Tigeron 500 mg No. 5 tablet p.o.

Pharmacological properties of the drug Tigeron

Pharmacodynamics . Levofloxacin has a wide spectrum of antibacterial action. The rapid effect is achieved due to the inhibition of the bacterial enzyme DNA gyrase, which belongs to type II topoisomerases, by levofloxacin. The result of such inhibition is the impossibility of the transition of bacterial DNA from the “relaxed” state to the “superfolded” state, which, in turn, makes further division (reproduction) of bacterial cells impossible. The spectrum of activity of levofloxacin includes gram-positive and gram-negative bacteria, including non-fermenting bacteria. The following microorganisms are sensitive to the drug: gram-positive aerobes - Enterococcus faecalis, Staphylococcus aureus methi-S, Staphylococcus haemolyticus methi-S, Staphylococcus saprophyticus, Streptococci group C, G, Streptococcus agalactiae, Streptococcus pneumoniae peni - i/S/R, Streptococcus pyogenes ; gram-negative aerobes - Acinetobacter baumannii, Citrobacter freundii, Eikenella corrodens, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae ampi-S/R, Haemophilus para-influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis β+/β-, Morganella morganii , Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens ; anaerobes - Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus ; others - Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae, Ureaplasma, H. pylori . The following are inconsistently sensitive to the effects of the drug: gram-positive aerobes - Staphylococcus haemolyticus methi-R ; gram-negative aerobes - Burkholderia cepacia ; anaerobes - Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgaris, Clostridium difficile . The following are resistant to the drug: gram-positive aerobes Staphylococcus aureus methi-R . Like other fluoroquinolones, levofloxacin is not active against spirochetes. Pharmacokinetics. There is no significant difference regarding the pharmacokinetics of levofloxacin after intravenous and oral administration. Levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations observed 1 hour after administration. Absolute bioavailability - almost 100%. Levofloxacin exhibits linear pharmacokinetics in the range of 50 to 600 mg. Eating slightly slows down its absorption. Approximately 30–40% of levofloxacin is bound to plasma proteins. The cumulative effect of levofloxacin at a dosage of 500 mg 1 time per day is not clinically significant and can be neglected. There is a slight accumulation of it at a dosage of 500 mg 2 times a day. Equilibrium concentration is achieved within 3 days. Distribution in the bronchial mucosa and the secretion of the bronchial epithelium. The maximum concentration of levofloxacin in the bronchial mucosa and the secretion of the bronchial epithelium at a dose of over 500 mg after oral administration was 8.3 and 10.8 mg/ml, respectively. Distribution in lung tissue. The maximum concentration of levofloxacin in lung tissue at a dose above 500 mg was approximately 11.3 mg/ml and was achieved within 4-6 hours after administration. Concentrations in the lungs consistently exceeded those in the blood plasma. Distribution in body fluids. The maximum concentration of levofloxacin in body fluids after taking 500 mg 1-2 times a day was 4 and 6.7 mg/ml, respectively. Distribution in cerebrospinal fluid. Levofloxacin penetrates poorly into the cerebrospinal fluid. The mean urinary concentrations of levofloxacin over 8 to 12 hours following a single oral dose of 150 mg, 300 mg, or 500 mg were 44 mg/mL, 91 mg/mL, and 200 mg/mL, respectively. Levofloxacin is metabolized to a very small extent, the metabolites being dismethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for less than 5% of the amount of the drug that is excreted in the urine. After oral administration, levofloxacin is eliminated from plasma relatively slowly (T 6–8 hours). Excretion is carried out mainly in the urine (over 85% of the administered dose). There is no significant difference regarding the pharmacokinetics of levofloxacin after intravenous and oral administration.

Use of the drug Tigeron

Taking into account the biological equivalence of the oral and parenteral forms, the same dosage is possible. Tigeron tablets are taken 1-2 times a day. The dose depends on the type and severity of the infection. The duration of treatment depends on the course of the disease and is no more than 14 days. It is recommended to continue treatment for at least 48–72 hours after normalization of body temperature or confirmed eradication of pathogens by microbiological tests. Tigeron tablets should be swallowed without chewing, with a sufficient amount of liquid. For ease of dosing, the tablet can be divided. You can take them both during meals and at other times. Solution for intravenous administration Tigeron is administered slowly , intravenously, by drip infusion. The duration of administration of one bottle of Tigeron (100 ml of solution for intravenous administration with 500 mg of levofloxacin) should be at least 60 minutes. Based on the patient’s condition, after a few days it is possible to switch from intravenous administration to oral administration with the same dosage . The duration of treatment depends on the course of the disease and is no more than 14 days. As with the use of other antibacterial agents, it is recommended to continue treatment with Tigeron (i.v. solution or tablets) for 48–72 hours after normalization of body temperature and negative results of microbiological tests. Recommended doses for adult patients with normal renal function and creatinine clearance greater than 50 ml/min.

