Tavanic (Levofloxacin) tablets, solution

The composition and form of issue: 

Tablets, film-coated. 1 tablet contains:

the levofloxacin hemihydrate 256, 23 mg

(corresponding to 250 mg levofloxacin) 

512, 46 mg

(corresponding to 500 mg levofloxacin) 

excipients: crospovidone — 7 mg/14 mg polymer in 5, 4 mg/10, 8 mg of MCC — 33, 87 mg/67, 74 mg of sodium fumarate, 5 mg/10 mg 

film shell:hypromellose — 5, 433 mg/10, 866 mg macrogol 8000 — 0, 288 mg/0, 575 mg talc and 0, 407 mg/0, 815 mg titanium dioxide (E171) — 1, 358 mg/2, 716 mg of iron oxide red (E172) — 0, 007 mg/0, 014 mg iron oxide yellow (E172) — 0, 007 mg/0, 014 mg 

in blister packs of 3, 5, 7 or 10 PCs(250 mg), or blistere in 5, 7 or 10 pieces(500 mg) in cartons of 1 blister.

Solution for infusion. 100 ml contains:

the levofloxacin hemihydrate 512, 46 mg

(corresponding to 500 mg levofloxacin) 

auxiliary substances: sodium chloride 900 mg sodium hydroxide 0-30 mg concentrated hydrochloric acid and 140 mg water for injection, 99047, 54 mg 

in bottles of 100 ml in a cardboard pack 1 bottle.

Description pharmaceutical form:

Tablets: oblong, biconvex tablets with a dividing groove on both sides, coated pale yellow-pink color.

Infusion solution: clear solution, greenish-yellow color.

Pharmacokinetics:

Absorption. Levofloxacin is rapidly and almost completely absorbed after ingestion, food intake has little effect on its absorption. The absolute oral bioavailability is 99-100%. After a single dose of 500 mg of levofloxacin Cmax in plasma is reached in 1-2 h and is (5, 2±1, 2) µg/ml the Pharmacokinetics of levofloxacin are linear in the dose range of 50 to 1000 mg. Css of levofloxacin in plasma at the dose of 500 mg of levofloxacin 1 or 2 times per day is achieved within 48 hours.

On the 10th day of ingestion of the drug Tavanic 500 mg 1 once a day, Cmax of levofloxacin in the plasma were (5, 7±1, 4) µg/ml, and Cmin of levofloxacin (concentration before taking another dose) in plasma were (0, 5±0, 2) µg/ml.

On the 10th day of ingestion of the drug Tavanic 500 mg 2 times a day, Cmax of levofloxacin in the plasma were (7, 8±1, 1) µg/ml, and Cmin of levofloxacin (concentration before taking another dose) in plasma was (3, 0±0, 9) µg/ml.

Distribution. The plasma protein binding is 30-40%. After a single dose of 500 mg of levofloxacin Stomatitis levofloxacin is approximately 100 l, indicating good penetration of levofloxacin in tissues and organs of the human body.

Penetration into bronchial mucosa, epithelial lining fluid, alveolar macrophages. After a single oral administration of 500 mg of levofloxacin Cmax of levofloxacin in bronchial mucosa and epithelial lining fluid are reached within 1-4 h and were 8, 3 µg/g and 10 8 µg/ml, respectively, with coefficients of penetration into the mucosa of the bronchi and epithelial lining fluid compared with plasma concentration, components of 1, 1-1, 8, and 0, 8-3, respectively.

After 5 days of ingestion of 500 mg of levofloxacin the average concentrations of levofloxacin after 4 h after the last administration of the drug in liquid epithelial lining was 9, 94 µg/ml in alveolar macrophages — 97, 9 µg/ml.

Penetration into lung tissue. Cmax in lung tissue after ingestion of 500 mg of levofloxacin was approximately 11, 3 µg/g and was reached after 4-6 h after administration of the drug with the penetration factors of 2-5 compared with the concentration in plasma.

