Levostar - instructions for use, dose, side effects, contraindications

excipients: tablet core - sodium stearyl fumarate - 6.4 mg, crospovidone (Polyplasdone XL) - 12.8 mg, silicon dioxide colloidal anhydrous (Aerosil 200) 1.6 mg, Copovidone (Plasdon S-630) - 16.0 mg, cellulose microcrystalline - 26.97 mg;

shell: Opaprai II pink 31K34554 (lactose monohydrate 3.84 mg, IRMS 2910 / hypromellose 15 cP 2.688 mg, titanium dioxide 2.2886 mg, triacetin 0.768 mg iron dye red oxide 0.0096 mg, iron oxide yellow oxide 0.0058 mg) .

1 tablet, film-coated, 500 mg contains:

active substance: levofloxacin hemihydrate - 512.46 mg corresponding to 500.0 mg of levofloxacin;

excipients: tablet core - sodium stearyl fumarate - 12.8 mg, crospovidone (Pollinasdon XL) - 25.6 mg, silicon dioxide colloidal anhydrous (Aerosil 200) - 3.2 mg, copovidone (Plasdon S-630) - 32.0 mg, cellulose microcrystalline - 53.94 mg;

shell: Drop 11 pink 31K34554 (lactose monohydrate - 7.68 mg.PRMC 2910 / hypromellose 15 cp - 5.376 mg, titanium dioxide 4.5772 mg, triacetin 1.536 mg, iron oxide red oxide 0.0192 mg, iron oxide yellow oxide 0.0116 mg).

Description:

Tablets 250 mg: oval biconvex tablets, covered with a pink film shell, with a risk on one side of the tablet and engraving "L" - another.

Tablets 500 mg: oval biconvex tablets, covered with a pink film shell, with a risk on one side of the tablet and engraving "L" - On the other.

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 the levorotatory isofloxacin isomer. It blocks DNA gyuriz (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, inhibits DIC synthesis, causes profound morphological changes in the cytoplasm, cell wall, and membranes of microbial cells. Effective against most strains of microorganisms both in conditions in vitro and in vivo.

In vitro

Sensitive microorganisms (MIIK ≤2 mg / l; inhibition zone ≥ 17 mm)

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

- Aerobic gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter cloacae, Enterobacter spp., Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R (ampicillin-sensitive / -resistant). Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Moraxella catarrhalis β+/β- (producing and ne producing beta-lactamases), Morganella niorganii, Neisseria gonorrhoeae non PPNG/PPNG (producing and ne producing penicillinase), Neisseria meningitidis. Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp., Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp., Pseudomonas aeruginosa (hospital infections caused by Pseudomonas aeruginosa, may require combined treatment), Pseudomonas spp., Salmonella spp., Serratia marcescens, Serratia spp.

- Anaerobic microorganisms: Bacteroides Fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veillonella spp.

- Other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci. Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp., Mycobacterium leprae, Mycobacterium tuberculosis. Mycoplasma hominis.Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Moderately sensitive microorganisms (IPC = 4 mg / l: inhibition zone 16-14 mm)

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

- Aerobic Gram-negative microorganisms: Campylobacter jejuni/coli.

- Anaerobic microorganisms: Prevotella spp., Porphyromonas spp.

Resistant to levofloxacin microorganisms (MIC ≥ 8 mg / l; inhibition zone ≤ 13 mm):

- Aerobic gram positive microorganisms: Staphylococcus aureus methi-R (methicillin-resistant), Staphylococcus coagulase-negative methi-R (coagulase-negative methicillin-resistant).

- Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.

- Anaerobic microorganisms: Bacteroides thetaiotaomicron.

- Other microorganisms: Mycobacterium avium.

In vivo

Clinical efficacy (effectiveness in clinical trials in the treatment infections caused by the following microorganisms)

- Aerobic Gram-positive microorganisms: Enterococcus Faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.

- Aerobic Gram-negative microorganisms: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis. Pseudomonas aeruginosa, Serratia marcescens.

