Ecology - instructions for use, doses, side effects, contraindications

Tablets covered with a film membrane, white or almost white, capsular, biconvex. On the cross-section, two layers are visible, the inner layer is from light yellow to yellow, white inclusions are allowed.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Levofloxacin is a synthetic broad-spectrum antibacterial agent from the group of fluoroquinolones, containing as an active substance the levorotatory isofloxacin isomer.

Levofloxacin blocks DNA-gyrase, disrupts supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes.

Levofloxacin acts bactericidal, is active against a large number of pathogens of bacterial infections both in conditions in vitro, and in vivo.

Aerobic Gram-positive microorganisms:

Corynebacterium diphtheriae,

Enterococcus spp. (at Tom number of Enterococcus faecalis),

Listeria monocytogenes,

Staphylococcus spp. (at Tom number of Staphylococcus coagulase-negative (sensitive to methicillin and moderately sensitive to methicillin), Staphylococcus aureus (sensitive to methicillin), Staphylococcus epidermidis (sensitive to methicillin)),

Streptococci 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. (at Tom number of Acinetobacter baumannii, Actinobacillus actinomycetemcomitans),

Citrobacter freundii,

Eikenella corrodens,

Enterobacter spp. (at Tom number of 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. (at Tom number of Klebsiella oxytoca, Klebsiella pneumoniae),

Moraxella catarrhalis,

Morganella morganii,

Neisseria gonorrhoeae (producing and not producing penicillinase),

Neisseria meningitidis,

Pasteurella spp. (at Tom number of Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis,

Proteus vulgaris,

Providencia spp. (at Tom number of Providencia rettgeri, Providencia stuartii),

Pseudomonas spp. (at Tom number of Pseudomonas aeruginosa),

Salmonella spp.,

Serratia spp. (at Tom number of Serratia marcescens).

Anaerobic microorganisms: 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. (at Tom number of Legionella pneumophila),

Mycobacterium spp. (at Tom number of Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis,

Mycoplasma pneumoniae,

Rickettsia spp.,

Ureaplasma urealyticum.

Pharmacokinetics:

After oral administration levofloxacin quickly and almost completely absorbed in the small intestine. Food intake has little effect on the speed and completeness of absorption. Bioavailability of 500 mg of levofloxacin after oral administration is almost 100%. After taking a single dose of 500 mg, the maximum concentration of levofloxacin is 5.2-6.9 μg / ml, the time to reach the maximum concentration - 1,3 hours, half-life - 6-8 hours.

The connection with plasma proteins is 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, organs of the genitourinary system, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes and alveolar macrophages.

In the liver, a small portion is oxidized and / or deacetylated. It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion.After oral administration, approximately 87% of the dose is excreted within 48 hours by the kidneys in unchanged form, less than 4% within 72 hours by the intestine.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- lower respiratory tract (exacerbation of chronic bronchitis, community-acquired pneumonia);

- ENT organs (including acute sinusitis);

- urinary tract and kidneys (including acute pyelonephritis);

- skin and soft tissues (abscesses, furunculosis);

- chronic bacterial prostatitis;

- intra-abdominal infections;

- drug-resistant forms of tuberculosis - as part of complex therapy.

Contraindications:

Hypersensitivity to levofloxacin, other fluoroquinolones or components of the drug, epilepsy, tendon damage with prior treatment with quinolones, pregnancy, lactation, children and adolescence (up to 18 years). Lactose intolerance or lactase deficiency, as well as glucose-galactose malabsorption.

Carefully:The elderly, with a deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

Inside, before meals or at a break between meals, without chewing, squeezed enough liquid.

Acute antritis: 500 mg once a day for 10-14 days;

Community-acquired pneumonia: 500 mg 1-2 times a day, 7-14 days;

Exacerbation of chronic bronchitis: 250-500 mg once a day for 7-10 days; Uncomplicated urinary tract infections-250 mg once daily for 3 days; Complicated urinary tract infections (including pyelonephritis): 250 mg once a day (for a severe course of the disease, the dose should be increased) within 7-10 days; Chronic bacterial prostatitis - 500 mg once a day, treatment course - 28 days; Infections of the skin and soft tissues: 250-500 mg 1-2 times a day for 7-14 days; Intra-abdominal infection - 500 mg once a day, treatment course 7-14 days (in combination with antibacterial drugs acting on anaerobic microflora);

Complex therapy of drug-resistant forms of tuberculosis: 500 mg 1-2 times a day, treatment course - up to 3 months;

The duration of treatment depends on the type and severity of the disease.

