Levofloxacin pills 500 mg, 10 pcs. – Pharmstandard

Briefly about the product

Levofloxacin is a broad-spectrum antibacterial drug. Disrupts the synthesis of microbial DNA, causes deep structural changes in the cells of sensitive microorganisms. Levofloxacin is active against most strains of microorganisms, both in vitro and in vivo.

Composition

Active ingredient: levofloxacin hemihydrate equivalent to levofloxacin-512.46 mg (500.00 mg).

Excipients: microcrystalline cellulose-44.69 mg; crospovidone-7.85 mg; sodium stearyl fumarate-1.41 mg; croscarmellose sodium-6.15 mg; colloidal silicon dioxide-15.38 mg; maltodextrin-24.60 mg; magnesium stearate-2.46 mg.

Shell: OPADRY Orange 20 A 230018 (OPADRY Orange 20 A 230018) – 15,000 mg [hydroxypropylmethylcellulose 2910/hypromellose 6 cP (E464) – 6,600 mg; titanium dioxide (E171) – 1,375 mg; talc – 3,150 mg; hyprolose (hydroxypropylcellulose, klucel EF) (E463) – 3,851 mg; dye sunset yellow (E 110) – 0.024 mg].

Pharmacological action

Pharmacodynamics

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones containing levofloxacin, the levorotatory isomer of ofloxacin, as the Active ingredient. It blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and crosslinking of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall, and membranes of sensitive microorganisms.

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

In in vitro

Sensitive microorganisms (MPC ≤ 2 mg / l; inhibition zone ≥ 17 mm)

Aerobic gram-positive microorganisms:

Corynebacterium diphtheriae, Corynebacterium striatum, Enterococcus spp., Enterococcus faecalis, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I) (coagulase-negative methicillin-sensitive/moderately sensitive strains, including methicillin-sensitive strains of Staphylococcus aureus methi-S (methicillin-sensitive), Staphylococcus epidermidis methi-S (methicillin-sensitive), Staphylococcus spp. CNS (coagulase-negative), Streptococci of groups C and G, Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus pneumonia peni I/S/R (penicillin-sensitive/moderately sensitive/resistant), penicillin-sensitive/resistant strains of Viridans streptococci peni-S/R).

Aerobic gram-negative microorganisms:

Acinetobacter spp. (including Acinetobacter baumanii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus spp. (including Haemophilus ducreyi, Haemophilus parainfluenzae, ampicillin-sensitive / resistant strains of Haemophilus influenza ampi-S/R), Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis β+/β-(beta-lactamase producing and non-producing strains), Morganella morganii, Neisseria meningitides, Neisseria gonorrhoeae non PPNG/PPNG (non-producing and penicillinase producing), 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 aeruginosa may require combined treatment), 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 (BMD = 4 mg/l; inhibition zone = 16-14 mm)

Aerobic gram-positive microorganisms:

Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant strains), Staphylococcus haemolyticus methi-R (methicillin-resistant strains).

Aerobic gram-negative microorganisms: Campylobacter jejuni / coli.

Anaerobic microorganisms: Prevotella spp., Porphyromonas spp.

Resistant microorganisms (MPC ≥ 8 mg/l; inhibition zone ≤ 13 mm)

Aerobic gram-positive microorganisms:

Staphylococcus spp. (coagulase-negative methicillin-resistant strains, including methicillin-resistant strains of Staphylococcus aureus).

Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.

Anaerobic microorganisms: Bacteroides thetaiotaomicron.

Other microorganisms: Mycobacterium avium.

Resistance

Resistance to levofloxacin develops as a result of a gradual process of mutations in the genes encoding both topoisomerases type II: DNA gyrase and toponzomerase 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.

Clinical efficacy (efficacy in clinical trials in the treatment of infections caused by the following microorganisms):

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 (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.

Others

Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

Pharmacokinetics

Absorption rate

After oral administration, levofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake has little effect on the rate and completeness of absorption. Absolute oral bioavailability is 99-100%. The maximum plasma concentration is reached after 1-2 hours and for a dose of levofloxacin 250 mg,500 mg and 750 mg is 2.8 mcg / ml,5.2 mcg / ml and 8.0 mcg / ml, respectively.