- Other: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

Resistance

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

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

Pharmacokinetics:

When ingested quickly and almost completely absorbed (food intake has little effect on the speed and completeness of absorption). Absolute bioavailability with ingestion is 99 - 100%. Time to reach the maximum concentration in the plasma (TC_m_Oh) - 1 hour. The connection with plasma proteins is about 30 - 40%. On the 10th day of taking levofloxacin in a dose of 500 mg once a day, the maximum concentration (C_max) of levofloxacin in blood plasma was 5.7 μg / ml, and the minimum concentration of levofloxacin (concentration before taking the next dose) (Cmin) in blood plasma was 0.5 μg / ml. On 10 day of ingestion of levofloxacin in a dose of 500 mg twice a day C_m_Oh levofloxacin in blood plasma was 7.8 μg / ml, and C_min - 3 μg / ml. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, polymorphonuclear leukocytes, alveolar macrophages. FROM_m_Oh levofloxacin in bronchial mucosa and epithelial lining fluid after a single oral intake of 500 mg of the drug - 8.3 μg / g and 10.8 μg / ml, respectively; FROM_m_Ohlevofloxacin in the blister fluid - 4,0 - 6.7 μg / ml, TS_m_Oh - 2 - 4 hours._m_Oh in the lung tissue after a single oral intake of 500 mg of the drug - 11.3 μg / g, and TC_m_Oh 4-6 hours. Levofloxacin penetrates into the cerebrospinal fluid in small amounts. When oral levofloxacin at a dose of 500 mg / day for the third day of treatment C_m_Oh in the tissues of the prostate gland 2, 6 and 24 hours after taking the drug - 8.7 μg / g, 8.2 μg / g and 2.0 μg / g, respectively. The ratio of prostatic / plasma concentrations averaged 1.84. The average value of C_m_Oh in the urine after taking 500 mg of the drug after 8-12 hours - 200 mg / l. In the liver, a small part of the preparation is oxidized and / or deacetylated. The half-life (T_1/2) - 6-8 hours. Excreted mainly by the kidneys (about 85% of the dose) by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites.

During clinical trials, there was a difference in the pharmacokinetics of the drug in both men and women.

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

With renal failure, the pharmacokinetics of levofloxacin varies. As the kidney function worsens, excretion through the kidneys and kidney clearance (ClR) decrease, and T_1/2increases.

Pharmacokinetics in renal failure after a single oral intake of 500 mg of levofloxacin.

CK (ml / min)	<20	20 - 49	50-80
C1R (ml / min)	13	26	57
T_1/2 (h)	35	27	9

Indications:

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

- infection of the lower respiratory tract (exacerbation of chronic bronchitis, community-acquired pneumonia):

- acute sinusitis;

- uncomplicated urinary tract infections;

- complicated urinary tract infections (including pyelonephritis);

- chronic bacterial prostatitis;

- skin and soft tissues;

- tuberculosis (complex therapy of drug-resistant forms).

Contraindications:

Hypersensitivity to levofloxacin or other fluoroquinolones, as well as to the auxiliary substances of the drug, epilepsy, pseudo-paralytic myasthenia gravis (myasthenia gravis), defeat of tendons with prior treatment with quinolones, pregnancy, the period of breastfeeding, children and adolescence (up to 18 years), lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

- In patients who are predisposed to developing seizures (in patients with previous central nervous system (CNS) lesions) in patients receiving concomitant medications that reduce the threshold of seizure readiness of the brain, such as fenbufen, theophylline).

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

- In patients with impaired renal function (mandatory control of kidney function, as well as correction of the dosing regimen) is required.

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

- In patients with diabetes mellitus receiving oral hypoglycemic drugs, for example glibenclamide or insulin preparations (the risk of developing hypoglycemia increases).

- In patients with severe adverse reactions to other fluoroquinolones, such as severe neurologic reactions (increased risk of similar adverse reactions with levofloxacin).