*Consideration should be given to increasing the dose in cases of severe infection (this footnote applies only to infusion solutions). ** According to the patient’s condition, after a few days it is possible to switch from intravenous administration to oral administration with the same dosage. ***In combination with antibiotics with an effect on anaerobic pathogens.

Dosage for patients with impaired renal function whose creatinine clearance is less than 50 ml/min:

1) After hemodialysis or chronic ambulatory peritoneal dialysis (CAPD), additional doses are not needed. For patients with impaired liver function, no dose adjustment is necessary, since levofloxacin is slightly metabolized in the liver.

For elderly patients with unchanged renal function, there is no need for dose adjustment.

Tigeron 500 mg No. 5 tablet p.o.

Instructions for medical use of the drug TYGERON® Trade name Tigeron® International nonproprietary name Levofloxacin Dosage form Film-coated tablets, 500 mg and 750 mg Composition One tablet contains the active substance - levofloxacin hemihydrate equivalent to levofloxacin 500 mg or 750 mg, excipients: microcrystalline cellulose (avicel PH 102) povidone K-30, crospovidone, magnesium stearate, silicon dioxide colloidal anhydrous shell composition: Opadry 03B84681 pink [hypromelose (E 464), polyethylene glycol/macrogol, iron (III) oxide red (E 172), iron ( III) yellow oxide (E 172), titanium dioxide (E 171)]. Description Capsule-shaped, pink film-coated tablets, embossed “500” (for a dosage of 500 mg) or “750” (for a dosage of 750 mg) on ​​one side. Pharmacotherapeutic group Antimicrobial drugs - quinolone derivatives. Fluoroquinolones. Levofloxacin. ATC code J01MA12 Pharmacological properties Pharmacokinetics After oral administration, levofloxacin is quickly and completely absorbed from the gastrointestinal tract (GIT), the absolute bioavailability of 500 mg and 750 mg tablets of levofloxacin is 99%. Cmax is reached 1–2 hours after administration. When taken simultaneously with food, the time to reach Cmax slightly increases (by 1 hour) and Cmax decreases slightly (by 14%), so levofloxacin can be prescribed regardless of food intake. The pharmacokinetics of levofloxacin after intravenous and oral administration are not significantly different, are linear and predictable with single and repeated oral and intravenous administration. The plasma concentration profile of levofloxacin after intravenous administration is similar to that after oral administration at an equivalent dose. After a single intravenous injection at a dose of 500 mg (infusion over 60 minutes), Cmax is 6.2±1.0 mcg/ml, at a dose of 750 mg (infusion over 90 minutes) - 11.5±4.0 mcg /ml. Constant concentration in plasma is achieved after 48 hours when taking 500–750 mg 1 time per day. With repeated administration to healthy volunteers, the Cmax values ​​were: with oral administration of 500 mg/day - 5.7 ± 1.4 μg/ml, 750 mg/day - 8.6 ± 1.9 μg/ml. The average volume of distribution is 74–112 l after single and repeated doses of 500 mg and 750 mg. Widely distributed in body tissues, penetrates well into lung tissue (concentration in the lungs is 2–5 times higher than the concentration in plasma). In vitro, in the concentration range corresponding to clinical values ​​(1–10 μg/ml), binding to plasma proteins (mainly albumin) is 24–38% and does not depend on the concentration of levofloxacin. Stereochemically stable in plasma and urine, does not convert to its enantiomer, D-ofloxacin. It is practically not metabolized in the body. It is excreted predominantly unchanged in the urine (about 87% of the dose within 48 hours), small amounts in feces (less than 4% within 72 hours). Less than 5% is determined in urine in the form of metabolites (desmethyl, nitric oxide), which have little specific pharmacological activity. T1/2 is 6–8 hours after single or repeated administrations orally or intravenously. Total clearance is 144–226 ml/min, renal clearance is 96–142 ml/min, excretion is carried out by glomerular filtration and tubular secretion. Concomitant use of cimetidine or probenecid leads to a decrease in renal clearance by 24 and 35%, respectively, indicating secretion of levofloxacin by the proximal tubules. Levofloxacin crystals were not detected in freshly collected urine. Patients with impaired renal function Impaired renal function affects the pharmacokinetics of levofloxacin. As renal function decreases, renal excretion and clearance are reduced and the half-life is increased, as shown in the table below. creatinine clearance (ml/min) < 20 20-40 50-80 levofloxacin clearance (ml/min) 13 26 57 half-life (hour) 35 27 9 Elderly patients There are no significant differences in the kinetics of levofloxacin between young and elderly patients, except except for differences associated with creatinine clearance. Pharmacodynamics Levofloxacin (fluorine-2, methyl-10-(1-piperazinyl)-oxo-7H-pyridol [1,2,3,-de-]-1,6-carboxylic acid) is a synthetic antibacterial agent of the fluoroquinolone group. Has a wide spectrum of antibacterial action. The rapid bactericidal effect is ensured by the inhibition of the bacterial enzyme DNA gyrase, which belongs to type II topoisomerases, by levofloxacin. As