Levolet R, 500 mg, film-coated tablets, 10 pcs.


Pharmacological properties of the drug Levolet

Pharmacodynamics. Levofloxacin is a broad-spectrum antibiotic. A rapid bactericidal effect is achieved due to inhibition of the bacterial enzyme DNA gyrase, which belongs to type II topoisomerases. As a result, the three-dimensional structure of bacterial DNA is disrupted and further reproduction of bacterial cells becomes impossible. The drug is active against a wide range of microorganisms: gram-positive aerobes: Enterococcus faecalis, Staphylococcus aureus methi-s, S taphylococcus haemolyticus methi-s, Staphylococcus saprophyticus, Streptococci group C, G, Streptococcus agalactiae, Streptococcus pneumoniae peni-i/S/R, Streptococcus pyogenes ; gram-negative aerobes: Acinetobacter baumanii, Citrobacter freundii, Eikenella corrodens, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae ampi-s/R, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis b+/b-, Morganella morganii, Pasteurella m ultocida , Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens ; anaerobes: Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus ; others: Clamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae, Ureaplasma, H. pylori. Like other fluoroquinolones, levofloxacin is inactive against spirochetes. Pharmacokinetics. When administered orally, levofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract, Cmax in blood plasma is reached 1 hour after administration. Absolute bioavailability is almost 100%. Levofloxacin is characterized by linear pharmacokinetics. Food intake has almost no effect on its absorption. 30–40% of levofloxacin is bound to plasma proteins. When taken orally at a dose of 500 mg 2 times a day, slight cumulation is possible. Levofloxacin is metabolized to a small extent (≤5% of the drug, which is excreted in the urine); metabolites - dimethyllevofloxacin and levofloxacin N-oxide. Levofloxacin is eliminated relatively slowly from blood plasma, half-life is 6–8 hours. It is eliminated mainly by the kidneys (85%).

Instructions:

Clinical and pharmacological group

06.038 (Antibacterial drug of the fluoroquinolone group)

Release form, composition and packaging

White or almost white, film-coated tablets, capsule-shaped, biconvex, embossed “RDY” on one side and “279” on the other.

1 tab.
levofloxacin hemihydrate256.233 mg,
 which corresponds to the content of levofloxacin250 mg

Excipients: microcrystalline cellulose (Avicel PH 101 and Avicel PH 102), corn starch, colloidal silicon dioxide, crospovidone, hypromellose (15 cps), magnesium stearate.

Film shell composition: opadry white dye OY 58900 (hypromellose 5 cP, titanium dioxide, macrogol 400).

10 pieces. - blisters (1) - cardboard packs.

White or almost white, film-coated tablets, capsule-shaped, biconvex, embossed “RDY” on one side and “280” on the other.

1 tab.
levofloxacin hemihydrate512.466 mg,
 which corresponds to the content of levofloxacin500 mg

Excipients: microcrystalline cellulose (Avicel PH 101 and Avicel PH 102), corn starch, colloidal silicon dioxide, crospovidone, hypromellose (15 cps), magnesium stearate.

Film shell composition: opadry white dye OY 58900 (hypromellose 5 cP, titanium dioxide, macrogol 400).

10 pieces. - blisters (1) - cardboard packs.

The solution for infusion is clear or slightly opalescent, pale yellow in color.

1 ml1 fl.
levofloxacin hemihydrate5.12 mg512 mg,
 which corresponds to the content of levofloxacin5 mg500 mg

Excipients: dextrose, hydrochloric acid, sodium hydroxide, water for injection.

100 ml - low density polyethylene bottles (1) - cardboard packs.

pharmachologic effect

Antibacterial drug of the fluoroquinolone group with a broad spectrum of action. Blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes.

Levofloxacin is active against the following strains of microorganisms, both in vitro and in vivo.

Sensitive microorganisms (MIC less than 2 mg/ml)

Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative methicillin-sensitive/moderately sensitive strains, leukotoxin-containing 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 viridans group (penicillin-sensitive/resistant strains).

Aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannil), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter spp. (including 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 (beta-lactamase producing and non-producing strains), Morganella morganii, Neisseria gonorrhoeae (penicillinase producing and non-producing strains), 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), Serratia spp. (including Serratia marcescens), Salmonella 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., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma hominis), Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Moderately sensitive microorganisms (MIC more than 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: Burkholderia cepacia, Campylobacter jejuni, Campylobacter coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp., Porphyromonas spp.

Resistant microorganisms (MIC more than 8 mg/l)

Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp. (coagulase-negative methicillin-resistant strains).

Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.

Other microorganisms: Mycobacterium avium.

Pharmacokinetics

The pharmacokinetics of levofloxacin with single and repeated administration of the drug is linear. The plasma profile of levofloxacin concentrations after intravenous administration is similar to that when taking tablets. Therefore, oral and intravenous routes of administration can be considered interchangeable.

Suction

After taking the drug orally, it is quickly and almost completely absorbed from the gastrointestinal tract. Food intake has little effect on the speed and completeness of absorption. Bioavailability - 99%. Tmax - 1-2 hours; when taken in doses of 250 and 500 mg, the average Cmax in plasma is 2.8 and 5.2 μg/ml, respectively.

After intravenous infusion of levofloxacin at a dose of 500 mg for 1 hour to healthy volunteers, the average Cmax in plasma was 6.2±1.0 μg/ml, Tmax - 1.0±0.1 hours.

Distribution

Plasma protein binding is 30-40%.

After single and multiple intravenous administration at a dose of 500 mg, the average Vd of levofloxacin is 89-112 l.

Penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, genitourinary organs, polymorphonuclear leukocytes, alveolar macrophages.

Metabolism

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

Removal

When taken orally, T1/2 is 6-8 hours. After a single intravenous administration at a dose of 500 mg, T1/2 is 6.4±0.7 hours. It is excreted from the body mainly by the kidneys by glomerular filtration and tubular secretion. Renal clearance accounts for 70% of the total clearance. Less than 5% of levofloxacin is excreted as metabolites. In urine over a period of 24 hours, 70% is found unchanged, and over 48 hours - 87% of the dose taken orally or administered intravenously. In stool over a period of 72 hours, 4% of the dose taken orally or administered intravenously is detected.

Pharmacokinetics in special clinical situations

In case of renal failure, a decrease in the clearance of the drug and its excretion by the kidneys depends on the degree of decrease in CC.

Dosage

Pills

The tablets are taken orally, before meals or between meals, without chewing, with a sufficient amount of liquid.

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

For patients with normal or slightly impaired renal function (creatinine clearance >50 ml/min), the drug is recommended to be prescribed in the following doses.

For sinusitis - 500 mg 1 time / day. The course of treatment is 10-14 days.

For exacerbation of chronic bronchitis - 250-500 mg 1 time / day. The course of treatment is 10-14 days.

For community-acquired pneumonia - 500 mg 1-2 times a day. The course of treatment is 7-14 days.

For uncomplicated urinary tract infections - 250 mg 1 time / day. The course of treatment is 3 days.

For complicated urinary tract infections (including pyelonephritis) - 250 mg 1 time / day. The course of treatment is 7-10 days.

For prostatitis - 500 mg 1 time / day. The course of treatment is 28 days.

For septicemia/bacteremia - 500 mg 1-2 times a day. The course of treatment is 10-14 days.

For intra-abdominal infection - 500 mg 1 time / day. The course of treatment is 7-14 days, in combination with antibacterial drugs that act on anaerobic flora.

For infections of the skin and soft tissues - 250 mg 1-2 times a day or 500 mg 1 time a day. The course of treatment is 7-14 days.

As part of complex therapy for drug-resistant forms of tuberculosis - 500-1000 mg of levofloxacin 1 time / day. The course of treatment is up to 3 months.

Patients with impaired renal function require adjustment of the dosage regimen, depending on the value of CC.

Creatinine clearanceOral dosage
250 mg/24 h500 mg/24 h500 mg/12h
first dose 250 mgfirst dose 500 mgfirst dose 500 mg
50-20 ml/minthen 125 mg/24 hthen 250 mg/24 hthen 250 mg/12 h
19-10 ml/minthen 125 mg/48 hthen 125 mg/24 hthen 125 mg/12 h
<10 ml/min (including hemodialysis and continuous ambulatory peritoneal dialysis)then 125 mg/48 hthen 125 mg/24 hthen 125 mg/24 h

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

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

If liver function is impaired, no special dose selection is required, since levofloxacin is slightly metabolized in the liver.

