Description
Release form
Film-coated tablets
Packing
5 pcs.
Pharmacological action
Levofloxacin is a synthetic broad-spectrum fluoroquinolone. Inhibits DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts the supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes deep morphological changes in the cytoplasm, cell wall and membranes of sensitive microorganisms.
Levofloxacin is effective against most strains of the following microorganisms:
aerobic gram-positive microorganisms – Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (leukotoxin-containing and coagulase-negative methicillin-sensitive / moderately sensitive strains, including methicillin-sensitive strains of Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus spp. resistant strains of Streptococcus pneumoniae, penicillin-sensitive / resistant strains of Streptococcus viridans group)
aerobic gram-negative microorganisms – Acinetobacter spp. (including Acinetobacter baumanii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus spp. (including Haemophilus ducreyi, Haemophilus parainfluenzae, ampicillin-sensitive / resistant strains of Haemophilus influenzae), Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis (strains producing and non-producing beta-lactamase), Morganella morganii, Neisseria spp. (including Neisseria meningitidis producing and non-producing penicillinase strains of Neisseria gonorroeae), Pasteurella spp. (including Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus spp. (including Proteus mirabilis, Proteus vulgaris), Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp. (including Serratia marcescens), Salmonella spp.
anaerobic microorganisms – Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterum spp., Veilonella spp.
other microorganisms – Bartonella spp., Chlamydia spp. (including Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis), Legionella pneumophila, Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma spp. (including Mycoplasma hominis, Mycoplasma pneumoniae), Rickettsia spp., Ureaplasma urealyticum.
Sustainable microorganisms:
aerobic gram-positive microorganisms – Corynebacterium jeikeium, Staphylococcus spp.
Indications
Infectious and inflammatory diseases of mild to moderate severity caused by microorganisms sensitive to the drug: lower respiratory tract infections (pneumonia, exacerbation of chronic bronchitis)
acute bacterial sinusitis
urinary tract and kidney infections (including acute pyelitis) soft tissues (suppurating atheromas, abscesses, boils)
chronic bacterial prostatitis
intra-abdominal infection (in combination with antibacterial drugs, d ystvuyuschimi anaerobic microflora)
tuberculosis (in the complex therapy of drug-resistant forms).
Contraindications
hypersensitivity to levofoxacin, other fluoroquinolones, or other components of the drug in the history of
epilepsy
tendon damage associated with taking quinolones in the history of
childhood 18 years of age and up to 18 years of age.
Precautions – advanced age (high likelihood of having a concomitant decrease in kidney function), glucose-6-phosphate dehydrogenase deficiency.
Special instructions
After normalization of body temperature, it is recommended to continue treatment for at least 48 72 hours. Levofloxacin is taken at least 2 hours before or 2 hours after taking magnesium / aluminum or sucralfate antacids, or other preparations containing calcium, iron or zinc. Due to possible photosensitization during the treatment period and within 5 days after the end of treatment with levofloxacin, it is necessary to avoid solar and artificial UV radiation. With the development of phototoxicity, drug treatment should be discontinued. When signs of tendonitis and pseudomembranous colitis appear, levofloxacin is immediately canceled. 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, a risk of hemolytic reactions is possible. In patients with diabetes mellitus during treatment with levofloxacin should carefully monitor the level of glucose in the blood. With the simultaneous use of levofloxacin and warfarin, monitoring of PV, INR or other anticoagulation tests is indicated, as well as monitoring of signs of bleeding. While taking levofloxacin, the patient s ability to concentrate and the speed of psychomotor reactions may be impaired. In this regard, care must be taken when driving vehicles and engaging in other potentially dangerous activities. After normalizing body temperature, it is recommended to continue treatment for at least 48 72 hours. Levofloxacin is taken at least 2 hours before or 2 hours after taking magnesium antacids / aluminum or sucralfate, or other preparations containing calcium, iron or zinc. Due to possible photosensitization during the treatment period and within 5 days after the end of treatment with levofloxacin, it is necessary to avoid solar and artificial UV radiation. With the development of phototoxicity, drug treatment should be discontinued. When signs of tendonitis and pseudomembranous colitis appear, levofloxacin is immediately canceled. 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, a risk of hemolytic reactions is possible. In patients with diabetes mellitus during treatment with levofloxacin should carefully monitor the level of glucose in the blood. With the simultaneous use of levofloxacin and warfarin, monitoring of PV, INR or other anticoagulation tests is indicated, as well as monitoring of signs of bleeding. While taking levofloxacin, the patient s ability to concentrate and the speed of psychomotor reactions may be impaired. In this regard, care must be taken when driving vehicles and engaging in other potentially hazardous activities.
