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General characteristics. Structure:

Active ingredient: 500 mg of a levofloksatsin in 100 ml.

Excipients: glucose anhydrous, dinatrium эдетат, Acidum hydrochloricum of 10%, divorced Acidum hydrochloricum or sodium hydroxide, water for injections.

Pharmacological properties:

Pharmacodynamics. Levofloxacin – synthetic antibacterial agent from group of ftorkhinolon, S-enantiomer of racemic mix of medicine of an ofloksatsin.

As antibacterial drug from group of ftorkhinolon levofloxacin affects complex DNK-DNK-girazy and topoisomerases IV.

Degree of bacterial activity of a levofloksatsin depends on a ratio of the maximum concentration in blood serum (Smakh) or the areas under a curve "concentration time" (AUC) and minimum inhibiting (подавляючо ї) concentration (MIK (MPK)).

The main mechanism of resistance is a consequence of a mutation in gyr-A genes. In vitro exists cross resistance between levofloksatsiny and other ftorkhinolona.

Thanks to the action mechanism usually there is no cross resistance between levofloksatsiny and other classes of antibacterial means.

The MIK boundary values recommended by the European committee on testing of antimicrobic sensitivity (EUCAST) for a levofloksatsin which separate sensitive microorganisms from organisms it is intermediate sensitive (moderately resistant) and is intermediate sensitive from resistant organisms, 3 testings of MIK (mg/l) are presented in the table.

Table 3. The MIK EUCAST clinical boundary values for a levofloksatsin (20.06.2006)

Pathogen	Sensitive	Resistant
Enterobacteriacae	≤ 1 mg/l	> 2 mg/l
Pseudomonas spp.	≤ 1 mg/l	> 2 mg/l
Acinetobacter spp.	≤ 1 mg/l	> 2 mg/l
Staphylococcus spp.	≤ 1 mg/l	> 2 mg/l
S.pneumoniae1	≤ 2 mg/l	> 2 mg/l
Streptococcus A, B, C, G	≤ 1 mg/l	> 2 mg/l
H. influenzae M.catarrhalis2	≤ 1 mg/l	> 1 mg/l
The boundary values which are not connected with vidami3	≤ 1 mg/l	> 2 mg/l
1 Granichne MIK value between sensitive is also intermediate sensitive (moderately resistant) strains was increased with 1 to 2 for the purpose of control of growth of wild strains of this microorganism that show variability of the specified parameter. Boundary values concern therapy of high doses. 2 Shtami with sizes MIK is higher than boundary value between sensitive and is intermediate sensitive (moderately resistant) strains, are very rare or was not reported about them yet. Tests for identification and antimicrobic sensitivity on any such isolate should be repeated and if the result is confirmed, to send isolate to help laboratory. 3 The MIK boundary values which are not connected with types were defined preferential, according to a pharmacokinetics/pharmacodynamics and are independent of distribution of MIK of certain types. The MIK boundary values are used only for types to which threshold value specific for the sake of appearances was not defined, and not used for types where testing for sensitivity is not recommended or for which there are not enough proofs of rather doubtful types (Enterococcus, Neisseria, gram-negative anaerobe bacterias).

The recommended CLSI (Institute of clinical and laboratory standards, earlier – NCCLS) the MIK boundary values for a levofloksatsin which separate sensitive from it is intermediate sensitive organisms, and is intermediate sensitive from resistant organisms, are presented in table 4, for testing of MIK (mkg/ml) or the disco - a diffusion method (diameter of a zone [mm] with use of a disk from levofloksatsiny 5 mkg).