The duration of treatment, depending on the course of the disease, is no more than 14 days. As with the use of other antibiotics, treatment with Levolet® R is recommended to be continued for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen.

Solution for infusion

The drug is administered intravenously.

The dose is determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

For community-acquired pneumonia - 500 mg 1-2 times a day. The course of treatment is 7-14 days.

For uncomplicated urinary tract infections - 250 mg 1 time / day. The course of treatment is 3 days.

For complicated urinary tract infections (including pyelonephritis) - 250 mg 1 time / day. For severe infections, the dose may be increased. The course of treatment is 7-10 days.

For bacterial prostatitis - 500 mg 1 time / day. The course of treatment is 28 days.

For septicemia/bacteremia - 500 mg 1-2 times a day. The course of treatment is 10-14 days.

For intra-abdominal infections - 500 mg 1 time / day. The course of treatment is 7-14 days, in combination with antibacterial drugs that act on anaerobic flora.

As part of complex therapy for drug-resistant forms of tuberculosis - 500 mg 1-2 times a day (500-1000 mg levofloxacin per day), depending on the severity of the disease and the treatment regimen used. The course of treatment is up to 3 months.

Patients with slightly impaired renal function (creatinine clearance >50 ml/min) do not require dose adjustment.

Patients with impaired renal function require adjustment of the dosage regimen, depending on the value of CC.

Creatinine clearanceDoses for intravenous administration
250 mg/24 h500 mg/24 h500 mg/12 h
first dose 250 mgfirst dose 500 mgfirst dose 500 mg
50-20 ml/minthen 125 mg/24 hthen 250 mg/24 hthen 250 mg/12 h
19-10 ml/minthen 125 mg/48 hthen 125 mg/24 hthen 125 mg/12 h
<10 ml/min (including hemodialysis and continuous ambulatory peritoneal dialysis)then 125 mg/48 hthen 125 mg/24 hthen 125 mg/24 h

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

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

The drug Levolet® R, in the form of a solution for infusion, is administered intravenously by slow drip. The duration of administration of the drug at a dose of 500 mg (100 ml infusion solution/500 mg levofloxacin) should be at least 60 minutes.

The Levolet® R solution is compatible with the following infusion solutions: 0.9% sodium chloride solution, 5% dextrose (glucose) solution, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). The drug solution should not be mixed with heparin or solutions with an alkaline reaction (for example, sodium bicarbonate solution).

If the patient’s clinical condition improves after a few days of treatment, it is possible to switch from intravenous drip administration to oral administration of the drug in the same dose.

The duration of treatment, depending on the course of the disease, is no more than 14 days (with the exception of bacterial prostatitis). As with the use of other antibiotics, treatment with Levolet® R is recommended to be continued for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen.

Overdose

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

Treatment: symptomatic, dialysis is ineffective.

Drug interactions

Increases T1/2 of cyclosporine.

The degree of absorption of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, antacid drugs containing aluminum and magnesium salts, as well as drugs containing iron salts (a break between doses of at least 2 hours is required).

NSAIDs and theophylline increase convulsive readiness.

GCS increases the risk of tendon rupture.

Cimetidine and drugs that block tubular secretion slow down excretion.

When used simultaneously with indirect anticoagulants (including warfarin), it is necessary to monitor blood clotting.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Side effects

The frequency of side effects is classified depending on the frequency of occurrence of the case: often (1-10%), sometimes (0.1-1%), rarely (0.01-0.1%), very rarely (less than 0.01%), including individual reports.

From the hematopoietic system: sometimes - eosinophilia, leukopenia; rarely - neutropenia, thrombocytopenia; very rarely - severe agranulocytosis; in some cases - hemolytic anemia, pancytopenia.

From the digestive system: often - nausea, diarrhea, increased activity of ALT, AST, dysbacteriosis; sometimes - loss of appetite, vomiting, abdominal pain, digestive disorders, hyperbilirubinemia; rarely - diarrhea with blood (in very rare cases this may be a sign of intestinal inflammation or pseudomembranous colitis); very rarely - hepatitis.