Composition
1 tab. contains:
active substance: levofloxacin hemihydrate 780.26 mg (corresponding to 750 mg of levofloxacin)
excipients: corn starch – 71.96 mg MCC – 60.5 mg povidone K30 – 7.5 mg methyl parahydroxybenzoate – 0, 9 mg propyl parahydroxybenzoate – 0.18 mg purified talc – 19.5 mg magnesium stearate – 9.6 mg sodium carboxymethyl starch – 9.6 mg
film coat: hypromellose talc purified macrogol 6000 titanium dioxide dye ² ÑSunny sunset ² Ñ yellow
Dosage and administration
Inside, before meals or between meals, without chewing, with plenty of water.
In adult patients with normal renal function (creatinine Cl> 50 ml / min), use in accordance with the schemes shown in the table: Hospital pneumonia 750 mg 1 time / day. 7-14 days
Community-acquired pneumonia 500 mg 12 times / day. 7-14 days 750 mg 1 time / day. 5 * days
Exacerbation of chronic bronchitis 500 mg 1 time / day. 7 days
Acute bacterial sinusitis 500 mg 1 time / day. 10-14 days 750 mg 1 time / day. 5 days
Uncomplicated urinary tract infections 250 mg 1 time / day. 3 days
Complicated urinary tract infections, including acute pyelonephritis 250 mg 1 time / day. 10 ** days 750 mg 1 time / day. 5 *** days
Uncomplicated infections of the skin and subcutaneous tissue 500 mg 1 time / day. 7-10 days
Complicated infections of the skin and subcutaneous tissues 750 mg 1 time / day. 7-14 days
Chronic bacterial prostatitis 500 mg 1 time / day. 28 days
Intraabdominal infection (in combination with antibacterial drugs acting on anaerobic microflora) 500 mg 1 time / day. 7-14 days
Tuberculosis (as part of complex therapy of drug-resistant forms) 750 mg 1 time / day. up to 3 months
* This regimen is indicated for the treatment of community-acquired pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae.
** This regimen is indicated for the treatment of urinary tract infections caused by Enterococcus faecalis, Enterococcus cloacae, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and acute pyelonephritis caused by Escherichia coli.
*** This regimen is indicated for the treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and acute pyelonephritis caused by Escherichia coli, including cases with concomitant bacteremia.
Side effects
From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, motor disorders, cramps.
On the part of the sensory organs: impaired vision, hearing, smell, taste and tactile sensitivity.
From the CCC side: decreased blood pressure, vascular collapse, tachycardia, lengthening of the QT interval, atrial fibrillation.
From the digestive system: nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis, increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis, dysbiosis.
From the side of metabolism: hypoglycemia (increased appetite, increased sweating, trembling, nervousness).
From the musculoskeletal system: arthralgia, muscle weakness, myalgia, rhabdomyolysis, tendon rupture, tendonitis.
From the urinary system: hypercreatininemia, interstitial nephritis, acute renal failure.
From the hemopoietic organs: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhage.
Allergic reactions: itching and hyperemia of the skin, swelling of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospasm, suffocation, anaphylactic shock, allergic pneumonitis.
Other: photosensitization, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.
Drug Interactions
Levofloxacin increases the half-life of cyclosporine. The effect of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, aluminum or magnesium-containing antacid drugs and iron preparations. NSAIDs and theophylline when used simultaneously with levofloxacin increase the risk of seizures in predisposed patients, and corticosteroids increase the risk of tendon rupture. With the simultaneous administration of levofloxacin with hypoglycemic drugs, changes in blood glucose levels are possible, including hyperglycemia and hypoglycemia. Levofloxacin enhances the effect of warfarin. Cimetidine and drugs blocking tubular secretion slow down the excretion of levofloxacin.
Storage Conditions
In a dry, dark place at 8 25 ° C.
Deystvuyuschee substances
Levofloxacin
drugstore terms and conditions
prescription
Dosage form
tablet
Highglans Laboratories Pvt. Co., Ltd.
