Levofloxacin tablets 500mg, No. 10

Infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin:

• lower respiratory tract infections (exacerbation of chronic bronchitis, community-acquired pneumonia);

• acute maxillary sinusitis;

• uncomplicated urinary tract infections;

• complicated urinary tract infections (including acute pyelonephritis);

• infections of the skin and soft tissues (festering atheroma, abscess, boils);

• chronic bacterial prostatitis;

• intra-abdominal infection;

• complex therapy of drug-resistant forms of tuberculosis.

The drug should be taken orally during meals or between meals, without chewing, drinking plenty of fluids.

Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

The recommended dose for adults with normal renal function (creatinine clearance (CC)> 50 ml / min): in acute bacterial sinusitis - 500 mg once a day for 10-14 days;

with exacerbation of chronic bronchitis - 250-500 mg once a day for 7-10 days;

with community-acquired pneumonia - 500 mg 1 or 2 times a day for 7-14 days;

for uncomplicated urinary tract and kidney infections - 250 mg once a day for 3 days;

for complicated urinary tract infections - 250 mg once a day for 7-10 days;

with chronic bacterial prostatitis - 500 mg once a day for 28 days;

with infections of the skin and soft tissues - 250-500 mg 1-2 times a day for 7-14 days;

intra-abdominal infections - 500 mg once a day - 7-14 days (in combination with antibacterial drugs acting on the anaerobic flora);

tuberculosis (complex therapy of drug-resistant forms) ~ 500 mg 1-2 times a day, the course of treatment is up to 3 months.

Additional doses are not required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

In case of impaired liver function, no special dose selection is required, since levofloxacin is only slightly metabolized in the liver and excreted mainly by the kidneys. If you missed taking the drug, you need to take the pill as soon as possible, until the time for the next dose is approaching. Then continue to take levofloxacin according to the scheme.

The duration of therapy depends on the type of disease (see above). In all cases, treatment should be continued from 48 to 72 hours after the disappearance of the symptoms of the disease.

1 tablet contains the active substance: levofloxacin hemihydrate in terms of levofloxacin - 250.00 mg or 500.00 mg.

• Hypersensitivity to levofloxacin or other fluoroquinolones, as well as to excipients of the drug,

• epilepsy,

• damage to the tendons with previous treatment with quinolones,

• pregnancy, lactation period,

• children and adolescents (up to 18 years old).

pharmachologic effect

Antimicrobial drug from the group of fluoroquinolones, levorotatory isomer of ofloxacin. Possesses a wide spectrum of antimicrobial action. Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and stitching of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall and membranes of bacteria. Effective against most strains of microorganisms in vitro and in vivo. Sensitive to the action of the drug: in vitro sensitive (minimum inhibitory concentration (MIC)? 2 mg / ml) aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative methicillin-susceptible / moderately susceptible strains),including Staphylococcus aureus (methicillin-susceptible strains), Staphylococcus epidermidis (methicillin-susceptible strains), Staphylococcus sp. (leukotoxin-containing); Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-susceptible moderately sensitive / resistant strains), Streptococcus pyogenes, Streptococcus spp. viridan groups (penicillin-susceptible / resistant strains); aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter spp. (including Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-susceptible / resistant strains),Haemophilus parainfl uenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (beta-lactamase-producing and non-beta-lactamase-producing strains), Morganella morganii, Neisseria gonorrhoeae (penicillinase-producing and non-penicillinase-producing strains), Neisseria metera (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), 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, Bifi dobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veilonella spp .; other microorganisms: Bartonella spp.,Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella spp. (including Legionella pneumophila), Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum. Moderately sensitive microorganisms (MIC ? 4 mg / l): aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticin-resistant strains; aerobic gram-negative microorganisms: Burkholderia cepacia, Campilobacter jejuni, Campilobacter coli; anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp., Porphyromonas spp. Resistant microorganisms (MIC ? 8 mg / l):aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp. (coagulase-negative methicillin-resistant strains); aerobic gram-negative microorganisms: Alcaligenes xylosoxidans; other microorganisms: Mycobacterium avium.