Infiltration in the alveolar fluid.After 3 days of taking 500 mg of levofloxacin 1 time or 2 times a day, Cmax of levofloxacin in the alveolar fluid was 4 and 6, 7 µg/ml, respectively, and were reached 2-4 h after ingestion, rate of penetration 1, compared to concentrations in plasma.

Penetration into bone tissue. Levofloxacin penetrates well into cortical and cancellous bone in the proximal and in the distal femur with a coefficient of penetration (bone tissue/plasma) 0, 1-3. Cmax of levofloxacin in the cancellous bone of the proximal femur after taking 500 mg of the drug inside was about 15 and 1 µg/g (2 hours after taking the drug).

Penetration into the cerebrospinal fluid. Levofloxacin poorly penetrates into the cerebrospinal fluid.

Penetration into the prostate tissue. After ingestion of 500 mg of levofloxacin 1 time per day for 3 days, the average concentration of levofloxacin in the prostate tissue was 8, 7 µg/g, the average ratio of the concentrations of the prostate/plasma was 1, 84.

Concentration in urine. The average concentrations in the urine after 8-12 hours after ingestion of doses of 150, 300 and 600 mg of levofloxacin were 44 , 91 and 162 µg/ml, respectively.

Metabolism. Levofloxacin is metabolized to a small extent (5% of dose). Its metabolites are desmethyl-levofloxacin and N-oxide levofloxacin, which are excreted by the kidneys. Levofloxacin is stereochemically stable and does not undergo chiral transformations.

Excretion. After oral levofloxacin is relatively slowly eliminated from plasma (T1/2 — 6-8 hours). Excretion is mainly through kidney (more than 85% of the dose). Total clearance of levofloxacin after a single dose of 500 mg was (175±29, 2) ml/min.

No significant differences in the pharmacokinetics of levofloxacin when it is on/in the introduction and ingestion, which confirms that the ingestion and/in the introduction are interchangeable.

Pharmacokinetics in specific groups of patients. The pharmacokinetics of levofloxacin in men and women did not differ.

In renal insufficiency the pharmacokinetics of levofloxacin is affected. With decreasing renal function the excretion through the kidneys and renal clearance is reduced and elimination half-life increases.

Pharmacokinetics in elderly patients does not differ from that in younger patients, with the exception of differences in the pharmacokinetics associated with differences in creatinine clearance.

After the on/in a 60-minute infusion of levofloxacin at a dose of 500 mg to healthy volunteers, an average Cmax in plasma was 6, 2 µg/ml the Pharmacokinetics of levofloxacin is linear and predictable at single and multiple administration of a drug. Plasma concentration profile of levofloxacin after I/V administration similar to that in the pill, so oral and intravenous routes of administration can be considered interchangeable.

The average Vd of levofloxacin ranges from 89 to 112 l after single and multiple in/in the dose of 500 mg.

Pharmacokinetic characteristics after single I/V administration of levofloxacin at a dose of 500 mg are: Cmax— (6, 2±1, 0) µg/ml, Tmax— (1, 0±0, 1) h, T1/2 — (6, 4±0, 7) h, respectively.

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

After I/V administration is predominantly excreted in the urine unchanged. Average end T1/2 of levofloxacin is 6 to 8 hours after single and multiple in/in the introduction.

In renal failure reduce clearance of the drug and its elimination through the kidneys depends on the degree of reduction in creatinine clearance.

Description pharmacological action:

Tavanic is a synthetic antibacterial broad-spectrum drugs of the fluoroquinolone group containing, as the active substance levofloxacin — levo isomer of ofloxacin.

Levofloxacin does DNK-girazu (topoisomerase II) and topoisomerase IV, violates supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, cell wall and membranes of microbial cells.

Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.

