Expiration date: 10/2025

Release form and composition:

Tablets, coated white or almost white, round

1 tablet contains:

levofloxacin (hemihydrate) 500mg

Excipients: hydroxypropyl cellulose LF, 102 microcrystalline cellulose, sodium starch of glycolate, crospovidon, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, hydroxypropyl methylcellulose 15 CPS, talc purified, titanium dioxide, triacetin.

5 PCs. - blisters (1) - packs of cardboard.

10 PCs. - blisters (1) - packs of cardboard.

Pharmacological action:

Antibacterial broad-spectrum drugs of the fluoroquinolone group. Active ingredient - levofloxacin - levo isomer of ofloxacin. Levofloxacin does DNK-girazu violates supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, cell wall and membranes.

Active against most strains of microorganisms in conditions in all vitr and in viv, including against aerobic gram-positive microorganisms: Crynebacterium diphtheriae, Entercccus spp. (including Entercccus faecais), Listeria mncytgenes, Staphycccus spp. coagulasenegative and methicillin-sensitive (i.e. is moderately sensitive), Staphycccus aureus (methicillin-sensitive), Staphycccus epidermidis (methicillin-sensitive), Staphycccus spp. (coagulasenegative), Streptcccus spp. (groups C and G), Streptcccus agaactiae, Streptcccus pneumniae (penicillin-sensitive, moderately sensitive, resistant), Streptcccus pygenes, Streptcccus viridans (penicillin-sensitive, moderately sensitive, resistant) aerobic gram-negative microorganisms: Acinetbacter spp. (including Acinetbacter baumanii), Actinbacius actinmycetemcmitans, Citrbacter freundii, Eikenea crrdens, Enterbacter spp. (incl. Enterbacter aergenes, Enterbacter aggmerans, Enterbacter cacae), Escherichia ci, Gardnerea vaginais, Haemphius ducreyi, Haemphius infuenae (ampicillin-sensitive and resistant), Haemphius parainfuenae, Heicbacter pyri, Kebsiea spp. (including Kebsiea xytca, Kebsiea pneumniae), Mraxea catarrhais (and reproducirse producing beta-lactamase), Mrganea mrganii, gnrrheae Neisseria gonorrhoeae (penicillin-sensitive, moderately sensitive, resistant), Neisseria meningitidis, Pasteurea spp. (incl. Pasteurea cnis, Pasteurea dagmatis, Pasteurea mutcida), Prteus mirabiis, Prteus vugaris, Prvidencia spp. (including Prvidencia rettgeri, Prvidencia stuartii), Pseudmnas spp. (including Pseudmnas aeruginsa), Samnea spp. Serratia spp. (including Serratia marcescens) anaerobic microorganisms: Bacterides fragiis, Bifidbacterium spp. Cstridium perfringens, Fusbacterium spp. Peptstreptcccus spp. Prpinibacterum spp. Veinea spp. other microorganisms: Bartnea spp. Chamydia pneumniae, Chamydia psittaci, Chamydia trachmatis, Leginea spp. (including Leginea pneumphia), Mycbacterium spp. (incl. Mycbacterium eprae, Mycbacterium tubercusis), Mycpasma hminis, Mycpasma pneumniae, Rickettsia spp. Ureapasma ureayticum.

Pharmacokinetics:

Levofloxacin is rapidly and almost completely absorbed after oral administration. Food intake has little effect on the rate and magnitude of absorption. The bioavailability of 500 mg of levofloxacin after oral administration is nearly 100%. After administration of a single dose of 500 mg of levofloxacin Cmax is 5.2-6.9 µg/ml, Tmax - 1.3 h, T1/2 6-8 hours

The plasma protein binding is 30-40%. Well into the organs and tissues: lungs, mucous membranes, bronchi, sputum, genitourinary system, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages.

In the liver, a small part is oxidized and/or deacetylated. Excreted mainly by the kidneys by glomerular filtration and tubular secretion. After oral administration, approximately 87% of the dose excreted in the urine unchanged within 48 hours, less than 4% in the feces within 72 h.

Indications:

Infectious-inflammatory diseases caused by susceptible microorganisms:

• acute sinusitis
  
• exacerbation of chronic bronchitis
  
• community acquired pneumonia
  
• complicated urinary tract infections (including pyelonephritis), uncomplicated urinary tract infection
  
• prostatitis
  
• infection of the skin and soft tissues
  
• septicemia/bacteremia (associated with the above indications)
  
• infection of the abdominal cavity.
  

