Glevo

General characteristics. Structure:

For a dosage of 250 mg:
Active agent: a levofloksatsina гемигидрат, in terms of levofloxacin – 250 mg.

Excipients: cellulose microcrystallic, starch, povidone (K-30 povidone), кросповидон, magnesium stearate, cellulose microcrystallic (avitset рН 101).
The cover is film: gipromelloza, macrogoal (polyethyleneglycol 6000), dibutyl phthalate, talc, titanium dioxide, dye ferrous oxide red.

For a dosage of 500 mg:
Active agent: a levofloksatsina гемигидрат, in terms of levofloxacin – 500 mg.

Excipients: cellulose microcrystallic, povidone (K-30 povidone), кросповидон, magnesium stearate, cellulose microcrystallic (avitset рН 101).
Cover: gipromelloza, macrogoal (polyethyleneglycol 6000), dibutyl phthalate, talc, titanium dioxide, dye ferrous oxide red, dye ferrous oxide yellow.

Pharmacological properties:

Pharmacodynamics. Glevo (levofloxacin) - an antimicrobic microbicide of a broad spectrum of activity from group of ftorkhinolon. Blocks DNK-girazu (topoisomerase II) and topoisomerase IV, breaks superspiralling and a stitching of ruptures of DNA, suppresses DNA synthesis, causes profound morphological changes in cytoplasm, a cell wall and membranes.
Are sensitive to drug:
Aerobic gram-positive organisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagulase-negative metitsillino-sensitive (metitsillino-moderately sensitive), Staphylococcus aureus metitsillino-sensitive, Staphylococcus epidermidis metitsillino-sensitive, Staphylococcus spp (CNS), Streptococci of group C and G, Streptococcus agalactiae, Streptococcus pneumoniae пенициллино - чувствительные/-moderately sensitive / - resistant, Streptococcus pyogenes, Viridans streptococci of penicillin – moderately sensitive / - resistant.
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 ampitsillino-chuvstvitelnye/-resistant, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Moraxella catarrhalis β+/β-, Morganella morganii, Neisseria gonorrhoeae which are not producing a penicillinase / the producing penicillinases, Neisseria meningitidis, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp., Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp., Pseudomonas aeruginosa, Pseudomonas spp., Salmonella spp., Serratia marcescens, Serratia spp.
Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veilonella spp.
Other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Micobacterium leprae, Micobacterium tuberculosis, Micobacterium spp., Mycoplasma hominis, Mycoplasma pneumoniae, Ricketsia spp., Ureaplasma urealyticum.

Pharmacokinetics. At intake it is quickly and almost completely soaked up (meal influences the speed and completeness of absorption a little). Bioavailability - 99%. Time of achievement of the maximum concentration in blood (Tcmax) - 1-2 h; at reception of 250 and 500 mg the maximum concentration in blood (Cmax) makes 2.8 and 5.2 mkg/ml respectively. Communication with proteins of plasma - 30-40%. Well gets into bodies and fabrics: lungs, mucous membrane of bronchial tubes, phlegm, bodies of urinogenital system, polymorphonuclear leukocytes, alveolar macrophages. In a liver a small part is oxidized and/or dezatsetilirutsya. The renal clearance makes 70% of the general clearance. An elimination half-life (T1/2) - 6-8 h. It is brought out of an organism preferential by kidneys by glomerular filtering and canalicular secretion. Less than 5% of a levofloksatsin are excreted in the form of metabolites. In not changed look kidneys during 24 h remove 70% and for 48 h - 87%; in intestines for 72 h 4% of the dose accepted inside are found.

Indications to use:

The infectious and inflammatory diseases caused sensitive to drug by microorganisms:
- The ENT SPECIALIST - bodies (including acute sinusitis);
- lower respiratory tracts (including exacerbation of chronic bronchitis, community-acquired pneumonia);
- the uncomplicated and complicated infections of urinary tract and kidneys (including acute pyelonephritis, prostatitis);
- generative organs;
- skin and soft tissues (the suppurated atheromas, abscess, furunkuleza);
- intraabdominal infections in a combination with the medicines operating on anaerobic microflora.

