Таваник®

General characteristics. Structure:

Active agent: levofloxacin - 250,000 mg (there correspond 256,230 mg of a levofloksatsin of a gemigidrat);
excipients: a gipromelloza - 5,400 mg, кросповидон - 7,000 mg, cellulose
microcrystallic - 33,870 mg; the sodium stearylfumarating - 5,000 mg;
film cover: a gipromelloza - 5,433 mg, a macrogoal of 8000 - 0,288 mg, titanium dioxide (Е
171) - 1,358 mg, talc - 0,407 mg, ferrous oxide red (Е 172) - 0,007 mg and ferrous oxide
yellow (Е 172) - 0,007 mg.
One tablet Таваник® 500 of mg contains:
active agent: levofloxacin - 500,000 mg (there correspond 512,460 mg of a levofloksatsin of a gemigidrat);
excipients: a gipromelloza - 10,800 mg, кросповидон - 14,000 mg, cellulose microcrystallic - 67,740 mg; the sodium stearylfumarating - 10,000 mg; film cover: a gipromelloza - 10,866 mg, a macrogoal of 8000 - 0,575 mg, titanium dioxide (Е 171) - 2,716 mg, talc - 0,815 mg, ferrous oxide red (Е 172) - 0,014 mg and ferrous oxide
yellow (Е 172) - 0,014 mg.
Description: Oblong biconvex tablets with a dividing groove on both sides, coated, pale flesh-colored color.

Pharmacological properties:

Pharmacodynamics. Таваник® - the synthetic antibacterial drug of a broad spectrum of activity from group of ftorkhinolon containing levofloxacin in quality of active agent - left-handed isomer of an ofloksatsin.
Levofloxacin blocks DNK-girazu (topoisomerase II) and topoisomerase IV, breaks superspiralling and a stitching of ruptures of DNA, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, a cell wall and membranes of microbic cells.
Levofloxacin is active concerning the majority of strains of microorganisms, as in the conditions of in vitro, and in vivo. In vitro
Sensitive microorganisms (MPK <2 mg/l; inhibition zone> 17 mm)
- Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Corynebacterium striatum, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I) [метициллино - чувствительные/-moderately sensitive)], Staphylococcus aureus methi-S, Staphylococcus epidermidis methi-S, Staphylococcus spp (CNS), Streptococci of group C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I/S/R (пенициллино - чувствительные/-moderately sensitive/-резистентные), Streptococcus pyogenes, Viridans streptococci peni-S/R.
- Aerobic gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter spp, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R (ampitsillino-chuvstviyelnye/-resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp, Moraxela catarrhalis Morganella morganii, Neisseria gonorrhoeae non PPNG/PPNG, Neisseria meningitidis, Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp, Pseudomonas aeruginosa (the hospital infections caused by Pseudomonas aeruginosa can demand the combined treatment), Pseudomonas spp, Salmonella spp, Serratia marcescens, Serratia spp.
- Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp, Clostridium perfringens, Fusobacterium spp, Peptostreptococcus, Propionibacterium spp, Veillonella spp.
- Other microorganisms: Bartonella spp, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp, Mycobacterium spp, Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp, Ureaplasma urealyticum. Moderately sensitive microorganisms (MPK = 4 mg/l; zone of inhibition of 16-14 mm)
- Aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (metitsillino-resistant), Staphylococcus haemolyticus methi-R.
- Aerobic gram-negative microorganisms: Burkholderia cepacia, Campylobacter jejuni/coli.
- Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp, Porphyromonas spp.
Microorganisms (MPK> of 8 mg/l, steady against levofloksatsin; inhibition zone <13 mm)
- Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R Staphylococcus coagulase-negative methi-R
- Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.
- Anaerobic microorganisms: Bacteroides thetaiotaomicron.
- Other microorganisms: Mycobacterium avium.
Clinical performance (efficiency in clinical trials at treatment of the infections caused by the listed below microorganisms)
- Aerobic gram-positive microorganisms
Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.
- Aerobic gram-negative microorganisms
Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxela (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.
- Others
Chlamydia pneumoniae; Legionella pneumophila, Mycoplasma pneumoniae.
Due to the features of the mechanism of action of a levofloksatsin usually it is not observed
cross resistance between levofloksatsiny and other antimicrobic
means.