a result, the three-dimensional structure of bacterial DNA is disrupted and their division is blocked. The spectrum of activity of levofloxacin includes gram-positive and gram-negative bacteria, including non-fermenting bacteria that often cause nosocomial infection, as well as atypical microorganisms such as C. pneumoniae, C. trachomatis, M. pneumoniae, L. pneumophila, Ureaplasma. In addition, pathogens such as mycobacteria, H. pylori and anaerobes are sensitive to levofloxacin. The following are sensitive to the drug: gram-positive aerobes - Enterococcus faecalis, Staphylococcus aureus methicillin-sensitive, Staphylococcus haemolyticus methicillin-sensitive, Staphylococcus saprophyticus, Streptococci C, G, Streptococcus agalactiae, Streptococcus pneumoniae, including those resistant to penicillin, Streptococcus pyogenes; gram-negative aerobes – Acinetobacter baumannii, Citrobacter freundii, Eikenella corrodens, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, including those resistant to ampicillin, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, including those producing α -lactamases , Morganella morganii, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens; anaerobes – Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus; others – Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae. The following are not consistently sensitive to the drug: gram-positive aerobes – Staphylococcus haemolyticus methicillin-resistant; gram-negative aerobes – Burkholderia cepacia; anaerobes – Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgaris, Clostridium difficile. The following are resistant to the drug: gram-positive aerobes – Staphylococcus aureus, methicillin-resistant. Like other fluoroquinolones, levofloxacin is not active against spirochetes. Indications for use - acute sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia - complicated and uncomplicated urinary tract infections (including pyelonephritis) - chronic bacterial prostatitis - skin and soft tissue infections - septicemia/bacteremia - intra-abdominal infection Method of administration and dosage Tigeron® tablets take 1-2 times a day. The dose depends on the type and severity of the infection. The duration of treatment depends on the course of the disease and is no more than 14 days. It is recommended to continue treatment for 48–72 hours after normalization of body temperature or destruction of pathogens confirmed by microbiological tests. Tigeron® tablets should be swallowed without chewing, with a sufficient amount of liquid. For ease of dosing, the tablet can be divided using scoring lines. The tablets can be taken with food or at other times. Recommended doses for adult patients with normal renal function (creatinine clearance > 50 ml/min) Indications Daily dose Number of doses per day. Duration of treatment Acute sinusitis 500 mg 1 time 10–14 days Exacerbation of chronic bronchitis 250–500 mg 1 time 7–10 days Community-acquired pneumonia 500 mg 1–2 times 7–14 days Uncomplicated urinary tract infections 250 mg 1 time 3 days Chronic bacterial prostatitis 500 mg 1 time 28 days Complicated urinary tract infections, including pyelonephritis 250 mg 1 time 7–10 days Skin and soft tissue infections 250-500 mg 1–2 times 7–14 days Septicemia/bacteremia 500 mg 1–2 times 10–14 days Intra-abdominal infection* 500 mg 1 time 7–14 days *In combination with antibiotics acting on anaerobic pathogens. Dosing for patients with impaired renal function (creatinine clearance < 50 ml/min) Creatinine clearance Dosage regimen (depending on severity of infection) 50–20 ml/min first dose 250 mg as follows: 125 mg/24 hours first dose: 500 mg as follows : 250 mg/24 hours first dose: 500 mg following: 250 mg/12 hours 19–10 ml/min first dose: 250 mg following: 125 mg/48 hours first dose: 500 mg following: 125 mg/24 hours first dose : 500 mg the following: 125 mg/12 hours < 10 ml/min, (also for hemodialysis and CAPD1) first dose: 250 mg the following: 125 mg/48 hours first dose: 500 mg the following: 125 mg/24 hours first dose : 500 mg as follows: 125 mg/24 hours 1 After hemodialysis or chronic ambulatory peritoneal dialysis (CAPD), no additional doses are needed. Side effects Often - lack of appetite, nausea, vomiting, abdominal pain, flatulence, digestive disorders, diarrhea, constipation - increased activity of liver enzymes (ALT, AST) and bilirubin levels in the blood serum Sometimes - skin rash, itching, redness of the skin - headache pain, dizziness, drowsiness, insomnia, asthenia - increased level of creatinine in the blood serum - eosinophilia, leukopenia Rarely - urticaria, bronchospasm, shortness of breath - melena - paresthesia in the hands, tremor, anxiety, fear, convulsions, confusion - tachycardia, decreased blood pressure – tendon damage, including tendonitis, joint or muscle pain – neutropenia; thrombocytopenia, leading to an increased tendency to hemorrhage or bleeding Very rarely - Quincke's edema, anaphylactic shock, anaphylactoid reactions - hypotension, shock, collapse - QT interval prolongation - renal dysfunction, acute renal failure, interstitial nephritis - pseudomembranous colitis, enterocolitis - photosensitivity - hypoglycemia - impaired vision and hearing, taste and smell, hypoesthesia - psychotic reactions, in the form of hallucinations and depression, including suicidal thoughts - tendon rupture, for example, rupture of the Achilles tendon (may appear within 48 hours from the start of treatment and affect both limbs) - hepatitis - agranulocytosis - fever, allergic pneumonitis, vasculitis - muscle weakness, which is of particular importance for patients with myasthenia gravis In isolated cases - attacks of porphyria - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme - rhabdomyolysis - extrapyramidal symptoms and other disorders of muscle coordination - hemolytic anemia, pancytopenia - candidiasis, development of resistance of microorganisms Contraindications - hypersensitivity to levofloxacin or other quinolones - epilepsy and other lesions of the central nervous system with a reduced seizure threshold - tendon lesions associated with the use of quinolones in history - pregnancy and lactation period - childhood and adolescence up to 18 years of age Drug interactions Absorption of levofloxacin is significantly reduced when used simultaneously with antacids containing magnesium and aluminum, as well as with iron preparations and sucralfate. The recommended period of time between taking Tigeron® and these drugs should be at least 2 hours. The pharmacokinetics of levofloxacin did not change to a clinically significant extent when Tigeron was used together with the following drugs: calcium carbonate, digoxin, glibenclamide, ranitidine. Effects of other drugs on Tigeron Theophylline, fenbufen and other similar non-steroidal anti-inflammatory drugs (NSAIDs) - concomitant use of quinolones with theophylline, NSAIDs and other drugs that lower the seizure threshold can lead to a marked decrease in cerebral seizure threshold, despite the absence of pharmacokinetic interactions of Tigeron with theophylline . In the presence of fenbufen, the concentration of Tigeron increases by almost 13%. Probenecid and cimetidine - Probenecid and cimetidine have a significant effect on the elimination of Tigeron. Cimetidine and probenecid reduce the renal clearance of levofloxacin (by 24% and 34%, respectively), since both drugs can block the tubular secretion of levofloxacin in the kidneys. With the simultaneous use of drugs such as probenecid and cimetidine, which affect tubular secretion of the kidneys, treatment with Tigeron should be carried out with caution, especially if renal function is impaired. Impact of Tigeron® on other drugs Cyclosporine - the half-life of cyclosporine increases by 33% when used simultaneously with Tigeron®. Vitamin K antagonists - treatment with Tigeron® in combination with a vitamin K antagonist (for example, warfarin) may lead to an increase in coagulation tests (prothrombin time (PT) taking into account the international normalized ratio (INR)) and/or increased bleeding, which can be serious form. Therefore, patients receiving vitamin K antagonists need to monitor coagulation tests. Glucocorticoids increase the risk of tendon rupture. Medicines that prolong the QT interval - Medicines that can prolong the QT interval (for example, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides) should be used with caution when used concomitantly with Tigeron® (see "Special Instructions"). The use of levofloxacin simultaneously with alcohol is not recommended. Special instructions In the most severe cases of pneumococcal pneumonia, Tigeron may not be the most optimal therapy. In rare cases, tendinitis can occur, most commonly in the Achilles tendon, which can lead to its rupture. The risk of developing tendinitis and tendon rupture is increased in older age and in patients using corticosteroid drugs. Strict monitoring of such patients is necessary when they are prescribed Tigeron. All patients should contact their doctor if signs of tendonitis appear. If tendonitis is suspected, treatment with Tigeron® should be stopped immediately and appropriate treatment of the affected tendon (eg immobilization) should be initiated. Patients with a predisposition to seizures Tigeron is contraindicated in patients with a history of epilepsy. As with other quinolones, extreme caution should be exercised in patients prone to epileptic seizures, for example, patients with existing lesions of the central nervous system, while being treated with fenbufen and the like, non-steroidal anti-inflammatory drugs or drugs that lower the cerebral seizure threshold, such as theophylline (see "Drug Interactions"). In case of convulsive seizures, treatment with Tigeron should be discontinued. Patients with glucose-6-phosphate dehydrogenase deficiency Patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase activity may be prone to hemolytic reactions when treated with antibacterial quinolones, so caution should be exercised when using Tigeron®. The combined use of any antibacterial agents can lead to disturbances associated with their effect on normal microflora. A secondary infection may develop, which will require additional treatment. Patients with impaired renal function Due to the elimination of levofloxacin primarily by the kidneys, the dose of Tigeron should be adjusted for patients with impaired renal function (see section “Dosage and