Levofloxacin pills 500 mg, 10 pcs.

Composition

One film-coated tablet contains:

Active ingredient:

levofloxacin hemihydrate 512.46 mg in terms of levofloxacin 500.0 mg.

Excipients (core):

microcrystalline cellulose (type 101) 38.54 mg,

low-substituted hyprolose 10.0 mg,

sodium carboxymethyl starch 16.0 mg,

povidone K-30 12.0 mg,

croscarmellose sodium 6.0 mg,

colloidal silicon dioxide 8.0 mg,

talc 4.0 mg/ 8.0 mg / 20.0 mg,

magnesium stearate 4.0 mg.

Excipients of the finished water-soluble shell / tablet shell: hypromellose-E 6 4,028 m, talc 1.040 mg, titanium dioxide 2,900 mg, iron oxide yellow dye 0.016 mg, iron oxide red dye 0.016 mg

. Pharmacological action

Pharmacotherapy group

Antimicrobial agent-fluoroquinolone

ATX code

J01MA

Pharmacodynamics:

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

Levofloxacin blocks DNA gyrase and topoisomerase IV disrupts supercoiling and crosslinking of DNA breaks inhibits DNA synthesis causes deep morphological changes in the cytoplasm cell wall and membranes of microbial cells. Levofloxacin is active against most strains of microorganisms both under invitro and invivo conditions.

Invitro

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

– Aerobic gram-positive microorganisms: BacillusanthracisCorynebacteriumdiphtheriaeCorynebacteriumjeikeiumEnterococcusfaecalisEnterococcusspp. ListeriamonocytogenesStaphylococcuscoagulase-negativemethi-S (I) [coagulase-negative methicillin-sensitive/ – moderately sensitive)] Staphylococcus Aureusmethi-S (methicillin-sensitive) Staphylococcus Epidermidismethi-S (methicillin-sensitive) Staphylococcusspp. CNS (coagulase-negative) Streptococcispp. C and GStreptococcusagalactiaeStreptococcuspneumoniapeniI/S/R (penicillin-moderately sensitive/-sensitive/ – resistant) StreptococcuspyogenesViridansstreptococcipeni-S/R (penicillin-sensitive/-resistant).

– Aerobic gram-negative microorganisms: AcinetobacterbaumanniiAcinetobacterspp. ActinobacillusactinomycetemcomitansCitrobacterfreundiiEikenellacorrodensEnterobacteraerogenesEnterobactercloacaeEnterobacterspp. EscherichiacoliGardnerellavaginalisHaemophilusducreyiHaemophilusinfluenzaeampi-S/R (ampicillin-sensitive/-resistant) HaemophilusparainfluenzaeHelicobacterpyloriKlebsiellaoxytocaKlebsiellapneumoniae. Klebsiellaspp. Moraxellacatarrhalis /?+//? – (producing and non-producing beta-lactamases) MorganellamorganiiNeisseriagonorrhoeaenonPPNG/PPNG (non-producing and penicillinase producing) NeisseriameningitidisPasteurellacanisPasteurelladagmatisPasteurellamultocidaPasteurellasppProteusmirabilisProteusvulgarisProvidenciarettgeriProvidenciastuartiiProvidenciaspp. Pseudomonasaeruginosa (hospital-acquired infections caused by Pseudomonasaeruginosa may require combined treatment) Pseudomonasspp. Salmonellaspp. SerratiamarcescensSerratiaspp.

– Anaerobic microorganisms: BacteroidesfragilisBifidobacteriumspp. ClostridiumperfringensFusobacteriumspp. PeptostreptococcusPropionibacteriumspp. Veillonellaspp.

– Other microorganisms: Bartonellaspp. ChlamydiapneumoniaeChlamydiapsittaciChlamydiatrachomatisLegionellapneumophilaLegionellaspp. Mycobacteriumspp. MycobacteriumlepraeMycobacteriumtuberculosisMycoplasmahominisMycoplasmapneumoniaeRickettsiaspp. Ureaplasmaurealyticum.

Moderately sensitive microorganisms (BMD = 4 mg / l; inhibition zone 16-14 mm)

– Aerobic gram-positive microorganisms: Corynebacteriumurealyticum CorynebacteriumxerosisEnterococcusfaeciumStaphylococcusepidermidismethi-R(methicillin-resistant) Staphylococcus Hemolyticusmethi-R (methicillin-resistant).

– Aerobic gram-negative microorganisms: Campylobacterjejuni / coli

-Anaerobic microorganisms: Prevotellaspp. Porphyromonasspp.

Levofloxacin-resistant microorganisms (MPC ≥ 8 mg / l: inhibition zone ≤ 13 mm):

– Aerobic gram-positive microorganisms: Staphylococcus Aureusmethi-R

(methicillin-resistant) Staphylococcus Coagulase-negativemethi-R (coagulase-negative methicillin-resistant).

