Eleflox tablets 500mg, No. 10

Bacterial infections sensitive to levofloxacin in adults:

• acute sinusitis;

• exacerbation of chronic bronchitis;

• community-acquired pneumonia;

• uncomplicated urinary tract infections;

• complicated urinary tract infections (including pyelonephritis);

• chronic bacterial prostatitis;

• infections of the skin and soft tissues;

• for the complex treatment of drug-resistant forms of tuberculosis;

• prevention and treatment of anthrax with airborne infection.

The drug is taken orally 1 or 2 times a day. Do not chew the tablets and drink a sufficient amount of liquid (from 0.5 to 1 cup), 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.

For patients with CC> 50 ml / min, the following dosing regimen is recommended:

acute sinusitis: 500 mg 1 time / day - 10-14 days;

exacerbation of chronic bronchitis: 500 mg 1 time / day - 7-10 days;

community-acquired pneumonia: 500 mg 1-2 times / day - 7-14 days;

uncomplicated urinary tract infections: 250 mg 1 time / day - 3 days;

complicated urinary tract infections: 500 mg 1 time / day - 7-14 days;

pyelonephritis: 500 mg 1 time / day - 7-10 days;

chronic bacterial prostatitis: 500 mg 1 time / day - 28 days;

infections of the skin and soft tissues: 500 mg 1-2 times / day - 7-14 days;

complex therapy of drug-resistant forms of tuberculosis: 500 mg 1-2 times / day, course of treatment - up to 3 months.

prevention and treatment of anthrax with airborne infection: 500 mg 1 time / day, the course of treatment is up to 8 weeks.

In case of impaired liver function, no special dose selection is required, since levofloxacin is metabolized in the liver only to an extremely insignificant extent.

For elderly patients, no change in the dosage regimen is required, except in cases of low CC.

As with the use of other antibiotics, it is recommended to continue treatment with the drug for at least 48-72 hours after normalization of body temperature or after reliable destruction of the pathogen.

If you missed taking the drug, you need to take the pill as soon as possible, until the time of the next dose is approaching. Then continue to take Eleflox according to the scheme.

Considering that the bioavailability of levofloxacin when taking Eleflox tablets is almost 100%, in case of transferring a patient from IV infusion of Eleflox to tablets, treatment should be continued at the same dose that was used during IV infusion.

Film-coated tablets of yellowish-pink color, biconvex, oval, engraved with '500' on one side.

1 tab.

levofloxacin hemihydrate 512.76 mg,

which corresponds to the content of levofloxacin 500 mg

Excipients: microcrystalline cellulose (Avicel PH101) - 77.94 mg, microcrystalline cellulose (Avicel PH 102) - 40 mg, hypromellose (5 cps) - 17 mg, polysorbate 80 - 1.7 mg, crospovidone - 23.8 mg, magnesium stearate - 6.8 mg, opadry 03B52874 - 20 mg.

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

• epilepsy;

• damage to the tendons with previous treatment with quinolones;

• children and adolescence (up to 18 years old) (due to incomplete growth of the skeleton, since the risk of damage to cartilaginous growth points cannot be completely excluded);

• pregnancy and during breastfeeding (the risk of damage to the cartilaginous points of growth and the fetus and the child cannot be completely excluded);

• myasthenia gravis;

• renal failure with CC less than 20 ml / min.

• in patients with CC less than 50 ml / min, it is impossible to use with a dosing regimen with an initial dose of 250 mg / 24 hours;

• in patients with CC less than 20 ml / min, it is impossible to use with a dosing regimen with an initial dose of 500 mg / 24 h and 500 mg /
  12 h.

Carefully

• in patients predisposed to the development of seizures in patients with previous lesions of the central nervous system, in patients simultaneously receiving drugs that lower the seizure threshold of the brain, such as fenbufen, theophylline (see the section 'Drug interactions');

• in patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions during treatment with quinolones).

• in patients with known risk factors for prolongation of the QT interval: in elderly patients; in female patients, in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital lengthening of the QT interval; with heart disease (heart failure, myocardial infarction, bradycardia); while taking medications that can lengthen the QT interval (antiarrhythmics of class IA and III, tricyclic antidepressants, macrolides, antipsychotics) (see sections 'Overdose', 'Drug interaction', 'Special instructions');

• in patients with diabetes mellitus receiving oral hypoglycemic drugs, such as glibenclamide or insulin preparations (the risk of hypoglycemia increases);

• in patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions when using levofloxacin);

• in patients with psychosis or in patients with a history of mental illness (see section 'Special instructions');

• in patients with impaired renal function with a CC of 50-20 ml / min (also see the section 'Contraindications').

pharmachologic effect

Broad-spectrum antimicrobial agent, fluoroquinolone. It has a bactericidal effect. 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.

It is active against Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter bacteri calcoacella, Providerus Providcncia stuartii, Serratia marcescens, Clostridium perfringens.

Pharmacokinetics

When taken orally, it is absorbed from the gastrointestinal tract quickly and almost completely. Food intake has little effect on the rate and completeness of absorption. Bioavailability is 99%. Cmax is achieved in 1-2 hours and when taking 250 mg and 500 mg is 2.8 and 5.2 ?g / ml, respectively. Plasma protein binding - 30-40%.

It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and / or deacetylated. Renal clearance is 70% of the total clearance.

T1 / 2 - 6-8 hours. It is excreted from the body mainly by the kidneys by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% is excreted in the urine within 24 hours and 87% in 48 hours; in feces for 72 hours, 4% of the dose taken orally is found.

Side effect

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

From the side of the cardiovascular system: lowering blood pressure, vascular collapse, tachycardia.

From the side of metabolism: hypoglycemia (increased appetite, sweating, tremors).

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: impairment of vision, hearing, smell, taste and tactile sensitivity. When applied topically - a short-term burning sensation in the eyes, redness of the eyes, decreased visual acuity, the appearance of mucus in the form of cords in the tear film, blepharitis, chemosis, papillary growths and the appearance of follicles on the conjunctiva, dry eye syndrome, erythema of the eyelids, itching and pain in the eyes, photophobia.

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

From the urinary system: hypercreatininemia, interstitial nephritis.

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

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

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

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

Application during pregnancy and lactation

Levofloxacin is contraindicated during pregnancy and lactation (breastfeeding).

Application in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

Levofloxacin is prescribed with caution in elderly patients (there is a high likelihood of a concomitant decrease in renal function).

special instructions

Levofloxacin is used with caution in elderly patients (there is a high likelihood of a concomitant decrease in renal function).

After the temperature has returned to normal, it is recommended to continue treatment for at least 48-78 hours.

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

If signs of tendinitis 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 - the risk of hemolysis.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

Levofloxacin increases the T1 / 2 of cyclosporin.

The effect of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, magnesium- and aluminum-containing antacids and iron salts (a break between doses of at least 2 hours is required).

With the simultaneous use of NSAIDs, theophylline increases convulsive readiness, GCS - increase the risk of tendon rupture.

Cimetidine and drugs that block tubular secretion slow down the excretion of levofloxacin