Ekolevid

General characteristics. Structure:

Active agent: levofloxacin (in the form of a gemigidrat) 250 mg

Excipients: lactulose - 300 mg, кросповидон - 32.5 mg, K17 povidone - 10 mg, the sodium stearylfumarating - 9.75 mg, talc - 6.5 mg, cellulose microcrystallic - to 650 mg.

Structure of a cover: (a gipromelloza - 9.52 mg, titanium dioxide - 5.22 mg, a macrogoal of 4000 - 4.16 mg, talc - 1.10 mg) - to 670 mg.
 
Active agent: levofloxacin (in the form of a gemigidrat) 500 mg

Excipients: lactulose - 600 mg, кросповидон - 65 mg, K17 povidone - 20 mg, the sodium stearylfumarating - 19.5 mg, talc - 13 mg, cellulose microcrystallic - to 1300 mg.

Structure of a cover: (a gipromelloza - 19.04 mg, titanium dioxide - 10.44 mg, a macrogoal of 4000 - 8.32 mg, talc - 2.2 mg) - to 1340 mg.

Pharmacological properties:

Pharmacodynamics. Levofloxacin – the synthetic antibacterial drug of a broad spectrum of activity from group of ftorkhinolon containing left-handed isomer of an ofloksatsin in quality of active agent.
Levofloxacin blocks DNK-girazu, breaks superspiralling and a stitching of ruptures of DNA, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, a cell wall and membranes of bacteria.
Levofloxacin works bakteritsidno, in vivo is active concerning a large number of causative agents of bacterial infections as in the conditions of in vitro, and.
Aerobic gram-positive microorganisms:
Corynebacterium diphtheriae,
Enterococcus spp. (including Enterococcus faecalis),
Listeria monocytogenes,
Staphylococcus spp. (including Staphylococcus koagulazonegativny (sensitive to Methicillinum and moderately sensitive to Methicillinum), Staphylococcus aureus (sensitive to Methicillinum), Staphylococcus epidermidis (sensitive to Methicillinum)),
Streptococci of group C and G,
Streptococcus agalactiae,
Streptococcus pneumoniae (sensitive and resistant to penicillin),
Streptococcus pyogenes,
Streptococcus viridans (sensitive and resistant to penicillin),
Aerobic gram-negative microorganisms:
Acinetobacter spp. (including Acinetobacter baumannii, Actinobacillus actinomycetemcomitans),
Citrobacter freundii,
Eikenellacorrodens,
Enterobacter spp. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae),
Escherichia coli,
Gardnerella vaginalis,
Haemophilus ducreyi,
Haemophilus influenzae (sensitive and resistant to ampicillin),
Haemophilus parainfluenzae,
Helicobacter pylori,
Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae),
Moraxella catarrhalis,
Morganella morganii,
Neisseria gonorrhoeae (which are producing and not producing a penicillinase),
Neisseria meningitidis,
Pasteurella spp. (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida),
Proteus mirabilis,
Proteus vulgaris,
Providencia spp. (including Providencia rettgeri, Providencia stuartii),
Pseudomonas spp. (including Pseudomonas aeruginosa),
Salmonella spp.,
Serratia spp. (including Serratia marcescens).
Anaerobnyemikroorganizma:
Bacteroides fragilis,
Bifidobacterium spp.,
Clostridium perfringens,
Fusobacterium spp.,
Peptostreptococcus spp.,
Propionibacterum spp.,
Veilonella spp.
Other microorganisms:
Bartonella spp.,
Chlamydia pneumoniae,
Chlamydia psittaci,
Chlamydia trachomatis,
Legionella spp. (including Legionella pneumophila),
Mycobacterium spp. (including Mycobacterium leprae, Micobacterium tuberculosis), Mycoplasma hominis,
Mycoplasma pneumoniae,
Rickettsia spp.,
Ureaplasma urealyticum.
The lactulose which is Ekolevid's part as a bifidogenny factor is synthetic disaccharide which molecule consists of the remains of a galactose and fructose. Lactulose in a stomach and upper parts of intestines is not soaked up and not hydrolyzed. Ekolevida who is released from tablets lactulose as substrate is fermented by normal microflora of a large intestine, stimulating growth of bifidobacteria and lactobacilli. As a result of hydrolysis of lactulose in a large intestine organic acids - milk, acetic and ant, suppressing growth of pathogenic microorganisms and reducing thereof products of nitrogen-containing toxic substances are formed.
Thus, lactulose as a part of Ekolevid reduces the damaging action of an antibiotic on the normal intestinal microflora and risks of side effects connected with disbioza.