Pharmacokinetics. Absorption
Levofloxacin is quickly and almost completely soaked up after intake,
meal influences its absorption a little. Absolute bioavailability at intake makes 99-100%. After a single dose of 500 mg of a levofloksatsin the maximum concentration in plasma is reached within 1-2 hours and makes 5,2+1,2 mkg/ml. The pharmacokinetics of a levofloksatsin is linear in the range of doses from 50 to 1000 mg. The equilibrium condition of concentration of a levofloksatsin in plasma at reception of 500 mg of a levofloksatsin 1 or 2 times a day is reached within 48 hours. For the 10th day of intake of the drug Таваник® 500 of mg of 1 times a day the maximum concentration of a levofloksatsin in plasma made 5,7+1,4 mkg/ml, and the minimum concentration of a levofloksatsin (concentration before reception of the next dose) in plasma made 0,5+0,2 mkg/ml.
For the 10th day of intake of the drug Таваник® 500 of mg 2 times a day the maximum concentration of a levofloksatsin in plasma made 7,8+1,1 mkg/ml, and the minimum concentration of a levofloksatsin (concentration before reception of the next dose) in plasma made 3,0+0,9 mkg/ml. Distribution
Communication with proteins of plasma makes 30-40%. After a single dose of 500 mg of a levofloksatsin the volume of distribution of a levofloksatsin makes about 100 l that indicates good penetration of a levofloksatsin into bodies and body tissues of the person.
Penetration into a mucous membrane of bronchial tubes, liquid of an epithelial vystilka, alveolar macrophages
After a single dose in 500 mg of a levofloksatsin the maximum concentration of a levofloksatsin in a mucous membrane of bronchial tubes and liquid of an epithelial vystilka were reached within 1-4 hours and made 8,3 mkg/g and 10,8 mkg/ml, respectively, with penetration coefficients in a mucous membrane of bronchial tubes and liquid of an epithelial vystilka in comparison with concentration in plasma, components 1,1-1,8 and 0,8-3, respectively.
After 5 days of intake of 500 mg of a levofloksatsin average concentration of a levofloksatsin in 4 hours after the last administration of drug in liquid of an epithelial vystilka made 9,94 mkg/ml and in alveolar macrophages - 97,9 mkg/ml.
Penetration into pulmonary fabric
The maximum concentration in pulmonary fabric after intake of 500 mg of a levofloksatsin made about 11,3 mkg/g and were reached in 4-6 hours after administration of drug with coefficients of a penetration 2-5 in comparison with concentration in plasma.
Penetration into alveolar liquid
After 3 days of reception of 500 mg of a levofloksatsin of 1 times or 2 times a day the maximum concentration of a levofloksatsin in alveolar liquid were reached in 2-4 hours after administration of drug and made 4,0 and 6,7 mkg/ml, according to penetration coefficient in comparison with concentration in plasma to components 1. Penetration into a bone tissue
Levofloxacin well gets into a cortical and spongy bone tissue, both in proximal, and in distal departments of a femur with penetration coefficient (bone fabric / plasma) 0,1-3. The maximum concentration of a levofloksatsin in a spongy bone tissue of proximal department of a femur after reception of 500 mg of drug inside made about 15,1 mkg/g (in 2 hours after administration of drug).
Penetration into cerebrospinal fluid
Levofloxacin badly gets into cerebrospinal fluid.
Penetration into prostate gland tissue
After intake of 500 mg of a levofloksatsin once a day within 3 days, average concentration of a levofloksatsin in tissue of a prostate gland made 8,7 mkg/g, the average ratio of concentration prostatic gland / plasma made 1,84. Concentration in urine
Average concentration in urine in 8-12 hours after intake of a dose of 150, 300 and 600 mg of a levofloksatsin made 44 mkg/ml, 91 mkg/ml and 162 mkg/ml, respectively. Metabolism
Levofloxacin is metabolized in insignificant degree (5% of the accepted dose). Its metabolites are деметиллевофлоксацин and N-oxide levofloxacin which are removed by kidneys. Levofloxacin is stereokhimichesk stable and is not exposed to chiral transformations.
Removal
After intake levofloxacin is rather slowly removed from plasma (an elimination half-life - 6-8 h). Removal is preferential through kidneys (more than 85% of the accepted dose). The general clearance of a levofloksatsin after a single dose of 500 mg made 175+29,2 ml/min.
There are no essential distinctions in pharmacokinetics of a levofloksatsin at its intravenous administration and intake that confirms that intake and intravenous administration are interchangeable. Pharmacokinetics at separate groups of patients
The pharmacokinetics of a levofloksatsin at men and women does not differ. At a renal failure the pharmacokinetics of a levofloksatsin changes. In process of depression of function of kidneys removal through kidneys and renal clearance decrease, and the elimination half-life increases.
The pharmacokinetics at patients of advanced age does not differ from that at young patients, except for the distinctions of pharmacokinetics connected with distinctions in clearance of creatinine.