Table 4. The MIK boundary values recommended to CLSI and the disco - a diffusion method for a levofloksatsin (M100-S17, 2007)

Pathogen	Sensitive	Resistant
Enterobacteriacae	≤ 2 mkg/ml ≥17 mm	≥ 8 mkg/ml ≤ 13 mm
Not Enterobacteriacae	≤ 2 mkg/ml ≥17 mm	≥ 8 mkg/ml ≤ 13 mm
Acinetobacter spp.	≤ 2 mkg/ml ≥17 mm	≥ 8 mkg/ml ≤ 13 mm
Stenotrophomonas maltophilia	≤ 2 mkg/ml ≥17 mm	≥ 8 mkg/ml ≤ 13 mm
Staphylococcus spp.	≤ 1 mkg/ml ≥19 mm	≥ 4 mkg/ml ≤ 15 mm
Enterococcus spp.	≤ 2 mkg/ml ≥17 mm	≥ 8 mkg/ml ≤ 13 mm
H. influenzae M.catarrhalis1	≤ 2 mkg/ml ≥17 mm
Streptococcus pneumoniae	≤ 2 mkg/ml ≥17 mm	≥ 8 mkg/ml ≤ 13 mm
Beta and hemolitic Streptococcus	≤ 2 mkg/ml ≥17 mm	≥ 8 mkg/ml ≤ 13 mm
1 Absence or rare distribution of resistant strains excludes previously determination of any categories of results, others, than "sensitive". For strains which yield the results testimonial of "insensitive" category identification of organisms and results of tests for antimicrobic sensitivity have to be confirmed with help laboratory with use of a reference method of cultivations of CLSI.

Antibacterial range. Prevalence of resistance of separate types can vary geographically and over time. It is desirable to obtain local information about resistance, especially at treatment of heavy infections. If necessary it is necessary to address for council the specialist when local prevalence of resistance such is that usefulness of the agent at least at some types of infections, is doubtful.

Usually sensitive types. Aerobic gram-positive bacteria: Staphylococcus aureus * metitsil_nchutliviya, Staphylococcus saprophyticus, Streptococci, group C and G, Streptococcus agalactiae, Streptococcus pneumoniae *, Streptococcus pyogenes *

Aerobic gram-negative bacteria: Burkholderia cepacia **, Eikenella corrodens, Haemophilus influenzae *, Haemophilus para - influenzae *, Klebsiella oxytoca, Klebsiella pneumoniae *, Moraxella catarrhalis *, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri

Anaerobic bacteria: Peptostreptococcus.

Others: Chlamydophila pneumoniae *, Chlamydophila psittaci, Chlamidia trachomatis, Legionella pneumophila *, Mycoplasma pneumoniae *, Mycoplasma hominis, Ureaplasma urealyticum.

Types for which the acquired (secondary) resistance can be problematic. Aerobic gram-positive bacteria: Enterococcus faecalis *, Staphylococcus aureus metitsillinrezistentny, Staphylococcus coagulase spp.

Aerobic gram-negative bacteria: Acinetobacter baumannii *, Citrobacter freundii *, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae *, Escherichia coli *, Morganella morganii *, Proteus mirabilis *, Providencia stuartii, Pseudomonas aeruginosa *, Serratia marcescens *

Anaerobic bacteria: Bacteroides fragilis, Bacteroides ovatus **, Bacteroides thetaiotamicron **, Bacteroides vulgatus **, Clostridium difficile **

* Clinical performance was shown for sensitive isolates in the approved clinical indications.

** Natural intermediate sensitivity.

Other data. The hospital infections caused by P. aeruginosa can demand a combination therapy.

Pharmacokinetics. Absorption. There is no essential difference concerning pharmacokinetics of a levofloksatsin after intravenous and oral administration.

After intravenous administration drug collects in a mucous membrane of bronchial tubes and a bronchial secret of tissue of lungs (concentration in lungs exceeds that in a blood plasma), urine. Levofloxacin gets to cerebrospinal fluid a little.

Distribution. About 30-40% of a levofloksatsin contact a blood serum protein. The Kumulyatsionny effect of repeated use of a levofloksatsin in a dose of 500 mg of 1 times a day is practically absent. There is an insignificant, but foreseen kumulyatsionny effect after use of doses on 500 mg twice for days. The stable state is reached within 3 days.