Administration”). Hypersensitivity reactions Tigeron® can cause serious, potentially fatal hypersensitivity reactions, such as angioedema, up to anaphylactic shock, sometimes after the first dose (see “Side Effects”). Patients should immediately stop treatment and contact their physician or emergency physician, who will take appropriate emergency measures. Hypoglycemia When using Tigeron, as with all quinolones, hypoglycemia may occur, usually in patients with diabetes mellitus who were simultaneously treated with oral hypoglycemic agents, for example, glibenclamide or insulin. In such patients, strict monitoring of blood glucose levels is recommended (see “Side Effects”). Prevention of photosensitization Although photosensitivity is rare during treatment with Tigeron, patients are advised not to unnecessarily expose themselves to strong sunlight or artificial ultraviolet radiation, for example, solar lamps, solariums, in order to avoid photosensitization. Patients being treated with vitamin K antagonists Due to the possible increase in coagulation test values ​​(prothrombin time/INR) and/or increased bleeding in patients being treated with Tigeron® in combination with a vitamin K antagonist (for example, warfarin), coagulation parameters should be monitored blood when prescribing the simultaneous use of these drugs (see “Drug Interactions”). Psychotic reactions Psychotic reactions have been reported in patients using quinolones, including Tigeron. In very rare cases, they progressed before thoughts about suicide and behavior with causing themselves to be injuries, sometimes even after one single dose of taigeronò (see “side effects”). In the case of a patient, psychotic reactions of Tigeron need to be canceled and proceeded with appropriate measures. Caution is recommended if the tigeron has to be prescribed to patients with psychoses or with a history of mental illness. Extension of the QT interval must be careful when using fluoroquinolons, including taigeron, in the case of patients with well -known risk factors of extension of the QT interval, such as, for example: - congenital syndrome of the elongated QT - the simultaneous use of drugs known for their ability to extend the QT interval (for example, antiarrhythmic agents classes IA and III, tricyclic antidepressants, macrolides), (see “Drug interactions”) - an incorrect violation of the electrolyte balance (for example, hypokalemia, hypomagnesia) - elderly age - heart disease (for example, cardiac insufficiency, myocardial infarction, bradycardia), ( See “side effects”, “overdose”). Peripheral neuropathy. Tigeron should be canceled if the patient has symptoms of neuropathy, in order to avoid the development of an irreversible state. Opiates. The definition of opiates in the urine in patients treated by taigeroneò can give falsely positive result. It may be necessary to confirm a positive result for opiates by another, more specific method. Violations of the liver and biliary tract. The patients should be advised to stop treatment and consult their doctor if they have signs and symptoms of liver disease, such as anorexia, jaundice, dark staining of urine, itching, and abdominal soreness. Pregnancy and lactation period. Pregnant and lactating women should not take Tigerona pills  Due to the lack of clinical research data and a possible risk of lesion of fluoro -restones to the bearing load of the cartilage tissue of the growing organism. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms, some side effects, for example, dizziness, drowsiness, visual impairment, can reduce the patient's ability to concentrate and the speed of his reactions, which can be dangerous in situations where such abilities are especially important (for example, when driving a car and working mechanisms). Overdose symptoms: nausea, dizziness, confusion, loss of consciousness, seizures, erosive damage to the mucous membrane of the gastrointestinal tract, lengthening of the QT interval. Treatment: It is necessary to carefully monitor the patient, including ECG. In cases of obvious overdose, gastric lavage is prescribed. Treatment is symptomatic. To protect the gastric mucosa, antacids are used. Hemodialysis, including peritoneal dialysis, are not effective for eliminating levofloxacin from the body. There is no specific antidote. Forms of release and packaging for 5 or 10 tablets in a contour cell package from a polyvinyl chloride film and aluminum foil. 1 contour cell package, along with instructions for medical use in the state and Russian languages, are placed in a cardboard pack. Storage conditions are stored in a place protected from light at a temperature of not higher than 25 ° C. Keep out of the reach of children. The shelf life of 3 years is not used after the expiration date indicated on the package! Conditions of vacation from pharmacies according to the recipe manufacturer Kusum Heltker PVT. LTD., SP 289 (A), Riiko Indr. Area Chopankanki, Bhivadi (Raj.), India address of the organization receiving in the territory of the Republic of Kazakhstan claims from consumers on the quality of products (goods): LLP "DWRI-Pharm, (Kazakhstan)", Republic of Kazakhstan, Almaty, Prospect Dostyk, 117/6, Han-Tengri BC, tel/fax: 295-26-50; 295-26-55

