Active substanceLevofloxacinLevofloxacin
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet contains:

    active substance Levofloxacin (levofloxacin hemihydrate) 500.00 (512.46) mg;

    Excipients: silicon dioxide colloid 12.00 mg, giprolose 28.00 mg, sodium carboxymethyl starch, type A 55.00 mg, talc 55.20 mg, croscarmellose sodium 20.60 mg, magnesium stearate 6.74 mg,

    sheath: Opadrai 15В26688 brown (hypromellose 2910 3 CP 4,760 mg, hypromellose 2910 6 CP 4.760 mg, titanium dioxide E171 3,044 mg, macrogol-400 1,120 mg, ionisorbate-80 0.140 mg, ferric iron oxide yellow 13172 0.120 mg, iron dye oxide red E172 0.043 mg, dye iron oxide black E172 0.013 mg).

    Description:

    Pale pink with a yellowish hue capsule-shaped tablets covered with a film sheath, with a risk on both sides of the tablet, with an engraving "LX" and "500" on one side of the tablet.

    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    J.01.M.A   Fluoroquinolones

    J.01.M.A.12   Levofloxacin

    Pharmacodynamics:

    Levofloxacin is an optically active levorotatory isofloxacin - L- ofloxacin (S- (-) - enantiomer). Has a wide spectrum of antimicrobial activity. It blocks bacterial topoisomerase IV and DNA gyrase (topoisomerase I). It disrupts supercoiling and cross-linking of DNA breaks, causes profound morphological changes in the cytoplasm, cell wall and membranes of microbial cells.In concentrations equivalent to or exceeding the minimum inhibitory concentrations (MICs), bactericidal effects are most common. Levofloxacin active against most strains of microorganisms, as in conditions in vitro, and in vivo.

    Sensitive microorganisms (MIC <2 mg / L, inhibition zone> 17 mm)

    Aerobic Gram-positive microorganisms: - Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus faecalis, Enterococcus spp.. Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I) (coagulase-negative) methicillin-sensitive / moderately sensitive strains), including Staphylococcus aureus methi-S (methicillin-sensitive strains), Staphylococcus epidermidis methi-S (methicillin-sensitive strains), Staphylococcus spp. CNS (coagulase-negative), Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I/S/R (penicillin-sensitive / moderately sensitive / resistant strains), Streptococcus pyogenes, Viridans streptococci peni- S/R (penicillin-sensitive / resistant strains);

    Aerobic Gram-negative microorganisms - Acinetobacter spp., including Acinetobacter baumannii, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp., including Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi- S/R (ampicillin-sensitive / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp., including Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis (producing and non-producing beta-lactamase strains), Morganella morganii, Neisseria gonorrhoeae non PPNG/BPNG (penicillinase-producing and non-producing penicillinase strains), Neisseria meningitidis, Pasteurella spp., including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida, Proteus vulgaris, Proteus mirabilis, 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 leprae, Mycobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

    Moderately sensitive microorganisms (MIC more than 4 mg / l, inhibition zone 16-14 mm)

    Aerobic Gram-positive microorganisms: Corynebacterium urealylicum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant strains), Staphylococcus haemolyticus methi-R (methicillin-resistant strains);

    Aerobic Gram-negative microorganisms: Campylobacter jejuni, Campylobacter coli;

    Anaerobic microorganisms: Prevotella spp., Porphyromonas spp.

    Resistant microorganisms (MIC of more than 8 mg / L, inhibition zone <13 mm)

    Aerobic Gram-positive microorganisms: Staphylococcus aureus methi-R (methicillin-resistant strains), Staphylococcus coagulase-negative methi-R (coagulase-negative methicillin-resistant strains);

    Aerobic Gram-negative microorganisms: Alcaligenes xylosoxidans;

    Anaerobic microorganisms: Bacteroides thetaiotaomicron;

    Other microorganisms: Mycobacterium avium.

