Levofloxacin-Teva - Instructions For Use, Tablets 500 Mg, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Levofloxacin-Teva

Levofloxacin-Teva: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Levofloxacin-Teva

ATX code: J01MA12

Active ingredient: Levofloxacin (Levofloxacin)

Manufacturer: Teva Pharmaceutical Plant, JSC (Hungary), Teva (Israel)

Description and photo updated: 2019-29-07

Prices in pharmacies: from 338 rubles.

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Levofloxacin-Teva is an antimicrobial drug of the fluoroquinolone group with a broad spectrum of action.

Release form and composition

Dosage forms:

• solution for infusion: clear greenish-yellow liquid (100 ml in glass transparent bottles without color, in a cardboard box 1 bottle);
• film-coated tablets: capsule-shaped, pale pink with a yellow tinge, engraved with "LX" and "500" on one side, with a dividing line on each side (7 pcs. in blisters, in a cardboard box 1 or 2 blister).

Each pack also contains instructions for the use of Levofloxacin-Teva.

1 ml of solution contains:

• active substance: levofloxacin hemihydrate - 5.125 mg (equivalent to 5 mg of levofloxacin);
• auxiliary components: sodium chloride, hydrochloric acid, water for injection.

1 tablet contains:

• active substance: levofloxacin hemihydrate - 512.46 mg (equivalent to 500 mg of levofloxacin);
• auxiliary components: hyprolose, colloidal silicon dioxide, croscarmellose sodium, sodium carboxymethyl starch (type A), magnesium stearate, talc;
• film shell: Opadrai 15B26688 brown - macrogol-400, hypromellose 2910 6cP, hypromellose 2910 3cP, polysorbate-80, titanium dioxide (E171), iron dye red oxide (E172), iron dye yellow oxide (E172), iron dye black oxide (E172).

Pharmacological properties

Pharmacodynamics

Levofloxacin-Teva is a synthetic antibacterial drug from the group of fluoroquinolones, has a wide spectrum of antimicrobial action. Its active substance, levofloxacin, is a levorotatory isomer of ofloxacin.

The mechanism of action of the drug is due to the property of levofloxacin to block DNA gyrase and topoisomerase IV, disrupt supercoiling and stitching of DNA breaks (deoxyribonucleic acid), inhibit DNA synthesis, and cause deep morphological changes in the cell wall, cytoplasm and membranes of microbial cells.

In vitro and in vivo, levofloxacin demonstrates activity against most strains of microorganisms.

In vitro, the following microorganisms are sensitive to it in the inhibition zone of 17 mm or more:

• aerobic gram-positive microorganisms: Corynebacterium jeikeium, Corynebacterium diphtheriae, Bacillus anthracis, Enterococcus spp. (speciales), Enterococcus faecalis, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S (I) (coagulase-negative methicillin-sensitive, moderately sensitive), Staphylococcus aureus methi-S (methicillin-sensitive), Staphylococcus aureus methi-S (methicillin. CNS (coagulase-negative), Staphylococcus epidermidis methi-S (methicillin-susceptible), Viridans streptococci (penicillin-sensitive, resistant), Streptococcus agalactiae, Streptococci groups C and G, Streptococcus pyogenes moderately, Streptococcus pneumoniae-susceptible;
• aerobic gram-negative microorganisms: Enterobacter spp., Enterobacter cloacae, Enterobacter aerogenes, Acinetobacter spp., Acinetobacter baumannii, Actinobacillus actinomycetemcomitans, Eikenella corrodens, Escherichia coli, Citrobacter freundii / Gardnere influenza vaginus, Gardnere influenza vaginus parainfluenzae,, Klebsiella spp., Klebsiella oxytoca, Klebsiella pneumoniae, Helicobacter pylori, Morganella morganii, Moraxella catarrhalis (producing and non-producing beta-lactamases), Neisseria meningitidis, Neisseria gonortizing multocida, Pasteurella dagmatis, Providencia spp., Providencia stuartii, Providencia rettgeri, Proteus vulgaris, Proteus mirabilis, Salmonella spp.,Pseudomonas spp., Pseudomonas aeruginosa, Serratia spp., Serratia marcescens;
• anaerobic microorganisms: Bifidobacterium spp., Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus, Fusobacterium spp., Veillonella spp., Propionibacterium spp.;
• other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Bartonella spp., Legionella spp., Legionella pneumophila, Mycobacterium spp., Mycobacterium tuberculosis, Mycobacterium lepalycoprae. Mycoprema hominisia spp.

