Levofloxacin 500mg tablets 10

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500 mg


Active substance: levofloxacin hemihydrate 512.46 mg, which corresponds to the content of levofloxacin 500 mg.

Excipients: microcrystalline cellulose, hypromellose (hydroxypropyl methylcellulose), primellose (croscarmellose sodium), calcium stearate.

Shell composition: hypromellose, macrogol 4000, talc, titanium dioxide, iron oxide yellow dye.

Pharmacological properties

The optically active levorocative isomer of ofloxacin is L-ofloxacin (S-(-)-enantiomer). It has a wide range of antimicrobial activity. Blocks bacterial topoisomerase IV and DNA gyrase (topoisomerase II). It disrupts the supercoilization and cross-linking of DNA breaks, causes deep morphological changes in the cytoplasm, cell wall. At concentrations equivalent to or greater than the minimum suppressive concentration (BMD), most often has a bactericidal effect. The main mechanism of resistance development is associated with a mutation of the gyr-A gene with the possible development of cross-resistance between levofloxacin and other fluoroquinolones. Cross-resistance between levofloxacin and antibacterial drugs of other classes usually does not occur.

Indications for use

Infectious and inflammatory diseases caused by sensitive microorganisms:

  • acute sinusitis;
  • exacerbation of chronic bronchitis;
  • community-acquired pneumonia;
  • complicated urinary tract infections (including pyelonephritis);
  • uncomplicated urinary tract infections;
  • prostatitis;
  • infections of the skin and soft tissues;
  • septicemia / bacteremia associated with the above indications;
  • intra-abdominal infection.
  • hypersensitivity to levofloxacin or to other quinolones;
  • renal failure (with creatinine clearance less than 20 ml / min. - due to the impossibility of dosing this dosage form);
  • epilepsy;
  • tendon lesions with previous treatment with quinolones;
  • children and adolescents (up to 18 years);
  • pregnancy and lactation.

Caution should be used in the elderly due to the high probability of a concomitant decrease in renal function, as well as with a deficiency of glucose-6-phosphate dehydrogenase.

Use in pregnancy and lactation

Contraindicated in pregnancy and lactation.

Use in case of impaired liver function

Patients with impaired liver function do not need special selection of doses, since levofloxacin is metabolized in liver only to an extremely small extent.

Use in renal dysfunction

Contraindicated in renal failure (with creatinine clearance of less than 20 ml / min. - due to the impossibility of dosing this dosage form).

Patients after hemodialysis do not require additional doses.

Use in children

Levofloxacin can not be used to treat children and adolescents (up to 18 years) due to the likelihood of damage to the articular cartilage.

Use in elderly patients

When treating patients of old age, it should be borne in mind that patients in this group often suffer from impaired renal function.

Special instructions

Levofloxacin can not be used to treat children and adolescents due to the likelihood of damage to the articular cartilage.

When treating patients of old age, it should be borne in mind that patients in this group often suffer from impaired renal function.

With severe inflammation of the lungs caused by pneumococci, levofloxacin may not give an optimal therapeutic effect. Hospital-lying infections caused by certain pathogens (P. aeruginosa) may require combined treatment.

During treatment with Levofloxacin, it is possible to develop an attack of seizures in patients with previous brain damage caused, for example, by a stroke or severe injury.

Despite the fact that photosensitivity is noted with the use of levofloxacin very rarely, in order to avoid it, patients are not recommended to be exposed unnecessarily to strong solar or artificial ultraviolet radiation.

If pseudomembranous colitis is suspected, levofloxacin should be discontinued immediately and appropriate treatment should be initiated. In such cases, you can not use drugs that inhibit intestinal motility.

Rarely observed with levofloxacin tendonitis (previously All inflammation of the Achilles tendon) can lead to rupture of the tendons. Elderly patients are more prone to tendonitis. Treatment with glucocorticosteroids is likely to increase the risk of tendon rupture. If tendonitis is suspected, treatment with Levofloxacin should be discontinued immediately and appropriate treatment of the affected tendon should be initiated.

Patients with glucose-6-phosphate dehydrogenase deficiency (hereditary metabolic disorder) can react to fluoroquinolones by destroying red blood cells (hemolysis). In this regard, the treatment of such patients with levofloxacin should be carried out with great caution.

