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

    Active substance: levofloxacin hemihydrate corresponding to 500 mg levofloxacin;

    auxiliary substancesa: crospovidone 22 mg, microcrystalline cellulose 65 mg, hypromellose 8 mg, silicon colloidal dioxide 5 mg, talc 3 mg, magnesium stearate 7 mg;

    composition of the shell: hypromellose 10.3 mg, macrogol 1.2 mg, titanium dioxide (E-171) 6 mg, talc 1.2 mg, methyl parahydroxybenzoate 0.12 mg, propyl parahydroxybenzoate 0.06 mg.

    Description:

    White capsular shaped film-coated tablets with a risk on both sides.

    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    J.01.M.A   Fluoroquinolones

    J.01.M.A.12   Levofloxacin

    Pharmacodynamics:

    Levofloxacin is a synthetic broad-spectrum antibacterial agent from the group of fluoroquinolones, containing as an active substance levofloxacin - the left-handed isomer of ofloxacin. It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps,suppresses the synthesis of DNA, causes profound morphological changes in the cytoplasm, cell wall and membranes.

    Effective against most strains of microorganisms both in conditions in vitro, and in vivo: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Clostridium perfringens, Mycobacterium tuberculosis.

    Pharmacokinetics:

    When ingested quickly and almost completely absorbed (eating little influence on speed and completeness of absorption). Bioavailability is 99%. The concentration of the drug in plasma reaches its peak 1-2 hours after its administration (Tcmah) - When taking 500 mg the maximum concentration of the drug in plasma (CmOh) - 5.2 mcg / ml. Relationship with plasma proteins 24 - 38%. 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 of the drug is oxidized and / or deacetylated. Kidney clearance is 70% of the total clearance. The half-life (T1 / 2) is 6-8 hours.It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% of the kidneys are excreted within 24 hours, 87% within 48 hours; During the 72 hours, 4% of the dose taken internally is excreted through the intestine.

    Indications:

    Bacterial infections of mild and moderate severity caused by microorganisms sensitive to levofloxacin:

    infections of the lower respiratory tract (exacerbation of chronic bronchitis, community-acquired pneumonia, including penicillin-resistant form Streptococcus pneumoniae), ENT organs (acute sinusitis, otitis media), complicated and uncomplicated urinary tract infections (including acute pyelonephritis), skin and soft tissues (festering atheromas, abscess, boils), bacterial prostatitis; intra-abdominal infections, tuberculosis (complex therapy of drug-resistant forms).

    Contraindications:

    Hypersensitivity to levofloxacin or other components of the drug, hypersensitivity to other quinolones, epilepsy, tendon damage with quinolones previously treated, pregnancy, lactation, children and adolescence (under 18 years).

    Carefully:Elderly age (due to high probability of concomitant decrease in kidney function); deficiency of glucose-6-phosphate dehydrogenase; complex therapy with drugs that slow kidney clearance.
    Pregnancy and lactation:

    Due to the inadequacy of clinical studies and the possible harmful effects of quinolones on articular cartilage in the growth period, Tanflomed should not be used during pregnancy and lactation.

    Dosing and Administration:

    Inside, before meals or in the interval between meals, without chewing, squeezed with enough liquid (0.5 to 1 cup). The dose is determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility.

    Patients with normal or moderately reduced renal function (creatinine clearance> 50 mL / min) are recommended the following dosing regimen:

    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 each mg Once a day - 3 days.

    Complicated urinary tract infections, including pyelonephritis: 250 mg once a day - 7-10 days.

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

    Infections of the skin and soft tissues: 250 mg once a day or 500 mg 1-2 times a day - 7-14 days.

    Intra-abdominal infections: 250 mg or 500 mg once a day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

    Tuberculosis: Inward, 500 mg 1-2 times a day for up to 3 months.

    Dosing regimen with impaired renal function:

    250 mg / 24 h

    500 mg / 24 h

    500 mg / 12 h

    Creatinine clearance

    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 / 12 h

    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 DAPD1)

    Then: 125 mg / 48 h

    Then: 125 mg / 24 h

    Then: 125 mg / 24 h

    1 - no additional doses are required after hemodialysis or long-term outpatient peritoneal dialysis (DAPD).

    If the liver function is not required, a special dose selection is required, since levofloxacin metabolized in the liver in small amounts.

    If you missed taking the drug, you need to take the pill as soon as possible until the time of the next appointment is approaching. Then continue to take Tanflomed 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

    Sometimes:

    Less than 1 patient out of 100

    Rarely:

    Less than 1 patient out of 1000

    Rarely:

    Less than 1 patient out of 10,000

    In some cases:

    less than 0.01%

    Allergic reactions

    Sometimes: itching and redness of the skin.

    Rarely: hypersensitivity reactions with such symptoms as hives, bronchospasm, severe choking.

    Rarely: swelling of the skin and mucous membranes, sudden drop in blood pressure and anaphylactic shock; photosensitivity (see "Special instructions"); allergic pneumonitis; vasculitis.

    In some cases: malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exudative erythema multiforme. Common hypersensitivity reactions can sometimes be preceded by lighter skin reactions. The above reactions may develop after the first dose in a few minutes or hours after the administration of the drug.

    From the gastrointestinal tract and metabolism

    Often: nausea, diarrhea.

    Sometimes: loss of appetite, vomiting, abdominal pain.

    Rarely: stool with an admixture of blood, which in very rare cases can be a sign of inflammation of the intestine and even pseudomembranous colitis (see "Special instructions"), dysbacteriosis.

