Glevo, pills 500mg, 5pcs

Composition

of 1 tab. levofloxacin (in the form of hemihydrate)500 mg

Auxiliary substances:  

• microcrystalline cellulose,

• povidone (K-30),

• crospovidone,

• magnesium stearate,

• microcrystalline cellulose (avicel pH 101).

Composition of the film shell:  

• hypromellose, macrogol (polyethylene glycol 6000),

• dibutyl phthalate,

• talc,

• titanium dioxide,

• iron oxide red

• dye, iron oxide yellow dye.

Pharmacological action

Broad-spectrum antibacterial drug of the fluoroquinolone group. Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and crosslinking of DNA breaks, suppresses DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall, and membranes of microorganisms.

The drug is active against aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative, including methicillin-sensitive/methicillin-moderately sensitive strains), Staphylococcus aureus (methicillin-susceptible strains),

Staphylococcus epidermidis (methicillin-susceptible strains), Streptococcus spp. group C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-susceptible/moderately sensitive/resistant strains), Streptococcus pyogenes, Streptococcus viridans (penicillin is moderately sensitive/resistant strains);

aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi,

Haemophilus influenzae (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-producing β-lactamases), Morganella morganii, Neisseria gonorrhoeae (producing and non-producing penicillinase),

Neisseria meningitidis, Pasteurella spp. (including Pasteurella conis, 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); anaerobic bacteria: 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., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Pharmacokinetics

Suction

When taken orally, it is rapidly and almost completely absorbed. Food intake has little effect on the rate and completeness of absorption. Bioavailability – 99%. Tmax – 1-2 hours. When taking the drug in doses of 250 mg and 500 mg, Cmax is 2.8 mcg / ml and 5.2 mcg/ml, respectively.

Distribution

Binding to plasma proteins is 30-40%. It penetrates well into organs and tissues (lungs, bronchial mucosa, sputum, genitourinary organs, polymorphonuclear leukocytes, alveolar macrophages).

Metabolism

In the liver, a small part of the drug is oxidized and / or deacetylated.

Deduction

Renal clearance is 70% of the total clearance. T 1/2 – 6-8 hours.

It is excreted mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. After oral use, about 70% of the dose is excreted unchanged in the urine within 24 hours, about 87% of the dose-within 48 hours; less than 4% – with feces for 72 hours.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infections of ENT organs (including acute sinusitis);
• infections of the lower respiratory tract (including exacerbation of chronic bronchitis, community-acquired pneumonia);
• uncomplicated and complicated urinary tract infections and kidney function (including acute pyelonephritis, prostatitis);
• genital infections;
• infections of skin and soft tissues (festering atheroma, abscess, furunkulez);
• infection of the abdominal cavity (in combination with drugs acting on the anaerobic microflora).

Use during pregnancy and lactation

Glevo is contraindicated in children under 18 years of age, as well as during pregnancy and lactation.

Contraindications

• Epilepsy.
• Tendon damage during previous treatment with quinolones.
• Pregnancy.
• The period of lactation (breastfeeding).
• Children and adolescents (under 18 years of age).
• Hypersensitivity to levofloxacin and other fluoroquinolones.

Caution should be exercised when prescribing the drug to elderly patients (due to the high probability of concomitant decline in renal function), with glucose-6-phosphate dehydrogenase deficiency.

Side effects

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

From the cardiovascular system: reduced blood pressure, vascular collapse, tachycardia, prolongation of the QT interval; extremely rare-atrial fibrillation.

From the endocrine system: hypoglycemia (increased appetite, increased sweating, trembling, nervousness).

From the central nervous system and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, motor disorders, epileptic seizures (in predisposed patients).

From the side of the senses: visual, hearing, olfactory, taste and tactile sensitivity disorders.

Musculoskeletal disorders: arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.

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

From the hematopoietic system: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

Allergic reactions: pruritus and hyperemia of the skin, edema 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.

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

Interaction

Concomitant use of levofloxacin increases the T 1/2 of cyclosporine.

The effect of the drug is reduced by drugs that inhibit intestinal motility, sucralfate, aluminum/magnesium-containing antacids and iron salts (a break between use of at least 2 hours is required).

Concomitant use of Glevo with NSAIDs, theophylline increases convulsive readiness.

Concomitant use of Glevo with corticosteroids increases the risk of tendon rupture.

Cimetidine and drugs that block tubular secretion slow down the elimination of levofloxacin.

Hypoglycaemic drugs may be used concomitantly with levofloxacin to cause hypo – and hyperglycaemia. Therefore, strict monitoring of blood glucose levels is necessary.

How to take, course of use and dosage

The drug is taken orally 1-2 times a day. Tablets should be swallowed whole, without chewing and washed down with a sufficient amount of liquid (from 0.5 to 1 cup). The drug can be taken before meals or between meals.

Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

The following dosage regimen is recommended for patients with normal or moderately reduced renal function (creatinine clearance > 50 ml/min).

For sinusitis,500 mg is prescribed 1 time/day for 10-14 days.

In case of exacerbation of chronic bronchitis-250 mg or 500 mg 1 time / day for 7-10 days.

For community-acquired pneumonia-500 mg 1-2 times / day for 7-14 days.

For uncomplicated urinary tract infections-250 mg 1 time/day for 3 days.

For prostatitis-500 mg 1 time/day for 28 days.

For complicated urinary tract infections, including pyelonephritis,250 mg 1 time/day for 7-10 days.

For skin and soft tissue infections-250-500 mg 1-2 times / day for 7-14 days.

For infections of the abdominal cavity-500 mg 1 time/day for 7-14 days (in combination with antibacterial drugs acting on the anaerobic flora).

In patients with impaired renal function, the following dosage regimen is used.

Creatinine clearance 250 mg / 24 h 500 mg/24 h 500 mg / 12 h first dose 250 mg first dose 500 mg first dose 500 mg 50-20 ml / min 125 mg / 24 h 250 mg / 24 h 250 mg / 12 h 19-10 ml / min 125 mg / 48 h 125 mg/24 h 125 mg/12 hthen 125 mg / 48 hthem 125 mg / 24 hthem 125 mg/24 h

No additional doses are required after hemodialysis or permanent outpatient peritoneal dialysis (PAPD).

When liver function is impaired, no special dose selection is required, since levofloxacin is metabolized in the liver only to an extremely small extent.

Elderly patients do not need to change the dosage regimen, except in cases of low creatinine clearance.

As with other antibiotics, treatment with Glevo is recommended to continue for at least 48-78 hours after normalization of body temperature or after reliable eradication of the pathogen.

If you miss taking the drug, you should take the pill as soon as possible, before the time of the next intake approaches. Then continue to take the drug according to the scheme.

Overdose

Symptoms: nausea, erosive lesions of the gastrointestinal mucosa, prolongation of the QT interval, confusion, dizziness, convulsions.

Treatment: symptomatic therapy is performed, dialysis is not effective.

Special instructions

Although levofloxacin is more soluble than other quinolones, patients should be adequately hydrated.

During treatment, it is necessary to avoid sun and artificial UV radiation in order to avoid damage to the skin (photosensitization).

If signs of tendinitis or pseudomembranous colitis appear, levofloxacin is immediately discontinued and appropriate therapy is prescribed.

It should be borne in mind that patients with a history of brain damage (stroke, severe injury) may develop seizures, and glucose-6-phosphate dehydrogenase deficiency increases the risk of hemolysis.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Glevo tablets.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Sinusitis, Bronchitis, Boils, Respiratory Tract Infections, Pneumonia, Skin Infections, Prostatitis, Urinary Tract Infections, Tuberculosis, Sinusitis