Penetration into fabrics and liquids of an organism. Penetration into a mucous membrane of bronchial tubes, bronchial secret of tissues of lungs (BSTL). The maximum concentration of a levofloksatsin in a mucous membrane of bronchial tubes and a bronchial secret of lungs after use of 500 mg orally made 8,3 mkg/g and 10,8 mkg/ml respectively. These indicators were reached within 1 hour after administration of drug.

Penetration into tissues of lungs. The maximum concentration of a levofloksatsin in tissues of lungs after use of 500 mg orally made about 11,3 mkg/g and were reached in 4-6 hours after drug use. Concentration in lungs exceeds that in a blood plasma.

Penetration into bubble contents. The maximum concentration of a levofloksatsin of 4,0-6,7 mkg/ml in contents of a bubble were reached in 2-4 hours after administration of drug within 3 days of use in doses of 500 mg of 1 times or 2 times a day respectively.

Penetration into cerebrospinal (spinal) liquid. Levofloxacin badly gets into cerebrospinal liquid.

Penetration into prostate tissues. After use of 500 mg of a levofloksatsin of 1 times a day within 3 days average concentration in tissue of a prostate reached 8,7 mkg/g, 8,2 mkg/g and 2,0 mkg/g respectively in 2 hours, 6 hours for 24 hours, the average coefficient of concentration prostate/plasma made 1,84.

Concentration in urine. Average concentration in urine in 8-12 hours after a single dose orally of a dose of 150 mg, 300 mg or 500 mg of a levofloksatsin made 44 mg/l, 91 mg/l and 200 mg/l respectively.

Biotransformation. Levofloxacin is metabolized in very insignificant measure, metabolites are dismetil-levofloxacin and N-oxide levofloxacin. These metabolites make less than 5% of amount of the drug emitted with urine. Levofloxacin is stereokhimichesk stable and is not subject to inversion of choral structure.

Conclusion. After peroral and intravenous administration levofloxacin is removed from a blood plasma rather slowly (the elimination half-life makes 6-8 hours). Removal happens usually kidneys (over 85% of the entered dose).

There is no essential difference in pharmacokinetics of a levofloksatsin after intravenous and oral administration that demonstrates that these ways (peroral and intravenous) are interchangeable.

Linearity. Levofloxacin has linear pharmacokinetics in the range of 50-600 mg.

Patients with a renal failure. The pharmacokinetics of a levofloksatsin is influenced by a renal failure. At depression of function of kidneys renal removal and clearance decreases, and elimination half-lives increase, apparently from table 5.

Clearance of creatinine (ml/min.)	<20	20-40	50-80
Renal clearance (ml/min.)	13	26	57
Period полувыведення (hours)	35	27	9

Patients of advanced age. There are no considerable differences in pharmacokinetics of a levofloksatsin at young patients and patients of advanced age, except the differences connected with clearance of creatinine.

Sexual distinctions. The separate analysis concerning patients women's and male showed insignificant differences in pharmacokinetics of a levofloksatsin depending on a floor. There are no proofs that these sexual distinctions are clinically significant.

Indications to use:

The bacterial inflammatory processes at adults caused by the bacteria sensitive to a levofloksatsin: pneumonia, the complicated infections of urinary tract (including pyelonephritises), infections of skin and soft tissues, chronic bacterial prostatitis.

Route of administration and doses:

Drug should be used directly after perforation of a rubber bung (within 3 hours), for the prevention of any bacterial pollution. Protection against light at infusion is not required.

Taking into account biological equivalence of peroral and parenteral forms possible identical dosing.

The dosage depends on a look and weight of an infection.

Table 1. The recommended drug doses for treatment of adults with normal function of kidneys at which the clearance of creatinine makes over 50 ml/min.