The pharmacokinetics of levofloxacin are linear in the range from 50 to 1000 mg. After taking a single, multiple dose, the amount of absorbed drug is directly proportional to the dose taken. Steady-state plasma concentrations of levofloxacin 500 mg 1-2 times a day are reached after 48 hours.

Distribution

The average volume of distribution of levofloxacin varies from 74 to 112 liters. Binding to plasma proteins is 30-40%. It penetrates well into organs and tissues: bronchial mucosa, epithelial lining fluid, alveolar macrophages (the concentration in lung tissues is 2-5 times higher than the concentration in plasma), lung tissue, bone tissue, genitourinary system organs, polymorphonuclear leukocytes.

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 administration, levofloxacin is relatively slowly eliminated from plasma (half-life 6-8 hours). It is excreted mainly by the kidneys through glomerular filtration and tubular secretion. Unchanged,70% of the oral dose is excreted by the kidneys within 24 hours and 87% – in 48 hours.4% of the oral dose is excreted by the intestines within 72 hours

. Pharmacokinetics in individual groups of patients

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

In patients with renal insufficiency, the pharmacokinetics of levofloxacin are altered. As renal function decreases, renal excretion and clearance decrease, and the elimination half-life increases.

The pharmacokinetics in elderly patients do not differ from those in young patients, with the exception of differences related to creatinine clearance.

Indications

Levofloxacin:– acute bacterial sinusitis;– exacerbation of chronic bronchitis;– community– acquired pneumonia;– uncomplicated urinary tract infections;– complicated urinary tract infections (including acute pyelonephritis);– chronic bacterial prostatitis;– skin and soft tissue infections (including suppurated atheromas, abscess, furunculosis);-tuberculosis (as part of complex therapy of drug-resistant forms). – prevention and treatment of anthrax in the airborne route of infection.

Use during pregnancy and lactation

Levofloxacin is contraindicated for use in pregnant women and women during breastfeeding.

Contraindications

– Hypersensitivity to levofloxacin, other fluoroquinolones or other components of the drug in the anamnesis;– epilepsy;– pseudoparalytic myasthenia gravis;– tendon damage associated with taking fluoroquinolones in the anamnesis;– children and adolescents under 18 years of age (due to incomplete growth of the skeleton, since the risk of damage to cartilage growth points cannot be completely excluded);– pregnancy (the risk of damage to cartilage points cannot be completely excluded). growth points in the fetus);– lactation period (the risk of damage to the cartilage points of bone growth in the child cannot be completely excluded). With caution– predisposition to convulsive reactions (in patients with previous lesions of the central nervous system (CNS), in patients simultaneously receiving drugs that reduce the threshold of convulsive readiness of the brain(fenbufen, theophylline));– latent, manifested glucose-6-phosphate dehydrogenase deficiency (increased risk of hemolytic reactions during treatment with quinolones);– impaired renal function (monitoring of renal function is required, as well as dosage adjustment, see “Dosage and administration”;– in patients with known risk factors for prolongation of the QT interval: in elderly patients (older than 65 years), in female patients, in patients with uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); with congenital prolongation of the QT interval; in patients with heart failure, myocardial infarction, bradycardia; while taking medications that prolong the QT interval (antiarrhythmic IA and III classes, tricyclic antidepressants, antipsychotics, macrolides);– in patients with diabetes mellitus receiving oral hypoglycemic drugs (increased risk of hypoglycemia);– 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.

Side effects

The following side effects are presented according to the following frequency gradations: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (

From the nervous system: often – headache, dizziness; infrequently – drowsiness, tremor, dysgeusia (taste distortion); rarely – paresthesia, convulsions (see section “Special instructions”); unspecified frequency – peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorders, loss of taste sensations, parosmia (odour sensation disorder, especially subjective odour sensation, objectively absent), including loss of smell, fainting, and benign intracranial hypertension.

Psychiatric disorders: often – insomnia; infrequently – feelings of anxiety, anxiety, confusion; rarely-mental disorders (for example, hallucinations, paranoia), depression, agitation, sleep disorders, nightmares; unspecified frequency – mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicide attempts.

From the side of the organ of vision: very rarely-visual disturbances, such as blurring of the visible image; unspecified frequency – transient loss of vision.