Dosing regimen:

The drug is taken orally 1 or 2 times/day. The tablets are taken before meals or between meals, with liquid squeezed enough liquid (0.5 to 1 Cup).

The dosage depends on the nature and severity of infection and sensitivity of the suspected pathogen.

Adult patients with normal or moderately reduced renal function (QC over 50 ml/min) recommend the following dose.

With sinusitis, the drug is administered at 500 mg 1 time/day, for 10 to 14 days.

Exacerbation of chronic bronchitis - 250 mg or 500 mg 1 time a day for 7-10 days.

In community-acquired pneumonia - 500 mg 1-2 times/day for 7-14 days.

In uncomplicated urinary tract infections - 250 mg 1 time/day for 3 days.

For prostatitis - 500 mg 1 times/day for 28 days.

In complicated urinary tract infections including pyelonephritis, 250 mg 1 times/day for 7-10 days.

When infections of skin and soft tissues 250 mg 1 times/day or 500 mg 1-2 times/day for 7-14 days.

When septicemia is prescribed for 250 mg or 500 mg 1-2 times/day for 10-14 days (after in/introductions to continue therapy).

In infections of the abdominal cavity is prescribed for 250 mg or 500 mg 1 times/day for 7-14 days (in combination with antibacterial drugs acting on the anaerobic flora) to continue therapy after I/V administration.

If impaired renal function the dose change in accordance with the following data.

Creatinine clearance	250 mg/24 h	500 mg/24 h	500 mg/12 h
first dose 250 mg	first dose 500 mg	first dose 500 mg
50-20 ml/min	then 125 mg/24 h	then 250 mg/24 h	then 250 mg/12 h
19-10 ml/min	then 125 mg/48 h	then 125 mg/24 h	then 125 mg/12 h
Less than 10 ml/min, including hemodialysis and papd)	then 125 mg/48 h	then 125 mg/24 h	then 125 mg/24 h

After hemodialysis or continuous ambulatory peritoneal dialysis (APD) does not require the introduction of additional doses.

When the liver does not require special selection of doses, as levofloxacin is metabolized in the liver only in very small extent.

For elderly patients does not require changes in dosing regimen, with the exception of cases of low creatinine clearance.

As with other antibiotics, treatment with Levofloxacin tablets 250 mg and 500 mg it is recommended to continue at least 48-78 hours after normalization of body temperature or after a reliable destruction of the pathogen.

If you skipped a dose, I needed to take the pill until almost time for the next appointment, then the drug is taken via the recommended scheme.

Side effects:

Frequency encountered side effects are presented according to the following criteria: frequently - 1-10 patients out of 100, sometimes less than 1 patient out of 100, rarely - less than 1 patient out of 1,000, very rare - less than 1 patient out of 10 000, in some cases, less than 0.01%.

Allergic reactions: sometimes - itching and redness of the skin rare - anaphylactic and anaphylactoid reactions (with symptoms such as hives, narrowing of the bronchi and possibly severe dyspnea) in very rare cases - swelling of the skin and mucous membranes (for example, in the facial area and throat), sudden drop in blood pressure and shock, hypersensitivity to the sun and ultraviolet radiation pneumonitis allergic vasculitis in some cases: severe reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme. General allergic reactions may sometimes be preceded by milder skin reactions may develop after the first dose in a few minutes or hours after drug administration.

From the digestive system: often - nausea, diarrhea, increased activity of liver enzymes in the serum of blood sometimes loss of appetite, vomiting, abdominal pain, indigestion is rarely severe diarrhea with blood in the stool (in rare cases, it may be a sign of inflammation of the intestine and even pseudomembranous colitis), increased levels of bilirubin in the blood serum very rarely - hepatitis.

From the metabolic: very rarely - hypoglycemia (should be considered in patients with diabetes mellitus) with the following symptoms: ravenous appetite, nervousness, perspiration, shakiness. The use of other quinolones suggests that they are able to exacerbate the already existing porphyria. A similar effect is not excluded when using the drug levofloxacin.

CNS and peripheral nervous system: sometimes - headache, dizziness and/or numbness, drowsiness, sleep disturbances rare depression, anxiety, psychotic reactions (e.g. with hallucinations), discomfort (e.g., paresthesia of the hands), tremor, psychomotor agitation, confusion, convulsions, anxiety very rare - disturbance of vision and hearing, disorders of taste and smell sensitivity, reduction of tactile sensitivity.

Of the cardiovascular system: rarely-increased heart rate, decreased blood pressure very rarely circulatory collapse in some cases - prolonged QT interval.

