Glevo, 500 mg 5 pcs.
€1.56 €1.42
Pharmacotherapeutic group
Antimicrobial agent – fluoroquinolone
b>Pharmacodynamics
A broad-spectrum antibacterial drug of the fluoroquinolone group. Levofloxacin blocks DNA-enzyme (topoisomerase II) and topoisomerase IV, breaks superspiralization and cross-linking of DNA breaks, inhibits DNA synthesis, causes deep morphological changes in cytoplasm, cell wall and membranes of microorganisms.
The drug is active against aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp.Staphylococcus aureus (methicillin-sensitive/methicillin-moderately sensitive strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Streptococcus spp. group 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. Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-producing ?-lactamases), Morganella morganii, Neisseria gonorrhoeae (producing and non-producing penicillinase), Neisseria meningitidis, Pasteurella spp. (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
absorption
Ingestion is fast and almost completely absorbed. Food intake has little effect on the speed and completeness of absorption. Bioavailability is 99%. Tmax is 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.
Distribution
The binding to plasma proteins is 30-40%. It penetrates well into organs and tissues (lungs, bronchial mucosa, sputum, urogenital organs, polymorphonuclear leukocytes, alveolar macrophages).
Metabolism
In the liver, a small portion of the drug is oxidized and/or deacetylated.
Elimation
Renal clearance is 70% of total clearance. T1/2 is 6-8 h. It is excreted mainly by the kidneys by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. After oral administration about 70% of the dose is excreted unchanged in the urine within 24 hours, about 87% of the dose – within 48 hours; less than 4% – with the feces within 72 hours.
Indications
Sinusitis, maxillary sinusitis, bronchitis, respiratory tract infections, prostatitis, tuberculosis, urinary tract infections, skin infections, pneumonia, furuncles Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
– ENT-organ infections (including acute sinusitis)
– lower respiratory tract infections (including acute sinusitis).Infections of the ENT-organs (including acute sinusitis);
– Lower respiratory tract infections (including Acute exacerbation of chronic bronchitis, community-acquired pneumonia);
– Uncomplicated and complicated infections of the urinary tract and kidneys (including Infections of genitals;
– Skin and soft tissue infections (suppurated atheromas, abscesses, furunculosis);
– Abdominal infections (in combination with drugs acting on anaerobic microflora).
Active ingredient
Levofloxacin
Composition
Levofloxacin (as hemihydrate)500 mg
Associates: Microcrystalline cellulose, povidone (K-30), crosspovidone, magnesium stearate, microcrystalline cellulose (avicel pH101).
Composition of film coating: Hypromellose, macrogol (polyethylene glycol 6000), dibutyl phthalate, talc, titanium dioxide, iron oxide red dye, iron oxide yellow dye.
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How to take, the dosage
The drug is taken orally 1-2 Tablets should be swallowed whole, without chewing and with plenty of liquid (0.5 to 1 cup). The drug may 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.
In patients with normal or moderately reduced renal function (CK > 50 ml/min) the following dosage regimen is recommended.
In sinusitis patients are prescribed by 500 mg once a day during 10-14 days.
In exacerbation of chronic bronchitis – by 250 mg or 500 mg once a day during 7-10 days.
In community-acquired pneumonia – 500 mg 1-2 times for 7-14 days.
In uncomplicated urinary tract infections – 250 mg once/ for 3 days.
In prostatitis – 500 mg once/ for 28 days.
In complicated urinary tract infections, including pyelonephritis – 250 mg once daily for 7-10 days.
In infections of the skin and soft tissues – 250-500 mg once daily for 7-14 days.
In case of infections of the abdominal cavity – 500 mg once/ for 7-14 days (in combination with antibacterials acting on anaerobic flora).
The following dosing regimen is used in patients with impaired renal function.
After hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) no additional doses are required.
In patients with impaired hepatic function no special dosage adjustment is required because levofloxacin is metabolized only to a very small extent in the liver.
Interaction
In concomitant use levofloxacin increases T1/2 of cyclosporine.
The action of the drug is reduced by intestinal motility depressant drugs, sucralfate, aluminum/magnesium-containing antacid drugs and iron salts (a break of at least 2 hours between doses is necessary).
Concomitant use of Glevo with NSAIDs, theophylline increases seizure activity.
The simultaneous use of Glevo with GCS increases the risk of tendon rupture.
Cimetidine and drugs that block tubular secretion slow the excretion of levofloxacin.
The simultaneous use of hypoglycemic agents with levofloxacin may lead to hypo- and hyperglycemia. Therefore, strict control of blood glucose levels is necessary.
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Special Instructions
Although levofloxacin is more soluble than other quinolones, patients should be adequately hydrated.
At the time of treatment, sunlight and artificial UV exposure should be avoided to avoid damage to the skin (photosensitization).
In case of signs of tendinitis, pseudomembranous colitis, levofloxacin should be stopped immediately and appropriate therapy should be prescribed.
It should be noted that patients with a history of brain damage (stroke, severe trauma) may have seizures; with insufficiency of glucose-6-phosphate dehydrogenase the risk of hemolysis increases.
Influence on driving and operating machinery
At the time of treatment, caution should be exercised while driving motor transport and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.
Contraindications
– epilepsy;
– tendon affection in previous treatment with quinolones;
– pregnancy;
– lactation (breastfeeding);
– childhood and adolescence (under 18 years);
– hypersensitivity to levofloxacin and other fluoroquinolones.
With caution the drug should be administered in elderly patients (due to high possibility of accompanying renal function decrease), with glucose-6-phosphate dehydrogenase deficiency.
Side effects
Digestive system: nausea, vomiting, diarrhea (including blood), indigestion, decreased appetite, abdominal pain, pseudomembranous enterocolitis, increased liver transaminases activity, hyperbilirubinemia, hepatitis, dysbacteriosis.
Cardiovascular system: decreased BP, vascular collapse, tachycardia, prolongation of QT interval, very rarely – atrial fibrillation.
Endocrine system: hypoglycemia (increased appetite, increased sweating, trembling, nervousness).
CNS and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, motor disorders, epileptic seizures (in predisposed patients).
Senses: disorders of vision, hearing, smell, taste and tactile sensitivity.
Musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.
Urinary system: hypercreatininemia, interstitial nephritis, acute renal failure.
Blood system: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.
Allergic reactions: itching and hyperemia of the skin, swelling of the skin and mucous membranes, urticaria, erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal.
Overdose
Nausea, gastrointestinal mucosal erosions, QT interval prolongation, confusion, dizziness, seizures.
Pregnancy use
Glevo is contraindicated in children under 18 years of age, as well as in pregnancy and lactation.
Similarities
Signicef, Tavanic, Oftavix, Flexid, Levolet R, Levofloxacin-Teva, Glevo, Haileflox, Leflobakt, L-Optik Rompharm, Levofloxacin, Korfecin
Weight | 0.060 kg |
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Shelf life | 2 years |
Conditions of storage | Storage temperature from 2℃ to 25℃ |
Manufacturer | Glenmark Pharmaceuticals Ltd, India |
Medication form | pills |
Brand | Glenmark Pharmaceuticals Ltd |
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