From the side of the organ of hearing and labyrinth disorders: infrequently-vertigo (feeling of deviation, whirling, own body, surrounding objects); rarely-ringing in the ears; unspecified frequency-hearing loss, hearing loss.

From the cardiovascular system: rarely-sinus tachycardia, palpitation, decreased blood pressure; unspecified frequency-prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the “pirouette” type, which can lead to cardiac arrest (see the sections “Overdose”, “Special instructions”).

From the blood and lymphatic system: infrequently – eosinophilia, leukopenia; rarely-neutropenia, thrombocytopenia; unspecified frequency-pancytopenia, agranulocytosis, hemolytic anemia.

From the gastrointestinal tract: often – nausea, vomiting, diarrhea; infrequently-abdominal pain, dyspepsia, flatulence, constipation; unspecified frequency-hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis (see the section “Special instructions”).

From the liver and biliary tract: often-increased alanine aminotransferase activity; infrequently-increased bilirubin levels; unspecified frequency-severe liver failure, including cases of acute acute liver failure, sometimes fatal, especially in patients with sepsis); hepatitis, jaundice. hepatitis.

Respiratory, thoracic and mediastinal disorders: infrequently-dyspnea; unspecified frequency-bronchospasm, allergic pneumonitis.

From the side of metabolism and nutrition: infrequently-anorexia; rarely-hypoglycemia (increased appetite, increased sweating, trembling, nervousness); unspecified frequency – hyperglycemia, hypoglycemic coma (see the section “Special instructions”).

Musculoskeletal and connective tissue disorders: infrequently-arthralgia, myalgia; rarely-tendon damage (for example, Achilles tendon), including tendinitis, muscle weakness, which can be dangerous in patients with pseudoparalytic myasthenia gravis (see section “With caution”); unspecified frequency – rhabdomyolysis, tendon rupture (for example, Achilles tendon). This side effect may occur within 48 hours after starting treatment and may be bilateral in nature), ligament rupture, muscle rupture, arthritis (see the section “Special instructions”).

From the side of the kidneys and urinary tract: infrequently-hypercreatininemia; rarely-acute renal failure (for example, due to the development of interstitial nephritis)..

From the blood and lymphatic system: infrequently – eosinophilia, leukopenia; rarely-neutropenia, thrombocytopenia; unknown frequency-pancytopenia, agranulocytosis, hemolytic anemia.

From the skin and subcutaneous tissues: infrequently-rash, pruritus, urticaria, hyperhidrosis; unspecified frequency – malignant exudate erythema (Stevens-Jobs syndrome), toxic epidermal necrolysis (Lyell’s syndrome), photosensitization reaction, leukocytoclastic vasculitis, stomatitis, exudative erythema multiforme. Skin and mucosal reactions, anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.

Infectious and parasitic diseases: infrequently-fungal infections, development of resistance of pathogenic microorganisms.

From the immune system: rarely-angioedema; unspecified frequency – anaphylactic shock, anaphylactoid shock.

Common disorders: infrequently-asthenia; rarely-pyrexia (fever); unspecified frequency-pain (including pain in the back, chest and extremities).

Other possible adverse effects related to all fluoroquinolones: very rare – attacks of porphyria in patients with porphyria.

Interaction

Interactions that require caution

With preparations containing magnesium, aluminum, iron and zinc, didanosine

Preparations containing divalent or trivalent cations, such as zinc and iron salts (drugs for the treatment of anemia), magnesium and/or aluminum containing drugs (such as antacid), didanosine (only dosage forms containing aluminum or magnesium as a buffer), it is recommended to take at least 2 hours before or 2 hours after taking Levofloxacin repair.

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

With sucralfate

The effect of levofloxacin is significantly weakened with simultaneous use of sucralfate. Patients receiving levofloxacin and sucralfate are advised to take sucralfate 2 hours after taking levofloxacin.

With theophylline, fenbufen, similar drugs from the group of nonsteroidal anti-inflammatory drugs that reduce the threshold of convulsive brain activity.