Indications to use:

The bacterial infections sensitive to a levofloksatsin, at adults: acute sinusitis;
exacerbation of chronic bronchitis; community-acquired pneumonia;
uncomplicated infections of urinary tract;
the complicated infections of urinary tract (including pyelonephritis); chronic bacterial prostatitis; infections of integuments and soft tissues;
septicaemia/bacteremia, connected with the indications stated above; infections of an abdominal cavity;
for complex treatment of drug resistant forms of tuberculosis.

Route of administration and doses:

The tablets Таваник® 250 of mg or 500 mg accept inside one or twice a day. A pill should be taken, without chewing and washing down with enough liquid (from 0,5 to 1 glasses). In need of a tablet it is possible to break on a dividing groove.
Drug can be accepted before food or at any time between meals as meal does not influence drug absorption (see the section "Pharmacokinetics").
It is necessary to accept drug not less than in 2 hours to or in 2 hours after reception of the antiacid drugs containing magnesium and/or aluminum, salts of iron or a sukralfat (see. "Interaction with other medicines").
The mode of dosing is defined by character and weight of an infection, and also sensitivity of the estimated activator. Duration of treatment varies depending on the course of a disease.
The dosing recommended the mode and duration of treatment at patients with normal or moderately reduced function of kidneys (clearance of creatinine> of 50 ml/min.)
- Acute sinusitis: on 2 tablets Таваник® 250 of mg or 1 tablet Таваник® 500 of mg once a day (respectively 500 mg of a levofloksatsin) - 10 - 14 days.
- Exacerbation of chronic bronchitis: on 1 tablet Таваник® 250 of mg once a day (respectively 250 mg of a levofloksatsin) or on 2 tablets Таваник® 250 of mg or 1 tablet Таваник® 500 of mg once a day (respectively 500 mg of a levofloksatsin) - 7-10 days.
- Community-acquired pneumonia: on 2 tablets Таваник® 250 of mg or on 1 tablet Таваник® 500 of mg 1-2 times a day (respectively 500-1000 mg of a levofloksatsin) - 7-14 days.
- Uncomplicated infections of urinary tract: on 1 tablet Таваник® 250 of mg once a day (respectively 250 mg of a levofloksatsin) - 3 days.
- The complicated infections of urinary tract (including pyelonephritis): on 1 tablet Таваник® 250 of mg once a day (respectively 250 mg of a levofloksatsin) - 7-10 days.
- Chronic bacterial prostatitis: on 2 tablets Таваник® 250 of mg or on 1 tablet Таваник® 500 of mg once a day (respectively 500 mg of a levofloksatsin) - 28 days.
- Infections of integuments and soft tissues: on 1 tablet Таваник® 250 of mg once a day (respectively 250 mg of a levofloksatsin) or on 2 tablets Таваник® 250 of mg or on 1 tablet Таваник® 500 of mg 1-2 times a day (respectively 500-1000 mg of a levofloksatsin) - 7-14 days.
- Septicaemia/bacteremia, connected with the indications stated above: on 2 tablets Таваник® 250 of mg or on 1 tablet Таваник® 500 of mg 1-2 times a day (respectively 500-1000 mg of a levofloksatsin) of-10-14 days.
- Infections of an abdominal cavity: on 2 tablets Таваник® 250 of mg or on 1 tablet Таваник® 500 of mg once a day (respectively 500 mg of a levofloksatsin) - 7-14 days (in a combination with the antibacterial drugs operating on anaerobic flora).
- Complex treatment of drug resistant forms of tuberculosis: on 1-2 tablets Таваник® 500 of mg 1-2 times a day (respectively 500-1000 mg of a levofloksatsin) - up to 3 months.
The dosing mode at patients with a renal failure
Levofloxacin is removed preferential through kidneys therefore at treatment of patients with an impaired renal function the drug dose decline is required (see the table below).