    Resistance

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

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

    Pharmacokinetics:

    Suction. Ingestion levofloxacin quickly and almost completely absorbed from the gastrointestinal tract (GIT). With a single dose of 500 mg, the maximum concentration (CmOh) in blood plasma is achieved after 1-2 hours. Absolute bioavailability of 99-100%. Eating slightly affects the speed and completeness of absorption. The equilibrium state of the concentration of levofloxacin in the blood plasma with the intake of 500 mg of levofloxacin I or 2 times a day is reached within 48 hours.

    Distribution. The connection with plasma proteins is 30-40%. The volume of distribution of levofloxacin is approximately 100 liters, which indicates a good penetration of levofloxacin into the organs and tissues of the human body: lungs, bronchial mucosa, sputum, urinary system, genital organs, bone tissue, prostate gland, polymorphonuclear leukocytes, alveolar macrophages, in small quantities penetrates into the cerebrospinal fluid. When ingestion of 500 mg twice a day, there is a slight accumulation of the drug in the body.

    Metabolism. In the liver, a small portion of levofloxacin is metabolized to form demethyllevofloxacin and Nlevofloxacin oxide. The molecule of levofloxacin is stereochemically stable and is not susceptible to chiral inversion. Excretion. After taking a single dose of 500 mg half-life (T1/2) is 6-8 hours. It is mainly excreted by the kidneys through glomerular filtration and tubular secretion. More than 85% of the dose is excreted by the kidneys unchanged. Less than 5% of the dose is secreted by the kidneys in the form of metabolites.

    Pharmacokinetics in special clinical cases

    The pharmacokinetics of levofloxacin in males and females differ.

    Pharmacokinetics in elderly patients does not differ from that in young patients, except for differences in pharmacokinetics associated with differences in creatinine clearance (CC).

    With renal failure, the pharmacokinetics of levofloxacin varies. As the kidney function decreases, excretion through the kidneys and kidney clearance (Clr) decrease, and T1/2 increases.

    Pharmacokinetics in renal failure after a single oral intake of 500 mg of levofloxacin is presented in Table 1.

    Table number 1

    CK (ml / min)

    <20

    20-49

    50-80

    Clr (ML / MIN)

    13

    26

    57

    T 1/ 2 (h)

    35

    27

    9

    Indications:

    Infectious-inflammatory diseases caused by susceptible to levofloxacin microorganisms:

    - acute bacterial sinusitis;

    - exacerbation of chronic bronchitis;

    - community acquired pneumonia;

    - uncomplicated urinary tract infections;

    - complicated urinary tract infections (including pyelonephritis);

    - chronic bacterial prostatitis;

    - infections of the skin and soft tissues;

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

    - prevention and treatment of anthrax during airborne infection.


    Contraindications:

    Hypersensitivity to levofloxacin, other quinolones or other components of the drug; epilepsy, including in the anamnesis; pseudo-paralytic myasthenia gravis (myasthenia gravis)-, affections of tendons associated with taking fluoroquinolones, in history; children and adolescents under 18; pregnancy; the period of breastfeeding.

    Carefully:

    In patients with a predisposition to developing seizures (in patients with previous lesions of the central nervous system, in patients receiving concurrent medications, lowering the threshold of seizure readiness of the brain, such as fenbufen, theophylline);

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

    In patients with impaired renal function:

    In patients with known risk factors for lengthening the interval QT: in elderly patients, in female patients, in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia), with the syndrome of congenital lengthening of the interval QT, with heart diseases (heart failure, myocardial infarction, bradycardia), while taking medications that can lengthen the interval QT (antiarrhythmic agents IA and III classes, tricyclic antidepressants, macrolides, neuroleptics);

    In patients with diabetes mellitus; in patients with severe adverse reactions to other fluoroquinolones, such as severe neurologic reactions (increased risk of similar adverse reactions with levofloxacin;

    In patients with psychoses or in patients who have a history of mental illness.

    Pregnancy and lactation:

    Levofloxacin is contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    Inside 1-2 times a day. The dose and duration of treatment are determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility. Tablets should be taken without chewing and drinking with a sufficient amount of liquid (from ½ before the glass). If necessary, the tablet can be broken down by risk. The drug can be taken before a meal or at any time between meals.