There was no pharmacokinetic interaction between levofloxacin and theophylline. However, with simultaneous administration of quinolones and theophylline, nonsteroidal anti-inflammatory drugs and other drugs that reduce the threshold of convulsive readiness of the brain, a pronounced decrease in the threshold of convulsive readiness of the brain is possible. The concentration of levofloxacin with simultaneous administration of fenbufen increases only by 13%.

With indirect coagulants

Patients treated with levofloxacin in combination with indirect anticoagulants (for example, warfarin) experienced an increase in prothrombin time/normalized international 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.

With probenicid and cimetidine

Caution should be exercised when concomitantly using medications that interfere with the renal tubular secretion of levofloxacin, such as probenicide and cimetidine, especially in patients with renal insufficiency. Cimetidine and probenicide slow the elimination of levofloxacin by 24% and 34%, respectively. It is unlikely that this can be of clinical significance in normal renal function.

With cyclosporine

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.

With glucocorticosteroids

Concomitant use of glucocorticosteroids increases the risk of tendon rupture.

With medications that extend the QT interval

Levofloxacin, like other quinolones, should be used with caution in patients receiving drugs that prolong the QT interval (for example, Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics).

Other services

The results of clinical and pharmacological studies on the possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide, ranitidine, and warfarin were shown. That the pharmacokinetics of levofloxacin when used concomitantly with these drugs do not change sufficiently to be of clinical significance.

How to take, course of administration and dosage

Inside once or twice a day (every 24,12 hours). Tablets should be taken without chewing and washed down with a sufficient amount of water (from 0.5 to 1 cup).

The drug can be taken before meals, at any time between meals, as food intake does not affect the absorption of the drug.

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 tablets is 99-100%, if the patient is transferred from an intravenous infusion of levofloxacin to taking tablets, treatment should continue at the same dose that was used for intravenous infusion (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 the drug according to the recommended dosage regimen.

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.

In adult patients with normal, moderately reduced renal function (creatinine clearance greater than 50 ml / min), use in accordance with the schemes shown in the table:

Infection Dose, mg Frequency of administration per day Duration of treatment, days

Acute bacterial sinusitis 500 1 10-14

750 1 5

Exacerbation of chronic bronchitis 500 1 7

Community-acquired pneumonia 500 1-2 7-14

750 1 5*

Uncomplicated urinary tract infections 250 1 3

Complicated urinary tract infections 500 1 7-14

Complicated urinary tract infections including acute pyelonephritis 750 1 5**

Pyelonephritis 500 1 7-10

Chronic bacterial prostatitis 500 1 28

Uncomplicated skin and subcutaneous tissue infections 500 1 7-10

Complicated skin and subcutaneous tissue infections 750 1 7-14

Tuberculosis (as part of complex therapy of drug-resistant forms) from 1-2 to 3 months

Prevention and treatment of anthrax in the airborne route of infection from 1 to 8 weeks

* This regimen is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae.

* * This regimen is indicated for the treatment of urinary tract infections caused by Enterococcus faecalis, Klebsiella pneumoniae, Proteus mirabilis and acute pyelonephritis caused by Escherichia coli, including cases with concomitant bacteremia.

Dose adjustment of levofloxacin in adult patients with impaired renal function (creatinine clearance less than 50 ml / min).

Dose for normal renal function every 24 hours Creatinine clearance from

20 to 49 ml / min Creatinine clearance from 10 to 19 ml / min Creatinine

clearance less than 10 ml / min (including hemodialysis, permanent outpatient peritoneal dialysis)

750 mg 750 mg every 48 h Starting dose of 750 mg and then 500 mg every 48 h Starting dose of 750 mg and then 500 mg every 48 hours

500 mg Initial dose of 500 mg, then 250 mg every 24 hours Initial dose of 500 mg, then 250 mg every 48 h Starting dose of 500 mg, then 250 mg every 48 h

250 mg dose Adjustment is not required 250 mg every 48 hours. No dose adjustment is required for uncomplicated urinary tract infections No information on dose adjustment is available

After hemodialysis, continuous outpatient peritoneal dialysis does not require additional doses.

In case of impaired liver function, no dose adjustment is required, since the volume of levofloxacin metabolism in the liver is limited.

For elderly patients, no dosage adjustment is required, except in cases of reduced creatinine clearance to 50 ml / min or lower.