Clearance of creatinine                      Mode of a drug dosing Tavanik®
                                       The recommended        Recommended dose  the Recommended dose
                                       dose at clearance   at clearance            at clearance
                                       creatinine> 50th       creatinine> 50th        creatinine> 50 ml/min.:
                                       ml/min.: 250 mg / 24    ml/min.: 500 mg / 24     500 mg / 12 hour.
                                       hour                            hour.                              
50-20 ml/min.               first dose: 250       first dose:               first dose: 500 mg then:                         
                                       mg then: on       125 500 mg then:              250 mg / 12 hour.
                                       mg / 24 hour                  on 250 mg / 24 hour.         
19-10 ml/min.               first dose: 250       first dose: 500 mg   first dose: 500 mg then:
                                       mg then:                   then:                          for 125/12 hour
                                       on 125 mg / 48 hour      on 125 mg / 24 hour.
<10 ml/min. (including the first dose: 250 mg  first dose: 500 mg    first dose: 500
гемодиа¬лиз and PAPD1 затем:по 125 mg / 48   zatem:125 mg / 24 hour   of mg then: 125/24
                                       hour                                                                 hour.

after a hemodialysis or the continuous out-patient peritoneal dialysis (COPPD) introduction of additional doses is not required.
The dosing mode at patients with abnormal liver functions.
At an abnormal liver function correction of the mode of dosing as levofloxacin is only slightly metabolized in a liver is not required. The dosing mode at patients of advanced age
Patients of advanced age do not require correction of the mode of dosing, except for cases of decrease in clearance of creatinine to 50 ml/min. and below. Precautionary measures at use
The hospital infections caused by a pyocyanic stick (Pseudomonas aeruginosa) can demand the combined treatment. The patients predisposed to development of spasms
As well as other hinolona, levofloxacin it has to be applied carefully at patients with predisposition to spasms. To such patients patients treat with the previous damages of the central nervous system, such as stroke, severe craniocereberal injury; the patients who are at the same time receiving the drugs reducing a threshold of convulsive readiness of a brain such as фенбуфен and another similar to it the non-steroidal anti-inflammatory drugs or other drugs lowering a threshold of convulsive readiness such as theophylline (see. "Interaction with other medicines"). Pseudomembranous colitis
The diarrhea which developed in time or after treatment levofloksatsiny, especially heavy, persistent and/or with blood can be symptoms of the pseudomembranous colitis caused by Clostridium difficile. In case of suspicion on development of pseudomembranous colitis treatment levofloksatsiny should be stopped immediately and at once to begin a specific antibioticotherapia (Vancomycinum, тейкопланин or metronidazole inside). Tendinitis
Seldom observed tendinitis at use of hinolon, including levofloxacin,
can lead to a rupture of sinews, including an Achilles tendon. This collateral
the effect can develop within 48 hours after an initiation of treatment and can be bilateral.  Patients  of advanced  age   are more predisposed to development of a tendinitis. The risk of a rupture of sinews can increase at a concomitant use of glucocorticosteroids. At suspicion on a tendinitis it is necessary to stop immediately treatment by the drug Tavanik® and to begin the corresponding treatment of the affected sinew, for example, having provided it a sufficient immobilization (see. "Contraindications for use" and "Possible side effects at medicine use"). Patients with a renal failure
As levofloxacin is excreted mainly through kidneys, obligatory control of function of kidneys, and also correction of the mode of dosing is required from patients with a renal failure (see. "Mode of dosing and route of administration"). At treatment of patients of advanced age it must be kept in mind that patients of this group often suffer from renal failures (see the section "Mode of Dosing and Route of Administration").
Prevention of development of reactions of a photosensitization
Though the photosensitization at use of a levofloksatsin meets very seldom, for prevention of its development patients are not recommended to be exposed without special need to power solar or artificial ultra-violet irradiation (for example, to visit a sunbed). Superinfection
As well as at use of other antibiotics, use of a levofloksatsin, especially for a long time, can lead to the strengthened reproduction of microorganisms, insensitive to it, that can cause changes of microflora (bacteria and mushrooms) which normal is present at the person that can lead to development of superinfection. Therefore during treatment it is obligatory to carry out repeated assessment of a condition of the patient and in case of development during treatment of superinfection it is necessary to take the appropriate measures. Lengthening of an interval of QT
It was reported about very exceptional cases of lengthening of an interval of QT at the patients receiving ftorkhinolona including levofloxacin.
At  use  of ftorkhinolon,   including  levofloxacin,   it is necessary  to observe
care at patients with the known risk factors of lengthening of an interval of QT: at patients of advanced age; at patients with not corrected electrolytic disturbances (with a hypopotassemia, a hypomagnesiemia); about a syndrome of inborn lengthening of an interval of QT; with heart diseases (heart failure, a myocardial infarction,
bradycardia); at a concomitant use of the medicines capable to extend an interval of QT, such as antiarrhytmic means 1A and the III class, tricyclic antidepressants, macroleads.
Patients with insufficiency glyukozo-6-fosfatdegidrogenazy
 Patients  with  the latent  or  demonstrated  insufficiency  glyukozo-6-fosfatdegidrogenazy have a predisposition to hemolitic reactions at treatment of a hinolonama that it is necessary to take into account at treatment levofloksatsiny. Hypoglycemia
At the patients with a diabetes mellitus receiving peroral hypoglycemic means, for example, glibenclamide or insulin at use of hinolon the risk of development of a hypoglycemia increases.    Careful monitoring of concentration of glucose in blood is required from these patients with a diabetes mellitus. Peripheral neuropathy
At the patients receiving ftorkhinolona including levofloxacin, touch and sensory-motor peripheral neuropathy which beginning can be bystry was noted. If the patient has neuropathy symptoms, use of a levofloksatsin has to be stopped. It minimizes possible risk of development of irreversible changes. Aggravation of a pseudoparalytic myasthenia (myasthenia gravis)
Levofloxacin should be applied with care at patients with a pseudoparalytic myasthenia (myasthenia gravis) (see the section "Possible Side Effects at Medicine Use").