Side effects

From the digestive system: nausea, vomiting, diarrhea (including blood), indigestion, loss of appetite, abdominal pain, pseudomembranous colitis, increased activity of liver transaminases, hyperbilirubinemia, hepatitis, dysbiosis.

From the side of the cardiovascular system: decreased blood pressure, vascular collapse, tachycardia, increased QT interval on the cardiogram, atrial fibrillation.

From the side of metabolism: hypoglycemia (increased appetite, increased sweating, trembling, nervousness), hyperglycemia (dry mouth, thirst, increased urination, fatigue, blurred vision, dry or itchy skin, arrhythmia).

From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, anxiety, paresthesia in the hands, fear, hallucinations, confusion, depression, movement disorders, seizures, peripheral sensory neuropathy, peripheral sensory-motor neuropathy, mental disorders with self-harming behavioral disorders, including suicidal thoughts and attempts, extrapyramidal disorders, agitation (agitation), nightmares.

From the senses: impaired vision, hearing, smell, taste and tactile sensitivity, ringing in the ears.

From the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendonitis, rhabdomyolysis.

From the urinary system: hypercreatininemia, interstitial nephritis, acute renal failure.

From the side of hematopoiesis: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

Allergic reactions: itching and flushing of the skin, edema of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, anaphylactic shock, allergic pneumonitis, vasculitis.

Others: asthenia, exacerbation of porphyria, photosensitivity, persistent fever, leukocytoclastic vasculitis, development of superinfection.

Special conditions

The drug should be used at least 2 hours before or 2 hours after taking preparations of iron salts, zinc, antacids and sucralfate.

During treatment with the drug, it is necessary to avoid solar and artificial UV irradiation in order to avoid damage to the skin (photosensitization).

When signs of tendenitis, pseudomembrane colitis, allergic reactions appear, the drug 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 a deficiency of glucose-6-phosphate dehydrogenase - the risk of hemolysis.

With the simultaneous use of levofloxacin and warfarin, careful monitoring of prothrombin time and other indicators of coagulation is necessary.

It is recommended to carefully monitor the concentration of glucose in the blood plasma while using the drug with hypoglycemic drugs.

Since levofloxacin is excreted mainly by the kidneys, in patients with impaired renal function, mandatory monitoring of renal function is required, as well as adjustment of the dosage regimen. Cases of prolongation of the QT interval have been reported in patients treated with fluoroquinolones, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for QT interval prolongation: elderly age; electrolyte imbalance (hypokalemia, hypomagnesemia); congenital lengthening of the QT interval; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous administration of drugs that can lengthen the QT interval.

Sensory and sensory-motor peripheral neuropathy has been reported in patients receiving fluoroquinolones, including levofloxacin, and can be rapidly onset. If the patient develops symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the possible risk of developing irreversible changes.

Influence on the ability to drive vehicles and mechanisms:

During the period of drug treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

Quinolones may enhance the ability of drugs, including theophylline, a non-steroidal anti-inflammatory drug, to lower the seizure threshold. When taken simultaneously with fenbufen, higher concentrations of levofloxacin are observed than with monotherapy.

The effect of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, magnesium- or aluminum-containing antacids, iron and zinc salts.

Taking glucocorticosteroids increases the risk of tendon rupture.

Levofloxacin enhances the anticoagulant activity of warfarin.

Excretion (renal clearance) of levofloxacin is slightly slowed down by cimetidine and probenecid in view of the possible blocking of the canalic secretion of levofloxacin in the kidneys. It should be noted that this interaction is of clinical significance, primarily for patients with impaired renal function.

Levofloxacin increases the half-life of cyclosporine.

The simultaneous use of levofloxacin and hypoglycemic agents leads to a change in the concentration of glucose in the blood plasma (hypoglycemia and hyperglycemia).

With simultaneous use with drugs that prolong the QT interval (antiarrhythmic classes IA and III, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, imidazole derivatives, some antihistamines, including astemizole, terfenadine, ebastine), the QT interval may be lengthened.