Moderate sensitivity (zone of inhibition 14-16 mm) to levofloxacin is shown by the following microorganisms:

• aerobic gram-positive microorganisms: Enterococcus faecium, Corynebacterium xerosis, Corynebacterium urealyticum, methicillin-resistant - Staphylococcus haemolyticus and Staphylococcus epidermidis;
• aerobic gram-negative microorganisms: Campylobacter jejuni, Campylobacter coli;
• anaerobic microorganisms: Porphyromonas spp., Prevotella spp.

In vitro resistance to levofloxacin (zone of inhibition 13 mm or less) is shown by the following microbes:

• aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-resistant), Staphylococcus coagulase-negative methi-R (coagulase-negative methicillin-resistant);
• aerobic gram-negative microorganisms: Alcaligenes xylosoxidans;
• anaerobic microorganisms: Bacteroides thetaiotaomicron;
• others: Mycobacterium avium.

Due to the stepwise process of gene mutations that encode both type II topoisomerases (DNA gyrase and topoisomerase IV), resistance to levofloxacin develops. In addition, resistance mechanisms such as the effect on the penetration barriers of the microbial cell (a characteristic mechanism of resistance for Pseudomonas aeruginosa) and efflux (active removal of the antimicrobial substance from the microbial cell) can reduce the sensitivity of microorganisms to levofloxacin. Cross-resistance between levofloxacin and other antimicrobial agents is usually not observed.

The effectiveness of Levofloxacin-Tev is confirmed by the results of clinical studies in the treatment of infectious diseases caused by the following microorganisms:

• aerobic gram-positive microorganisms: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae;
• aerobic gram-negative microorganisms: Enterobacter cloacae, Klebsiella pneumoniae, Citrobacter freundii, Escherichia coli, Haemophilus parainfluenzae, Haemophilus influenzae, Serratia marcescens, Moraxella (Branhamella) catarrhalis, Proteus mirabilis, Morganosa
• others: Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila.

Pharmacokinetics

After a single drip intravenous (intravenous) injection at a dose of 500 mg (duration of infusion is 1 hour), the maximum concentration of levofloxacin in blood plasma (C _max) reaches an average of 0.006 2 mg / ml, at a dose of 750 mg (duration of infusion is 1, 5 hours) - 0.011 5 mg / ml. With single and repeated intravenous administration, the pharmacokinetics of the drug is predictable and linear.

After oral administration, the drug is absorbed quickly and almost completely. The absolute bioavailability is almost 100%. Simultaneous food intake has little effect on the absorption of levofloxacin. Against the background of a single oral dose of Levofloxacin-Teva 500 mg, its _{Cmax is} reached within 1-2 hours and is approximately 0.005 2 mg / ml. With a single / double dose of the drug at a dose of 500 mg, the equilibrium concentration of levofloxacin in the blood plasma is reached within 48 hours.

Serum protein binding - 30-40%. The average volume of distribution (V _d) after a single and multiple intravenous administration or oral administration in a dose of 500 mg averages 100 liters. This indicates a good penetration of levofloxacin into such organs and tissues of the body as lungs, bronchial mucosa, sputum, polymorphonuclear leukocytes, alveolar macrophages, organs of the urinary system, genitals, prostate gland, bone tissue. Levofloxacin penetrates into the cerebrospinal fluid in small amounts.

When prescribed in a dose of 1000 mg per day, cumulation is possible to a small extent.

The drug is metabolized in the liver with the formation of levofloxacin N-oxide and demethyl levofloxacin, which are excreted by the kidneys. Due to the stereochemical stability, levofloxacin does not undergo chiral transformations.

Against the background of a daily dose of 500 mg of levofloxacin, its half-life (T _1/2) is 6-8 hours.

The substance is excreted through the kidneys mainly by glomerular filtration and tubular secretion: more than 85% of the dose - unchanged, less than 5% - in the form of metabolites. The rest of the drug is excreted through the intestines.

In renal failure, T _{1/2 of} levofloxacin increases as the renal creatinine clearance (CC) decreases. After a single dose of 500 mg in patients with CC less than 20 ml / min T _1/2 is 35 hours, CC 20-49 ml / min - 27 hours, CC 50-80 ml / min - 9 hours.

