Levofloxacin-VERTEX - Instructions For Use, Tablets 500 Mg, Price

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

Levofloxacin-VERTEX

Levofloxacin-VERTEX: 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-VERTEX

ATX code: J01MA12

Active ingredient: Levofloxacin (Levofloxacin)

Manufacturer: JSC "VERTEX" (Russia)

Description and photo update: 2020-10-08

Prices in pharmacies: from 639 rubles.

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Levofloxacin-VERTEX is a broad-spectrum antimicrobial agent.

Release form and composition

The drug is produced in the form of film-coated tablets: biconvex, round, yellow; the cross section shows the core from white to pale yellow (5 or 10 pcs. in a blister strip, in a cardboard box 1-2 packs of 5 pcs. or 1 pack of 10 pcs.; 5 or 10 pcs. in in a polyethylene can, in a cardboard box of 1 can. Each pack also contains instructions for the use of Levofloxacin-VERTEX).

1 tablet contains:

• active substance: levofloxacin - 250 or 500 mg;
• additional components: croscarmellose sodium, microcrystalline cellulose, polysorbate 80, hypromellose, calcium stearate;
• film shell: hypromellose (hydroxypropyl cellulose), hypromellose, titanium dioxide, dye iron oxide yellow (iron oxide), talc.

Pharmacological properties

Pharmacodynamics

Levofloxacin is a synthetic broad-spectrum antibacterial drug that belongs to the group of fluoroquinolones. The active substance is the levorotatory isomer of ofloxacin. The drug inhibits the synthesis of deoxyribonucleic acid (DNA), disrupts supercoiling and stitching of DNA breaks, inhibits topoisomerase IV and DNA gyrase, promotes the development of deep morphological changes in the membranes, cytoplasm and cell wall of bacteria. Shows activity against most strains of microorganisms in vitro and in vivo.

In vitro sensitivity to Levofloxacin-VERTEX is shown by the following microorganisms [in the zone of inhibition ≥ 17 mm, minimum inhibitory concentration (MIC) ≤ 2 mg / L]:

• Gram-negative aerobes: Acinetobacter spp., Citrobacter freundii, Acinetobacter baumannii, Aggregatibacter (formerly Actinobacillus) actinomycetemcomitans, Enterobacter aerogenes, Eikenella corrodens, Escherichia coli, Enterobacter Rugilis spp., Enterobacter vaginus cloacae, Enterobacter influenza cloacae ampicillin-susceptible / -resistant), Klebsiella oxytoca, Klebsiella spp., Helicobacter pylori, Klebsiella pneumoniae, Haemophilus parainfluenzae, Moraxella catarrhalis β + / β- (producing and non-producing PPr-lactamase non-beta-lactamase), Morganella Nephi producing and non-producing penicillinase), Pasteurella dagmatis, Pasteurella canis, Neisseria meningitidis, Pasteurella spp., Pasteurella multocida, Proteus vulgaris, Proteus mirabilis, Providencia spp., Providencia stuartii,Providencia rettgeri, Pseudomonas aeruginosa, Pseudomonas spp., Serratia marcescens, Salmonella spp., Serratia spp.;
• aerobes gram-positive: Corynebacterium jeikeium, Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Corynebacterium diphtheriae, Enterococcus spp., Staphylococcus coagulase-negative methi-S (I) (moderately sensitive, methi-S (I) (coagulasesensitive / sensitive) Staphylococcus aureus methi-S (methicillin-sensitive), Staphylococcus spp. CNS (coagulase negative), Streptococcus agalactiae; Streptococci groups C and G, Streptococcus pneumoniae peni I / S / R (penicillin-moderately sensitive / -sensitive / -resistant), Viridans streptococci peni-S / R penicillin-sensitive / -resistant);
• anaerobes: Bifidobacterium spp., Bacteroides fragilis, Clostridium perfringens, Veillonella spp., Propionibacterium spp., Peptostreptococcus, Fusobacterium spp.;
• other microorganisms: Chlamydia psittaci, Chlamydia pneumoniae, Bartonella spp., Chlamydia trachomatis, Legionella spp., Legionella pneumophila, Mycobacterium tuberculosis, Mycobacterium spp., Mycoplasma hominalyumis.