Indications		Daily dose	The number of introductions in days
Extra hospital pneumonia		500 mg	1-2 times
The complicated infections of urinogenital ways, including pyelonephritis		250 mg *	1 time
Chronic bacterial prostatitis	500 mg **		1 time
_nfektion of skin and soft tissues		500 mg	1-2 times

* It is necessary to consider expediency of increase in a dose in cases of a heavy infection (this reference concerns only solutions for infusions).

** According to a condition of the patient in several days transition from initial intravenous administration to oral administration with the same dosing is possible.

As levofloxacin is removed preferential by kidneys, for patients with the weakened function of kidneys the dose needs to be reduced.

Table 2. Dosing for adult patients with an impaired renal function at whom the clearance of creatinine makes less than 50 ml/min.

Clearance of creatinine	The dosing mode ( depending on weight of an infection and a nosological form)
50-20 ml/min.	250 mg / 24 hour	500 mg / 24 hour	500 mg / 12 hours
	the first dose – 250 mg, the following – 125 mg / 24 hour	the first dose – 500 mg, following – 250 mg / 24 hours	the first dose – 500 mg, following – 250 mg / 12 hours
19-10 ml/min.	the first dose – 250 mg, following – 125 mg / 48 hours	the first dose – 250 mg, following – 125 mg / 24 hours	the first dose – 250 mg, following – 125 mg / 12 hours
<10 ml/min. ( and also at a hemodialysis and HAPD 1)	the first dose – 250 mg, following – 125 mg / 48 hours	the first dose – 250 mg, following – 125 mg / 24 hours	the first dose – 250 mg, following – 125 mg / 24 hours

1 After a hemodialysis or the chronic out-patient peritoneal dialysis (COPPD) additional doses are not necessary.

Dosing for patients with the broken function of a liver. Dose adjustment is not necessary as levofloxacin in insignificant degree is metabolized in a liver.

Dosing for patients of advanced age. If renal function is not broken, there is no need for dose adjustment.

The drug is administered intravenously slowly, by drop infusion. Duration of introduction of one bottle of drug (100 ml of solution for intravenous administration from 500 mg of a levofloksatsin) has to make not less than 60 min.

According to a condition of the patient in several days transition from intravenous administration to oral administration with the same dosing is possible.

Duration of treatment depends on disease. As well as at use of other antibacterial means, it is recommended to continue treatment by drug at least within 48 - 72 hours after normalization of body temperature or the destruction of activators confirmed with microbiological tests.

Features of use:

Use during pregnancy or feeding by a breast. Due to the lack of researches and possible injury of a joint cartilage by hinolona to an organism which grows pregnant women and women who nurse cannot appoint drug. If during treatment drug diagnoses pregnancy, it is necessary to report about it to the doctor.

Children. Use of drug is contraindicated to children as injury of a joint cartilage is not excluded.

Features of use. At very heavy course of pneumonia caused by pneumococci, drug can not give optimum therapeutic effect.

The hospital infections caused by P. aeruginosa can demand a combination therapy.

Introduction duration. The recommended duration of introduction makes not less than 60 minutes for 500 mg of solution for infusions. Concerning an ofloksatsin it is known that during infusion tachycardia and temporary increase in arterial pressure can be noted. In rare instances sharp decrease hell, a circulator collapse can be observed as a result. If during introduction of a levofloksatsin (l-isomer of an ofloksatsin) the expressed lowering of arterial pressure is observed, administration of drug should be stopped immediately.

Tendinitis and ruptures of sinews. Seldom tendinitis chances, are more often – an Achilles tendon, up to a rupture of a sinew. The risk of a tendinitis and rupture of a sinew increases at patients of advanced age and patients accepting corticosteroids. Therefore careful observation of such patients if by it appoint levofloxacin is necessary. Patients should consult with the doctor if at them appeared tendinitis symptoms. At suspicion on a tendinitis treatment it is necessary to stop and begin with drug immediately necessary treatment (for example to provide a sinew immobilization).