– 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 topoisomerase IV.

Other mechanisms of resistance, such as the mechanism of influence on microbial cell penetration barriers (a mechanism characteristic of Pseudomonas Aeruginosa) and the mechanism of efflux (active removal of the 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: EnterococcusfaecalisStaphylococcusaureusStreptococcuspneumoniaeStreptococcuspyogenes.

– Aerobic gram-negative microorganisms: CitrobacterfreundiiEnterobactercloacaeEscherichiacoliHaemophilusinfluenzaeHaemophilusparainfluenzaeKlebsiellapneumoniaeMoraxella (Branhamella) catarrhalisMorganellamorganiiProteusmirabilisPseudomonasaeruginosaSerratiamarcescens.

– Others: Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae.

Pharmacokinetics:

Absorption rate

Levofloxacin is rapidly and almost completely absorbed after ingestion. 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 52 ± 12 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 administration of 500 mg of levofloxacin once a day, the cmax of levofloxacin was 57 ± 14 mcg / ml and the minimum concentration of levofloxacin (concentration before taking the next dose) in blood plasma (Cmin) was 05 ± 02 mcg/ml.

On day 10 of oral administration of 500 mg of levofloxacin 2 times a day, the cmax of levofloxacin was 78 ± 11 mcg / ml and the Cmin was 30 ± 09 mcg/ml.

Distribution

The relationship with serum proteins is 30-40%. After a single and repeated administration of 500 mg of levofloxacin, the volume of distribution of levofloxacin averages 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 83 mcg/g and 108 mcg / ml, respectively, with penetration coefficients into the bronchial mucosa and epithelial lining fluid compared to plasma concentrations of 11-18 and 08-3, respectively. After 5 days of oral administration 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 994 mcg/ml and in alveolar macrophages-979 mcg/ml.

Penetration of lung tissue

Maximum concentrations in the lung tissue after oral administration of 500 mg of levofloxacin were approximately 113 mcg/g and reached 4-6 hours after taking the drug with penetration coefficients 2-5 compared to 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 40 and 67 micrograms / ml, respectively, with a penetration coefficient of 1 compared to 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 01-3. The maximum concentrations of levofloxacin in the spongy bone tissue of the proximal femur after oral administration of 500 mg of the drug were approximately 151 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 administration of 500 mg of levofloxacin once a day for 3 days, the average concentration of levofloxacin in prostate tissue was 87 mcg/g. The average ratio of prostate / blood plasma concentrations was 184.

Concentrations in the urine

Mean urinary concentrations 8-12 hours after oral doses of 150 mg,300 mg, 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 administration, 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 ± 292 ml/min.

There are no significant differences in the pharmacokinetics of levofloxacin when administered intravenously and when taken orally, which confirms that oral administration and intravenous administration 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 decreases, renal excretion and renal clearance (C1R) decrease and T 1/2 increases.

Pharmacokinetics in patients with renal insufficiency after a single oral dose of 500 mg levofloxacin.

Indications

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

– acute sinusitis;

– exacerbation of chronic bronchitis;

– community-acquired pneumonia;

– uncomplicated cystitis *;

– complicated urinary tract infections including pyelonephritis;

chronic bacterial prostatitis;

infections of skin and soft tissues;

for a comprehensive treatment of drug-resistant forms of tuberculosis;

– prevention and treatment of anthrax when airborne path of infection.

Use during pregnancy and lactation

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

Contraindications

– Hypersensitivity to levofloxacin or other hinolona as well as to any of the excipients of the drug Levofloxacin;

– Epilepsy;

– Psevdoparalitichesky myasthenia gravis (myasthenia gravis) (see “Side effects” “Special instructions”);

– lesions of the tendons when receiving fluoroquinolones in history;

– Children’s and teenage age up to 18 years (due to the incomplete growth of the skeleton as it is impossible to completely eliminate the risk of cartilage growth points);

– Pregnancy (it is impossible to completely eliminate the risk of destruction of the cartilage growth points in the fetus);

– The period of breastfeeding (it is impossible to completely eliminate the risk of destruction of the cartilage of the points of growth of bones in children).

With caution:

-In patients predisposed to the development of seizures [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, 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 administration”).

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

-In patients with diabetes mellitus receiving oral hypoglycemic agents such as 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 and with concomitant use of glucocorticosteroids (increased risk of tendinitis and tendon rupture) (see the section “Special instructions”).

Side effects

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

Data obtained in clinical trials and post-marketing use of the drug

Cardiac disorders

Rarely: sinus tachycardia palpitation of the heart.