The following microbes exhibit moderate sensitivity to Levofloxacin-VERTEX (inhibition zone 16–14 mm, MIC = 4 mg / l):

• gram-negative aerobes: Campylobacter coli, Campylobacter jejuni;
• gram-positive aerobes: Enterococcus faecium, Corynebacterium xerosis, Corynebacterium urealyticum; Staphylococcus haemolyticus methi-R and Staphylococcus epidermidis methi-R (methicillin-resistant);
• anaerobes: Porphyromonas spp., Prevotella spp.

In vitro resistance to Levofloxacin-VERTEX is shown by the following microorganisms (zone of inhibition ≤ 13, MIC ≥ 8 mg / l):

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

Resistance in strains of infectious pathogens to the action of levofloxacin arises as a result of the stepwise process of the formation of mutations in genes that encode both type II topoisomerases - DNA gyrase and topoisomerase IV. Also, mechanisms such as the effect on the penetration fences of the microbial cell (characteristic of Pseudomonas aeruginosa) and efflux (active excretion of the antibacterial agent from the microbe cell) can also contribute to the increase in the resistance of microorganisms to Levofloxacin-VERTEX.

As a rule, cross-resistance between levofloxacin and other antimicrobial drugs is not observed, which is explained by the mechanism of action of this active substance.

In the course of clinical studies, the efficacy of Levofloxacin-VERTEX in the treatment of infectious lesions excited by the following microorganisms was established:

• gram-negative aerobes: Haemophilus influenzae, Citrobacter freundii, Escherichia coli, Haemophilus parainfluenzae, Enterobacter cloacae, Klebsiella pneumoniae, Morganella morganii, Moraxella (Branhamella) catarrhalis, Pseudomonas aerugilis, Proteces marns;
• gram-positive aerobes: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae;
• other microorganisms: Legionella pneumophila, Chlamydia pneumoniae, Mycoplasma pneumoniae.

Pharmacokinetics

After oral administration of Levofloxacin-VERTEX, the active substance is rapidly and almost completely absorbed. Food intake has little effect on its absorption. Absolute bioavailability is 99-100%. The maximum concentration (C _max) of levofloxacin in the blood plasma after taking it at a dose of 500 mg is fixed after 1-2 hours and is 5.2 ± 1.2 μg / ml. After taking doses in the range of 50-1000 mg, the pharmacokinetics of the antimicrobial agent is linear. The equilibrium state of the plasma content of levofloxacin when taken orally at a dose of 500 mg 1-2 times / day is achieved within 48 hours.

On the 10th day of treatment with levofloxacin at a dose of 500 mg 1 time / day, its C _max was 5.7 ± 1.4 μg / ml, and the minimum plasma concentration (C _min), the level before the next dose, was 0.5 ± 0, 2 μg / ml. On the 10th day of taking 500 mg 2 times / day, C _max was 7.8 ± 1.1 μg / ml, C _min - 3.0 ± 0.9 μg / ml.

The agent binds to serum proteins by 30-40%. With single and repeated use at a dose of 500 mg, the volume of distribution (V _d) of the active substance is on average 100 liters, which indicates a wide distribution in organs and tissues.

After oral administration 1 time / day at a dose of 500 mg in the fluid of the epithelial lining and bronchial mucosa, C _{max of} levofloxacin was observed for 4 or 1 h, respectively, and amounted to 10.8 μg / ml and 8.3 μg / g, with penetration coefficients in epithelial lining fluid and bronchial mucosa compared with plasma levels in the blood - 0.8-3 and 1.1-1.8, respectively. On the sixth day of treatment at the same dose, 4 hours after the last use of Levofloxacin-VERTEX, its mean concentrations in alveolar macrophages and epithelial lining fluid were 97.9 and 9.94 μg / ml, respectively.

In lung tissue after oral administration of the active substance at a dose of 500 mg, C _max was approximately 11.3 μg / g and was fixed after 4–6 hours, with penetration coefficients of 2–5 when compared with plasma levels.