The diseases caused by Clostridium difficile. Diarrhea, especially in hard cases, persistent and/or hemorrhagic, in time or after treatment by drug can be a symptom of the disease caused by Clostridium difficile most of which severe form is pseudomembranous colitis. If there are suspicions of pseudomembranous colitis, it is necessary to stop immediately drug infusion, and patients need to be treated urgently supporting means ± specific therapy (for example, oral administration of Vancomycinum). The means oppressing motility of intestines are contraindicated in this clinical situation.

Patients inclined to spasms. Drug is contraindicated to patients with epilepsy in the anamnesis. As well as in a case with other hinolona, levofloxacin should be applied with extreme care to the patients inclined to spasms, in particular patients with the previous damages of the central nervous system, at simultaneous therapy fenbufeny and similar to it the nonsteroid antiinflammatory medicines or drugs increasing convulsive readiness (reduce a convulsive threshold), for example theophylline (see the section "Interaction with Other Medicines and Other Types of Interactions"). In case of spasms treatment levofloksatsiny should be stopped.

Patients with insufficiency glyukozo-6-fosfatdegidrogenazy. Patients with the latent or available defects of activity glyukozo-6-fosfatdegidrogenazy can be subject to hemolitic reactions at treatment by antibacterial agents of group of hinolon, and therefore, they should apply levofloxacin with care.

Patients with a renal failure. As levofloxacin is removed preferential by kidneys, dose adjustment for patients with (renal failure) weakened by function of kidneys is required (see the section "Route of Administration and Doses").

Hypersensitivity reactions (hypersensitivity. Levofloxacin can cause from time to time serious, potentially fatal hypersensitivity reactions (for example a Quincke's disease up to an acute anaphylaxis) after use of an initial dose (see the section "Side reactions"). In this case patients should stop treatment immediately and to see a doctor.

Hypoglycemia. As well as at use of any hinolon, it was reported about hypoglycemia cases, especially at the patients sick with a diabetes mellitus who received the accompanying therapy by hypoglycemic means orally (for example Glibenclamidum) or insulin. Careful observation of glucose levels in blood at the patients sick with a diabetes mellitus is recommended (see the section "Side reactions").

Prevention of a photosensitization. Though the photosensitization arises very seldom at reception of a levofloksatsin, for the purpose of its avoidance it is not recommended to patients without special need to be affected by strong sunshine or artificial Uv-radiation (for example, lamps of artificial ultraviolet radiation, a sunbed).

Patients who received antagonists of vitamin K. Due to the possible increase in indicators of coagulative tests (PCh / the international normalizing ratio) and/or bleedings at the patients accepting levofloxacin in combination with the antagonist of vitamin K (for example warfarin), it is necessary to watch indicators of coagulative tests (see the section "Interaction with Other Medicines and Other Types of Interactions").

Psychotic reactions. It was reported about psychotic reactions at the patients accepting hinolona including levofloxacin. Seldom or never these reactions progressed to suicide thoughts and self-destructive behavior, sometimes even after reception of the only dose of a levofloksatsin (cm. section "Side reactions"). If the patient has these reactions, reception of a levofloksatsin it is necessary to stop and resort to the relevant activities. It is recommended to apply with care levofloxacin to patients with psychotic frustration and to patients with mental diseases in the anamnesis.

Lengthening of an interval of QT. It is necessary to apply with care ftorkhinolona, including levofloxacin, to patients with the known risk factors to lengthening of an interval of QT, such as:

• inborn syndrome of lengthening of an interval of QT,
• the accompanying use of the medicines known for the ability to extend QT interval (for example with antiarrhythmic means of a class ІА and III, tricyclic antidepressants, macroleads),
• not corrected electrolytic imbalance (for example a hypopotassemia, a hypomagnesiemia),
• advanced age,
• a heart trouble (for example heart failure, a myocardial infarction, bradycardia) (see the sections "Route of Administration and Doses" (Patients of advanced age), "Interaction with other medicines and other types of interactions", "Side reactions", "Overdose").