    Rarely: hypoglycemia (possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling).

    The experience of using other quinolones indicates that they are capable of causing an exacerbation of porphyria in patients already suffering from this disease. A similar effect is not excluded when using the drug Tanflomed.

    From the nervous system

    Sometimes: headache, weakness, dizziness and / or numbness, drowsiness, sleep disturbance (including insomnia).

    Rarely: depression, anxiety, hallucinations, paresthesia, tremor, psychomotor agitation, confusion, fear, epileptic seizures, anxiety.

    Rarely: visual and hearing impairments, violation of taste sensitivity and smell, reduction of tactile sensitivity.

    From the side of the cardiovascular system

    Rarely: increased heart rate (heart rate), increased heart rate, lower blood pressure.

    Rarely: cardiovascular collapse.

    In some cases: interval lengthening Q-T.

    From the side of the musculoskeletal system

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

    Rarely: rupture of tendons (eg, Achilles tendon); this side effect can be observed within 48 hours after the start of treatment and can be bilateral (see "Special instructions"); Muscle weakness, which is of particular importance for patients suffering from myasthenia gravis.

    In some cases: muscle damage (rhabdomyolysis).

    From the liver and kidneys

    Often: increased activity of liver enzymes (alanine aminotransferase and aspartate aminotransferase).

    Rarely: hyperbilirubinemia, hypercreatininaemia.

    Rarely: hepatitis; acute renal failure, interstitial nephritis.

    From the blood and organs of hematopoiesis

    Sometimes: an increase in the number of eosinophils, a decrease in the number of leukocytes.

    Rarely: neutropenia; thrombocytopenia, which can be accompanied by hemorrhages and increased bleeding.

    Rarely: agranulocytosis and the development of severe infections.

    In some cases: hemolytic anemia; pancytopenia.

    Other

    Sometimes: general weakness (asthenia).

    Rarely: fever, development of superinfection.

    Overdose:

    Symptoms overdoses of the drug Tanflomed manifest at the level of the central nervous system (confusion, dizziness, impaired consciousness and seizures of the type of epiprip). In addition, gastrointestinal disorders (eg, nausea) and erosive lesions of the mucous membranes may occur.

    Treatment symptomatic. Levofloxacin not output by dialysis. There is no specific antidote.

    Interaction:

    There are reports of a marked decrease in the level of convulsive readiness with simultaneous use of quinolones and substances, which in turn can reduce the cerebral threshold of convulsive readiness. This applies equally to the simultaneous application of quinolones, theophylline and non-steroidal anti-inflammatory agents.

    The effect of levofloxacin is significantly weakened by simultaneous application of sucralfate. The same happens with simultaneous application magnesium- or aluminum containing antacid agents, and preparations of iron salts.

    Levofloxacin should be taken at least 2 hours before or 2 hours after taking these funds.

    Reception glucocorticosteroids increases the risk of rupture of tendons.

    With simultaneous use antagonists of vitamin K it is necessary to monitor the indicators by the blood coagulation system.

    Excretion (renal clearance) of levofloxacin slightly slows down under the action of cimetidine and probenecid, which block tubular secretion.

    Levofloxacin slightly increases half-life cyclosporine.

    Special instructions:

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

    Tanflomed can not be used to treat children and adolescents because of the possibility of joint cartilage damage.

    When treating patients of senile age, it should be borne in mind that patients of this group often suffer from impaired renal function (see section "Method of administration and dose");

    In severe pneumonia caused by pneumococci, Tanflomed may not provide the optimal therapeutic effect. Hospital infections caused by specific pathogens (Pseudomonas aeruginosa), may require combined treatment.

    During treatment with Tanflomed, it is possible to develop an episode of seizures in patients withprevious brain damage due, for example, to a stroke or severe trauma.

    Despite the fact that photosensitization is observed with levofloxacin very rarely, it is not recommended to undergo severe sunlight or artificial ultraviolet irradiation (for example, sun exposure in the highlands or visiting the solarium) without special need to avoid it.

    If suspicion of pseudomembranous colitis should immediately cancel Tanflomed and begin appropriate treatment. In such cases, drugs that depress intestinal motility should not be used.

    Rarely observed with the use of the drug Tanflomed tendonitis (primarily inflammation of Achilles tendon) can lead to rupture of tendons. The elderly are more likely to develop tendonitis. Treatment with glucocorticosteroids increases the risk of rupture of tendons. If suspicion of tendonitis should immediately stop treatment with Tanflomed and begin appropriate treatment of the affected tendon, providing the patient with a resting state (see "Contraindications" and "Side effect").

    Patients with insufficiency of glucose-6-phosphate dehydrogenase (hereditary metabolic disorder) may respond to the administration of fluoroquinolones by the development of hemolysis (see "Contraindications / with caution").

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

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

    Form release / dosage:

    Tablets, film-coated 500 mg.

    Packaging:

    5 tablets per blister (PVC / Aluminum foil). For 10 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    In a dry, protected from light 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 expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009443/09
    Date of registration:24.11.2009
    The owner of the registration certificate:Emkur Pharmaceuticals Inc. Emkur Pharmaceuticals Inc. USA
    Manufacturer: & nbsp
    Representation: & nbspEMKYUR PHARMACEUTICALS LIMITEDEMKYUR PHARMACEUTICALS LIMITEDRussia
    Information update date: & nbsp10.10.2015
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