Side effects of the drug Tigeron

from the skin and general hypersensitivity reactions: in some cases - itching and redness of the skin; rarely - general hypersensitivity reactions (anaphylactic and anaphylactoid): urticaria, bronchospasm; very rarely - swelling of the skin and mucous membranes (for example, facial skin and pharyngeal mucosa); sudden drop in blood pressure and shock; prolongation of the QT interval, sensitization to sunlight and ultraviolet rays; in isolated cases - a severe rash on the skin and mucous membranes with the formation of blisters, such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme. General hypersensitivity reactions are sometimes preceded by milder skin reactions. Such reactions may appear after the first dose and for several minutes or hours after administration. From the gastrointestinal tract: often - nausea, diarrhea; in some cases - lack of appetite, vomiting, abdominal pain, digestive disorders; rarely - bloody diarrhea, which may be a sign of intestinal inflammation, including pseudomembranous colitis; very rarely - a decrease in blood glucose levels (hypoglycemia), which is of particular importance for patients with diabetes. Signs of hypoglycemia may include increased appetite, nervousness, increased sweating, and tremors of the limbs. Drugs from the quinolone group can cause attacks in patients with porphyria. This may also apply to Tigeron. From the side of the central nervous system: in isolated cases - headache, dizziness, drowsiness, sleep disturbances; rarely - paresthesia in the hands, tremor, restlessness, anxiety, seizures and confusion; very rarely - visual and hearing impairment, impaired taste and smell, decreased tactile sensitivity, as well as psychotic reactions such as hallucinations and depressive mood changes, psychotic reactions with suicidal ideas and actions. Impaired coordination of movement while walking. From the cardiovascular system: rarely - tachycardia, hypotension; very rarely - collapse. From the musculoskeletal system: rarely - damage to the tendons, including inflammation, arthralgia, myalgia; very rarely - tendon rupture (for example, Achilles tendon rupture). This side effect may appear within 48 hours of starting treatment and may affect the Achilles tendon of both legs. Muscle weakness is possible, which may be of particular importance in patients with myasthenia gravis; in isolated cases - muscle damage (rhabdomyolysis). From the liver: often - increased levels of liver enzymes (ALAT, AST); rarely - increased levels of bilirubin and creatinine in the blood plasma; very rarely - hepatic reactions such as liver inflammation. From the kidneys: deterioration of kidney function, up to acute renal failure, for example, due to allergic reactions (interstitial nephritis). From the blood system: in some cases - eosinophilia, leukopenia; rarely - neutropenia, thrombocytopenia, which can cause an increased tendency to hemorrhage or bleeding; very rarely - agranulocytosis, which can lead to severe clinical manifestations (prolonged or recurrent fever, pharyngitis, malaise); in isolated cases - hemolytic anemia, pancytopenia. Others: rarely - general weakness (asthenia); very rarely - hyperthermia, allergic reactions in the lungs (allergic pneumonitis) or small blood vessels (vasculitis). The use of antibacterial agents can lead to disorders associated with their effect on the normal microflora of the human body. For this reason, a secondary infection may develop, which may require additional treatment.