Route of administration and doses:

Drug accept inside one or twice a day. Tablets should be swallowed entirely, without chewing and washing down with enough liquid (from 0.5 to 1 glasses). Drug can be accepted before food or between meals. Doses are defined by character and weight of an infection, and also sensitivity of the estimated activator.
The patient with normal or moderately reduced function of kidneys (clearance of creatine> of 50 ml/min.) recommends the following mode of a drug dosing:
Sinusitis: on 500 mg once a day - 10-14 days.
Exacerbation of chronic bronchitis: on 250 mg or on 500 mg 1 in day - 7-10 days.
Community-acquired pneumonia: on 500 mg 1-2 times a day - 7-14 days.
Uncomplicated infections of urinary tract: on 250 mg once a day - 3 days.
Prostatitis - on 500 mg once a day - 28 days.
The complicated infections of urinary tract, including pyelonephritis - on 250 mg once a day - 7-10 days.
Infections of skin and soft tissues: on 250-500 mg 1-2 times a day - 7-14 days.
Intraabdominal infection: on 500 mg once a day - 7-14 days (in a combination with the antibacterial drugs operating on anaerobic flora).
The mode of dosing of patients with an impaired renal function:

Clearance of creatinine	250 mg / 24 h	500 mg / 24 h	500 mg / 12 h
	first dose of 250 mg	first dose of 500 mg	first dose of 500 mg
50-20 ml/min.	then on 125 mg / 24 h	then on 250 mg / 24 h	then on 250 mg / 12 h
19-10 ml/min.	then on 125 mg / 48 h	then on 125 mg / 24 h	then on 125 mg / 12 h
<10 ml/min. (including a hemodialysis and PAPD)	then on 125 mg / 48 h	then on 125 mg / 24 h	then on 125 mg / 24 h

After a hemodialysis or the continuous out-patient peritoneal dialysis (COPPD) introduction of additional doses is not required.
At an abnormal liver function special selection of doses as levofloxacin is metabolized in a liver only in extremely insignificant measure is not required.
Patients of advanced age do not require change of the mode of dosing, except for cases of low clearance of creatinine.
As well as at use of other antibiotics, treatment by Glevo's drug of a tablet, is recommended to continue film coated, 250 mg and 500 mg not less than 48-78 hours after normalization of body temperature or after a reliable eradikation of the activator.
If administration of drug is missed, it is necessary to take as soon as possible a pill, time of the next reception did not come yet. Further to continue to accept drug according to the scheme.

Features of use:

Though and more we will dissolve levofloxacin, than other hinolona, patients should carry out adequate hydration of an organism. During treatment it is necessary to avoid solar and artificial UF-radiation in order to avoid damage of integuments (photosensitization).
At emergence of signs of a tendinitis, pseudomembranous colitis levofloxacin is immediately cancelled and appoint the corresponding therapy.
It must be kept in mind that at patients with damage of a brain in the anamnesis (a stroke, a severe injury) development of spasms is possible, at insufficiency glyukozo-6-fosfatdegidrogenaza - the risk of development of hemolysis increases.
During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

- From the alimentary system: nausea, vomiting, diarrhea (including with blood), digestion disturbance, a loss of appetite, an abdominal pain, a pseudomembranous coloenteritis - increase in activity of hepatic transaminases, a hyperbilirubinemia, hepatitis, dysbacteriosis.
- From cardiovascular system: lowering of arterial pressure, vascular collapse, tachycardia, lengthening of an interval of Q-t; extremely seldom - a ciliary arrhythmia.
- From a metabolism: a hypoglycemia (increase in appetite, the increased sweating, a shiver, nervousness).
- From a nervous system: a headache, dizziness, weakness, drowsiness, sleeplessness, a tremor, concern, paresthesias, fear, hallucinations, confusion of consciousness, a depression, motive frustration, epileptic seizures (at predisposed patients).
- 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.
- 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.
- Other: photosensitization, adynamy, porphyria aggravation, persistent fever, development of superinfection.

Interaction with other medicines:

Increases cyclosporine T1/2. The effect of drug is reduced by the medicines oppressing motility of intestines, сукральфат, aluminum-/magniysoderzhashchiye antiacid medicines and salts of iron (the break between reception not less than 2 h is necessary). Non-steroidal anti-inflammatory drugs (NPVP), theophylline increase convulsive readiness, glucocorticosteroids increase risk of a rupture of sinews. Cimetidinum and drugs blocking canalicular secretion slow down removal. Hypoglycemic drugs: strict control of glucose level in blood as there is a probability hyper - and a hypoglycemia at their simultaneous use with levofloksatsiny is necessary.

Contraindications:

Hypersensitivity to a levofloksatsin and other ftorkhinolona, epilepsy, damage of sinews at earlier carried out treatment of a hinolonama, pregnancy, the lactation period, children's and teenage age (up to 18 years).

With care
Advanced age (high probability of existence of the accompanying depression of function of kidneys), deficit glyukozo-6-fosfatdegidrogenazy.

Overdose:

Symptoms: nausea, erosive damages of mucous membranes of digestive tract, lengthening of an interval of Q-T, confusion of consciousness, dizziness, spasms.

Treatment: symptomatic, dialysis is not effective.

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, film coated, 250 mg and 500 mg.
On 5 tablets in a blister strip packaging from PVC-aluminum foil 1 or 5 of blister strip packagings place in a cardboard pack together with the application instruction.