Indications for use

The use of Levofloxacin-Teva is indicated for the following infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin:

• community-acquired pneumonia;
• exacerbation of chronic bronchitis;
• acute bacterial sinusitis;
• uncomplicated and complicated urinary tract infections, including pyelonephritis;
• a chronic form of bacterial prostatitis;
• infections of the skin and soft tissues;
• drug-resistant forms of tuberculosis - as part of complex therapy;
• anthrax - prevention and treatment of airborne infection.

Contraindications

Absolute:

• epilepsy (including history);
• an indication of a history of tendon lesions caused by fluoroquinolones;
• period of pregnancy;
• breast-feeding;
• age up to 18 years;
• individual intolerance to drugs of the quinolone group;
• hypersensitivity to the components of Levofloxacin-Teva.

In addition, additional contraindications for each of the dosage forms:

• solution: peripheral neuropathy, a decrease in the threshold of seizure activity (including acute cerebrovascular accident, inflammatory diseases of the central nervous system, traumatic brain injury), deficiency of glucose-6-phosphate dehydrogenase;
• tablets: pseudoparalytic myasthenia gravis (myasthenia gravis).

Levofloxacin-Teva should be prescribed with caution in case of impaired renal function (CC less than 50 ml / min), impaired liver function, diabetes mellitus, congenital lengthening of the QT interval syndrome, concomitant use of drugs that can cause prolongation of the QT interval (including antiarrhythmic drugs IA and III classes, macrolides, tricyclic antidepressants, antipsychotics, antifungal drugs), electrolyte imbalance (including hypokalemia, hypomagnesemia), cardiovascular diseases (including chronic heart failure, myocardial infarction, bradycardia), mental illness (including anamnesis), concomitant drug therapy the threshold of convulsive readiness of the brain (theophylline, fenbufen), in the elderly patient, female patients.

In addition, when prescribing certain dosage forms of Levofloxacin-Tev, care should be taken if the patient has the following diseases / conditions:

• solution: pseudoparalytic myasthenia gravis, hepatic porphyria, hemodialysis and peritoneal dialysis;
• tablets: the patient's predisposition to the development of seizures (including previous lesions of the central nervous system), latent or manifested deficiency of glucose-6-phosphate dehydrogenase.

Levofloxacin-Teva, instructions for use: method and dosage

Solution for infusion

Levofloxacin-Teva solution is used by intravenous drip.

When using the drug at a dose of 250 mg (50 ml of solution), intravenous infusion should last at least half an hour, at a dose of 500 mg (100 ml of solution) - at least 1 hour.

The following solvents can be used to prepare the infusion solution: 0.9% sodium chloride solution, 5% dextrose solution, or 2.5% Ringer's solution with dextrose.

Recommended dosage:

• community-acquired pneumonia: 500 mg 1-2 times a day, course duration - from 7 to 14 days;
• pyelonephritis and other complicated pathologies of the urinary tract: 250 mg once a day. In a severe course of the disease, an increase in the dose of Levofloxacin-Teva is allowed. Duration of treatment is 7-10 days;
• infectious and inflammatory diseases of the skin and soft tissues: 500 mg 2 times a day (with the same interval between infusions) for 7-14 days.

The course of treatment should not exceed 14 days. After normalization of body temperature, the use of the drug is recommended to continue for at least another 2-3 days.

In case of impaired liver function and in elderly patients, dose adjustment is not required.

In patients with impaired renal function with intravenous drip or oral administration of Levofloxacin-Teva, correction of the dosage regimen is required, which is performed taking into account the CC indicator.

In pathologies with a general dosage regimen of 250 mg once a day, the first dose in patients with impaired renal function should be 250 mg once a day, then the following dosage regimen is adjusted:

• CC 49–20 ml / min: 125 mg once a day;
• CC 19–10 ml / min: 125 mg once every 2 days;
• CC less than 10 ml / min, including patients on continuous outpatient peritoneal dialysis and hemodialysis: 125 mg 1 time in 2 days.

In pathologies with a general dosage regimen of Levofloxacin-Teva, 500 mg once a day, the first dose in patients with impaired renal function should be 500 mg once a day, then the following dosage regimen is adjusted:

• CC 49–20 ml / min: 250 mg once a day;
• CC 19–10 ml / min: 125 mg once a day;
• CC less than 10 ml / min, including patients on continuous outpatient peritoneal dialysis and hemodialysis: 125 mg once a day.

