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

    Eleflox 250 mg

    Each film-coated tablet contains:

    Active substance: levofloxacin hemihydrate - 256.38 mg, equivalent to levofloxacin 250 mg.

    Excipients: microcrystalline cellulose (Avicel PH 101) 38.97 mg, microcrystalline cellulose (Avicel PH 102) -20.00 mg, hypromellose (5 cps) - 8.50 mg, polysorbate 80 - 0.85 mg, crospovidone - 11.90 mg, magnesium stearate - 3.40 mg, opadrai OZV52874 - 10.00 mg

    Composition of Opadrai 03V52874: hypromellose 2910 6 csp (E 464) -62,50 mg, titanium dioxide - 29,675 mg, macrogol - 6,250 mg, iron oxide yellow - 1,410 mg, iron oxide red - 0,165 mg.

    Eleflox 500 mg

    Each film-coated tablet contains:

    Active substance: levofloxacin hemihydrate - 512.76 mg, equivalent to levofloxacin - 500 mg.

    Excipients: microcrystalline cellulose (Avicel PH 101) 77.94 mg, microcrystalline cellulose (Avicel PH 102) - 40.00 mg, hypromellose (5 cps) - 17,00 mg, polysorbate 80 - 1,70 mg, crospovidone - 23.80 mg, magnesium stearate - 6.80 mg, opadrai 03V52874 - 20.00.

    Composition of Opadrai 03V52874: hypromellose 2910 6 csp (E464) -62,50 mg, titanium dioxide (E 171) - 29,675 mg, macrogol - 6,250 mg, iron oxide yellow - 1,410 mg, iron oxide red - 0,165 mg.

    Description:

    Eleflox 250 mg: yellowish-pink color, biconvex oval tablet, film-coated, engraved with "250" on one side.

    Eleflox 500 mg: yellowish-pink color, biconvex oval-shaped tablets coated with a film membrane, engraved with "500" on one side.
    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    J.01.M.A   Fluoroquinolones

    J.01.M.A.12   Levofloxacin

    Pharmacodynamics:

    Eleflox is a synthetic broad-spectrum antibacterial agent from the group of fluoroquinolones, containing as an active substance levofloxacin - the left-handed isomer of ofloxacin. Levofloxacin blocks DNA-gyrase, disrupts supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes. Levofloxacin active against most strains of microorganisms both in conditions in vitro and in vivo.

    Sensitive microorganisms (MCP ≤ 2 mg / L)

    Aerobic Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (incl. Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. Coagulase-negative methicillin-sensitive / -modern sensitive (incl. Staphylococcus aureus methicillin-sensitive, Staphylococcus epidermidis methicillin-sensitive), Streptococcus spp. (groups C and G), Streptococcus agalactiae, Streptococcus pneumoniae penicillin-sensitive / -residually sensitive / -resistant, Streptococcus pyogenes, Streptococcus spp. groups viridans penicillin-sensitive / -resistant.

    Aerobic Gram-negative microorganisms: Acinetobacter spp. (at t.h. Acinetobacter baumannii), Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (at t.h. Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampicillin-sensitive/-resistant, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (at t.h. Klebsiella pneumoniae, Klebsiella oxytoca), Moraxella catarrhalis (producing and non-reducing beta-lactamase strains), Morganella morganii, Neisseria gonorrhoeae (at Tom number of producing penicillinase), Neisseria meningitidis, Pasteurella spp: (at t.h. Pasteurella multocida, Pasteurella dagmatis, Pasteurella canis), Proteus mirabilis, Proteus vulgaris, Providencia spp. (at t.h. Providencia stuartii, Providencia rettgeri), Pseudomonas spp. (at t.h. Pseudomonas aeruginosa), Salmonella spp., Serratia spp. (at t.h. Serratia marcescens).

    Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus, Propionibacterium spp., Veilonella spp.

    Other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella spp. (at t.h. Legionella pneumophila), Mycobacterium spp. (at t.h. Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

    Moderately sensitive (IPC ≥ 4 mg / l):

    Aerobic Gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methicillin-resistant, Staphylococcus haemolyticus methicillin-resistant.