Features of use:

Tavanik it is impossible to apply to treatment of children and teenagers in view of probability of damage of joint cartilages.
At treatment of patients of senile age it must be kept in mind that patients of this group often suffer from renal failures (see the section "Route of Administration and Doses")
At very heavy pneumonia caused by pneumococci, Tavanik can not give optimum therapeutic effect. The hospital infections caused by certain activators (R. of aeruginosa), can demand the combined treatment.
During treatment by drug Tavanik development of an attack of spasms in patients with the previous damage of a brain caused, for example, by a stroke or a severe injury is possible. Convulsive readiness can increase also at simultaneous use of a fenbufen, non-steroidal anti-inflammatory drugs or theophylline, similar to it (see. "Interaction").
In spite of the fact that the photosensitization is noted at use of a levofloksatsin very seldom, in order to avoid its patients are not recommended to be exposed without special need to power solar or artificial ultra-violet irradiation (for example, stay in the sun in the mountain area or visit of a sunbed).
At suspicion of pseudomembranous colitis it is necessary to cancel immediately Tavanik and to begin the corresponding treatment. In such cases it is impossible to apply the medicines oppressing motility of intestines.
Tavanik who is seldom observed at drug use can lead a tendinitis (first of all an Achilles tendon inflammation) to a rupture of sinews. Patients of advanced age are more inclined to a tendinitis. Treatment by corticosteroids ("kortizonovy drugs") most likely increases risk of a rupture of sinews. At suspicion on a tendinitis it is necessary to stop immediately treatment by drug Tavanik and to begin the corresponding treatment of the affected sinew, for example, having provided it a condition of rest (see. "Contraindications" and "Side effect").
Patients with insufficiency glyukozo-6-fosfatdegidrogenazy (an inherited disorder of a metabolism) can react to ftorkhinolona destruction of erythrocytes (hemolysis). In this regard, treatment of such patients levofloksatsiny should be carried out carefully.
Such side effects of drug Tavanik as dizziness or catalepsy, drowsiness and visual disturbances (see also undressed "Side effect), can worsen reactionary ability and ability to concentration of attention. It can represent a certain risk in situations when these abilities have special value (for example, when driving, at service of cars and mechanisms, when working in unstable situation). In a special measure it concerns cases of interaction of drug with alcohol.

