Levofloxacin Ecolevid pills 500mg, 5pcs

Composition

Composition per tablet:

Active ingredient, mg: Levofloxacin hemihydrate 256,230 512,460 (based on levofloxacin) 250,000 500,000

Excipients, mg: Lactitol 300,000 600,000 Crospovidone XL-10 32,500 65,000 Sodium Stearyl Fumarate 13,000 26,000 Hyprolose 7,245 14,490 Silicon Dioxide 6,500 13,000 Talc 3,250 6,500 Sodium Lauryl Sulfate 0.830 1,660

Harke PlusTab / Harke PlusTab Prime (Microcrystalline Cellulose 84.0%, Hyprolose 15.0%, Calcium Hydrophosphate 1.0%) 650,000 1300,000

Excipients of the shell, mg: 670,000 1340,000 Hypromellose 9,520 19,040 Titanium dioxide 5,220 10,440 Macrogol-4000 3,744 7,488 Talc 1,100 2,200 Povidone K-17 0,416 0,832

Pharmacological action

Pharmacotherapy group: antimicrobial agent, fluoroquinolone.

ATX code: J01MA12.

Pharmacological properties

Pharmacodynamics

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones containing the levorotatory isomer ofloxacin as the Active ingredient.

Levofloxacin blocks DNA gyrase, disrupts supercoiling and crosslinking of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall, and membranes of bacteria.

Levofloxacin is bactericidal, active against a large number of pathogens of bacterial infections both in vitroand in vivo.

Sensitive microorganisms (minimum inhibitory concentration (MPC) ≤ 2 mg/l):

aerobic gram-positive microorganisms:

Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus spp., including Enterococcus faecalis, Listeria monocytogenes, Staphylococcus spp. (coagulase-negative, methicillin-sensitive / leukotoxin-containing / moderately sensitive strains), including Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive / moderately sensitive / resistant strains), Streptococcus pyogenes, Streptococcus spp. of the Viridans group (penicillin-sensitive / resistant strains);

aerobic gram-negative microorganisms:

Acinetobacter spp., including Acinetobacter baumannii, Acinetobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp., including Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillinampicillin / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp., including Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis (producing and reproducirse beta-lactamase strains), Morganella morganii, Neisseria gonorrhoeae (and reproducirse producing penicillinase strains), 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 (hospital infections caused by Pseudomonas aeruginosamay require combined treatment), Serratia spp., including Serratia marcescens, Salmonella spp. ;

anaerobic microorganisms:

Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veillonella 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.

Moderately sensitive microorganisms (MPC = 4 mg / l):

aerobic gram-positive microorganisms:

Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (Methicillin-resistant strains);

aerobic gram-negative microorganisms:

Campylobacter jejuni, Campylobacter coli;

anaerobic microorganisms:

Prevotella spp., Porphyromonas spp.

Resistant microorganisms (MPC greater than 8 mg / l):

aerobic gram-positive microorganisms:

Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp. (coagulase-negative methicillin-resistant strains);

aerobic gram-negative microorganisms:

Alcaligenes xylosoxidans;

anaerobic microorganisms:

Bacteroides thetaiotaomicron

other microorganisms:

Mycobacterium avium.

Clinical efficacy (efficacy in clinical trials for infections caused by the microorganisms listed below):

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, Moraxella catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens;

Other microorganisms :

Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

Resistance to levofloxacin develops as a result of a gradual process of mutations in the genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV. Other mechanisms of resistance, such as the mechanism of influence on the penetration barriers of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of an antimicrobial agent from the microbial cell), can also reduce the sensitivity of microorganisms to levofloxacin.

Due to the specific mechanism of action of levofloxacin, there is usually no cross-resistance between levofloxacin and other antimicrobial agents.

Pharmacokinetics

Absorption rate

Levofloxacin is rapidly and almost completely absorbed after oral use, food intake has little effect on its absorption. Absolute oral bioavailability is 99-100%. After a single dose of 500 mg of levofloxacin, the maximum plasma concentration (Cmax) is reached within 1-2 hours and is 5.2±1.2 mcg / ml. The pharmacokinetics of levofloxacin are linear in the dose range from 50 to 1000 mg. The equilibrium state of levofloxacin concentration in blood plasma when taking 500 mg of levofloxacin 1 or 2 times a day is reached within 48 hours.