From the side of musculoskeletal system: rare - lesions tendonitis (including tendonitis), joint and muscle pain is very rare - tendon rupture, for example, the Achilles tendon (this side effect may occur within 48 h after the start of treatment and may be bilateral in nature), muscle weakness, of particular importance for patients with bulbar syndrome and in some cases - muscle damage (rhabdomyolysis).

From the urinary system: rarely - increased creatinine in the serum, very rarely - acute renal failure (interstitial nephritis).

On the part of the hemopoietic system : sometimes – eosinophilia, leukopenia, rarely - neutropenia thrombocytopenia (may be accompanied by increased bleeding) very rare – agranulocytosis, the development of severe infections (persistent or recurrent fever, deterioration of health), in some cases, hemolytic anemia and pancytopenia.

Other: sometimes - General weakness (asthenia) very rare - fever. Any antibiotic can lead to secondary infection and superinfection.

Contraindications:

• epilepsy
  
• the defeat tendons at the earlier treatment quinolones
  
• childhood and adolescence (up to 18 years)
  
• pregnancy
  
• lactation (breast-feeding)
  
• hypersensitivity to the drug and other hinolonam.
  

The drug should be used with caution in the elderly because of the high probability of having a concomitant decrease in renal function, with a deficit glukozo-6-fosfatdegidrogenaza.

Pregnancy and lactation:

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Special instructions:

In the appointment of persons age should be borne in mind that patients in this group often suffer from impaired renal function.

In case of severe pneumonia caused by pneumococcus, levofloxacin may not provide the optimal therapeutic effect. Hospital infections caused by certain pathogens (including ?seudmnas aeruginsa), may require combination therapy.

During treatment with levofloxacin may develop an attack of convulsions in patients with previous brain damage due, for instance, by stroke or severe trauma. Convulsive readiness may rise and while the application of fenbufen (or other NSAIDs of similar chemical structure).

On the background of the use of levofloxacin, patients should avoid sun exposure and UV exposure.

If you suspect pseudomembranous colitis should be promptly discontinued levofloxacin and start appropriate treatment. In such cases it is impossible to use drugs that suppress intestinal motility.

Rarely observed in applying the drug levofloxacin tendonitis (e.g. Achilles tendonitis) can lead to tendon rupture. In elderly age or with simultaneous use of corticosteroids the risk of developing tendinitis is higher. If you suspect tendonitis, you should immediately cancel levofloxacin and start appropriate treatment of the affected tendon, for example, providing him rest.

In patients with a deficit glukozo-6-fosfatdegidrogenaza in the application of fluoroquinolones may develop hemolysis, therefore, the appointment of the drug in this group of patients requires caution.

On the background of the use of the drug should avoid alcohol.

Use in Pediatrics

Levofloxacin should not be used for the treatment of children and adolescents because of the likelihood of injury to the articular cartilage.

Effects on ability to drive vehicles and management mechanisms

During treatment, patients should avoid driving vehicles and other activities, require high concentration and speed of psychomotor reactions, because on the background of the use of levofloxacin, possible dizziness, drowsiness, visual disturbances.

Overdose:

Symptoms: sputannosti consciousness, dizziness, impairment of consciousness, seizures, nausea, vomiting and erosive lesions of the mucous membranes. In studies it was shown that when using levofloxacin in doses exceeding the medium-therapeutic, possible prolonged QT interval .

Treatment: if necessary, symptomatic therapy. Levofloxacin is not derived by in hemodialysis, peritoneal dialysis and continuous peritoneal dialysis. There is no specific antidote.

Drug interactions:

There are reports of marked decrease in seizure threshold in concurrent usage of quinolones and substances, which can in turn lower the threshold of convulsive readiness. This equally applies also to the simultaneous use of quinolones and theophylline, fenbufen or similar NSAIDs.

Action of levofloxacin is significantly attenuated with concomitant use with sucralfate, magnesium or aluminum-containing antacids, and iron preparations (interval between meals must be at least 2 hours).

While the use of indirect anticoagulants is necessary to monitor the indicators of blood coagulation.

The renal clearance of levofloxacin is slightly reduced with simultaneous use with cimetidine and probenecid (has little to no clinical significance, however, the use of such combinations requires caution, especially in patients with impaired renal function).

When used together, levofloxacin increases T1/2 of cyclosporine.

Concurrent use of corticosteroids increases the risk of tendon rupture.

Terms and conditions of storage:

The drug should be stored in a dry, dark, inaccessible to children place at temperature not exceeding 25°C. shelf Life - 3 years.