Overdose

Symptoms: impaired consciousness, including confusion, dizziness, convulsions, possible nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, prolongation of the QT interval, hallucinations, tremor.

In case of overdose, careful monitoring of the patient is required, including ECG monitoring.

Treatment: symptomatic. In case of acute overdose, gastric lavage and administration of antacids to protect the gastric mucosa are indicated. There is no specific antidote, and dialysis is ineffective.

Description

Tablets covered with a film-coated pinkish-orange color, oval biconvex. On the cross-section from white to light yellow.

Special instructions

Hospital-acquired Pseudomonas aeruginosa infections may require combination therapy.

The prevalence of acquired resistance of absorbed 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 streptococcus aureus

There is a high probability that methicillin-resistant streptococcus 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 streptococcus aureus, if laboratory tests have not confirmed the sensitivity of this microorganism to levofloxacin.

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 CNS disorders, such as stroke, severe traumatic brain injury; patients receiving concomitant medications that lower the threshold for convulsive readiness of the brain, such as fenbufen and other similar nonsteroidal anti-inflammatory drugs or other drugs that lower the threshold for convulsive readiness, such as theophylline (see the section “Interaction with other drugs”).

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 diffieile. If pseudomembranous coli is suspected, treatment with levofloxacin should be stopped immediately and special antibiotic therapy (vancomycin, teicoplanin, or oral metronidazole) should be initiated immediately. Drugs that inhibit intestinal perestalsis are contraindicated.

Tendinitis

Rarely observed tendinitis with quinolones, including levofloxacin, can lead to tendon rupture, including the Achilles tendon. This side effect may develop within 48 hours of starting treatment and may be bilateral. Elderly patients are more likely to develop tendinitis. The risk of tendon rupture may increase with concomitant use of corticosteroids. If tendinitis is suspected, treatment with Levofloxacin should be stopped immediately and appropriate treatment of the affected tendon should be initiated, for example, 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 4.4).section “Side effects”). Patients should be warned to stop treatment and seek immediate medical attention if signs and symptoms of liver damage occur, such as anorexia, jaundice, dark urine, itching, and abdominal pain.

Patients with renal insufficiency

Since levofloxacin is mainly excreted by the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as correction of the dosage regimen (see the section “Method of administration and doses”). When treating elderly patients, it should be borne in mind that patients in this group often suffer from impaired renal function.

Preventing the development of photosensitization reactionsc

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

Superinfection

Like the use of other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased reproduction of microorganisms that are not sensitive to it (bacteria and fungi), which can cause changes in the microflora that is normally present in humans, which can lead to the development of superinfection. Therefore, during treatment, it is necessary to re-evaluate the patient’s condition 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 treated with 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 antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.

Elderly and female patients may be more sensitive to drugs that prolong the QT interval. Therefore, fluoroquinolones, including levofloxacin, should be used with caution (see sections “With caution”, “Dosage and administration”, “Side effects”, “Overdose”, “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 hemolytic reactions when treated with quinolones, which should be taken into account when treated with levofloxacin.

Hypo – and hyperglycemia (dysglycemia)

As with other quinolones, cases of hypo – and hyperglycemia have been reported with lefloxacin, usually in diabetic patients receiving concomitant treatment with oral hypoglycemic drugs (e. g., glibenclamide) or insulin preparations. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, careful monitoring of blood glucose concentration is required. (see the section “Side effects”).

Peripheral neuropathy

Patients receiving fluoroquinolones, including levofloxacin, have experienced sensory and sensorimotor peripheral neuropathy, which may start quickly. If the patient develops symptoms of neuropathy, levofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.

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 anthracis to 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 have been reported with the use of quinolones, including levofloxacin, which in very rare cases progressed to the development of suicidal thoughts and behavioral disorders with self-harm (sometimes after taking a single dose of levofloxacin (see section “Side effects”)). 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.

Visual impairment

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

Caution should be exercised when driving vehicles and engaging in other potentially dangerous activities, as some of the side effects of levofloxacin, such as dizziness, drowsiness and visual disturbances, may adversely affect the ability to drive vehicles and perform potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form of production

Film-coated tablets.

Storage conditions

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

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

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

Infections Weight

Weight: 100 gr.