On day 10 of oral use of Levofloxacin Ecolevid® 500 mg 1 time per day, the cmax of levofloxacin was 5.7±1.4 mcg / ml, and the minimum concentration of levofloxacin (concentration before the next dose) (Cmin) in blood plasma was 0.5±0.2 mcg/ml.

On day 10 of oral use of Levofloxacin Ecolevid® 500 mg 2 times a day, the cmax was 7.8±1.1 mcg / ml, and the C min was 3.0±0.9 mcg/ml.

Distribution

The relationship with serum proteins is 30-40%. After a single and repeated use of 500 mg of levofloxacin, the volume of distribution of levofloxacin is, on average,100 liters, which indicates a good penetration of levofloxacin into the organs and tissues of the human body.

Penetration into the bronchial mucosa, epithelial lining fluid, alveolar macrophages

After a single oral dose of 500 mg of levofloxacin, the maximum concentrations of levofloxacin in the bronchial mucosa and epithelial lining fluid were reached within 1 h or 4 h and were 8.3 mcg/g and 10.8 mcg / ml, respectively, with penetration coefficients into the bronchial mucosa and epithelial lining fluid, compared with plasma concentrations of 1.1-1.8 and 0.8-3, respectively.

After 5 days of oral use of 500 mg of levofloxacin, the average concentrations of levofloxacin 4 hours after the last dose of the drug in the fluid of the epithelial lining were 9.94 mcg / ml and in alveolar macrophages – 97.9 mcg/ml.

Penetration of lung tissue

Maximum concentrations in the lung tissue after oral use of 500 mg of levofloxacin were approximately 11.3 mcg / g and reached 4-6 hours after taking the drug with penetration coefficients 2-5, compared with the concentration in blood plasma.

Penetration into the alveolar fluid

After 3 days of taking 500 mg of levofloxacin 1 or 2 times a day, the maximum concentrations of levofloxacin in the alveolar fluid were reached 2-4 hours after taking the drug and were 4.0 and 6.7 micrograms / ml, respectively, with a penetration coefficient of 1, compared with plasma concentrations.

Bone penetration

Levofloxacin penetrates well into the cortical and spongy bone tissue in both the proximal and distal femur, with a penetration coefficient (bone/blood plasma) of 0.1-3. The maximum concentrations of levofloxacin in the spongy bone tissue of the proximal femur after oral use of 500 mg of the drug were approximately 15.1 mcg/g (2 hours after taking the drug).

Penetration into the cerebrospinal fluid

Levofloxacin does not penetrate well into the cerebrospinal fluid.

Penetration of prostate tissue

After oral use of 500 mg of levofloxacin once a day for 3 days, the average concentration of levofloxacin in the prostate tissue was 8.7 mcg/g, the average ratio of prostate / blood plasma concentrations was 1.84.

Concentrations in the urine

Mean urinary concentrations 8-12 hours after oral doses of 150,300, and 600 mg of levofloxacin were 44 mcg / ml,91 mcg/ml, and 162 mcg / ml, respectively.

Metabolism

Levofloxacin is only slightly metabolized (5% of the dose taken). Its metabolites are demethylvofloxacin and levofloxacin N-oxide, which are excreted by the kidneys. Levofloxacin is stereochemically stable and does not undergo chiral transformations.

Deduction

After oral use, levofloxacin is relatively slowly eliminated from the blood plasma (half-life (T 1/2) – 6-8 hours). Excretion, mainly through the kidneys (more than 85% of the dose taken). The total clearance of levofloxacin after a single 500 mg dose was 175±29.2 ml/min.

There are no significant differences in the pharmacokinetics of levofloxacin when administered intravenously and when taken orally, which confirms that oral use and intravenous use are interchangeable.

Pharmacokinetics in individual groups of patients

, the pharmacokinetics of levofloxacin in men and women do not differ.

Pharmacokinetics in elderly patients do not differ from those in young patients, with the exception of pharmacokinetic differences associated with differences in creatinine clearance (CC).