In pathologies with a general dosage regimen of 500 mg 2 times a day, the first dose in patients with impaired renal function should be 500 mg 1 time per day, then the following dosage regimen is adjusted:

• CC 49–20 ml / min: 250 mg 2 times a day;
• CC 19-10 ml / min: 125 mg 2 times a day;
• CC less than 10 ml / min, including patients on continuous outpatient peritoneal dialysis and hemodialysis: 125 mg once a day.

Additional doses are not required after peritoneal dialysis or hemodialysis.

Film-coated tablets

Levofloxacin-Teva tablets are taken orally, swallowing whole and drinking 100 ml or more of liquid, regardless of food intake.

The dose and period of treatment is determined by the doctor, taking into account the sensitivity of the alleged pathogen, the nature and severity of the infection.

If necessary, you can divide the pill by risk.

If taking Levofloxacin-Teva tablets is prescribed after preliminary therapy with a solution of the drug, then the treatment is continued at the same dose.

Recommended dosage:

• acute bacterial sinusitis: 1 pc. (500 mg) once a day for 10-14 days;
• exacerbation of chronic bronchitis: 1 pc. Once a day for 7-10 days;
• community-acquired pneumonia: 1 pc. 1-2 times a day for 7-14 days;
• uncomplicated urinary tract infections: 1/2 each (250 mg) once a day, the course of treatment is 3 days;
• pyelonephritis: 1 pc. Once a day for 7-10 days;
• complicated urinary tract infections: 1 pc. Once a day for 7-14 days;
• chronic bacterial prostatitis: 1 pc. Once a day, duration of treatment - 28 days;
• drug-resistant forms of tuberculosis (as part of complex therapy): 1 pc. 1-2 times a day, course duration - up to 90 days;
• infections of the skin and soft tissues: 1 pc. 1-2 times a day for 7-14 days;
• prevention or treatment of anthrax in case of infection by airborne droplets: 1 pc. Once a day, the duration of therapy is 56 days.

After normalization of body temperature or after reliable eradication of the pathogen, it is recommended to continue taking pills for another three days.

If the liver function is impaired or the patient is elderly, the dose adjustment of Levofloxacin-Teva is not required.

In case of impaired renal function (CC less than 50 ml / min), the dosage regimen is adjusted taking into account the individual CC indicator.

Side effects

Side effects of Levofloxacin-Teva are classified as follows: very often -> 10%; often -> 1% and 0.1% and 0.01% and <0.1%; very rarely - <0.01%, including isolated cases.

Solution for infusion

• on the part of the lymphatic system and the blood system: infrequently - leukopenia, eosinophilia; rarely - thrombocytopenia, neutropenia; very rarely - hemorrhages, agranulocytosis; frequency not established - pancytopenia, hemolytic anemia;
• from the immune system: infrequently - hyperemia, pruritus, rash, swelling of the skin and mucous membranes, urticaria; rarely - difficulty breathing, bronchospasm; very rarely - photosensitivity, angioedema, anaphylactic shock; frequency not established - allergic vasculitis, Lyell's syndrome (toxic epidermal necrolysis), exudative erythema multiforme, Stevens-Johnson syndrome;
• from the nervous system: infrequently - drowsiness, headache, dizziness, insomnia; rarely - anxiety, psychotic reactions, fear, nightmares, anxiety, paresthesia, agitation, confusion, seizures, peripheral sensory neuropathy, tremor, depression, dyskinesia, peripheral sensory-motor neuropathy; very rarely - hypesthesia, impaired vision and hearing, parosmia, loss of smell, impaired tactile sensitivity, loss of taste, dysgeusia, hallucinations; frequency not established - psychotic reactions (including suicidal thoughts, life-threatening actions of the patient), muscle coordination disorders (including extrapyramidal symptoms);
• from the digestive system: often - diarrhea, nausea; infrequently - abdominal pain, vomiting, dyspepsia, anorexia, dysbiosis, indigestion; rarely - pseudomembranous colitis, diarrhea with blood (in rare cases, it is a symptom of enterocolitis); very rarely - symptoms of hypoglycemia (intense sweating, increased appetite, tremors), more often in patients with diabetes mellitus;
• from the hepatobiliary system: often - an increase in the activity of liver transaminases; infrequently - an increase in the level of bilirubin; very rarely - hepatitis;
• on the part of the cardiovascular system: very rarely - lowering blood pressure (BP), sinus tachycardia, vascular collapse, prolongation of the QT interval;
• from the urinary system: infrequently - increased serum creatinine levels; very rarely - interstitial nephritis, acute renal failure;
• on the part of the musculoskeletal system: rarely - muscle weakness, arthralgia, myalgia, tendonitis (including the Achilles tendon); very rarely - tendon rupture (rupture can be bilateral and occur 48 hours after the start of therapy); frequency not established - rhabdomyolysis;
• local reactions: often - redness, pain and / or phlebitis at the injection site;
• others: infrequently - shortness of breath, growth of resistant microorganisms (including fungal flora), asthenia; the frequency is not established - fever, allergic pneumonitis, in patients with porphyria - attacks of porphyria.