Pharmacokinetics. After oral administration levofloxacin is quickly and almost completely soaked up in a small bowel. Meal influences the speed and completeness of absorption a little. Bioavailability of 500 mg of a levofloksatsin after oral administration makes nearly 100%. After reception of a single dose of 500 mg the maximum concentration of a levofloksatsin makes 5.2-6.9 mkg/ml, time of achievement of the maximum concentration – 1.3 h, an elimination half-life – 6-8 h.
Communication with proteins of plasma – 30-40%. Well gets into bodies and fabrics: lungs, mucous membrane of bronchial tubes, bodies of urinogenital system, bone tissue, medullispinal liquid, prostate, polymorphonuclear leukocytes and alveolar macrophages.
In a liver a small part is oxidized and/or dezatsetilirutsya. It is brought out of an organism preferential by kidneys by glomerular filtering and canalicular secretion. After oral administration about 87% of a dose less than 4% within 72 hours intestines are allocated within 48 hours with kidneys in not changed look.
The lactulose which is Ekolevid's part does not exert impact on the key pharmacokinetic parameters characterizing bioavailability of a levofloksatsin.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to drug:
— lower respiratory tracts (exacerbation of chronic bronchitis, community-acquired pneumonia);
— ENT organs (including acute antritis);
— urinary tract and kidneys (including acute pyelonephritis);
— skin and soft tissues (abscesses, furunculosis);
— chronic bacterial prostatitis;
— intraabdominal infections;
— drug resistant forms of tuberculosis - as a part of complex therapy.

Route of administration and doses:

Inside, to food or in a break between meals, without chewing, washing down with enough liquid.
Acute antritis: on 500 mg of 1 time/days within 10-14 days;
Community-acquired pneumonia: on 500 mg of 1-2 times/days, 7-14 days;
Exacerbation of chronic bronchitis: on 250-500 mg of 1 time/days within 7-10 days;
Uncomplicated infections of urinary tract: 250 mg of 1 time/days within 3 days;
The complicated infections of urinary tract (including pyelonephritis): 250 mg of 1 time/days (at a severe disease the dose should be increased) within 7-10 days;
Chronic bacterial prostatitis: 500 mg of 1 time/days, a course of treatment – 28 days;
Infections of skin and soft tissues: on 250-500 mg of 1-2 times/days within 7-14 days;
Intraabdominal infection: on 500 mg of 1 time/days, a course of treatment of 7-14 days (in a combination with the antibacterial drugs operating on anaerobic microflora);
Complex therapy of drug resistant forms of tuberculosis: on 500 mg of 1-2 times/days, a course of treatment - up to 3 months;
Duration of treatment depends on a look and disease severity.
After stopping of symptoms of an acute inflammation and normalization of temperature it is recommended to continue therapy levofloksatsiny within 48-72 hours.
Drug dosing at patients with an impaired renal function (clearance of creatinine less than 50 ml/min.)

Clearance of creatinine, ml/min.	Dosing mode
	Initial dose of 250 mg / 24 h	Initial dose of 250 mg / 24 h	Initial dose of 500 mg / 12 h
50-20	Further 125 mg / 24 h	Further 250 mg / 24 h	Further 250 mg / 12 h
19-10	Further 125 mg / 48 h	Further 125 mg / 24 h	Further 125 mg / 12 h
Less than 10 (including at a hemodialysis and continuous out-patient peritoneal dialysis)	Further 125 mg / 48 h	Further 125 mg / 24 h	Further 125 mg / 24 h

After a hemodialysis or continuous out-patient peritoneal dialysis introduction of additional doses is not required.
Dose adjustment is not required from patients with abnormal liver functions.

Features of use:

At treatment of patients of advanced age it must be kept in mind that they often suffer from renal failures (see the section "Route of Administration and Doses").

In spite of the fact that the photosensitization against the background of treatment levofloksatsiny is noted rather seldom, patients are not recommended to be exposed to power solar or artificial ultra-violet irradiation.

At suspicion of pseudomembranous colitis it is necessary to cancel immediately levofloxacin and to begin the corresponding treatment. In such cases it is impossible to apply the medicines oppressing motility of intestines.

Patients with insufficiency glyukozo-6-fosfatdegidrogenazy (an inherited disorder of a metabolism) can react to ftorkhinolona destruction of erythrocytes (hemolysis). In this regard, treatment levofloksatsiny should be carried out with care.

Such side effects of a levofloksatsin as dizziness or drowsiness, and also visual disturbances (see the section "Side effect"), can worsen reactionary ability and complicate driving, service of cars and mechanisms.