    Aerobic Gram-negative microorganisms: Burkholderia cepacia, Campilobacter jejuni, Campilobacter coli.

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

    Sustainable (IPC ≥ 8 mg/l):

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

    Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.

    Other microorganisms. Mycobacterium avium.

    Pharmacokinetics:

    Levofloxacin is rapidly and almost completely absorbed after oral administration. Food intake has little effect on the speed and completeness of absorption. Bioavailability of 500 mg of levofloxacin after oral administration is almost 100%. After taking a single dose of 500 mg of levofloxacin, the maximum concentration is 5.2-6.9 μg / ml, the time to reach the maximum concentration is 1.3 hours, the half-life is 6-8 hours.

    The connection with plasma proteins is 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages.

    In the liver, a small portion is oxidized and / or deacetylated. It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion. After oral intake, approximately 87% of the dose received is excreted by the kidneys unchanged for 48 hours, less than 4% by the intestine for 72 hours.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

    - ENT organs (including acute sinusitis);

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

    - urinary tract and kidneys (including acute pyelonephritis);

    - bacterial prostatitis;

    - infections of the skin and soft tissues (festering atheromas, abscess, furunculosis);

    - intra-abdominal infections;

    - as part of complex therapy of drug-resistant forms of tuberculosis.

    Contraindications:

    hypersensitivity to levofloxacin or other quinolones;

    - epilepsy;

    - damage to the tendons during the previous treatment with quinolones;

    - Children and adolescence (up to 18 years);

    - pregnancy and lactation.

    Carefully:

    The elderly, with a deficiency of glycose-6-phosphate dehydrogenase, with impaired renal function.

    Dosing and Administration:

    The drug is taken orally once or twice a day. Tablets can not be chewed and washed down with a sufficient amount of liquid (0.5 to 1 cup), can be taken before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility.

    Patients with a creatinine clearance> 50 mL / min are recommended the following dosing regimen:

    - acute sinusitis: 500 mg once a day - 10-14 days.

    - exacerbation of chronic bronchitis: 250 mg or 500 mg once a day - 7-10 days.

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

    - uncomplicated urinary tract infections: 250 mg once a day - 3 days.

    - Complicated urinary tract infections (including pyelonephritis): 250 mg once a day - 7-10 days (with a heavy disease, the dose should be increased).

    - bacterial prostatitis: 500 mg once a day - 28 days.

    - skin and soft tissue infections: for 250-500 mg - 1-2 times a day - 7-14 days.

    - intra-abdominal infection: 500 mg once a day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

    - complex therapy of drug-resistant forms of tuberculosis: 500 mg 1-2 times per day! day, the course of treatment - up to 3 months.

    Dosing regimen in patients with impaired renal function:

    Clearance

    creatinine

    Dosing regimen

    250 mg / 24 h

    500 mg / 24 h

    500mg / 12h

    first dose: 250 mg

    first dose: 500 mg

    first dose: 500 mg

    50-20 ml / min

    then:

    125 mg / 24 h

    then: 250 mg / 24 h

    then: 250 mg / 12h

    19-10 ml / min

    then:

    125 mg / 48 h

    then: 125 mg / 24 h

    then: 125 mg / 12 h

    <10 ml / min (including hemodialysis and CAPD)

    then:

    125 mg / 48 h

    then: 125 mg / 24 h

    then: 125 mg / 24 h

    After hemodialysis or permanent ambulatory peritoneal dialysis (CAPD), no additional doses are required.

    If the liver function is not required, a special dose selection is required, since levofloxacin is metabolized in the liver only to a very small extent.

    For elderly patients, there is no need to change the dosage regimen, except for cases of low creatinine clearance.

    As with the use of other antibiotics, treatment with the drug is recommended to continue for at least 48-72 hours after the normalization of body temperature or after reliable destruction of the pathogen.

    If you missed taking the drug, you should take a pill as soon as possible until the time of the next appointment is near. Further continue to take Eleflox according to the scheme.