Film-coated tablets

• parasitic diseases and infections: infrequently - the growth of resistant pathogenic microorganisms, fungal infections;
• mental disorders: often - insomnia; infrequently - a feeling of anxiety and / or anxiety, confusion; rarely - agitation, sleep disturbances, mental disorders (including hallucinations, paranoia), nightmares, depression; frequency not established - mental disorders with behavioral disorders with self-harm (including suicidal thoughts and attempts);
• from the nervous system: often - headache, dizziness; infrequently - taste perversion (dysgeusia), drowsiness, tremors; rarely - convulsions, paresthesia; frequency not established - loss of taste (ageusia), parosmia (including the subjective sense of odor, which is objectively absent), loss of smell, dyskinesia, peripheral sensory-motor neuropathy, extrapyramidal disorders, sensory peripheral neuropathy, benign intracranial hypertension, syncope;
• from the lymphatic system and blood: infrequently - leukopenia, eosinophilia; rarely - thrombocytopenia, neutropenia; frequency not established - hemolytic anemia, agranulocytosis, pancytopenia;
• from the side of metabolism: infrequently - anorexia; rarely - hypoglycemia (more often in patients with diabetes mellitus); frequency not established - hyperglycemia, hypoglycemic coma;
• from the digestive system: often - diarrhea, nausea, vomiting; infrequently - abdominal pain, constipation, dyspepsia, flatulence; the frequency has not been established - pancreatitis, hemorrhagic diarrhea (including which is a sign of enterocolitis), pseudomembranous colitis;
• from the hepatobiliary system: often - an increase in the activity of liver enzymes in the blood (including alanine aminotransferase, aspartate aminotransferase), alkaline phosphatase and / or gamma-glutamyl transferase; infrequently - an increase in the level of bilirubin in the blood; the frequency has not been established - severe hepatic failure, hepatitis, jaundice, acute liver failure (including cases with a fatal outcome, more often with sepsis or other severe complication of the underlying disease);
• from the side of the organ of vision: very rarely - visual impairment in the form of a blurred visible image; frequency not established - uveitis, transient loss of vision;
• from the organ of hearing and labyrinth disorders: infrequently - vertigo; rarely - ringing in the ears; frequency not established - hearing loss or loss;
• from the respiratory system, chest and mediastinal organs: infrequently - shortness of breath; frequency not established - bronchospasm, allergic pneumonitis;
• on the part of the cardiovascular system: rarely - lowering blood pressure, palpitations, sinus tachycardia; frequency not established - ventricular arrhythmias, prolongation of the QT interval, ventricular tachycardia (including ventricular tachycardia of the "pirouette" type, cardiac arrest);
• from the urinary system: infrequently - an increase in serum creatinine levels; rarely - acute renal failure (including against the background of the development of interstitial nephritis);
• from the immune system: rarely - anaphylactic edema; frequency not established - anaphylactoid shock, anaphylactic shock;
• on the part of the musculoskeletal system: infrequently - myalgia, arthralgia; rarely - muscle weakness, tendon damage (including Achilles tendonitis); the frequency has not been established - arthritis, rhabdomyolysis, ligament rupture, muscle rupture, tendon rupture, including the Achilles tendon (can occur within the first 48 hours after starting Levofloxacin-Teva and be bilateral in nature);
• dermatological reactions: infrequently - rash, itching, hyperhidrosis, urticaria; frequency not established - stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitization reactions, exudative erythema multiforme, leukocytoclastic vasculitis;
• others: infrequently - asthenia; rarely - pyrexia; frequency not established - back pain, chest pain, limb pain; very rarely - attacks of porphyria (in patients with porphyria).