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

Dosing and Administration:

The drug Levostar in a dose of 250 mg or 500 mg is taken orally once or twice a day. Tablets should be swallowed, ns chewing and squeezed with a sufficient amount of liquid (0.5 to 1 cup). If necessary, tablets can be broken at risk.

The drug can be taken before meals or at any time between meals, as eating does not affect the absorption of the drug.

Given that the bioavailability of levofloxacin when taking Levostar in tablets is 99-100%,in the case of transfer of a patient with intravenous infusion of levofloxacin on the taking of tablets, the treatment should be continued at the same dose as was used for intravenous infusion.

In case of skipping Levostar, it is necessary to take the next dose as soon as possible and continue taking the drug according to the recommended dosage regimen.

The recommended dose of the drug for adults with normal renal function (CK> 50 ml / min):

In acute sinusitis - 2 tablets 250 mg or 1 tablet 500 mg once a day for 10 to 14 days;

With an exacerbation of chronic bronchitis - 2 tablets 250 mg or 1 tablet 500 mg once a day for 7 to 10 days;

With community-acquired pneumonia - 2 tablets 250 mg or 1 tablet 500 mg 1 - 2 times a day for 7-14 days;

With uncomplicated urinary tract infections - 1 tablet 250 mg once a day for 3 days;

With complicated infections of the urinary tract - 2 tablets 250 mg or 1 tablet 500 mg once a day for 7-14 days;

With pyelonephritis - but 2 tablets 250 mg or 1 tablet 500 mg once daily for 7-10 days;

With chronic bacterial prostatitis - 2 tablets 250 mg or 1 tablet 500 mg once a day for 28 days;

With infections of the skin and soft tissues - but 2 tablets 250 mg or 1 tablet 500 mg 1 or 2 times a day for 7 to 14 days.

In the complex treatment of drug-resistant forms of tuberculosis - Inside, 1 tablet 500 mg 1 - 2 times a day for up to 3 months.

For patients with impaired renal function (CK <50 ml / min):

Creatinine clearance, ml / min	Dosing regimen
Creatinine clearance, ml / min	250 mg / 24 hours first dose: 250 mg	500 mg / 24 hours first dose: 500 mg	500 mg / 12 h, the first dose of 500 mg
50-20	then: 125 mg / 24 h	then: 250 mg / 24 h	then: 250 mg / 12 h
19-10	then: 125 mg / 48 h	then: 125 mg / 24 h	then: 125 mg / 12 h
<10 (including hemodialysis and DAPD) *	then: 125 mg / 48 h	then: 125 mg / 24 h	then: 125 mg / 24 h

* No additional doses are required after hemodialysis or prolonged outpatient peritoneal dialysis (DAPD).

If the liver function is not required, a special dose selection is required, since levofloxacin It is only slightly metabolized in the liver and excreted mainly by the kidneys.

The duration of therapy depends on the type of disease (see above). In all cases, treatment is recommended to continue for 48 to 72 hours after the disappearance of the symptoms of the disease.

Side effects:

The incidence of adverse reactions is distributed as follows: Often (≥ 1/10), often (≥ 1/100, ≤1/10), infrequently (≥ 1/1000, ≤1/100), rarely (≥ 1/10000, ≤1/1000), rarely (≤ 1/10000) (including individual messages), frequency unknown (according to available data, it is not possible to determine the frequency of occurrence).

Infectious and parasitic diseases

Infrequently - mycoses, development of resistance of pathogenic microorganisms.

Impaired curvature and lymphatic system

Infrequently - leukopenia (decrease in the number of leukocytes in the peripheral blood), eosinophilia (an increase in the number of eosinophils in peripheral blood).

Rarely - Thrombocytopenia (decrease in the number of platelets in the peripheral blood), neutropenia (a decrease in the number of neutrophils in peripheral blood).

Frequency unknown - pancytopenia (decrease in the number of all elements in the peripheral blood), agranulocytosis (absence or sharp decrease in the amount of granulocytes in the peripheral blood), hemolytic anemia.

Immune system disorders

Rarely - angioedema.

Frequency unknown - hypersensitivity, anaphylactoid shock, anaphylactic shock (see section "Special instructions").