Side effects:

From the alimentary system: nausea, vomiting, diarrhea (including with blood), digestion disturbance, a loss of appetite, an abdominal pain, pseudomembranous colitis; increase in activity of "hepatic" transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.
From cardiovascular system: lowering of arterial pressure, vascular collapse, tachycardia, lengthening of an interval of QT, ciliary arrhythmia.
From a nervous system: pain, dizziness, weakness, drowsiness, sleeplessness, tremor, concern, paresthesias, fear, hallucinations, confusion of consciousness, depression, motive frustration, spasms.
From sense bodys: vision disorders, hearing, sense of smell, flavoring and tactile sensitivity.
From a musculoskeletal system: arthralgia, muscular weakness, mialgiya, rupture of sinews, tendinitis, рабдомиолиз.
From an urinary system: giperkreatininemiya, intersticial nephrite, acute renal failure.
From bodies of a hemopoiesis: eosinophilia, hemolitic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.
From a metabolism: a hypoglycemia (increase in appetite, the increased sweating, a shiver).
Allergic reactions: itch and dermahemia, cutaneous dropsy and mucous membranes, small tortoiseshell, malignant exudative erythema (Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease), bronchospasm, suffocation, acute anaphylaxis, allergic pneumonitis, vasculitis.
Others: adynamy, porphyria aggravation, photosensitization, persistent fever, development of superinfection.

Interaction with other medicines:

There are messages on the expressed reduction of the threshold of convulsive readiness at simultaneous use of the hinolon and substances reducing a cerebral threshold of convulsive readiness. It concerns also a concomitant use of hinolon and theophylline, and also non-steroidal anti-inflammatory drugs - derivatives of propionic acid.

Effect of drug is weakened at simultaneous use with sukralfaty, the antacids containing magnesium or aluminum and iron salts. It is necessary to accept levofloxacin not less, than in 2 hours prior to reception of these medicines.

At simultaneous use of antagonists of vitamin K control of indicators coagulant system of blood is necessary.

Renal clearance of a levofloksatsin slightly slow down Cimetidinum and пробенецид. Levofloxacin slightly increases a cyclosporine elimination half-life.

Reception of glucocorticosteroids increases risk of a rupture of sinews.

Contraindications:

— hypersensitivity to a levofloksatsin, other ftorkhinolona or components of drug;
— epilepsy;
— damage of sinews at earlier carried out treatment of a hinolonama;
— pregnancy;
— lactation period;
— children's and teenage age (up to 18 years);
— lactose intolerance or insufficiency of lactase, and also glyukozo-galaktozny malabsorption.
With care: to elderly people, at deficit glyukozo-6-fosfatdegidrogenazy.

Use of the drug EKOLEVID® at pregnancy and feeding by a breast
It is contraindicated at pregnancy and in the period of a lactation.

Use at abnormal liver functions
Dose adjustment is not required from patients with abnormal liver functions.

Use at renal failures
Drug dosing at patients with an impaired renal function (KK less than 50 ml/min.)

KK, ml/min.	Dosing mode
	Initial dose of 250 mg / 24 h	Initial dose of 250 mg / 24 h	Initial dose of 500 mg / 12 h
50-20	Further 125 mg / 24 h	Further 250 mg / 24 h	Further 250 mg / 12 h
19-10	Further 125 mg / 48 h	Further 125 mg / 24 h	Further 125 mg / 12 h
Less than 10 (including at a hemodialysis and continuous out-patient peritoneal dialysis)	Further 125 mg / 48 h	Further 125 mg / 24 h	Further 125 mg / 24 h

Use for elderly patients
With care: to elderly people. At treatment of patients of advanced age it must be kept in mind that they often suffer from renal failures (see the section "Route of Administration and Doses").

Use for children
Contraindication: children's and teenage age up to 18 years.

Overdose:

Drug overdose symptoms levofloxacin are shown at the level of the central nervous system (confusion of consciousness, dizziness, disturbance of consciousness and a spasm). Besides, gastrointestinal frustration (for example, nausea, vomiting) and erosive damages of mucous membranes of digestive tract can be noted. In the researches conducted with use of ultrahigh doses of a levofloksatsin lengthening of an interval of QT was shown.

Levofloxacin is not removed by means of a hemodialysis or peritoneal dialysis. The specific antidote (counteracting substance) does not exist.

Treatment – a gastric lavage and symptomatic therapy.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, покр. film cover, 250 mg: 5, 7, 10, 14 or 20 pieces.

Tablets, покр. film cover, 500 mg: 5, 7, 10, 14 or 20 pieces.