Side effects:

The side effects provided below are presented according to the following gradation of frequency of their emergence: very frequent (> 1/10), frequent (> 1/100, <1/10); infrequent (> 1/1000, <1/100); rare (> 1/10000, <1/1000); very rare (<1/10000) (including separate messages), unknown frequency (it is not possible to determine occurrence frequency by the available data).
Data from clinical trials and post-marketing use of drug
Disturbances from heart
Rare: sinus tachycardia
Unknown frequency (post-marketing data): lengthening of an interval of QT (cm sections "Precautionary Measures at Use", "Overdose"). Disturbances from blood and lymphatic system.
Infrequent: a leukopenia (reduction of quantity of leukocytes in peripheral blood),
eosinophilia (increase in quantity of eosinophils in peripheral blood).
Rare: a neutropenia (reduction of quantity of neutrophils in peripheral
blood), thrombocytopenia (reduction of quantity of thrombocytes in peripheral blood). Unknown frequency (post-marketing data): a pancytopenia (reduction of quantity of all uniform elements in peripheral blood), an agranulocytosis (absence or sharp reduction of quantity of granulocytes in peripheral blood), hemolitic anemia.
Disturbances from a nervous system
Frequent: headache, dizziness.
Infrequent: drowsiness, tremor, dysgeusia (food faddism).
Rare: paresthesia, spasms.
Unknown frequency (post-marketing data): peripheral touch neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal frustration, loss of flavoring feelings, a parosmiya (frustration of feeling of a smell, especially subjective feeling of the smell which is objectively absent), including loss of sense of smell.
Disturbances from an organ of sight
Very rare: vision disorders, such as vagueness of the visible image.
Disturbances from an acoustic organ and labyrinth disturbances
Infrequent: вертиго (feeling of a deviation or spinning or own body or surrounding objects). Rare: a ring in ears.
Unknown frequency (post-marketing data): decrease in hearing.
Disturbances from respiratory system, bodies of a thorax and a mediastinum
Infrequent: asthma
Unknown frequency (post-marketing data): bronchospasm, allergic pneumonitis.
Disturbances from digestive tract Frequent diarrhea, vomiting, nausea. Infrequent: abdominal pains, dyspepsia.
Unknown frequency (post-marketing data): hemorrhagic diarrhea which seldom or never can be a coloenteritis sign, including pseudomembranous colitis.
Disturbances from kidneys and urinary tract
Infrequent: increase in concentration of creatinine in blood serum.
Rare: an acute renal failure (for example, owing to development of intersticial nephrite).
Disturbances from skin and hypodermic fabrics Infrequent: rash, itch, urticaria.
Unknown frequency (post-marketing data): toxic epidermal некролизис, Stephens-Johnson's syndrome, an exudative mnogoformny erythema, reactions of a photosensitization (hypersensitivity to solar and ultraviolet radiation), a leykotsitoklastichesky vasculitis.
Reactions from skin and mucous membranes can sometimes develop even after reception of the first dose of drug.
Disturbances from skeletal and muscular system and connecting fabric Infrequent: arthralgia, mialgiya
Rare: damage of sinews, including a tendinitis (for example, an Achilles tendon),
muscular weakness which can be especially dangerous at patients with a pseudoparalytic myasthenia (myasthenia gravis) (see the section "Precautionary Measures at Medicine Use").
Unknown frequency (post-marketing data): рабдомиолиз, rupture of a sinew (for example, Achilles tendon). This side effect can be observed within 48 hours after an initiation of treatment and can have bilateral character (see also section "Precautionary Measures at Drug Use"). Disturbances from a metabolism and food Infrequent: anorexia.
Rare: a hypoglycemia, especially at patients with a diabetes mellitus (possible
hypoglycemia signs: "wolf" appetite, nervousness, perspiration, shiver). Infectious and parasitic diseases
Infrequent: fungal infections, development of resistance of pathogenic microorganisms.
Disturbances from vessels
Rare: lowering of arterial pressure.
General frustration
Infrequent: adynamy.
Rare: pyrexia (fervescence).
Disturbances from immune system
Rare: Quincke's disease.
Unknown frequency (post-marketing data): acute anaphylaxis, anaphylactoid shock.
Anaphylactic and anaphylactoid reactions can sometimes develop even after reception of the first dose of drug.
Disturbances from a liver and biliary tract
Frequent: increase in activity of "hepatic" enzymes in blood (for example,
alaninaminotranspherases (ALAT), aspartate aminotransferases (ASAT)). Infrequent: increase in concentration of bilirubin in blood.
Unknown frequency (post-marketing data): a heavy liver failure, including cases of development of an acute liver failure, especially at patients with a serious basic disease (for example, at sepsis); hepatitis.
Disturbances of mentality Frequent: sleeplessness.
Infrequent: feeling of concern, confusion of consciousness.
Rare: mental disturbances (for example, with hallucinations), a depression, agitation (excitement), sleep disorders, nightmares.
Unknown frequency (post-marketing data): disturbances of mentality with behavior disorders with causing to harm, including suicide thoughts and suicide attempts.
Other possible undesirable effects relating to all ftorkhinolona
Very rare: porphyria attacks (very rare disease of a metabolism) at
the patients who already have this disease.