    Side effects:

    The frequency of this or that side effect is determined by the following table:

    Frequency

    The appearance of side effects

    often:

    in 1-10 patients out of 100

    infrequently:

    less than 1 patient out of 100

    rarely:

    less than 1 patient out of 1,000

    rarely:

    less than 1 patient out of 10 000

    in some cases:

    less than 1 patient out of more than 10 000

    From the digestive system

    Often: nausea, diarrhea, increased activity of liver enzymes (eg, alanine aminotransferase and aspartate aminotransferase).

    Infrequently: decreased appetite, vomiting, abdominal pain, digestive disorders.

    Rarely: Diarrhea (including blood), which in very rare cases can be a sign of inflammation of the intestine and even pseudomembranous colitis (see section "Special instructions"), increased serum bilirubin concentration, dysbacteriosis.

    Rarely: increased serum creatinine concentration, impaired liver function, acute renal failure, hepatitis.

    From the nervous system

    Infrequently: headache, dizziness, drowsiness, insomnia.

    Rarely: depression, anxiety, psychotic reactions (for example, with hallucinations), unpleasant sensations (for example, paresthesia in the hands), tremor, weakness, excited state, motor disorders, convulsions and confusion, suicidal thoughts.

    Rarely: impaired vision and hearing, impaired taste sensitivity and smell, decreased tactile sensitivity, peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal frustration, fear, agitation, mental disorders with behavioral disorders with self-harm, suicide attempts.

    From the side of cardiovascular systems

    Rarely: tachycardia, decrease blood pressure.

    Rarely: cardiovascular collapse.

    In some cases: lengthening interval QT, atrial fibrillation.

    From the side of metabolism

    Rarely: decrease in concentration glucose in the blood (hypoglycemia), which is of particular importance for diabetics, with symptoms: increased appetite, nervousness, sweating, trembling.

    From the side of the locomotor system apparatus

    Rarely: affections of tendons (including tendonitis), arthralgia, myalgia.

    Rarely: rupture of tendons (for example, Achilles tendon), muscle weakness.

    In some cases: muscle damage (rhabdomyolysis).

    From the urinary system

    Rarely: hypercreatininaemia, interstitial nephritis, renal dysfunction, acute renal failure.

    On the part of the organs of hematopoiesis

    Infrequently: eosinophilia, leukopenia.

    Rarely: neutropenia; thrombocytopenia, hemorrhage.

    Rarely: agranulocytosis.

    In some cases: hemolytic anemia, pancytopenia.

    Allergic reactions

    Infrequently: itching and redness of the skin.

    Rarely: are common reactions hypersensitivity (anaphylactic and anaphylactoid reactions) with symptoms such as urticaria, bronchospasm and laryngospasm, severe suffocation.

    In very rare cases: swelling of the skin and mucous membrane (for example, in the face and pharynx), anaphylactic shock, allergic pneumonitis, vasculitis.

    In some cases: severe skin rashes with the formation of blisters, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and exudative erythema multiforme.

    Other

    Infrequently: general weakness (asthenia).

    Rarely: "tinnitus".

    Rarely: exacerbation of porphyria, fever, photosensitivity, development of superinfection, dyspnea; the development of severe infections (persistent or recurrent fever, sore throat and persistent worsening of health).

    Overdose:

    Symptoms: are manifested mainly from the side of the central nervous system (confusion of consciousness, impaired consciousness, dizziness and seizures like epileptic seizures).In addition, gastrointestinal disorders may occur (for example, nausea) and erosive lesions of the mucous membranes of the gastrointestinal tract, lengthening the interval QT.

    Treatment: symptomatic.

    Levofloxacin is not excreted by dialysis (hemodialysis, peritoneal dialysis and permanent peritoneal dialysis). There is no specific antidote.

    In connection with the possible increase in the duration of the interval QT, ECG monitoring should be performed.