Disorders from the metabolism and nutrition

Infrequently anorexia.

Rarely - hypoglycemia, usually in patients with diabetes mellitus (possible signs of hypoglycemia: increased appetite, increased sweating, trembling) (see section "Special instructions").

Frequency unknown hyperglycemia, hypoglycemic coma.

Disorders of the psyche

Often - Insomnia.

Infrequently - a feeling of anxiety, anxiety, confusion.

Rarely - psychotic disorders (eg, hallucinations, paranoia), depression, agitation, sleep disturbances, nightmares.

Frequency unknown - psychotic reactions associated with suicidal thoughts or attempts and attempts to harm their own health (see section "Special instructions").

Disturbances from the nervous system

Often - headache, dizziness.

Infrequently - drowsiness, tremor, dysgeusia (perversion of taste).

Rarely - cramps, paresthesia.

Frequency unknown - sensory or sensory-motor peripheral neuropathy: dyskinesia, extrapyramidal disorders, loss of taste sensations; distortion of the sense of smell, including its loss, fainting, benign intracranial hypertension.

Disturbances on the part of the organ of sight

Rarely - visual impairment, such as the vagueness of the visible image.

Frequency unknown - transient loss of vision.

Hearing disorders and labyrinthine disorders

Infrequently - Vertigo.

Rarely - ringing in the ears.

Frequency unknown - Hearing loss, hearing loss.

Heart Disease

Rarely - Sinus tachycardia, palpitation.

Frequency unknown - interval lengthening QT, ventricular arrhythmias, ventricular tachycardia, ventricular pirouette tachycardia, which can lead to cardiac arrest (see sections "Special instructions", "Overdose").

Vascular disorders

Rarely - lowering blood pressure.

Disturbances from the respiratory system, chest and mediastinal organs

Infrequently - shortness of breath.

Frequency unknown - bronchospasm, allergic pneumonitis.

From the digestive system

Often - diarrhea, vomiting, nausea.

Infrequently - pain in the abdomen, indigestion, flatulence, constipation.

Frequency unknown - diarrhea with an admixture of blood, which in very rare cases can indicate the development of enterocolitis, including pseudomembranous colitis, pancreatitis.

Disturbances from the liver and bile ducts

Often - increased activity of "hepatic" transaminases (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase).

Infrequently - Increased bilirubin concentration in the blood.

Frequency unknown - hepatitis, jaundice, severe hepatic failure, including cases of acute liver failure, sometimes fatal, particularly in patients with severe underlying disease patients (eg, patients with sepsis) (see. section "Special instructions").

Disturbances from the skin and subcutaneous tissues

Infrequently - rash, itching, hives, hyperhidrosis.

Frequency unknown - toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, photosensitivity reactions, leukocytoclastic vasculitis, stomatitis. Mucosal reactions can sometimes occur after the first dose of the drug.

Disturbances of musculoskeletal and connective tissue

Infrequently - Arthralgia, myalgia.

Rarely - defeat of tendons (seesection "Special instructions"), including tendonitis, muscle weakness, which may be of particular importance for patients with myasthenia gravis gravis.

Frequency unknown - rhabdomyolysis, tendon rupture (this side effect can develop within 48 hours after initiation of therapy, and may be noted bilateral), ligament rupture, muscle rupture, arthritis.

Disorders from the kidneys and urinary tract

Infrequently - Increased serum creatinine concentration.

Rarely - Acute renal failure (for example, caused by the development of interstitial nephritis).

General disorders and disorders at the site of administration

Infrequently - asthenia.

Rarely - Hyperthermia.

Other side effects that may be associated with the use of fluoroquinolones: porphyria attacks in patients with porphyria.

Frequency unknown - pain (including pain in the back, chest, limbs)

Overdose:

The expected symptoms of an overdose of Levostar are manifested at the level of the central nervous system (confusion, dizziness, impaired consciousness, and epileptic seizures). In addition, gastrointestinal disorders (eg, nausea) and erosive lesions of the gastrointestinal mucosa can be noted.

