycemic drugs with levofloxacin, the development of hypo-and hyperglycemia. Therefore, strict control of blood glucose is necessary.
special instructions
Although levofloxacin is more soluble than other quinolones, patients should be adequately hydrated. During treatment, sun and artificial UV irradiation should be avoided to avoid damage to the skin (photosensitization). If signs of tendinitis develop, pseudomembranous colitis levofloxacin is immediately canceled and appropriate therapy is given .It should be borne in mind that patients with a history of brain damage (stroke, severe injury) may develop seizures; and glucose-6-phosphate dehydrogenase increases the risk of hemolysis. Impact on the ability to drive vehicles and control mechanisms. During the period of treatment, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require high concentration of attention and quickness of psychomotor reactions.