In vitro:

Sensitive microorganisms (IPC&le2 mg/ml zone of inhibition &ge17 mm)

Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Corynebacterium striatum, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S/I (methicillin-sensitive/moderately sensitive), Staphylococcus aureus methi-S, Staphylococcus epidermidis methi-S, Staphylococcus spp (CNS), Streptococci groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae penis/I/R (penicillinsusceptible/moderately sensitive/resistant), Streptococcus pyogenes, Viridans streptococci penis/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 (ampicillin-sensitive/resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp, Moraxella catarrhalis &beta+/&beta, Morganella morganii, Neisseria gonorrhoeae non PPNG/PPNG, Neisseria meningitidis, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp, Pseudomonas aeruginosa (hospital infections caused by Pseudomonas aeruginosa may require 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, Ricketsia spp, Ureaplasma urealyticum.

Moderately susceptible organisms (IPC=4 mg/l zone of inhibition — mm 16-14):

Aerobic gram-positive microorganisms: Corynebacterium past, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant), Staphylococcus haemolyticus methi-R.

Aerobic gram-negative organisms: Burkholderia cepacia, Campylobacter jejuni/coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, and Prevotella spp. Porphyromonas spp.

Levofloxacin-resistant microorganisms (IPC&ge8 mg/l zone of inhibition <13 mm)

Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R Staphylococcus coagulase-negative methi-R.

Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.

Other microorganisms: Mycobacterium avium.

The clinical efficacy (efficacy in clinical trials in the treatment of infections caused by the following 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.

In connection with the peculiarities of the mechanism of action of levofloxacin is usually not observed cross-resistance between levofloxacin and other antimicrobial agents.

Indications:

Therapy of mild and severe bacterial infections that are sensitive to levofloxacin in adults.

Pills

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

Solution for infusion

• community-acquired pneumonia
• complicated urinary tract infections (including pyelonephritis)
• uncomplicated urinary tract infection
• chronic bacterial prostatitis
• septicemia/bacteremia associated with the above indications
• intra-abdominal infection
• comprehensive treatment of drug-resistant forms of tuberculosis.

Contraindications:

• hypersensitivity (including to other hinolonam)
• epilepsy
• lesions of the tendons when taking fluoroquinolones in anamnesis
• childhood and adolescence till 18 years (due to the incomplete growth of the skeleton, because it is impossible to completely eliminate the risk of destruction of the cartilage growth points)
• pregnancy(it is impossible to completely eliminate the risk of destruction of the cartilaginous points of growth in the fetus)
• lactation (it is impossible to completely eliminate the risk of destruction of the cartilage of the growth points of bones in children).

Application of pregnancy and breast-feeding:

Tavanic is contraindicated in pregnant women, women in lactation, children and adolescents up to 18 years.

Side effects:

The following side effects are presented in accordance with the following graduations of the frequency of their occurrence: very common (&GE. 1/10), common (&GE. 1/100, <1/10) uncommon (&ge1/1000, <1/100) rare (&ge1/10000, <1/1000) very rare (<1/10000) (including private messages), unknown frequency (according to the available data to determine the frequency of occurrence is not possible).

Data from clinical studies and post-marketing use of the drug

Heart: rarely — sinus tachycardia unknown frequency (post marketing data) — prolonged QT interval (see sections “Special instructions”, “Overdose”).

The blood and lymphatic system: rarely — leukopenia (decrease in the number of leukocytes in peripheral blood), eozinofilia (increase in the number of eosinophils in peripheral blood) rare — neutropenia (decrease in the number of neutrophils in the peripheral blood), thrombocytopenia (reduction of platelets in peripheral blood) unknown frequency (post marketing data) — pancytopenia (decrease of all formed elements in the peripheral blood), agranulocytosis (absence or sharp decrease in the number of granulocytes in the peripheral blood), hemolytic anemia.

From the nervous system: often — headache, dizziness, rarely — drowsiness, tremor, dysgeusia (dysgeusia) is rare — paresthesia, convulsions unknown frequency (post marketing data) — peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorder, loss of taste, parosmia (disorder of the sense of smell, especially the subjective feeling of smell, objectively absent), including loss of smell.