Interaction with other medicines:

The interactions demanding respect for care
With the iron salts, antiacid means containing magnesium and/or aluminum
It is recommended the drugs containing bivalent or trivalent cations
such as iron salts (means for treatment of an anemia), antiacid means,
the containing magnesium and/or aluminum to accept not less than in 2 hours prior to or through 2
hour after reception of the tablets Tavanik®. With interaction calcium carbonate not
it is revealed.
With sukralfaty
Effect  of the drug Tavanik®  is considerably weakened at simultaneous use of a sukralfat (means for protection of a mucous membrane of a stomach). The patients receiving levofloxacin and сукральфат are recommended to accept сукральфат in 2 hours after reception of a levofloksatsin.
With theophylline, fenbufeny or the similar medicines from group of non-steroidal anti-inflammatory drugs reducing a threshold of convulsive readiness of a brain
Pharmacokinetic interaction of a levofloksatsin with theophylline is not revealed. Concentration of a levofloksatsin at a concomitant use of a fenbufen increases only by 13%.
However at co-administration of the hinolon and theophylline,  non-steroidal anti-inflammatory drugs and other drugs reducing a threshold of convulsive readiness of a brain, perhaps expressed reduction of the threshold of convulsive readiness of a brain. With indirect anticoagulants
At the patients receiving treatment levofloksatsiny in a combination with indirect anticoagulants (for example, warfarin), observed increase in prothrombin time / the normalized international relation and/or development of bleeding including heavy. Therefore at simultaneous use of indirect anticoagulants and a levofloksatsina regular control of indicators of a blood coagulation is necessary. With probenitsidy and Cimetidinum
At simultaneous use of the medicines breaking renal canalicular secretion of a levofloksatsin such as пробеницид and Cimetidinum, it is necessary to be careful especially at patients with a renal failure. Removal (renal clearance) of a levofloksatsin is slowed down under the influence of Cimetidinum for 24% and a probenitsid for 34%. It is improbable that it can have clinical value at normal function of kidneys. With cyclosporine
Levofloxacin increased a cyclosporine elimination half-life by 33%. As this increase is clinically insignificant, dose adjustment of cyclosporine at its simultaneous use with levofloksatsiny is not required. With glucocorticosteroids
The concomitant use of glucocorticosteroids increases risk of a rupture of sinews. With the medicines extending QT interval.
Levofloxacin, as well as other ftorkhinolona, has to be applied with care at the patients   receiving   the drugs   extending      QT interval   (for example, antiarrhythmic drugs of the class IA and III, tricyclic antidepressants, macroleads). Other
The conducted kliniko-pharmacological researches for studying of possible pharmacokinetic interactions of a levofloksatsin from calcium a carbonate, digoxin, glibenclamide, ranitidine and warfarin showed that the pharmacokinetics of a levofloksatsin at simultaneous use with these drugs does not change sufficiently that it had clinical value.
Opportunity and features of a medical use of medicine pregnant women, women during breastfeeding, the children, adults having chronic diseases
Таваник® it is contraindicated for use for pregnant women, women during breastfeeding, children and teenagers up to 18 years.
Possible influence on ability of control of vehicles or other mechanisms
Such side effects of the drug Tavanik® as dizziness or вертиго, drowsiness and visual disturbances (see the section "Side effect"), can reduce psychomotor reactions and ability to concentration of attention. It can represent a certain risk in situations when these abilities have special value (for example, when driving, at service of cars and mechanisms, when working in unstable situation).