In patients with renal insufficiency, the pharmacokinetics of levofloxacin are altered. As renal function worsens, renal excretion and renal clearance (CIR) decrease and T 1/2 increases.

Pharmacokinetics in patients with renal insufficiency after a single oral dose of 500 mg of Levofloxacin Ecolevid®.

CC (ml / min) <20 20-49 50-80CIR (ml / min) 13 26 57 T 1/2 (h) 35 27 9

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin:

community-acquired pneumonia;

complicated urinary tract infections and pyelonephritis;

chronic bacterial prostatitis;

infections of the skin and soft tissues;

for the complex treatment of drug-resistant forms of tuberculosis;

prevention and treatment of anthrax in the airborne route of infection.

For the treatment of the following infectious and inflammatory diseases, levofloxacin can be used as an alternative to other antimicrobial drugs:

acute sinusitis;

exacerbation of chronic bronchitis;

uncomplicated cystitis.

When using Levofloxacin Ecolevid®, you should take into account the official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogens in a particular country (see the section “Special instructions”).

Use during pregnancy and lactation

Levofloxacin is contraindicated in pregnant and breast-feeding women.

Contraindications

Hypersensitivity to levofloxacin, other fluoroquinolones or components of the drug, epilepsy, tendon damage during previous treatment with quinolones, pregnancy, lactation, children and adolescents (up to 18 years), myasthenia gravis.

Congenital intolerance to fructose, galactose, galactosemia, glucose-galactose malabsorption.

Due to the inability to divide the tablet in two, the drug is contraindicated in patients with impaired renal function. :

in patients with creatinine clearance less than 50 ml/min cannot be used in the dosing regimen with an initial dose of 250 mg/24 h

in patients with creatinine clearance less than 20 ml/min cannot be used in the dosing regimen with an initial dose of 500 mg/24 h 500 mg/12 h and

if creatinine clearance less than 10 ml/min (including in hemodialysis and continuous ambulatory peritoneal dialysis) cannot apply for all dosing regimens.

With caution

In patients predisposed to the development of seizures [in patients with previous lesions of the central nervous system (CNS); in patients simultaneously taking drugs that reduce the threshold of convulsive brain activity, such as fenbufen, theophylline] (see the section “Interaction with other drugs”);

In patients with latent or manifest glucose-6-phosphate dehydrogenase deficiency (increased risk of hemolytic reactions during treatment with quinolones);

In patients with impaired renal function (mandatory monitoring of renal function is required, as well as correction of the dosage regimen, see the section “Dosage and use”);

In patients with known risk factors for QT interval prolongation: patients of advanced age; female patients; in patients with uncorrected electrolyte disorders (hypokalemia with a hypomagnesemia), a syndrome of congenital QT prolongation; cardiac (heart failure, myocardial infarction, bradycardia); the simultaneous use of drugs that can prolong the QT interval (antiarrhythmic agents class IA and III, tricyclic antidepressants, macrolides, antipsychotics) (see sections on “Overdose”, “Interaction with other medicinal products”, the “Special instructions”);

In patients with diabetes mellitus who receive oral hypoglycemic drugs (for example, glibenclamide) or insulin preparations (the risk of hypoglycemia increases);

In patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions with levofloxacin);

In patients with psychosis or in patients with a history of mental illness (see the section “Special instructions”);

In elderly patients, in patients after transplantation, as well as with concomitant use of glucocorticosteroids (increased risk of tendinitis and tendon rupture) (see the section “Special instructions”).

Side effects

The frequency of adverse reactions is classified according to WHO recommendations: very common ≥1/10, often ≥1/100 to <1/10, infrequently ≥1/1000 to <1/100, rarely ≥1/10000 to <1/1000, very rarely from

From the cardiovascular system

Rarely: sinus tachycardia, palpitation of the heart.

Frequency unknown: prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the “pirouette” type, which can lead to cardiac arrest.

Blood and lymphatic system disorders

Infrequently: leukopenia (a decrease in the number of white blood cells in the peripheral blood), eosinophilia (an increase in the number of eosinophils in the peripheral blood).