Peripheral neuropathy. It was reported about touch or sensomotor peripheral neuropathy which can quickly come, at the patients accepting ftorkhinolona including levofloxacin. Reception of a levofloksatsin should be stopped if at the patient neuropathy symptoms are observed to prevent emergence of an irreversible state.

Opiates. At the patients receiving levofloxacin, definition of opiates in urine can yield false positive result. There can be a need of confirmation of positive takes on opiates by means of more specific methods.

Gepatobiliarny disturbances. It was reported about cases of necrotic hepatitis, up to a liver failure, life-threatening, it is preferential at patients with serious basic diseases, for example sepsis (cm. section "Side reactions"). Patients should recommend to stop treatment and to see the doctor if there are such symptoms of a disease of a liver as anorexia, jaundice, black urine, an itch or abdominal pains.

Ability to influence speed of response at control of motor transport or work with other mechanisms. To patients who manage vehicles work with machines and mechanisms, it is necessary to consider possible undesirable reactions from a nervous system (dizziness, drowsiness, confusion of consciousness, a visual disturbance and hearing, disorder of processes of the movement also during walking).

Side effects:

Infections and invasions: infrequently – mycoses (and proliferation of other resistant microorganisms).

From system of blood and lymphatic system: infrequently – a leukopenia, an eosinophilia, it is rare – thrombocytopenia, a neutropenia, is very rare – an agranulocytosis, frequency is unknown – a pancytopenia, hemolitic anemia.

From immune system: very seldom – an acute anaphylaxis (see the section "Features of Use"). Anaphylactic and anaphylactoid reactions can sometimes arise even after reception of the first dose, frequency is unknown – hypersensitivity (hypersensitivity) (see the section "Features of Use").

Metabolic disturbances: infrequently – anorexia, it is very rare – a hypoglycemia, especially at the patients sick with diabetes (see the section "Features of Use").

From mentality: infrequently – sleeplessness, nervousness; seldom – psychotic frustration, a depression, confusion of consciousness, uneasiness, agitation, concern; very seldom – psychotic reactions with self-destructive behavior, including a suicide orientation of thinking or actions (see the section "Features of Use"), hallucinations.

From a nervous system: infrequently – dizziness, a headache, drowsiness, is rare – spasms, a tremor, paresthesia, is very rare – touch or sensomotor peripheral neuropathy, a dysgeusia (subjective disorder of taste), including an ageusia (taste loss), a parosmiya (disturbance of sense of smell), including аносмію (lack of sense of smell).

From an organ of sight: very seldom – visual disturbances.

From an acoustic organ: infrequently – вертиго, it is very rare – a hearing disorder, frequency is unknown – a ring in ears.

From cardiovascular system: seldom – tachycardia, arterial hypotension, rate is unknown – lengthening of an interval of QT on the electrocardiogram (see the section "Features of Use" (Lengthening of an interval of QT) and the section "Overdose").

From respiratory system: seldom – a bronchospasm, диспноэ; very seldom – an allergic pneumonitis.

From a digestive tract: often – diarrhea, nausea, infrequently – vomiting, abdominal pains, dyspepsia, abdominal distention, locks, it is rare – diarrhea hemorrhagic that seldom or never can testify about a coloenteritis, including pseudomembranous colitis.

From gepatobiliarny system: often – increase in indicators of hepatic enzymes (ALT/nuclear heating plant, an alkaline phosphatase, GGTP), infrequently – increase in bilirubin of blood; very seldom – hepatitis, rate it is unknown – it was reported about cases of jaundice and severe damage of a liver, including cases of an acute liver failure, it is preferential at patients with serious basic diseases (see the section "Features of Use").

From skin and hypodermic fabrics: infrequently – rash, an itch, it is rare – a small tortoiseshell, is very rare – a Quincke's disease, hypersensitivity to solar and ultraviolet radiation, rate is unknown – a toxic epidermal necrolysis (Lyell's disease), Stephens-Johnson's syndrome, an exudative mnogoformny erythema, a hyperhidrosis.