Overdose

Symptoms: Central nervous system disorders, including confusion, hallucinations, convulsions, tremors. Perhaps the appearance of nausea, erosive lesions of the mucous membranes, against the background of exceeding the average therapeutic doses - prolongation of the QT interval.

Treatment: the appointment of symptomatic therapy. There is no specific antidote, therefore, in case of an overdose, careful monitoring of the patient's condition is required (including monitoring the electrocardiogram). If an acute overdose occurs while taking pills, then immediate gastric lavage, the use of antacids to protect the gastric mucosa are indicated. The use of dialysis (hemodialysis, peritoneal dialysis, continuous ambulatory peritoneal dialysis) is ineffective.

special instructions

The therapeutic effect of levofloxacin in severe pneumonia caused by Streptococcus pneumoniae may be ineffective.

Combination therapy may be required to treat hospital-acquired Pseudomonas aeruginosa infections.

For the treatment of severe infections or in the absence of a sufficient effect from therapy, it is necessary to confirm the diagnosis with the results of a microbiological study, including the determination of the sensitivity of the isolated pathogen to levofloxacin.

It is not recommended to prescribe Levofloxacin-Teva for the treatment of infections caused by methicillin-resistant Staphylococcus aureus, due to the established resistance of the latter to all fluoroquinolones.

It should be borne in mind that with intravenous administration of the drug, a transient decrease in blood pressure, increased heartbeat, vascular collapse may occur. In this regard, during the infusion, it is necessary to control blood pressure and in the case of a pronounced decrease in it, immediately stop the procedure for the administration of Levofloxacin-Teva.

Tendon rupture, including the Achilles tendon, can develop within 48 hours after the first dose of the drug and be bilateral. With simultaneous treatment with glucocorticosteroids, the risk of tendon rupture increases. Elderly patients are more prone to the development of tendonitis. Suspicion of tendonitis is the basis for immediate withdrawal of levofloxacin.

If you suspect the development of pseudomembranous colitis (the symptom is severe, persistent and / or bloody diarrhea), the use of levofloxacin should be discontinued immediately. In such cases, the use of drugs that inhibit intestinal motility is contraindicated.

In order to reduce the risk of developing photosensitization reactions during the period of therapy and within 48 hours after its completion, patients should avoid exposure to direct sunlight or artificial ultraviolet radiation.

Due to the fact that the use of levofloxacin can contribute to the increased reproduction of microorganisms that are insensitive to it (bacteria and fungi), causing a change in the normal composition of microflora and the development of superinfection in the body, during treatment it is required to re-evaluate the patient's condition.

With the use of levofloxacin, the rapid development of sensory and sensory-motor peripheral neuropathy is possible. To prevent or minimize the risk of irreversible changes, when the first symptoms of neuropathy appear, it is necessary to stop treatment with the drug.

Consideration should be given to the existing risk of developing psychotic reactions that may occur after a single dose of levofloxacin and progress until the patient has suicidal thoughts or actions. Particular attention should be paid to patients with a history of psychosis or mental illness. When the first signs of mental disorders appear, treatment with Levofloxacin-Teva should be canceled.

In patients with sepsis or other severe underlying disease, the use of levofloxacin increases the risk of developing hepatic necrosis (including cases of fatal liver failure). It is recommended to closely monitor such patients and if signs or symptoms appear that indicate liver damage (including dark urine, abdominal pain, itching, anorexia, jaundice), discontinue drug therapy and seek urgent medical attention.

During the period of treatment with levofloxacin, the results of laboratory tests for the determination of opiates in urine may be false positive. In addition, due to the inhibition of the growth of Mycobacterium tuberculosis by levofloxacin, further bacteriological diagnosis of tuberculosis may give a false negative result.

Influence on the ability to drive vehicles and complex mechanisms

During the period of treatment with Levofloxacin-Teva, patients are advised to refrain from potentially hazardous activities that require increased attention and high speed of psychomotor reactions, including driving.

Application during pregnancy and lactation

The use of Levofloxacin-Teva is contraindicated during the period of gestation and breastfeeding.

Pediatric use

The appointment of Levofloxacin-Teva for the treatment of patients under the age of 18 is contraindicated.

With impaired renal function

Levofloxacin-Teva should be used with caution in patients with impaired renal function (CC less than 50 ml / min).