From the side of the cardiovascular system, lengthening of the interval QT.

Treatment is symptomatic. In case of acute overdosage, gastric lavage and administration of antacids are indicated to protect the gastric mucosa. It is necessary to conduct ECG monitoring to monitor the interval QT. Levofloxacin is not excreted 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 threshold of convulsive readiness. Equally, this also applies to simultaneous use of quinolones. theophylline and non-steroidal anti-inflammatory drugs. Preparations containing divalent or trivalent cations, such as sucralfate, magnesium or aluminum-containing agents (such as antacids), didanosine (only dosage forms containing aluminum or magnesium as a buffer), iron and zinc salts should be taken with a break between receptions for at least 2 hours. Calcium salts have a minimal effect on the absorption of levofloxacin upon ingestion.

Levofloxacin, like other quinolones, should be used with caution in patients taking drugs that extend the interval QT (antiarrhythmic drugs class IA and III, tricyclic antidepressants, neuroleptics, macrolides); The use of glucocorticosteroids increases the risk of rupture of tendons.

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

Removal (renal clearance) of levofloxacin slightly slows down under the action of cimetidine and probenecid in view of the possible blocking of the tubular secretion of levofloxacin in the kidneys. It should be noted that this interaction is of clinical importance, primarily for patients with impaired renal function.

Levofloxacin increases the half-life of cyclosporine.

Clinical and pharmacological studies of possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide. ranitidine and warfarin showed that changes in pharmacokinetic parameters of levofloxacin when used simultaneously with these drugs are clinically insignificant.

Special instructions:

Treatment of hospital infections caused by certain pathogens (Pseudomonas aeruginosa), may require combination therapy. The prevalence of the acquired resistance of the sown strains of microorganisms can vary depending on the geographical region and over time. In this regard, information about drug resistance in a particular country is required. For the therapy of severe infections and in the ineffectiveness of treatment, a microbiological diagnosis should be made with the isolation of the pathogen and the determination of its sensitivity to levofloxacin.

Methicillin-resistant strain Staphylococcus aureus (MRSA)

Methicillin-resistant strains Staphylococcus aureus most likely to have cross-resistance to fluoroquinolones, including levofloxacin. Therefore, levofloxacin therapy is not recommended in case of suspicion or in the case of confirmation of a disease caused by MRSA until the sensitivity of the microorganism to levofloxacin is confirmed.

Tendonitis and rupture of tendons

In rare cases, with the drug Levostar may develop tendonitis. Tendinitis (primarily, inflammation of the Achilles tendon), developed against the background of the drug, can lead to rupture of tendons. This side effect can develop within 48 hours after the start of treatment and can be bilateral. Elderly patients and patients taking glucocorticosteroids are most prone to developing tendonitis. When taking the drug in this group of patients, you should carefully monitor their condition. Patients should inform the attending physician about the appearance of symptoms of tendinitis. If suspected pa tendonitis should immediately stop treatment with Levostar and begin appropriate treatment of the affected tendon, for example, providing him with a resting state (see the sections "Contraindications", "Side effect").

Diseases caused by Clostridium difficile

Diarrhea, especially a severe, persistent form with an admixture of blood, occurring during or after taking the drug, may be a sign of a disease caused by Clostridium difficile. The most severe form of this disease is pseudomembranous colitis. If suspected pseudomembranous colitis should immediately stop taking Levostar and immediately begin a specific antibiotic therapy (for example, intake of vancomycin). In this case, drugs that inhibit intestinal peristalsis are contraindicated.

Patients who are predisposed to develop seizures

It should be borne in mind that in patients with a history of brain damage (stroke, severe craniocerebral injury) may develop seizures. Also, caution should be exercised when taking Levostar and taking medications that lower the threshold for convulsive readiness (see "Interaction with Other Drugs"). In case of seizures, taking Levostar should be stopped.

Patients with deficiency of glucose-6-phosphate dehydrogenase

With a deficiency of glucose-6-phosphagdehydrogenase, but the time of treatment with quinolones, there is a risk of hemolysis.