There can sometimes be skin and mucous reactions even after reception of the first dose.

From a musculoskeletal system: seldom – damages of sinews (see the section "Features of Use"), including their inflammation (tendinitis) (for example, an Achilles sinew), an arthralgia, a mialgiya, is very rare – a rupture of a sinew (see the section "Features of Use"). This undesirable side effect can be shown for 48 hours from an initiation of treatment and affect an Achilles tendon of both legs. Muscular weakness which can have special value for patients with a heavy myasthenia of gravis is possible, rate is unknown – damage of muscles (рабдомиолиз).

From an urinary system: infrequently – the raised creatinine indicators in blood serum, it is very rare – an acute renal failure (for example owing to intersticial nephrite).

General and local disturbances: infrequently – an adynamy, it is very rare – a pyrexia, rate is unknown – pain (including a dorsodynia, breasts and extremities).

Among other undesirable side effects which are associated with reception of a ftorkhinolon, the following: - extrapyramidal symptoms and other lacks of coordination of movements, a hyper sensitive vasculitis, porphyria attacks at patients with existence of a porphyria.

Interaction with other medicines:

Theophylline, фенбуфен or similar nonsteroid antiinflammatory medicines. Pharmacokinetic interaction of a levofloksatsin with theophylline was not revealed. However perhaps essential decrease in a convulsive threshold at simultaneous use of hinolon with theophylline, non-steroidal anti-inflammatory drugs and other agents who reduce a convulsive threshold. Concentration of a levofloksatsin in the presence of a fenbufen was about 13% higher, than at reception only a levofloksatsina.

Probenetsid and Cimetidinum. Probenetsid and Cimetidinum statistically authentically influence removal of a levofloksatsin. The renal clearance of a levofloksatsin decreases in the presence of Cimetidinum by 24% and a probenetsid for 34%. It because both drugs are capable to block canalicular secretion of a levofloksatsin. However at the doses tested during the research there is no probability that statistically significant kinetic distinctions will be clinically significant. It is necessary to apply with care levofloxacin along with the medicines influencing canalicular secretion such as пробенецид and Cimetidinum, especially to patients with a renal failure.

Other information. On pharmacokinetics of a levofloksatsin at use, simultaneous with it, do not cause any clinically significant influence calcium carbonate, digoxin, glibenclamide, ranitidine.

Cyclosporine. The elimination half-life of cyclosporine increases by 33% at simultaneous use with levofloksatsiny.

Antagonists of vitamin K. At simultaneous use with antagonists of vitamin K (for example warfarin) it was reported about increase in coagulative tests (PCh/the international normalizing ratio) and/or bleedings which can be expressed. Despite it, at patients who receive in parallel antagonists of vitamin K it is necessary to exercise control of indicators of coagulation (see the section "Features of Use").

The medicines extending QT interval. Levofloxacin, like other ftorkhinolona, should be applied with care to patients who receive the medicines known for the ability to extend QT interval (for example, antiarrhythmic means of a class ІА and III, tricyclic antidepressants and macroleads), (see the section "Features of Use" (Lengthening of an interval of QT)).

Contraindications:

Hypersensitivity to a levofloksatsin, other hinolona or to any of drug components, epilepsy, complaints to side reactions from sinews after the previous use of hinolon. Pregnancy and period of feeding by a breast. Children's age.

Overdose:

Symptoms: dizziness, disturbance of consciousness and convulsive attacks. There were messages that at use of doses, above therapeutic, lengthening of a QT interval was observed. In cases of overdose careful observation of the patient, including carrying out an ECG is necessary.

Treatment: therapy is symptomatic. The hemodialysis, including peritoneal dialysis or HAPD, is not effective for removal of a levofloksatsin from an organism. There are no specific antidotes.

Storage conditions:

To store in the place protected from light at a temperature not over 25 ºС. To store in the place, unavailable to children. Not to freeze. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

On 100 ml in a bottle, on 1 bottle in a package from polyethylene in cardboard packaging.