Rarely: neutropenia (a decrease in the number of neutrophils in the peripheral blood), thrombocytopenia (a decrease in the number of platelets in the peripheral blood).

Frequency unknown: pancytopenia (decrease in the number of all formed elements in the peripheral blood), agranulocytosis (absence and / or sharp decrease in the number of granulocytes in the peripheral blood), hemolytic anemia.

From the nervous system

Often: headache, dizziness.

Infrequently: drowsiness, tremor, dysgeusia (perversion of taste).

Rarely: paresthesia, convulsions (see section “Special instructions”).

Frequency unknown: peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see section “Special instructions”), dyskinesia, extrapyramidal disorders, ageusia (loss of taste sensations), parosmia (odour sensation disorder, especially subjective odour sensation, objectively absent), including loss of smell; syncope, benign intracranial hypertension.

From the side of the visual organ

Very rarely: visual disturbances, such as blurring of the visible image.

Frequency unknown: uveitis, a temporary loss of vision.

Hearing disorders and labyrinth disorders

Infrequently: vertigo (feeling of deflection or whirling of one’s own body or surrounding objects).

Rarely: ringing in the ears.

Frequency unknown: hearing loss.

Respiratory, thoracic and mediastinal disorders

Infrequently: shortness of breath.

Frequency unknown: bronchospasm, allergic pneumonitis.

From the gastrointestinal tract

Often: diarrhea, nausea, vomiting.

Infrequently: abdominal pain, flatulence, constipation, dyspepsia.

Frequency unknown: hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis (see the section “Special instructions”), pancreatitis.

From the side of the kidneys and urinary tract

Infrequently: hypercreatininemia (increased serum creatinine).

Rarely: acute renal failure (for example, due to the development of interstitial nephritis).

Skin and subcutaneous tissue disorders

Infrequently: rash, pruritus, urticaria, hyperhidrosis.

Frequency unknown: Stevens-Johnson syndrome, toxic epidermal necrolysis, exudative erythema multiforme, photosensitization reactions (hypersensitivity to sunlight and ultraviolet radiation) (see the section “Special instructions”), leukocytoclastic vasculitis, stomatitis.

Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug.

Musculoskeletal and connective tissue disorders

Infrequently: arthralgia, myalgia.

Rarely: tendon damage, including tendinitis (such as Achilles tendon), muscle weakness that can be particularly dangerous in patients with pseudoparalytic myasthenia gravis (see section “Special instructions”).

Frequency unknown: rhabdomyolysis, a torn tendon (for example, the Achilles tendon. This side effect may occur within 48 hours after starting treatment and may be bilateral in nature( see also the section “Special instructions”), ligament rupture, muscle rupture, arthritis.

From the side of metabolism and nutrition

Infrequently: anorexia.

Rarely: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: “wolfish” appetite, nervousness, perspiration, trembling).

Frequency unknown: severe hypoglycemia, up to hypoglycemic coma, especially in elderly patients, patients with diabetes mellitus, taking oral hypoglycemic drugs or insulin (see the section “Special instructions”).

Infectious and parasitic diseases

Infrequently: fungal infections, development of resistance of pathogenic microorganisms.

From the side of blood vessels

Rare: low blood pressure.

Common disorders

Infrequently: asthenia.

Rarely: pyrexia (increased body temperature).

Frequency unknown: pain (including pain in the back, chest, and extremities).

From the immune system

Rarely: angioedema.

Frequency unknown: anaphylactic shock, anaphylactoid shock.

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

From the liver and biliary tract

Often: increased activity of “liver” enzymes in the blood (for example, alanine aminotransferase (AlAT), aspartate aminotransferase (AsAT)), increased activity of alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT).

Infrequently: increased bilirubin concentration in the blood.

Frequency unknown: severe hepatic insufficiency, including cases of acute hepatic insufficiency, sometimes fatal, especially in patients with a severe underlying disease (for example, in patients with sepsis); hepatitis, jaundice.

Mental disorders

Are Common: insomnia.

Infrequently: feeling restless, anxious, confused.