Influence on the ability to drive vehicles and control mechanisms

Side effects of Levofloxacin, such as dizziness or torpor, drowsiness and visual disturbances, can impair the ability to react and concentrate. This can pose a certain risk in situations where these abilities are of particular importance (e.g. when driving a car, when servicing machinery, when performing work in an unstable position)

Drug Interactions

There are reports of a pronounced decrease in the threshold of convulsive readiness with the simultaneous use of quinolones and substances that can, in turn, reduce the cerebral threshold of convulsive readiness. This also applies to the simultaneous use of quinolones and theophylline.

The effect of the drug Levofloxacin is significantly weakened when used simultaneously with sucralfate. The same thing happens with the simultaneous use of magnesium- or aluminum-containing antacids, as well as iron salts. Levofloxacin should be taken at least 2 hours before or 2 hours after taking these drugs. No interaction with calcium carbonate was detected.

With the simultaneous use of vitamin K antagonists, control of the blood coagulation system is necessary.

Excretion (renal clearance) of levofloxacin slows down slightly under the action of cimetidine and probenicide. It should be noted that this interaction has virtually no clinical significance. However, with the simultaneous use of drugs such as probenicide and cimetidine, blocking a certain route of excretion (tubular secretion), treatment with levofloxacin should be carried out with caution. This applies primarily to patients with limited renal function.

Levofloxacin slightly increases the half-life of cyclosporine.

Taking glucocorticosteroids increases the risk of tendon rupture.

Dosage and Administration

Levofloxacin is taken orally 1-2 times a day. The dose and duration of treatment are determined by the nature and severity of the infection, as well as the nature of the alleged pathogen. Tablets should be taken without chewing and drinking enough liquid (from 1/2 to 1 glass). When selecting doses, the tablet can be broken along the dividing groove into equal parts. The drug can be taken before meals or at any time between meals.

Treatment with Levofloxacin is recommended to continue for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen.

Acute bacterial sinusitis: 1 tablet (500 mg) 1 time per day for 10-14 days.

Acute bronchitis and exacerbation of chronic bronchitis: 1/2-1 tablet (250-500 mg) 1 time per day for 7-10 days.

Community-acquired pneumonia: 1 tablet (500 mg) 1-2 times a day for 7-14 days.

Complicated infectious diseases of the kidneys and urinary tract, including pyelonephritis: 1/2 tablet (250 mg) 1 time per day for 7-10 days.

Chronic bacterial prostatitis: 1 tablet (500 mg) 1 time per day for 28 days.

Skin and soft tissue infections: 1 tablet each (500 mg) 1-2 times a day for 7-14 days.

Patients with impaired liver function dosing adjustment is not required.

Patients with impaired renal function (QC less than 50 ml / min) require adjustment of the dosage regimen depending on the value of the QC.


Symptoms: nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, dizziness, clouding of consciousness and seizures of the type of epileptic seizures.

Treatment: conduct symptomatic therapy, ECG monitoring. There is no specific antidote. Hemodialysis is not effective.

Side effects

From the digestive system: nausea, vomiting, diarrhea, anorexia, abdominal pain, pseudomembranous enterocolitis, increased activity of "hepatic" transaminoses, hyperbilirubinemia, hepatitis, dysbacteriosis.

From the cardiovascular system: decreased blood pressure, vascular collapse, tachycardia.

From the outside metabolism: hypoglycemia (increased appetite, sweating, trembling).

From the side of the central nervous system and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesia, anxiety, fear, hallucinations, confusion, depression, movement disorders, convulsions.

From the senses: visual impairment, hearing, smell, taste and tactile sensitivity.

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

From the urinary system: hypercreatininemia, interstitial and nephritis.

From the hematopoietic system: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhage.

Dermatological reactions: photosensitivity, itching, swelling of the skin and mucous membranes, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Allergic reactions: urticaria, bronchospasm, suffocation, anaphylactic shock, allergic pneumonitis, vasculitis.

Other: exacerbation of porphyria, rhabdomyolysis, persistent fever, development of superinfection.

Storage conditions

At a temperature not exceeding 25 ° C in a place protected from light. Keep out of reach of children.

Shelf life 3 years.

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Product Details

Data sheet

Dosage form
500 mg
Number of tablets
INN Russian
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