    Treatment with the drug Levofloxacin-Teva is recommended to continue for at least 48-72 hours after the normalization of body temperature or after a reliable eradication of the pathogen.

    Given that the bioavailability of levofloxacin when taking levofloxacin-Teva in tablets is 99-100%, in the case of transferring the patient from an intravenous infusion of Levofloxacin-Teva to the tablets, the treatment should be continued at the same dose that was used for intravenous infusion.

    Acute bacterial sinusitis: 1 tablet (500 mg) once a day for 10-14 days.

    Exacerbation of chronic bronchitis: 1 tablet (500 mg) once a day for 7-10 days.

    Community-acquired pneumonia: 1 tablet (500 mg) 1-2 times a day for 7-14 days.

    Complex treatment of drug-resistant forms of tuberculosis: 1 tablet (500 mg) 1-2 times a day - up to 3 months.

    Uncomplicated urinary tract infections: by ½ tablet (250 mg) once a day for 3 days.

    Complicated urinary tract infections: 1 tablet (500 mg) once a day for 7-14 days. Pyelonephritis: 1 tablet (500 mg) once a day for 7-10 days. The drug can be taken before meals or at any time between meals, as eating does not affect the absorption of the drug.

    Chronic bacterial prostatitis: but 1 tablet (500 mg) once a day for 28 days.

    Infections of rut and soft tissues: 1 tablet (500 mg) 1-2 times a day for 7-14 days.

    Prevention and treatment of anthrax during airborne infection: 1 tablet (500 mg) once a day for 8 weeks.

    Patients with impaired hepatic function correction of the dosing regimen is not required.

    Patients with impaired renal function (KK less than 50 ml / min) correction of the dosage regimen is required depending on the QC value.

    The first dose

    KK 20-49 ml / min

    KK 10-19 ml / min

    KK less than 10 ml / min

    (including hemodialysis and peritoneal dialysis)

    500 mg

    250 mg

    250 mg

    250 mg

    every 12 hours

    every 12 hours

    every 24 hours

    every 48 hours

    500 mg

    250 mg

    250 mg

    250 mg

    every 24 hours

    every 24 hours

    every 48 hours

    every 48 hours

    250 mg

    250 mg

    250 mg

    250 mg

    every 24 hours

    every 24 hours

    every 48 hours

    every 48 hours

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

    To patients of advanced age correction of the dosing regimen is not required.

    Side effects:

    Side effects are classified according to the following frequency: very often: ≥ 1/10; often: ≥ 1/100, but <1/10; infrequently: ≥ 1/1000,but <1/100; rarely: ≥ 1/10000, but <1/1000; very rarely: <1/10000; unknown frequency (can not be estimated based on available data).

    Infectious and parasitic diseases: infrequently - fungal infections, the growth of resistant pathogenic microorganisms.

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

    From the side of metabolism: infrequently - anorexia; rarely - hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling); frequency unknown - hyperglycemia, hypoglycemic coma.

    From the nervous system: often - dizziness, headache; infrequently - drowsiness, tremor, dysgeusia (perversion of taste); rarely - paresthesia, convulsions; frequency is unknown - sensory peripheral neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorders, agevia (loss of taste sensations), parosmia (odor disorder, especially subjective sense of smell, objectively absent), including loss of smell; fainting, benign intracranial hypertension.

    Disorders of the psyche: often - insomnia, infrequently - a feeling of anxiety, anxiety, confusion of consciousness; rarely - mental disorders (eg, hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares; frequency is unknown - mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicidal attempts.

    From the side of the organ of vision: very rarely - visual impairment, such as the vagueness of the visible image; frequency unknown - transient loss of vision, uveitis.

    From the side of the hearing organ and labyrinthine disorders: infrequently - vertigo; rarely - ringing in the ears; frequency unknown - hearing loss, hearing loss.