    Interaction:

    Quinolones in combination with other drugs that reduce the threshold of convulsive activity (for example, with theophylline, fenbufen and other nonsteroidal anti-inflammatory drugs) can cause a marked decrease in the threshold of convulsive activity. The effect of levofloxacin is significantly weakened when applied simultaneously with sucralfate. The same thing happens with the simultaneous use of magnesium or aluminum-containing antacid means, as well as iron salts. Levofloxacin should be taken at least 2 hours before or 2 hours after receiving these funds. Calcium carbonate was not detected in the interaction.When used simultaneously with indirect anticoagulants, Coumarin derivatives require control over the blood coagulation system.

    Removal (renal clearance) of levofloxacin is insignificant slows down under the action of cimetidine and probenecid.

    When combined with hypoglycemic drugs, strict control over the concentration of glucose in the blood is necessary, since there is a probability hyper- and hypoglycemia.

    Levofloxacin is insignificant increases the half-life of cyclosporine.

    The use of glucocorticosteroids increases the risk of rupture of tendons.

    Levofloxacin, like others fluoroquinolones, should be used with caution in combinations with drugs that cause an increase in the interval QT (eg: antiarrhythmic medicines class IA and III, tricyclic antidepressants, macrolides, antipsychotics).

    Special instructions:

    In the treatment of the elderly, it should be borne in mind that patients of this group often suffer from impaired renal function (see section "Method of administration and dose").

    During treatment with Eleflox, it is possible to develop an attack of seizures in patients with previous brain damage due, for example,stroke or severe trauma. Convulsive activity may also increase with simultaneous use of fenbufen and other non-steroidal anti-inflammatory drugs or theophylline (see "Interaction with other medicinal products ").

    Despite the fact that photosensitivity is noted when applying levofloxacin is very rare, in avoiding it, patients are not advised to undergo solar and artificial ultraviolet irradiation.

    If suspected pseudomembranous colitis should immediately abolish the Elephlox and start the appropriate treatment. In such cases, medicines should not be used, suppressing bowel motility.

    If suspected of tendonitis should immediately stop treatment with the Eleflox preparation and begin the appropriate treatment of the affected tendon, for example, providing a resting state.

    Patients with insufficiency of glucose-6-phosphate dehydrogenase can react on fluoroquinolones by destruction of erythrocytes (hemolysis). Therefore, treatment of such patients with levofloxacin should be carried out with caution.

    In the process of any antibiotic therapy, a sensitive prescribed drugs normal flora (bacteria and fungi). For this reason, a secondary infection or superinfection, which may require additional treatment.

    When using fluoroquinolones, including levofloxacin, caution should be exercised in patients at risk of increasing the duration of the interval QT (lengthening interval syndrome QT in the anamnesis or a condition and disease, accompanied syndrome of increasing the duration of the interval QT): elderly age; violation of electrolyte balance (hypokalemia, hypomagnesemia); congenital lengthening syndrome Q-T; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous reception of drugs that can lengthen the interval Q-T.

    After normalization of body temperature, it is recommended to continue treatment at least 48-78 hours, since levofloxacin excreted mainly through the kidneys, in patients with impaired renal function, control over the kidney function is required, as well as correction of the dosing regimen. In patients with diabetes mellitus receiving oral hypoglycemic agents (for example, glibenclamide) or insulin, the use of levofloxacin increases the risk of developing hypoglycemia. Such patients need to monitor the concentration of glucose in the blood. In patients receiving fluoroquinolones, including levofloxacin, sensory and sensory-motor peripheral neuropathy was noted, the onset of which can be rapid. When a patient develops symptoms of neuropathy, the use of levofloxacin should be discontinued (minimizes the possible risk of irreversible changes). The Eleflox preparation should be used with caution in patients with pseudo-paralytic myasthenia gravis (myasthenia gravis).

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

    During the treatment period, care must be taken when driving motor transport and employment by other potentially dangerous kinds of activity demanding the raised concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Film coated tablets 250 mg and 500 mg.
    Packaging:

    For 5 tablets in a blister of aluminum foil and PVC. For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:In dry, dark place at a temperature of no higher than 25 ° C.Keep out of the reach of children.
    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016110 / 01
    Date of registration:23.11.2009
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp10.10.2015
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