From the body of the vision: rarely — visual disturbances such as blurring of the visible image.

On the part of the organ of hearing and labyrinth disorders: infrequent — vertigo (feeling of whirling or rejection or the self or surrounding things), rarely — ringing in the ears unknown frequency (post marketing data) — hearing loss.

The respiratory system of the chest and mediastinum: infrequently — shortness of breath unknown frequency (post marketing data), bronchospasm, allergic pneumonitis.

By the blood: often — diarrhea, vomiting, nausea uncommon — abdominal pain, dyspepsia unknown frequency (post marketing data) — haemorrhagic diarrhoea, which in very rare cases, it may be a symptom of enterocolitis, including pseudomembranous colitis.

The kidneys and urinary tract: rarely — increased concentration of creatinine in serum rarely — acute renal failure (for example due to development of interstitial nephritis).

The skin and subcutaneous tissue: often — rash, itching, hives unknown frequency (post marketing data) — necrolysis toxic epidermal, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reaction (increased sensitivity to sun and ultraviolet radiation), leukocytoclastic vasculitis. Reactions of skin and mucous membranes may sometimes develop even after the first dose of the drug.

On the part of the musculoskeletal system and connective tissue: infrequent — arthralgia, myalgia rare — the defeat tendons, including tendinitis (e.g. Achilles tendon) muscular weakness which can be especially dangerous in patients with psevdoparalitichesky myasthenia(myasthenia gravis) (see “Special instructions”) unknown frequency (post marketing data): rhabdomyolysis, tendon rupture (e.g. Achilles tendon). This side effect may occur within 48 h after the start of treatment and may be bilateral in nature (see also the section “Special instructions”).

From the metabolic and nutritional: rarely — anorexia rare hypoglycaemia, particularly in patients with diabetes mellitus (possible signs of hypoglycemia: the “wolf” appetite, nervousness, perspiration, shakiness).

Infectious and parasitic diseases: rare fungal infections, the development of resistance of pathogenic microorganisms.

From vessels: rare — reducing AD.

General disorders: uncommon — asthenia rarely pyrexia (increased body temperature).

The immune system: seldom — angioedema unknown frequency (post marketing data), anaphylactic shock, anaphylactoid shock.

Anaphylactic and anaphylactoid reactions may sometimes develop even after the first dose of the drug.

The liver and biliary tract: often — increased activity of “liver” enzymes in the blood (e.g. ALT, AST), rarely — increased concentration of bilirubin in the blood unknown frequency (post marketing data) — severe hepatic failure, including cases of acute liver failure, especially in patients with severe underlying disease (such as sepsis) hepatitis.

On the part of the psyche: often — insomnia rare — anxiety, confusion, rarely — mental disturbances (such as hallucinations), depression, agitation (agitation), sleep disturbance, nightmares unknown frequency (post marketing data) — psychiatric disorders with disturbances of conduct causing harm to themselves, including suicidal thoughts and suicide attempts.

Other possible unwanted effects related to all of the fluoroquinolones:very rare — attacks of porphyria (a very rare metabolic diseases) in patients already suffering the disease.

Other side effects (infusion dosage form): often — pain and redness at the injection site and phlebitis sometimes — General weakness (asthenia) very rare — fever.

Any antibiotic can cause changes in the microflora (bacteria and fungi), which is normally present in humans. For this reason, may occur increased growth of bacteria and fungi resistant to commonly used antibiotics (secondary infection and superinfection), which in rare cases may require additional treatment.

Drug interactions:

Interactions that require caution

With iron salts, antacids containing magnesium and/or aluminum. It is recommended that preparations containing divalent or trivalent cations such as iron salts (treatment for anemia), antacids containing magnesium and/or aluminum, to take at least 2 hours before or 2 hours after taking the pill Tavanic. With calcium carbonate interactions have been identified.