Correction of the dosage regimen should be made individually, taking into account the QC indicator.

For violations of liver function

Caution should be exercised when using Levofloxacin-Teva for the treatment of patients with impaired liver function. No dose adjustment is required.

Use in the elderly

Levofloxacin-Teva should be used with caution to treat elderly patients. No dosage adjustment is required.

Drug interactions

No pharmacokinetic interaction between levofloxacin and theophylline was found. However, when treating with Levofloxacin-Teva, it should be borne in mind that quinolones can enhance the ability of fenbufen, theophylline and similar non-steroidal anti-inflammatory drugs (NSAIDs) to lower the seizure threshold of the brain.

The combination with fenbufen increases the concentration of levofloxacin by 13%.

With concomitant therapy with probenecid, cimetidine and other drugs that disrupt renal tubular secretion, there is a slight slowdown in the excretion of levofloxacin. This combination can have clinically significant consequences in patients with impaired renal function, therefore, caution is advised.

The combination of levofloxacin with warfarin and other indirect anticoagulants derived from coumarin increases the risk of bleeding and / or hypercoagulability. Therefore, if necessary, the simultaneous use of these funds requires regular monitoring of blood clotting indicators (prothrombin time, international normalized ratio).

The risk of developing hyperglycemia or hypoglycemia increases when Levofloxacin-Teva is combined with oral hypoglycemic agents (including glibenclamide) or insulin, therefore, during the treatment period, more careful monitoring of blood glucose levels in patients with diabetes is required.

Against the background of combination therapy with glucocorticosteroids, the risk of tendon rupture increases.

T _{1/2 of} cyclosporin increases by 33%, however, its dose adjustment is not required when used simultaneously with levofloxacin.

With the simultaneous use of Levofloxacin-Teva with antiarrhythmic drugs of IA and III classes, tetracyclic and tricyclic antidepressants, neuroleptics, macrolides, some antihistamines (including astemizole, ebastine, terfenadine), antifungal agents, imidazole derivatives, the QT interval may be lengthened.

The solution for infusion is not compatible with solutions that have an alkaline reaction, heparin. It can be mixed with combined solutions for parenteral nutrition (electrolytes, amino acids, carbohydrates).

If it is necessary to simultaneously use the tablet form of Levofloxacin-Teva with dosage forms of didanosine containing aluminum or magnesium as a buffer, or other magnesium-, aluminum-, zinc or iron-containing agents, it is recommended to take a break of at least 2 hours between the ingestion of levofloxacin and these drugs.

When taking levofloxacin inside, calcium salts have a minimal effect on its absorption.

With concomitant therapy with sucralfate, it should be taken only 2 hours after oral administration of Levofloxacin-Teva, so as not to weaken the effect of Levofloxacin.

The results of clinical and pharmacological studies indicate the absence of a clinically significant pharmacokinetic interaction of levofloxacin with ranitidine, warfarin, digoxin, glibenclamide.

Analogs

Levofloxacin-Teva analogs are: Levofloxacin, Levofloxacin Stada, Ashlev, Glevo, Ivacin, Levolet P, Levostar, Lebel, Levoximed, Levotek, Levoflox, Levoflox-Routek, Leobeg, Leflobakt, Levofloxacin, Leflobakt-Forlocine -Levox, Lefsan, Lufy, Remedia, Flexid, Floracid, Haileflox, Eleflox, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store in a dark place at a temperature: up to 30 ° C - solution, up to 25 ° C - tablets. The solution must not be frozen!

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Levofloxacin-Teva

Reviews of Levofloxacin-Teva from doctors and patients are predominantly positive. They indicate the high efficiency of the drug in the treatment of severe infectious and inflammatory diseases. At the same time, many patients attribute frequent mental disorders, undesirable phenomena from the nervous and digestive systems to the disadvantages of Levofloxacin-Teva.

Price for Levofloxacin-Teva in pharmacies

The price of Levofloxacin-Teva 500 mg per package containing 7 tablets can be 306–408 rubles, 14 tablets - 580–749 rubles. 1 bottle of solution costs from 344 rubles.

Levofloxacin-Teva: prices in online pharmacies

Drug name Price Pharmacy

Levofloxacin-Teva 500 mg film-coated tablets 7 pcs. 338 r Buy

Levofloxacin-Teva 500 mg film-coated tablets 14 pcs. 487 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!