From the cardiovascular system: rarely - tachycardia, decreased blood pressure; very rarely - vascular collapse; in some cases - prolongation of the QT interval.

From the central and peripheral nervous system: sometimes - headache, dizziness, drowsiness, sleep disturbances; rarely - paresthesia in the hands, trembling, anxiety, states of fear, seizures and confusion; very rarely - psychotic reactions such as hallucinations and depression, movement disorders.

From the senses: very rarely - disturbances in vision and hearing, smell, taste and tactile sensitivity.

On the metabolic side: very rarely - hypoglycemia (manifested by a sharp increase in appetite, nervousness, perspiration, trembling); in some cases - exacerbation of existing porphyria.

From the urinary system: rarely - hypercreatininemia; very rarely - deterioration of kidney function up to acute renal failure (for example, due to allergic reactions - interstitial nephritis).

From the musculoskeletal system: rarely - tendon damage (including tendinitis), joint and muscle pain; very rarely - tendon rupture (including Achilles tendon rupture, which can be bilateral and appear within 48 hours after the start of treatment), muscle weakness (of particular importance for patients with myasthenia gravis); in some cases - rhabdomyolysis.

Allergic reactions: sometimes - itching and redness of the skin; rarely - anaphylactic and anaphylactoid reactions (manifested by symptoms such as urticaria, bronchospasm and possible severe suffocation, as well as - in rare cases - swelling of the face and larynx); very rarely - a sharp decrease in blood pressure, anaphylactic shock; in some cases - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme, allergic pneumonitis, vasculitis.

Dermatological reactions: very rarely - photosensitivity.

Other: sometimes - asthenia; very rarely - persistent fever, development of superinfection.

Local reactions: often with intravenous administration - pain, redness, phlebitis.

Storage conditions and periods

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25°C; do not freeze. Shelf life: 2 years.

Indications

Infectious and inflammatory diseases of mild to moderate severity caused by pathogens sensitive to the drug:

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

— community-acquired pneumonia (for solution for infusion);

— infections of the ENT organs (acute sinusitis) (for tablets);

— infections of the skin and soft tissues (for tablets);

— as part of complex therapy of drug-resistant forms of tuberculosis;

- complicated kidney and urinary tract infections, including pyelonephritis;

- uncomplicated urinary tract infections;

- prostatitis;

- septicemia/bacteremia associated with the above indications;

- intra-abdominal infections.

Contraindications

- epilepsy;

- tendon lesions associated with a history of taking quinolones;

- children and adolescents up to 18 years of age;

- pregnancy;

- lactation period (breastfeeding);

- hypersensitivity to levofloxacin or other quinolones;

- hypersensitivity to the auxiliary components of the drug.

The drug should be prescribed with caution in cases of glucose-6-phosphate dehydrogenase deficiency and in elderly patients (there is a high probability of concomitant decline in renal function).

special instructions

For severe pneumonia caused by Streptococcus pneumoniae, levofloxacin may not be effective.

Administration should be carried out over at least 60 minutes; during administration, palpitations and a transient decrease in blood pressure may be observed; collapse may rarely develop.

If there is a significant decrease in blood pressure, the administration of levofloxacin is stopped.

If the development of pseudomembranous colitis caused by Clostridium difficile is suspected, treatment with levofloxacin is canceled and appropriate therapy is prescribed.

During treatment, it is necessary to avoid solar and artificial ultraviolet irradiation to avoid damage to the skin (photosensitization).

If signs of tendinitis, pseudomembranous colitis, or allergic reactions appear, levofloxacin is immediately discontinued.

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

Impact on the ability to drive vehicles and operate machinery

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

Use for renal impairment

Patients with slightly impaired renal function (creatinine clearance >50 ml/min) do not require dose adjustment.

Patients with impaired renal function require adjustment of the dosage regimen, depending on the magnitude of creatinine clearance.