With sucralfate. The effect of the drug Tavanic significantly attenuated with concomitant use of sucralfate (means for protection of the gastric mucosa).

Patients receiving sucralfate and levofloxacin, it is recommended to take sucralfate 2 hours after taking levofloxacin.

With theophylline, fenbufen or similar drugs from the group of NSAIDs that reduce the seizure threshold of the brain. Pharmacokinetic interaction levofloxacin theophylline was not detected. The concentration of levofloxacin at simultaneous reception of fenbufen increased by only 13%.

However, concomitant administration of quinolones and theophylline, NSAIDs and other drugs that reduce the seizure threshold of the brain, possible a marked reduction in the threshold of convulsive readiness of the brain.

Indirect anticoagulants, in patients treated with levofloxacin in combination with indirect anticoagulants (e.g. warfarin), there was an increase in PT/INR and/or development of bleeding, including severe. Therefore, while the use of anticoagulants and levofloxacin requires regular monitoring of indicators of blood coagulation.

With probenecid and cimetidine. While the use of drugs violating renal tubular secretion of levofloxacin, such as probenecid and cimetidine, use caution especially in patients with renal insufficiency.

The elimination (renal clearance) of levofloxacin slows down under the effect of cimetidine on 24% and probenecid by 34%. It is unlikely that this may have clinical significance in normal kidney function.

With cyclosporine. Levofloxacin increased the half-life of cyclosporine is 33%. As this increase is clinically relevant, dose adjustment of cyclosporine in its concomitant use with levofloxacin are not required.

WITH GKS. Concomitant use of corticosteroids increases the risk of tendon rupture.

With drugs, extension QT interval. Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that lengthen the QT interval (e.g., antiarrhythmic drugs of IA and III class, tricyclic antidepressants, macrolides).

Other. A clinical-pharmacological study to investigate the possible pharmacokinetic interactions of levofloxacin with calcium carbonate, digoxin, glibenclamide, ranitidine and warfarin showed that the pharmacokinetics of levofloxacin with the simultaneous use of these drugs is not altered sufficiently to have clinical significance.

Method of application and dose:

Pills

Inside, with liquid squeezed enough liquid (from 0, 5 to 1 Cup), before a meal or anytime between meals, because food intake does not affect absorption of medication (see “Interactions”). Selection of dose pills you can break in a dividing groove.

The drug should be taken at least 2 hours before or 2 hours after taking antacids containing magnesium and/or aluminium, iron salts or sucralfate (see “Interactions”).

The dosage depends on the nature and severity of infection and sensitivity of the suspected pathogen. The duration of treatment varies depending on the disease.

The recommended dosing regimen and duration of treatment in patients with normal or moderately reduced renal function (creatinine Cl>50 ml/min.):

Sinusitis (inflammation of the sinuses) — 2 table. Tavanic 250 mg or 1 tab. Tavanic 500 mg 1 time per day (500 mg of levofloxacin) is 10-14 days.

Exacerbation of chronic bronchitis — 1 table. Tavanic 250 mg 1 time per day (respectively 250 mg levofloxacin) or 2 table. Tavanic 250 mg or 1 tab. Tavanic 500 mg 1 time per day (500 mg of levofloxacin) for 7-10 days.

Community — acquired pneumonia table 2. Tavanic 250 mg or 1 table. Tavanic 500 mg 1-2 times a day (respectively 500-1000 mg levofloxacin) is 7-14 days.

Uncomplicated urinary tract infections — on 1 tab. Tavanic 250 mg 1 time per day (respectively 250 mg of levofloxacin) is 3 days.

Prostatitis — 2 table. Tavanic 250 mg or 1 table. Tavanic 500 mg 1 time per day (500 mg of levofloxacin) is 28 days.

Complicated urinary tract infections including pyelonephritis, — 1 table. Tavanic 250 mg 1 time per day (respectively 250 mg levofloxacin) for 7-10 days.