After relief of symptoms of acute inflammation and normalization of temperature, it is recommended to continue therapy with levofloxacin within 48-72 hours.

Dosing of the drug in patients with impaired renal function (creatinine clearance less than 50 ml / min)

Creatinine clearance,	Dosing regimen
ml / min	Initial	Initial	Initial
	dose 250 mg / 24 h	dose 500 mg / 24 h	dose of 500 mg / 12 h
50-20	Further 125 mg / 24 h	Then 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 with hemodialysis and continuous outpatient peritoneal dialysis)	Further 125 mg / 48 h	Further 125 mg / 24 h	Further 125 mg / 24 h

After hemodialysis or permanent ambulatory peritoneal dialysis, no additional doses are required.

Do not require dose adjustment in patients with impaired liver function.

Side effects:

From the digestive system: nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis; increased activity of "hepatic" transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.

From the side of the cardiovascular system: lowering blood pressure, cardiovascular collapse, tachycardia, lengthening of the interval QT,atrial fibrillation.

From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations,confusion, depression, movement disorders, convulsions.

From the sense organs: impaired vision, hearing, smell, taste and tactile sensitivity.

From the side of the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendonitis, rhabdomyolysis.

From the urinary system: hypercreatininaemia, interstitial nephritis, acute renal failure.

On the part of the organs of hematopoiesis: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

From the side of metabolism: hypoglycemia (increased appetite, increased sweating, trembling).

Allergic reactions: itching and hyperemia of the skin, swelling of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, suffocation, anaphylactic shock, allergic pneumonitis, vasculitis.

Other: asthenia, exacerbation of porphyria, photosensitivity, persistent fever, development of superinfection.

Overdose:

Symptoms of drug overdose levofloxacin manifest themselves at the level of the central nervous system (confusion, dizziness, impaired consciousness and convulsions). In addition, gastrointestinal disorders (eg, nausea, vomiting) and erosive lesions of the mucous membranes of the gastrointestinal tract can be noted. In studies conducted using ultra-high doses of levofloxacin, the elongation of the interval QT.

Levofloxacin is not excreted by hemodialysis or peritoneal dialysis. Specific safener (counter material) does not exist.

Treatment - gastric lavage and symptomatic therapy.

Interaction:

There are reports of a marked decrease in the threshold of convulsive readiness with simultaneous use of quinolones and substances that reduce the cerebral threshold of convulsive readiness. This applies to the simultaneous administration of quinolones and theophylline, as well as non-steroidal anti-inflammatory drugs - derivatives of propionic acid.

The effect of the drug is weakened when used simultaneously with sucralfate, antacids containing magnesium or aluminum, and iron salts. Levofloxacin should be taken at least 2 hours before taking these medicines.

With the simultaneous use of vitamin K antagonists, monitoring of blood coagulation indexes is necessary.

Renal clearance of levofloxacin slightly slows down cimetidine and probenecid. Levofloxacin slightly increases the half-life of cyclosporine.

The use of glucocorticosteroids increases the risk of rupture of tendons.

Special instructions:

In the treatment of elderly patients, it should be borne in mind that they often suffer from impaired renal function (see section "Method of administration and dose").

Despite the fact that photosensitivity is relatively rare in the treatment with levofloxacin, it is not recommended for patients to undergo strong sunlight or artificial ultraviolet irradiation.

If suspected pseudomembranous colitis should be immediately withdrawn levofloxacin and begin appropriate treatment. In such cases, drugs that depress intestinal motility should not be used.

Patients with insufficiency of glucose-6-phosphate dehydrogenase (hereditary metabolic disorders) can react to fluoroquinolones by destruction of erythrocytes (hemolysis).In this regard, treatment with levofloxacin should be done with caution.

Effect on the ability to drive transp. cf. and fur:

Such side effects of levofloxacin as dizziness or drowsiness, as well as visual impairments (see the "Side effect" section), can worsen the reactivity and make it difficult to drive, maintain machinery and mechanisms.

Form release / dosage:Tablets, film-coated 250 mg and 500 mg.

Packaging:

For 5, 7 or 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 10 tablets in a plastic bottle with a screw cap or a polymer can with a screw cap.

For 1 or 2 contour squares or 1 bottle or 1 jar along with the instructions for use are placed in a pack of cardboard.

Storage conditions:In a place protected from moisture and light at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005589/10

Date of registration:18.06.2010

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp09.10.2015

Illustrated instructions

Instructions

Ecolevid® (Ecolevid®)