Rare: mental disorders (e. g. hallucinations, paranoia), depression, agitation (agitation), sleep disorders, nightmares.

Frequency unknown: mental disorders with self-harm behavioral disorders, including suicidal thoughts and suicidal attempts, attention disorders, disorientation, agitation, nervousness, memory impairment, delirium.

Other possible undesirable effects related to all fluoroquinolones

Very rare: attacks of porphyria (a very rare metabolic disease) in patients with porphyria.

Interaction

There are reports of a marked decrease in the seizure threshold when quinolones and substances that lower the cerebral seizure threshold are used simultaneously. This also applies to the simultaneous use of quinolones and theophylline, as well as nonsteroidal anti-inflammatory drugs-propionic acid derivatives.

There was no pharmacokinetic interaction between levofloxacin and theophylline.

Oral use of levofloxacin together with drugs containing two – and three-valent cations, such as zinc or iron salts (drugs for the treatment of anemia), magnesium-and/or aluminum-containing drugs (such as antacids), didanosine (only dosage forms containing aluminum or magnesium as a buffer), leads to a decrease in absorption and a weakening of the effect of levofloxacin, so it should be prescribed 2 hours before or 2 hours after taking the above medications.

Calcium salts have a minimal effect on the absorption of levofloxacin when taken orally.

The effect of levofloxacin is significantly weakened with the simultaneous use of sucralfate (a means to protect the gastric mucosa). Patients receiving levofloxacin and sucralfate are advised to take sucralfate 2 hours after taking levofloxacin.

The concentration of levofloxacin with simultaneous use of fenbufen increases only by 13%.

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

Patients treated with levofloxacin in combination with indirect anticoagulants (for example, warfarin) experienced an increase in prothrombin time/international normalized ratio and/or the development of bleeding, including severe bleeding. Therefore, with the simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood clotting parameters is necessary.

Caution should be exercised when concomitantly using medications that interfere with renal tubular secretion, such as probenecid and cimetidine, and levofloxacin, especially in patients with renal insufficiency. Elimination (renal clearance)of levofloxacin is slowed by cimetidine by 24% and probenecid by 34%. It is unlikely that this can be of clinical significance in normal renal function.

Levofloxacin, when used concomitantly with class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, and neuroleptics, may cause prolongation of the QT interval.

Levofloxacin increases the half-life of cyclosporine by 33%. Since this increase is clinically insignificant, no dose adjustment of cyclosporine is required when it is co-administered with levofloxacin.

Taking glucocorticosteroids increases the risk of tendon rupture.

The pharmacokinetics of levofloxacin when used concomitantly with digoxin, glibenclamide, ranitidine, warfarin do not change sufficiently to be of clinical significance.

How to take, course of use and dosage

Inside. Once or twice a day. Tablets should be swallowed 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 at any time between meals, since food intake does not affect the absorption of the drug (see the section “Pharmacokinetics”).

The drug should be taken at least 2 hours before or 2 hours after taking medications containing magnesium and / or aluminum, iron, zinc, or sucralfate (see the section “Interaction with other medications”).

Given that the bioavailability of levofloxacin when taking Levofloxacin Ecolevid® tablets is 99-100%, if the patient is transferred from intravenous infusion with other levofloxacin preparations, Levofloxacin Ecolevid® tablets should be continued at the same dose as was used for intravenous infusion of levofloxacin preparations (see the section “Pharmacokinetics”).

Skipping one or more doses of the drug

If you accidentally miss taking the drug, then you should take the next dose as soon as possible and then continue taking Levofloxacin Ecolevid® according to the recommended dosage regimen.

Dosage and duration of treatment

The dosage regimen is determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. The duration of treatment varies depending on the course of the disease.

Recommended dosage regimen and duration of treatment in patients with normal renal function (creatinine clearance >50 ml / min)

Acute sinusitis: 2 tablets of Levofloxacin Ecolevid ® 250 mg or 1 tablet of Levofloxacin Ecolevid® 500 mg once a day (respectively,500 mg of levofloxacin) – 10-14 days.