Infections of skin and soft tissues: — 1 table. Tavanic 250 mg 1 time per day (respectively 250 mg levofloxacin) or 2 table. Tavanic 250 mg or 1 table. Tavanic 500 mg 1-2 times a day (respectively 500-1000 mg levofloxacin) is 7-14 days.

Septicemia/bacteremia — 2 table. Tavanic 250 mg or 1 table. Tavanic 500 mg 1-2 times a day (respectively 500-1000 mg levofloxacin) is 10-14 days.

Infection of the abdominal cavity — 2 table. Tavanic 250 mg or 1 table. Tavanic 500 mg 1 time per day (500 mg of levofloxacin) — 7-14 days (in combination with antibacterial drugs acting on the anaerobic flora).

Comprehensive treatment of drug-resistant forms of tuberculosis are on the table 1-2. Tavanic 500 mg 1-2 times a day (respectively 500-1000 mg levofloxacin) — up to 3 months.

Levofloxacin is excreted primarily through the kidneys, so in patients with impaired renal function require a lower dose of the drug. Relevant information about this is contained in the table.

The dosage regimen

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

The dosage in patients with impaired liver function.When the liver does not require correction of dosing regimen, as levofloxacin is only slightly metabolized in the liver.

The dosage regimen in patients of advanced age.For elderly patients do not require correction of dosing regimen, with the exception of reductions in creatinine clearance to 50 ml/min and below.

The drug should be taken at least 2 chdo or 2 hours after taking antacids, iron salts or receive sucralfate (see “Interactions”).

Solution for infusion

In/in drip slowly (duration of infusion 100 ml with 500 mg of levofloxacin solution should not be less than 60 min) — see “Special instructions”. Depending on the condition of the patient after a few days of treatment can go from in/in drip introduction to the reception of the same dose of the drug in a form intended for ingestion.

Doses are determined by the nature and severity of the infection, and the alleged sensitivity of the pathogen. In patients with normal renal function (creatinine clearance >50 ml/min) to recommend the following dosing regimen of the drug: community-acquired pneumonia — 500 mg of levofloxacin 1-2 times a day (respectively 500-1000 mg levofloxacin) is 7-14 days.

Complicated urinary tract infections (including pyelonephritis) — on 250 mg of levofloxacin 1 time per day (for severe infections may increase dose) (respectively 250 mg levofloxacin) for 7-10 days.

Uncomplicated urinary tract infections — 250 mg of levofloxacin 1 time per day (respectively 250 mg of levofloxacin) is 3 days.

Chronic bacterial prostatitis — 500 mg of levofloxacin 1 time per day (500 mg of levofloxacin) is 28 days.

Septicemia/bacteremia — 500 mg of levofloxacin 1-2 times a day (respectively 500-1000 mg levofloxacin) is 10-14 days.

Intra — abdominal infection: 500 mg of levofloxacin 1 time per day (500 mg of levofloxacin) — 7-14 days (in combination with antibacterial drugs acting on the anaerobic flora).

Comprehensive treatment of drug-resistant forms of TB — 500 mg of levofloxacin 1-2 times a day (respectively 500-1000 mg levofloxacin) — up to 3 months.

Levofloxacin is excreted primarily through the kidneys, so in patients with impaired renal function require a lower dose of the drug. Relevant information about this is contained in the table for the solution for infusion should be guided by the data about the dosage, presented in boxes of 250 mg/24 h 500 mg/24 h

Tavanic, solution for infusion 500 mg is compatible with the following infusion fluids: 0 9% sodium chloride solution, 5% dextrose solution, 2, 5% ringer solution with dextrose, combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Solution Javanica 500 mg should not be mixed with heparin or solutions having an alkaline reaction (e.g. with sodium bicarbonate solution).

The duration of treatment is oriented at the course of the disease, should be no more than 14 days.