    On the part of the respiratory system, the organs of the thoracic label and the mediastinum: infrequently - dyspnea: frequency unknown - bronchospasm, allergic pneumonitis.

    From the cardiovascular system: rarely - sinus tachycardia, lowering blood pressure, feeling palpitations; frequency unknown - interval elongation QT, ventricular arrhythmias, ventricular tachycardia, ventricular pirouette tachycardia, which can lead to cardiac arrest.

    From the digestive system: often - nausea, vomiting, diarrhea; infrequently - abdominal pain, indigestion, flatulence, constipation; the frequency is unknown - hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis, pancreatitis.

    Disorders from the liver and bile ducts: often - increased activity of "hepatic" enzymes in the blood (for example, alanine aminotransferase (LL1), aspartate aminotransferase (ACT)), increased activity of alkaline phosphatase (APP) and gamma-glutamyl transferase (PT); infrequently - increased bilirubin concentration in the blood; unknown frequency - severe hepatic insufficiency, including cases of development of acute hepatic insufficiency, sometimes with fatal outcome, especially in patients with severe underlying disease (eg, in patients with sepsis), hepatitis, jaundice.

    From the side of the kidneys and the urinary system: infrequently - increased serum creatinine concentration; rarely acute renal failure (eg, due to the development of interstitial nephritis).

    Disturbances from the skin and subcutaneous tissues: infrequently - a rash, itching, hives, hyperhidrosis; frequency unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reactions, leukocytoclastic vasculitis, stomatitis.

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

    Immune system disorders: rarely - anaphylactic swelling; frequency unknown - anaphylactic shock, anaphylactoid shock.

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

    Co side of the musculoskeletal system: infrequently - arthralgia, myalgia; rarely - the defeat of tendons, including tendonitis Achilles tendon, muscle weakness, which can be especially dangerous in patients with pseudo-paralytic myasthenia gravis (myasthenia gravis); frequency unknown - rupture of tendon, for example, Achilles tendon (this side effect can be observed within 48 hours after the beginning of treatment and can be bilateral, ligament rupture, muscle rupture, arthritis, rhabdomyolysis.

    General disorders: infrequent - asthenia; rarely pyrexia; frequency unknown - pain (including pain in the back, chest and extremities).

    Other possible undesirable effects related to all fluoroquinolones: very rarely - porphyria attacks in patients with porphyria.

    Overdose:

    Overdose Symptoms

    Based on the data obtained in toxicological studies conducted in animals, the most important expected symptoms of an acute overdose of Levofloxacin-Teva are the symptoms of the central nervous system (impaired consciousness, including confusion, dizziness and convulsions). In the post-marketing use of the drug in overdose, there were effects from the central nervous system, including confusion, convulsions, hallucinations and tremors.

    Perhaps the development of nausea and the occurrence of erosion of the mucous membrane of the gastrointestinal tract.

    In clinical and pharmacological studies conducted with doses of levofloxacin. exceeding therapeutic, there was an elongation of the interval QT.

    Treatment of overdose

    In case of an overdose, careful monitoring of the patient, including monitoring the electrocardiogram, is required. Treatment is symptomatic.In the case of an acute overdose of Levofloxacin-Teva tablets, gastric lavage and administration of antacids are indicated to protect the gastric mucosa. Levofloxacin not displayed by dialysis (hemodialysis, peritoneal dialysis and continuous outpatient peritoneal dialysis). There is no specific antidote.

    Interaction:

    ATcooperative actions

    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), it is recommended to take at least 2 hours before or 2 hours after taking Levofloxacin-Teva tablets.

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

    FROM sucralfate

    The effect of Levofloxacin-Teva is significantly weakened by the simultaneous use of sucralfate (a means to protect the gastric mucosa).Patients receiving levofloxacin and sucralfate, it is recommended to take sucralfate 2 hours after taking levofloxacin.