Use for liver dysfunction

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

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Use of the drug Levolet

Take orally, regardless of meals, 1-2 times a day. The tablets are swallowed without chewing, washed down with a sufficient amount of liquid (at least 200 ml of water). The dose of the drug and duration of use depend on the nosological form, severity and course of the disease; The course of treatment is, as a rule, no more than 14 days (for the treatment of prostatitis - up to 28 days). It is recommended to continue treatment for 2–3 days after normalization of body temperature or confirmation of the absence of the pathogen by microbiological tests. General recommendations for dosing of the drug in adult patients with normal renal function (creatinine clearance 50 ml/min) (Table 1).

Table 1

Acute sinusitis
500 mg 1 time per day
10–14 days
Exacerbation of chronic bronchitis 250–500 mg 1 time per day 7–10 days
Pneumonia 500–1000 mg 1–2 times a day 7–14 days
Uncomplicated urinary tract infections 250 mg 1 time per day 3 days
Complicated urinary system infections (pyelonephritis) 250 mg 1 time per day 7–10 days
Prostatitis 500 mg 1 time per day 28 days
Skin and soft tissue infections 500–1000 mg 1–2 times a day 7–14 days
Septicemia/bacteremia 500–1000 mg 1–2 times a day 10–14 days
Intra-abdominal infections 500 mg 1 time per day (in combination with antibiotics that act on anaerobes) 7–14 days

In patients with impaired renal function (creatinine clearance ≤50 ml/min), it is initially recommended to take the full dose of the drug; in subsequent days it is necessary to reduce the dose depending on creatinine clearance (Table 2).

table 2

Creatinine clearance (ml/min)
Pneumonia, acute sinusitis, complicated skin and soft tissue infections, septicemia/bacteremia
Acute and exacerbation of chronic bronchitis, bacterial prostatitis, uncomplicated skin and soft tissue infections, intra-abdominal infections
Complicated urinary tract infections (including pyelonephritis)
20–49 ml/min Initial dose: 500 mg, subsequent: 250 mg/12 hours Initial dose: 500 mg, subsequent: 250 mg/24 hours No dose adjustment required
10–19 ml/min Initial dose: 500 mg, subsequent: 250 mg/24 hours Initial dose: 500 mg, subsequent: 250 mg/48 hours 250 mg/48 h
≤10 ml/min, hemodialysis, chronic ambulatory peritoneal dialysis Initial dose: 500 mg, subsequent: 250 mg/48 hours Initial dose: 500 mg, subsequent: 250 mg/48 hours 250 mg/48 h

Side effects of the drug Levolet

Skin and general hypersensitivity reactions: in some cases - itching and redness of the skin; rarely - anaphylactic and anaphylactoid reactions (urticaria, bronchospasm, suffocation, Quincke's edema); very rarely - anaphylactic shock, prolongation of the QT interval, photosensitivity; in isolated cases - exudative polymorphic erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). General hypersensitivity reactions may sometimes be preceded by milder skin reactions. Such reactions may appear after the first dose for several hours after administration. From the gastrointestinal tract, metabolism: often - nausea, diarrhea; in some cases - anorexia, vomiting, abdominal pain, digestive disorders; rarely - colitis, including pseudomembranous (manifested by hemorrhagic diarrhea); very rarely - hypoglycemia (considered in case of diabetes mellitus). Signs of hypoglycemia: severe hunger, tremors of the limbs, irritability, hyperhidrosis. From the side of the central nervous system: in isolated cases - headache, dizziness, drowsiness, dyssomnia; rarely - paresthesia, tremor, anxiety, fear, seizures and disturbances of consciousness; very rarely - visual and hearing disturbances, taste and smell disturbances, hypoesthesia, as well as hallucinations and depressive mood changes, movement disorders. From the cardiovascular system: rarely - tachycardia, decreased blood pressure; very rarely - collapse, shock. From the musculoskeletal system: rarely - tendon damage, tendonitis, pain in joints or muscles; very rarely - tendon rupture (usually the Achilles tendon). This side effect can develop within 48 hours from the start of treatment and affects the Achilles tendons of both legs. In isolated cases, muscle damage (rhabdomyolysis). From the liver and kidneys: often - increased levels of liver enzymes (ALAT, AST), bilirubin, plasma creatinine; very rarely - hepatitis, impaired renal function, up to acute renal failure (with interstitial nephritis). From the blood system: eosinophilia, leukopenia; rarely - neutropenia, thrombocytopenia (tendency to hemorrhage or bleeding); very rarely - agranulocytosis; isolated cases - hemolytic anemia, pancytopenia. Other side effects: in isolated cases - asthenia; very rarely - fever, allergic reactions in the lungs (allergic pneumonitis) or small blood vessels (vasculitis). The use of antibacterial agents negatively affects the normal microflora of the human body and can lead to various forms of dysbiosis; for this reason, a secondary infection may develop, requiring additional treatment.