Exacerbation of chronic bronchitis: 2 tablets of Levofloxacin Ecolevid ® 250 mg or 1 tablet of Levofloxacin Ecolevid® 500 mg once a day (respectively,500 mg of levofloxacin) – 7-10 days.

Community-acquired pneumonia: 2 tablets of Levofloxacin Ecolevid ® 250 mg or 1 tablet of Levofloxacin Ecolevid® 500 mg 1-2 times a day (respectively 500-1000 mg of levofloxacin) – 7-14 days.

Uncomplicated urinary tract infections: 1 tablet of Levofloxacin Ecolevid® 250 mg once a day (respectively 250 mg of levofloxacin) – 3 days.

Complicated urinary tract infections: 2 tablets of Levofloxacin Ecolevid ® 250 mg 1 time a day or 1 tablet of Levofloxacin Ecolevid® 500 mg 1 time a day (respectively,500 mg of levofloxacin) – 7-14 days.

Pyelonephritis:2 tablets of Levofloxacin Ecolevid ® 250 mg 1 time a day or 1 tablet of Levofloxacin Ecolevid® 500 mg 1 time a day (respectively,500 mg of levofloxacin) – 7-10 days.

Chronic bacterial prostatitis: 2 tablets of Levofloxacin Ecolevid ® 250 mg or 1 tablet of Levofloxacin Ecolevid® 500 mg once a day (respectively,500 mg of levofloxacin) – 28 days.

Skin and soft tissue infections: 2 tablets of Levofloxacin Ecolevid ® 250 mg or 1 tablet of Levofloxacin Ecolevid® 500 mg 1-2 times a day (respectively 500-1000 mg of levofloxacin) – 7-14 days.

Comprehensive treatment of drug-resistant forms of tuberculosis: 1 tablet of Levofloxacin Ecolevid® 500 mg 1-2 times a day (respectively 500-1000 mg of levofloxacin) – up to 3 months.

Prevention and treatment of anthrax in the airborne pathway of infection: 2 tablets of Levofloxacin Ecolevid ® 250 mg or 1 tablet of Levofloxacin Ecolevid® 500 mg (respectively,500 mg of levofloxacin) 1 time a day for up to 8 weeks.

Dosage regimen in patients with impaired renal function (CC

Levofloxacin is mainly excreted by the kidneys, so when treating patients with impaired renal function, a reduction in the dose of the drug is required.

Dosage regimen in patients with impaired liver function

If liver function is impaired, no dosage adjustment is required, since levofloxacin is only slightly metabolized in the liver.

Dosage regimen in elderly patients

Elderly patients do not need to adjust the dosage regimen, except in cases where creatinine clearance decreases to 50 ml/min or lower.

Overdose

Symptoms of overdose:

Based on the data obtained in toxicological studies conducted in animals, the most important expected symptoms of acute levofloxacin overdose are symptoms from the central nervous system (disorders of consciousness, including confusion, dizziness and convulsions).

Central nervous system effects, including confusion, convulsions, hallucinations, and tremors, have been observed with post-marketing use of levofloxacin in overdose.

Nausea and erosions of the gastrointestinal mucosa may occur.

In clinical and pharmacological studies conducted with doses of levofloxacin exceeding therapeutic ones, prolongation of the QT interval was observed.

Overdose treatment:

In case of overdose, careful monitoring of the patient is required, including monitoring of the electrocardiogram. Treatment is symptomatic. In case of acute overdose, gastric lavage and use of antacids to protect the gastric mucosa are indicated. Levofloxacin is not eliminated by dialysis (hemodialysis, peritoneal dialysis, and permanent outpatient peritoneal dialysis). There is no specific antidote.

Description

Capsule-shaped biconvex tablets covered with a film-coated white or almost white color; two layers are visible on the cross-section, the inner layer is from light yellow to yellow, white inclusions are allowed.

Special instructions

Hospital infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) may require combined treatment.

Risk of developing resistance

The prevalence of acquired resistance of the seeded strains of microorganisms may vary depending on the geographical region and over time. Therefore, information on drug resistance in a particular country is required. For the treatment of severe infections or if treatment is ineffective, a microbiological diagnosis should be established with the isolation of the pathogen and determination of its sensitivity to levofloxacin.