Frequency unknown (post-marketing data): prolongation of the QT interval ventricular arrhythmias ventricular tachycardia ventricular tachycardia of the “pirouette” type that can lead to cardiac arrest (see the sections “Overdose” and “Special instructions”).

Disorders of the blood and lymphatic system

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

Rare: neutropenia (decrease in the number of neutrophils in the peripheral blood) thrombocytopenia (decrease in the number of platelets in the peripheral blood).

Frequency unknown (post-marketing data): pancytopenia (decrease in the number of all shaped elements in the peripheral blood) agranulocytosis (absence or sharp decrease in the number of granulocytes in the peripheral blood) hemolytic anemia.

Vascular disorders

Rarely: reducing blood pressure.

Nervous system disorders

are Common: headache dizziness.

Infrequently: drowsiness tremor dysgeusia (perversion of taste).

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

Frequency unknown (post-marketing data): 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 sense of smell objectively absent) including loss of smell syncope benign intracranial hypertension.

Visual disturbances

Rare: visual disturbances such as blurring of the visible image.

Frequency unknown (post-marketing data): temporary loss of vision uveitis.

Hearing disorders and labyrinth disorders

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

Rare: ringing in the ears.

Frequency unknown (post-marketing data): hearing loss hearing loss.

Respiratory, thoracic and mediastinal disorders

Infrequently: shortness of breath.

Frequency unknown (post-marketing data): bronchospasm allergic pneumonitis.

Disorders of the gastrointestinal tract

Often: diarrhea vomiting nausea.

Infrequently: abdominal pain dyspepsia flatulence constipation.

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

Kidney and urinary tract disorders

Infrequently: increased serum creatinine.

Rare: acute renal failure (e. g. due to interstitial nephritis).

Skin and subcutaneous tissue disorders

Infrequently: rash pruritus urticaria hyperhidrosis.

Frequency unknown (post-marketing data): toxic epidermal necrolysis Stevens-Johnson syndrome exudative erythema multiforme photosensitization reactions (hypersensitivity to sunlight and ultraviolet radiation) (see 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

Rare: Tendon involvement including tendinitis (e. g. Achilles tendon) muscle weakness that can be particularly dangerous in patients with pseudoparalytic myasthenia gravis (see section “Special instructions”).

Frequency unknown (post-marketing data): rhabdomyolysis is a torn tendon (for example, the Achilles tendon. This side effect may occur within 48 hours after starting treatment and may be two-sided (see also the section “Special instructions”)) torn ligaments torn muscles arthritis.

Metabolic and nutritional disorders

Infrequently: anorexia nervosa.

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

Frequency unknown: hyperglycemia severe hypoglycemia up to the development of 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.

Common disorders

Infrequently: asthenia.

Rare: pyrexia (fever).

Frequency unknown: pain (including back chest and limb pain).

Immune system disorders

Rare: angioedema.

Frequency unknown (post-marketing data): anaphylactic shock anaphylactoid shock.

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

Liver and biliary tract disorders

are common: increased activity of” liver ” enzymes in the blood (for example, alanine aminotransferase (ALT) aspartate aminotransferase (ACT)) increased activity of alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT).

Infrequently: increased bilirubin concentration in the blood.

Frequency unknown (post-marketing data): severe hepatic insufficiency including cases of acute hepatic insufficiency, sometimes fatal, especially in patients with a severe underlying disease (for example, patients with sepsis) (see section “Special instructions”); hepatitis jaundice.

Mental disorders

Often: insomnia.

Infrequently: feeling restless, anxious, confused.

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

Frequency unknown (post-marketing data): mental disorders with self-harm behavioral disorders including suicidal thoughts and suicidal attempts attention disorders disorientation nervousness memory disorders delirium.

Other possible undesirable effects related to all fluoroquinolones

Very rare: attacks of porphyria (a very rare metabolic disease) 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 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) are recommended to be taken at least 2 hours before or 2 hours after taking Levofloxacin tablets.

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

With sucralfate

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.

No pharmacokinetic interaction of levofloxacin with theophylline was detected with theophylline fenbufen or similar drugs from the group of nonsteroidal anti-inflammatory drugs that reduce the threshold of convulsive readiness of the brain

. However, with the simultaneous use 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 anticoagulants (vitamin K antagonists)

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.

With probenecid and cimetidine

Caution should be exercised when concomitantly using drugs 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.

With cyclosporine

Levofloxacin increased the T 1/2 of cyclosporine by 33%. Since this increase is clinically insignificant, there is no need to adjust the dose of cyclosporine 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 fluoroquinolones, 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

Clinical and pharmacological studies conducted to study possible pharmacokinetic interactions of levofloxacin with digoxin glibenclamide ranitidine and warfarin showed that the pharmacokinetics of levofloxacin when used simultaneously with these drugs do not change sufficiently to make it clinically relevant.