Special instructions for the use of Levolet

It is recommended to increase the amount of fluid consumed during treatment with levofloxacin to prevent the development of crystalluria. Do not use antacids containing magnesium and aluminum, vitamins or mineral supplements containing metal ions (iron, zinc) less than 2 hours before or after taking Levolet, as simultaneous use may reduce the effect of the antibiotic. During treatment, it is contraindicated to drink alcohol or be exposed to direct sunlight or artificial ultraviolet irradiation for a long time. It must be taken into account that levofloxacin, like most antibacterial agents, can cause the development of peripheral neuropathy, pseudomembranous colitis, tendonitis and tendon ruptures, dysbiosis, secondary infection (fungal lesions of different locations). It is necessary to strictly adhere to the dosage regimen and treatment regimen throughout the course of therapy, do not skip doses of the drug and take it at regular intervals. If a dose of the drug has been missed, it should be taken as soon as possible, but if it is time for the next dose, the dose should not be doubled. Follow the full course of therapy. Elderly patients. It is necessary to take into account the possible decrease in renal function and follow general dosage recommendations (see Table 2 ). If liver function is impaired, no dose adjustment is required, since levofloxacin is slightly metabolized in the liver. During pregnancy and breastfeeding. Contraindicated due to the possible development of damage to the cartilage tissue of the fetus and/or infant. Children. Contraindicated in children under 18 years of age due to the possible development of damage to the child’s cartilage tissue. The ability to influence reaction speed when driving vehicles or working with other mechanisms. During treatment, you must refrain from driving vehicles and/or operating other machinery.

Levoleta price

The antibacterial agent Levolet is sold in pharmacies. A doctor's prescription may be required at the time of purchase. The cost and availability of the release form you need can be checked in advance on the corresponding Internet resource. Average price range for the drug Levolet in different release forms:

Release form Price range, rubles
LevoletR 500 No. 10 325-490
LevoletR 250 No. 10 166-310
Levolet solution for infusion 340-525

Drug interactions Levolet

The absorption of levofloxacin is significantly reduced when used simultaneously with antacids containing magnesium, aluminum, as well as drugs containing iron salts. The bioavailability of the tablet form of Levolet is significantly reduced when taken in combination with gastroprotectors (sucralfate). The time interval between taking these drugs should be at least 2 hours. It is possible to reduce the seizure threshold with simultaneous use of levofloxacin with theophylline, NSAIDs and other drugs that reduce the seizure threshold. When used in combination with warfarin, levofloxacin enhances its anticoagulant effect, so it is necessary to monitor coagulogram parameters. When levofloxacin is used simultaneously with hypoglycemic agents, changes in plasma glucose levels are observed, so glycemic control is necessary. It must be taken into account that the renal clearance of levofloxacin is reduced in the presence of probenecid and cimetidine, which can block the tubular excretion of levofloxacin. Half-life of cyclosporine increases by 1/3 when combined with levofloxacin. The use of levofloxacin simultaneously with alcohol is not recommended.

Compound

1 tab. levofloxacin hemihydrate 768.7 mg, which corresponds to the content of levofloxacin 750 mg Excipients: microcrystalline cellulose (Avicel PH 101) - 76 mg, corn starch - 75.3 mg, colloidal silicon dioxide - 15 mg, crospovidone - 64 mg, hypromellose (15 cps) - 21 mg, microcrystalline cellulose (PH 102) - 90 mg, magnesium stearate - 15 mg. Shell composition: opadry white OY 58900 - 28 mg (hypromellose 5 cP - 62.5%, titanium dioxide (E171) - 31.25%, macrogol 400 - 6.25%).

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