Methicillin-resistant Staphylococcus aureus

There is a high probability that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, if laboratory tests have not confirmed the sensitivity of this microorganism to levofloxacin.

Disability and potential irreversible serious adverse reactions due to the use of fluoroquinolones

The use of fluoroquinolones, including levofloxacin, has been associated with disability and the development of irreversible serious adverse reactions from various body systems that can develop simultaneously in the same patient. Adverse reactions caused by fluoroquinolones include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and nervous system side effects (hallucinations, anxiety, depression, insomnia, headaches, and confusion). These reactions may occur within a few hours to several weeks after starting levofloxacin therapy.

The development of these adverse reactions was observed in patients of any age or without the presence of previous risk factors. If the first signs or symptoms of any serious adverse reactions occur, levofloxacin should be discontinued immediately. The use of fluoroquinolones, including levofloxacin, should be avoided in patients who have experienced any of these serious adverse reactions.

Patients predisposed to developing seizures

Like other quinolones, levofloxacin should be used with great caution in patients with a predisposition to seizures. These patients include patients with previous central nervous system disorders, such as stroke, severe traumatic brain injury; patients who are simultaneously taking medications that lower the threshold for convulsive activity of the brain, such as fenbufen and other similar nonsteroidal anti-inflammatory drugs or other drugs that lower the threshold for convulsive activity, such as theophylline (see the section “Interaction with other drugs”).

If seizures develop, treatment with levofloxacin should be discontinued.

Pseudomembranous colitis

Diarrhea that develops during or after treatment with levofloxacin, especially severe, persistent and/or bloody, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. If pseudomembranous colitis is suspected, treatment with levofloxacin should be stopped immediately and specific antibiotic therapy (vancomycin, teicoplanin or metronidazole orally) should be initiated immediately. Drugs that inhibit intestinal motility are contraindicated.

Tendinitis and tendon rupture

When using quinolones, including levofloxacin, tendinitis is rarely observed, which can sometimes lead to rupture of tendons, including the Achilles tendon, and can be bilateral.

This side effect may develop within 48 hours of starting treatment or several months after the end of fluoroquinolone therapy.

Elderly patients are more likely to develop tendinitis; in patients taking fluoroquinolones, the risk of tendon rupture may increase with concomitant use of glucocorticosteroids. In addition, patients after transplantation have an increased risk of developing tendinitis, so caution is recommended when prescribing fluoroquinolones to this category of patients. In patients with impaired renal function, the daily dose should be adjusted based on creatinine clearance. Patients should be advised to remain at rest at the first sign of tendinitis or tendon tears and consult their healthcare provider. If tendinitis or tendon rupture is suspected, treatment with Levofloxacin Ecolevid® should be discontinued immediately and appropriate treatment of the affected tendon should be initiated, for example, by ensuring that it is sufficiently immobilized (see sections “Contraindications” and “Side effects”).

Hypersensitivity reactions

Levofloxacin can cause serious, potentially fatal, hypersensitivity reactions (angioedema, anaphylactic shock), even with the use of initial doses (see the section “Side effects”). Patients should immediately stop taking the drug and consult a doctor.

Severe bullous reactions

Severe bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been reported with levofloxacin (see section “Side effects”). In case of any skin or mucosal reactions, the patient should immediately consult a doctor and not continue treatment until after consultation.

Liver and biliary tract disorders

Hepatic necrosis, including fatal liver failure, has been reported with levofloxacin, mainly in patients with severe underlying medical conditions, such as sepsis (see section “Adverse effects”). Patients should be warned to stop treatment and seek immediate medical attention if signs and symptoms of liver damage appear, such as anorexia, jaundice, dark urine, itchy skin, and abdominal pain.

Patients with impaired renal function

Since levofloxacin is mainly excreted through the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as correction of the dosage regimen (see the section “Dosage and use”). When treating elderly patients, it should be taken into account that patients in this group often have impaired renal function (see the section “Dosage and use”).

Prevention of photosensitization reactions

Although photosensitization with levofloxacin is very rare, to prevent its development, patients are not recommended to be exposed to strong solar or artificial ultraviolet radiation (for example, to visit a tanning salon) during treatment and within 48 hours after the end of treatment with levofloxacin.