How to take, course of administration and dosage

Levofloxacin tablets 250 mg 500 mg or 750 mg are taken orally 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). If necessary, tablets can be broken at risk. 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 drugs”).

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 missed taking the drug, you should take the next dose as soon as possible and then continue taking Levofloxacin 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 250 mg or 1 tablet of Levofloxacin 500 mg once a day (respectively, a daily dose of 500 mg of levofloxacin) – 10-14 days; 1 tablet of Levofloxacin 750 mg once a day (a daily dose of 750 mg of levofloxacin) – 5 days;

– Exacerbation of chronic bronchitis: 2 tablets of Levofloxacin 250 mg or 1 tablet of Levofloxacin 500 mg once a day (respectively, the daily dose of 500 mg of levofloxacin) – 7-10 days;

– Community-acquired pneumonia: 2 tablets of Levofloxacin 250 mg or 1 tablet of Levofloxacin 500 mg 1-2 times a day (respectively, a daily dose of 500-1000 mg of levofloxacin) for 7-14 days; 1 tablet of Levofloxacin 750 mg 1 time a day (a daily dose of 750 mg of levofloxacin) – 5 days (Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-moderately sensitive/-sensitive/-resistant) HaemophilusinfluenzaHaemophilusparainfluenzaeMycoplasmapneumoniaeChlamydiapneumoniae);

– Hospital pneumonia: 1 tablet of Levofloxacin 750 mg once a day (daily dose of 750 mg levofloxacin) – 7-14 days;

– Uncomplicated cystitis: 1 tablet of Levofloxacin 250 mg once a day (daily dose of 250 mg levofloxacin) – 3 days;

– Complicated urinary tract infections: 2 tablets of preparationlocal 250 mg 1 time per day or 1 tablet of Levofloxacin 500 mg 1 time per day (respectively, the daily dose of 500 mg of levofloxacin) – 7-14 days; 1 tablet of Levofloxacin 750 mg 1 time a daCases of liver necrosis, including fatal liver failure, have been reported with levofloxacin, mainly in patients with severe underlying diseases 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 such as anorexia jaundice dark urine pruritus and abdominal pain occur.

Patients with impaired renal function

Since levofloxacin is mainly excreted through the kidneys in patients with impaired renal function, it is necessary to monitor renal function and adjust the dosage regimen (see the section “Dosage and administration”). 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 administration”).

Prevention of photosensitization reactions

Although photosensitization with levofloxacin develops very rarely, 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) what 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.

When using fluoroquinolones including levofloxacin, caution should be exercised in patients with known risk factors for QT prolongation: in patients with uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); with congenital QT prolongation syndrome; with heart diseases (heart failure, myocardial infarction, bradycardia); with concomitant use of medications that can prolong the QT interval such as Class IA and III antiarrhythmic drugs tricyclic drugs antidepressants macrolides neuroleptics.

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” 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, hyperglycemia and hypoglycemia have been reported with levofloxacin. During levofloxacin therapy, dysglycemia was more likely to occur in elderly patients and patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, glibenclamide) or insulin. When using levofloxacin in such patients, the risk of hypoglycemia increases up to hypoglycemic coma. It is necessary to inform patients about the symptoms of hypoglycemia (confusion dizziness “wolfish” appetite headache nervousness palpitation or rapid pulse paleness of the skin perspiration trembling weakness). If the patient develops hypoglycemia, levofloxacin treatment should be discontinued immediately and appropriate therapy should be initiated. In these cases, it is recommended to switch to therapy with another antibiotic other than fluoroquinolones, if possible. When treating elderly patients with levofloxacin, careful monitoring of blood glucose levels is recommended in patients with diabetes mellitus.

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.

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 requiring 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 anthrax is obtained in invitro 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 any side effects from the central nervous system develop, including mental disorders, levofloxacin treatment should be stopped immediately and appropriate therapy should be prescribed. In these cases, it is recommended to switch to therapy with another antibiotic other than fluoroquinolones, if possible. Caution should be exercised when prescribing the drug to patients with psychosis or a history of mental illness.

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 may inhibit growth Mycobacteriumtuberculosis and lead in the future to false negative results of the bacteriological diagnosis of tuberculosis.

Influence on the ability to drive vehicles and mechanisms:

Such side effects of Levofloxacin as dizziness or vertigo drowsiness and visual disturbances (see section “Side effects”) may reduce psychomotor reactions and the ability to concentrate. This can pose a certain risk in situations where these abilities are of particular importance (for example, when driving a car, when servicing machines and mechanisms, when performing work in an unstable position).

Storage conditions

Store in a dark place at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 13 gr.