    FROM theophylline, fenbufen, or similar drugs from a group of non-steroidal anti-inflammatory drugs that reduce the threshold of convulsive brain readiness

    The pharmacokinetic interaction of levofloxacin with theophylline has not been revealed. However, with the simultaneous use of quinolones and theophylline. non-steroidal anti-inflammatory drugs and other drugs that reduce the threshold of convulsive readiness of the brain, possibly a marked decrease in the threshold of convulsive readiness of the brain.

    The concentration of levofloxacin with simultaneous administration of fenbufen is only increased by 13%.

    FROM indirect anticoagulants (antagonists of vitamin K)

    In patients treated with levofloxacin in combination with indirect anticoagulants (eg, warfarin), prothrombin time / international normalized ratio and / or bleeding, including severe, increased. Therefore, with simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood clotting parameters is necessary.

    FROM probenecid and cimetidine

    With the simultaneous use of drugs that disrupt renal tubular secretion, such as probenecid and cimetidine, and levofloxacin, caution should be used, especially in patients with renal insufficiency. Removal (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 kidney function.

    FROM cyclosporin

    Levofloxacin increased T1 / 2 cyclosporine by 33%. Since this increase is clinically insignificant, correction of the dose of cyclosporine when it is used simultaneously with levofloxacin is not required.

    With glucocorticosteroids

    Simultaneous reception of glucocorticosteroids increases the risk of rupture of tendons.

    With medications that extend the interval QT

    Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that extend the range QT (for example, antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, neuroleptics).

    Other

    Conducted clinical and pharmacological studies to study the possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide, ranitidine and warfarin showed that the pharmacokinetics of levofloxacin when used concomitantly with these drugs does not change sufficiently to make it clinically important.

    Special instructions:

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

    The prevalence of acquired resistance of the sown strains of microorganisms can vary depending on the geographic region and over time. In this regard, information about drug resistance in a particular country is required. For the treatment of severe infections or in the ineffectiveness of treatment, a microbiological diagnosis should be made, isolating the pathogen and determining its sensitivity to levofloxacin.

    Methicillin-resistant golden streptococcus

    There is a high likelihood that Methicillin-Resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. therefore levofloxacin It is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus,if the laboratory tests did not confirm the sensitivity of this microorganism to levofloxacin.

    Patients who are predisposed to develop seizures

    Like other quinolones, levofloxacin should be used with great care in patients with a predisposition to convulsions. Such patients include patients with previous lesions of the central nervous system, such as stroke, severe craniocerebral trauma; patients simultaneously receiving drugs that reduce the threshold of convulsive brain readiness, such as fenbufen and other nonsteroidal anti-inflammatory drugs like it or other drugs that lower the threshold of convulsive readiness, such as theophylline (see section "Interaction with other drugs").

    Pseudomembranous disease

    Developed during or after levofloxacin treatment, diarrhea, especially severe, persistent and / or with blood, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. In case of suspected development of pseudomembranous colitis, treatment with levofloxacin should be stopped immediately and immediately begin specific antibiotic therapy (vancomycin, teicoplanin or metronidazole inside). Drugs that inhibit the intestinal peristalsis are contraindicated.

    Tendonitis

    Rarely observed tendonitis in the use of quinolones, including levofloxacin. can lead to the rupture of tendons, including the Achilles tendon. This side effect can develop within 48 hours after the start of treatment and can be bilateral. Older patients are more prone to tendonitis. Risk of rupture of tendons may increase with simultaneous admission glucocorticosteroids. If suspicion of tendonitis should immediately stop the drug Levofloxacin-Teva and begin appropriate treatment affected tendon, for example, providing him with sufficient immobilization (see the sections "Contraindications" and "Side effect").

    Hypersensitivity reactions

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

    Severe bullous reactions

    When taking levofloxacin, there were cases of severe bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section "Side effect"). In case of any reactions from the skin or mucous membranes, the patient should immediately consult a doctor and do not continue treatment until his consultation.

    Disturbances from the liver and bile ducts

    There have been reports of hepatic necrosis, including the development of fatal liver failure with levofloxacin, mainly in patients with severe underlying diseases, for example, with sepsis (see section "Side effect"). Patients should be warned about the need for discontinuation of treatment and urgent medical attention in case of signs and symptoms of liver damage such as anorexia, jaundice, darkening of urine, pruritus and abdominal pain.