Superinfection

As with other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased reproduction of microorganisms that are insensitive to it (bacteria and fungi), which can cause changes in the microflora that is normally present in humans. As a result, superinfection may develop. Therefore, it is mandatory to re-evaluate the patient’s condition during treatment, and if superinfection develops during treatment, appropriate measures should be taken.

Prolongation of the QT interval

Very rare cases of QT prolongation have been reported in patients taking fluoroquinolones, including levofloxacin.

Caution should be exercised when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval: in patients with uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); with congenital QT prolongation syndrome; with heart diseases (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval, such as class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics.

Elderly and female patients may be more sensitive to drugs that prolong the QT interval. Therefore, they should be treated with caution with fluoroquinolones, including levofloxacin (see sections “With caution”, “Dosage and use”, “Side effects”, “Overdose” and “Interaction with other drugs”).

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with latent or manifest glucose-6-phosphate dehydrogenase deficiency have a predisposition to develop hemolytic reactions during treatment with quinolones, which should be taken into account when treating with levofloxacin.

Hypo – and hyperglycemia (dysglycemia)

As with other quinolones, hyperglycaemia and hypoglycaemia have been reported with levofloxacin, usually in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycaemic drugs (e. g., glibenclamide) or insulin preparations. Cases of hypoglycemic coma have been reported. Blood glucose monitoring is required in patients with diabetes mellitus (see section “Side effects”).

Peripheral neuropathy

Patients taking fluoroquinolones, including levofloxacin, have been reported to develop sensory and sensorimotor peripheral neuropathy, the onset of which may be rapid. If the patient develops symptoms of neuropathy, levofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.

Patients should be informed about the need to inform their attending physician about any symptoms of neuropathy. Fluoroquinolones should not be used in patients with a history of peripheral neuropathy.

Exacerbation of pseudoparalytic myasthenia gravis

Fluoroquinolones, including levofloxacin, are characterized by neuromuscular blocking activity and may increase muscle weakness in patients with pseudoparalytic myasthenia gravis. In the post-marketing period, adverse reactions were observed, including pulmonary insufficiency that required mechanical ventilation, and death, which were associated with the use of fluoroquinolones in patients with pseudoparalytic myasthenia gravis. The use of levofloxacin in a patient with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended (see the section “Side effects”).

Application in the airborne pathway of anthrax infection

The use of levofloxacin in humans for this indication is based on data on the sensitivity of Bacillus anthracisto it, obtained in vitro studies and in experimental studies conducted on animals, as well as on limited data on the use of levofloxacin in humans. Treating physicians should refer to national and / or international documents that reflect a common point of view on the treatment of anthrax.

Psychotic reactions

Psychotic reactions, including suicidal thoughts/attempts, have been reported in patients taking fluoroquinolones, including levofloxacin, sometimes after a single dose. If such reactions develop, treatment with levofloxacin should be discontinued and appropriate therapy should be prescribed. Caution should be exercised when prescribing the drug to patients with psychosis or a history of mental illness (see section “With caution”).

Visual disturbances

If you develop any visual disturbances, you should immediately consult an ophthalmologist (see the section “Side effects”).

Impact on laboratory tests

In patients taking levofloxacin, the determination of opiates in the urine may lead to false positive results, which should be confirmed by more specific methods.

Levofloxacin can inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false negative results of the bacteriological diagnosis of tuberculosis.

Influence on the ability to drive vehicles and mechanisms

During treatment, you should refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Film-coated tablets,250 mg and 500 mg

5,7 or 10 tablets in a contour cell package made of polyvinyl chloride/polyvinylidene chloride film and aluminum foil printed varnished.

1 or 2 contour cell packages together 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 not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Adults as prescribed by a doctor

Indications

Infectious Diseases, Boils, Skin Infections, Respiratory Tract Infections, Sinusitis, Bronchitis, Prostatitis, Inflammation of the female genital organs, Pneumonia, Urinary Tract Infections, Sinusitis, Tuberculosis