Special instructions for the use of the drug Tigeron

When treating elderly patients, it is necessary to take into account frequent cases of decreased renal function. During treatment, it is necessary to avoid solar and artificial UV irradiation to prevent photosensitivity. If signs of tendinitis appear, levofloxacin is immediately discontinued. In patients with a history of brain damage (stroke, severe trauma), seizures may develop; with glucose-6-phosphate dehydrogenase deficiency, there is a risk of hemolysis. Use during pregnancy or breastfeeding. Tigeron should not be prescribed during pregnancy and breastfeeding. If you become pregnant during treatment with Tigeron, you should inform your doctor. The ability to influence the reaction rate when driving vehicles or other mechanisms. Patients who drive vehicles or work with machines and mechanisms must take into account possible side effects from the central nervous system (dizziness, drowsiness, confusion, visual and hearing impairment, impaired motor coordination). Children. The drug is not used in children and adolescents under 18 years of age.

Interactions of the drug Tigeron

Adsorption of levofloxacin is significantly reduced when used simultaneously with antacids that contain magnesium and aluminum, as well as with drugs containing iron. The recommended time interval between taking Tigeron and these drugs should be at least 2 hours. The bioavailability of Tigeron tablets is significantly reduced when taken simultaneously with sucralfate. The time interval between taking these drugs should be at least 2 hours. Clinical studies have not established an interaction between levofloxacin and theophylline, but a significant decrease in the seizure threshold is possible with simultaneous use of quinolones with theophylline, NSAIDs and other drugs that lower the seizure threshold. The concentration of levofloxacin when used simultaneously with fenbufen was approximately 13% higher than when taking levofloxacin alone. Probenicid and cimetidine have a statistically significant effect on the excretion of levofloxacin. The renal clearance of levofloxacin is reduced in the presence of probenecid by 34%, and cimetidine by 24%. Due to this, both drugs are able to block the tubular excretion of levofloxacin. Tmax of cyclosporine increases by 33% when taken simultaneously with levofloxacin. When used concomitantly with vitamin K antagonists, such as warfarin, coagulation tests (PT/international normalization ratio) and/or the risk of bleeding are increased, which may be severe. Taking this into account, patients who receive vitamin K antagonists in parallel should monitor their coagulogram parameters. Drinking alcohol is not recommended when using levofloxacin.

Note!

Description of the drug Tigeron table. p/o 500 mg No. 5 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Overdose of the drug Tigeron, symptoms and treatment

Symptoms : confusion, dizziness, impaired consciousness and seizures, nausea, damage to the mucous membranes, prolongation of the QT interval. Treatment : symptomatic therapy. Gastric lavage is prescribed. Careful monitoring of the patient is necessary, including an ECG. Antacids are used to protect the gastric mucosa. Hemodialysis, including peritoneal dialysis or CAPD, is not effective in removing levofloxacin from the body. There is no specific antidote.

Indications for use

The drug is prescribed to adults for the treatment of the following infections:

• Acute bacterial sinusitis.
• Exacerbation of chronic bronchitis.
• Community-acquired pneumonia.
• Complicated skin and soft tissue infections.

For the above infections, the drug should only be used when it is considered inappropriate to use the antibacterial drugs that are usually recommended for the initial treatment of these infections.

• Complicated urinary tract infections (including pyelonephritis).
• Chronic bacterial prostatitis.
• Intractable cystitis.

The drug may also be used to complete a course of therapy in patients who show improvement during initial treatment with intravenous levofloxacin.

Official recommendations for the appropriate use of antibacterial drugs should be considered.