    Patients with renal insufficiency

    As levofloxacin excreted mainly through the kidneys, in patients with impaired renal function, mandatory monitoring of kidney function is required, as well as correction of the dosing regimen (see section "Method of administration and dose").In the treatment of elderly patients, it should be borne in mind that patients of this group often have impaired renal function (see section "Method of administration and dose").

    Prevention of the development of photosensitization reactions

    Although photosensitization is very rare in the use of levofloxacin, it is not recommended for patients to be prevented from developing during treatment and to undergo, without special need for strong sunlight or artificial ultraviolet irradiation (for example, to visit the solarium) for 48 hours after the end of treatment with levofloxacin.

    Superinfection

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

    Lengthening the interval QT

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

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

    Elderly patients and female ileal patients may be more sensitive to drugs that extend the interval QT. Therefore, care should be taken to use fluoroquinolones, including levofloxacin (see the sections "With caution", "Method of administration and dose", "Side effect" and "Overdose" "Interaction with other drugs").

    Patients with deficiency of glucose-6-phosphate dehydrogenase

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

    Hypo-and hyperglycemia (dysglycemia)

    As with the use of other quinolones, when levofloxacin was used, cases of hyperglycaemia and hypoglycemia were observed, usually in patients with diabetes mellitus, who received treatment with oral hypoglycemic drugs (eg, glibenclamide) or with insulin preparations. There have been reports of cases of hypoglycemic coma. Patients with diabetes are required to monitor the concentration of glucose in the blood (see section "Side effect").

    Peripheral Neuropathy

    In patients taking fluoroquinolones, including levofloxacin, sensory and sensory-motor peripheral neuropathy was noted, the onset of which can be rapid. If the patient has symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.

    Exacerbation of pseudo-paralytic myasthenia gravis (myasthenia gravis)

    Fluoroquinolones, including levofloxacin, are characterized by neuromuscular blocking of activity and may increase muscle weakness in patients with pseudo-paralytic myasthenia gravis. In the postmarketing period, adverse reactions were observed, including pulmonary insufficiency, requiring artificial ventilation, and fatal outcome, which were associated with the use of fluoroquinolones in patients with pseudo-paralytic myasthenia gravis. The use of levofloxacin in patients with established diagnosis of pseudo-paralytic myasthenia is not recommended (see section "Side effect"),

    Application in the airborne route of infection with anthrax

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

    Psychotic reactions

    When using quinolones, including levofloxacin, reported on the development of psychotic reactions, 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 the section "Side effect")). With the development of such reactions, treatment with levofloxacin should be discontinued and appropriate therapy prescribed. Caution should be used to prescribe the drug to patients with psychoses or patients who have a history of mental illness.

    Visual disturbances

    With the development of any visual impairment, an immediate consultation of the ophthalmologist is required (see the "Side effect" section).

    Impact on laboratory tests

    In patients receiving levofloxacin, the definition of opiates in urine can lead to false positive results, which should be confirmed by more specific methods.

    Levofloxacin can inhibit growth Mycobacterium tuberculosis and lead in the future to false-negative results of a bacteriological diagnosis of tuberculosis.

    Effect on the ability to drive transp. cf. and fur:

    It should refrain from driving and other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions, since Levofloxacin-Teva can cause dizziness or vertigo, drowsiness and visual disturbances, which can reduce the speed of psychomotor reactions and the ability to concentration of attention. This can represent a certain risk in situations where these abilities are of particular importance.

    Form release / dosage:

    Tablets, film-coated, 500 mg.

    Packaging:

    For 7 tablets in blisters from G1VX / 11VDH / aluminum foil;

    1 or 2 blisters, together with instructions for use in a cardboard bundle.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C in a dark place.

    Keep out of the reach of children!

    Shelf life:

    3 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000096
    Date of registration:21.12.2010
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp07.10.2015
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