Patients with impaired renal function

Because the levofloxacin is excreted mainly by the kidneys, in patients with impaired renal function, a correction of the dosing regimen is required (see Fig.section "Method of administration and dose") and control of renal function. In the treatment of elderly patients, it should be borne in mind that patients of this group often have impaired renal function.

Hypersensitivity reactions

Levofloxacin can cause severe hypersensitivity reactions that threaten the patient's life (eg, angioedema, up to anaphylactic shock), even after the first intake of the drug. If these reactions develop, Levodar should be stopped immediately and appropriate therapy started.

Severe bullous reactions

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

Hypo-and hyperglycemia

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

Prevention of photosensitivity reactions

Although the occurrence of photosensitivity reactions during the admission of levofloxacin is very rare, sunlight and artificial ultraviolet irradiation (solarium) should be avoided during treatment and during 48 hours after the end of levofloxacin treatment to avoid damage to the skin (photosensitivity).

Superinfection

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

Psychotic reactions

In patients taking quinolones, including levofloxacin, it is possible to develop psychotic reactions. In very rare cases, even after taking the first dose of levofloxacin, these reactions can go into suicidal thoughts and behavior aimed at causing harm to one's health (see the "Side effect" section). In case of occurrence of the reactions described above, stop taking Levostar and take appropriate measures. It should be used with caution in the appointment of patients with psychosis or patients with a history of mental illness.

Visual disturbances

With the development of any visual impairment, an immediate consultation of the ophthalmologist is necessary.

Increase in the interval OT

Use with caution in patients who have risk factors for lengthening the interval QT:

- congenital lengthening interval QT;

- simultaneous use of drugs that extend the interval QT (for example, antiarrhythmic drugs of the class IA and III, tricyclic antidepressants, macrolides, neuroleptics);

- electrolyte balance disorders (eg, hypokalemia, hypomagnesemia);

- patients of advanced age;

- female patients;

- heart disease (eg, heart failure, myocardial infarction, bradycardia).

Peripheral Neuropathy

When taking fluoroquinolones, including when taking levofloxacin, there were reports of the development of sensory or sensorimotor peripheral neuropathy, the symptoms of which develop rapidly. If the patient has symptoms of neuropathy, stop taking Levostar in order to prevent the development of an irreversible condition of the disease.

Exacerbation of pseudo-paralytic myasthenia gravis (myasthenia gravis)

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

Laboratory Tests

Levofloxacin can give a false positive result for opiates, determined in urine using immunological test systems. Therefore, during the treatment with levofloxacin, more specific methods for the analysis of opiates should be used.

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

Dysfunction of the liver and bile duct

There have been reports of the development of liver necrosis including the development of fatal liver failure with levofloxacin. These phenomena were observed, first of all, in patients with a severe course of a disease (for example, sepsis) (see section "Side effect"). Patients should be alerted to stop treatment and seek immediate medical attention if signs and symptoms of liver damage such as anorexia, jaundice, darkening of the urine, pruritus and abdominal pain occur.

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

During the treatment with Levostar, care must be taken when driving vehicles and mechanismsand the employment of other potentially hazardous activities requiring an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 250 mg, 500 mg.

Packaging:

5, 7 or 10 tablets per blister 1 IBX/Aluminium foil. For 1 or 2 blisters but 5 or 7 tablets or 1 blister for 10 tablets, along with the instruction, but they are placed in a cardboard box.

Storage conditions:

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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006453/09

Date of registration:13.08.2009 / 10.07.2017

Expiration Date:Unlimited

The owner of the registration certificate:AKTAVIS GROUP, AO AKTAVIS GROUP, AO Iceland

Manufacturer: & nbsp

ACTAVIS hf. Iceland

ACTAVIS, Ltd. Iceland

Representation: & nbspAktavis, Open Company Aktavis, Open Company

Information update date: & nbsp07.03.2018

Illustrated instructions

Instructions

Levostar (Levostar)