Contraindications:

Hypersensitivity to a levofloksatsin or to other hinolona. Epilepsy.
Damages of sinews at reception of ftorkhinolon in the anamnesis.
Children's and teenage age up to 18 years (in connection with incompleteness of growth of a skeleton as it is impossible to exclude completely risk of defeat of cartilaginous apical points).
Pregnancy (it is impossible to exclude completely risk of defeat of cartilaginous apical points at a fruit).
The lactation period (it is impossible to exclude completely risk of defeat of cartilaginous apical points of bones at the child). With care
- At the patients predisposed to development of spasms [at patients with the previous damages of the central nervous system (CNS), at the patients who are at the same time receiving the drugs reducing a threshold of convulsive readiness of a brain such as фенбуфен, theophylline] (see. "Interaction with other medicines").
- At patients with the latent or demonstrated deficit glyukozo-6-fosfatdegidrogenazy (the increased risk of hemolitic reactions at treatment of a hinolonama).
- At patients with a renal failure (obligatory control of function of kidneys, and also correction of the mode of dosing is required, see. "Route of administration and doses").
- Patients with the known risk factors for lengthening of an interval have QT: at patients of advanced age; at patients with not corrected electrolytic disturbances (with a hypopotassemia, a hypomagnesiemia); about a syndrome of inborn lengthening of an interval of QT; with heart diseases (heart failure, a myocardial infarction, bradycardia); at a concomitant use of the medicines capable to extend QT interval (see. "Interaction with other medicines").
- At the patients with a diabetes mellitus receiving peroral hypoglycemic means, for example, glibenclamide or insulin (the risk of development of a hypoglycemia increases).
- At patients with heavy undesirable reactions to other ftorkhinolona, such as heavy neurologic reactions (the increased risk of emergence of similar undesirable reactions at use of a levofloksatsin).
- At patients with a pseudoparalytic myasthenia is (myasthenia gravis) (see the section "Possible Side Effects at Medicine Use").

Overdose:

Proceeding from the data obtained in researches on animals, the major expected symptoms of overdose of the drug Tavanik® are symptoms from the central nervous system (consciousness disturbance, including confusion of consciousness, dizziness and spasms).
At post-marketing use of drug at overdose effects from the central nervous system were observed, including confusion of consciousness, a spasm, hallucination and a tremor.
Nausea and erosion of digestive tract can be noted.
In the kliniko-pharmacological researches conducted with the doses of a levofloksatsin exceeding therapeutic lengthening of an interval of QT was shown. Measures for assistance at overdose
In case of overdose observation of the patient, including an ECG is required carefully -
monitoring.    Symptomatic treatment.    In case of  overdose  of the tablets Tavanik® the gastric lavage and introduction of antacids for protection mucous a stomach is shown. Levofloxacin is not removed by means of dialysis (a hemodialysis, peritoneal dialysis and continuous peritoneal dialysis). The specific antidote (counteracting substance) does not exist.
Actions of the doctor, the paramedic or the patient at the admission of one or several doses of medicine.
If administration of drug is accidentally missed, then it is necessary to take, as soon as possible, a pill and further to continue to accept Tavanik® according to the recommended mode of its dosing.

Storage conditions:

Period of validity of 5 years. After a period of validity drug cannot be used. At a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 250 mg.
On 3, 5, 7 or 10 tablets in the blister from PVC / aluminum foil.
On 1 blister together with the application instruction in a cardboard pack.
Tablets, film coated, 500 mg.
On 5, 7 or 10 tablets in the blister from PVC / aluminum foil.
On 1 blister together with the application instruction in a cardboard pack.