In the alveolar fluid, 3 days after the start of administration, 1 or 2 times / day, 500 mg _{Cmax of} levofloxacin was reached 2–4 hours after administration and amounted to 4 and 6.7 μg / ml, respectively, with a penetration coefficient of 1, compared to plasma level. In the tissue of the prostate gland after taking 1 time / day for 3 days, the content of the agent was 8.7 μg / g, the ratio of prostate / blood plasma concentrations was approximately 1.84.

8–12 hours after oral administration of levofloxacin at doses of 150, 300, or 600 mg, its mean urinary concentrations were 44, 91, or 162 μg / ml, respectively.

The drug does not penetrate well into the cerebrospinal fluid. It is well distributed in cancellous and cortical bone tissue, including the proximal and distal femur, with a penetration coefficient (bone tissue / blood plasma) of 0.1–3. In the cancellous bone tissue of the proximal femur, after taking 500 mg after 2 hours, the C _{max of} levofloxacin averaged 15.1 μg / g.

The active substance is biotransformed very weakly, at the level of 5% of the dose received. In the process of metabolism of levofloxacin, N-oxide levofloxacin and desmethyl levofloxacin are formed, excreted by the kidneys. Due to stereochemical stability, the starting material is not subject to chiral transformations.

Levofloxacin is excreted slowly from plasma after oral administration, half-life (T _1/2) is 6–8 hours. More than 85% of the dose taken is eliminated in the urine, total clearance after administration of 500 mg is 175 ± 29.2 ml / min.

Oral administration and intravenous (IV) administration of levofloxacin are interchangeable, as indicated by the absence of significant differences in its pharmacokinetics after oral and parenteral use.

Pharmacokinetic parameters of levofloxacin do not differ in women and men.

Indications for use

Levofloxacin-VERTEX is recommended for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• chronic bacterial prostatitis;
• complicated urinary tract infections, including pyelonephritis;
• community-acquired pneumonia;
• infectious lesions of the skin and soft tissues;
• anthrax with airborne transmission of infection (treatment and prevention);
• drug-resistant forms of tuberculosis (as part of a combination treatment).

In addition, Levofloxacin-VERTEX can be used to treat the following infectious and inflammatory lesions as an alternative to other antibacterial agents: acute sinusitis, uncomplicated cystitis, chronic bronchitis in the acute phase.

It is necessary to take into account official national recommendations on the appropriate use of antibacterial drugs, as well as the sensitivity of infectious agents to levofloxacin.

Contraindications

Absolute:

• pseudoparalytic myasthenia gravis (myasthenia gravis);
• an indication of a history of tendon lesions while taking fluoroquinolones;
• epilepsy;
• age up to 18 years;
• pregnancy and lactation;
• hypersensitivity to any component of the drug or to other drugs of the quinolone group.

Relative (use Levofloxacin-VERTEX tablets with caution):

• deficiency of glucose-6-phosphate dehydrogenase latent / manifest (the risk of hemolytic reactions during therapy with quinolones is aggravated);
• impaired renal function;
• a predisposition to seizure activity, including the presence of previous lesions of the central nervous system (CNS), for example, stroke or severe traumatic brain injury, combined with drugs that reduce the threshold for seizure activity of the brain (theophylline, fenbufen);
• diabetes mellitus, taking oral antidiabetic drugs such as glibenclamide or insulin preparations (the threat of hypoglycemia is increasing);
• psychoses or a history of mental illness;
• old age, the period after transplantation, concomitant treatment with glucocorticosteroids (GCS) (the threat of tendinitis and tendon rupture increases);
• the presence of risk factors for lengthening the QT interval: uncorrected electrolyte disturbances, including hypokalemia and hypomagnesemia; syndrome of congenital lengthening of the QT interval, heart disease (heart failure, bradycardia, myocardial infarction); combination therapy with drugs that can prolong the QT interval, such as tricyclic antidepressants, class IA and III antiarrhythmics, antipsychotics, macrolides; old age, female sex;
• history of severe adverse effects, including neurological reactions associated with the intake of other fluoroquinolones.

Levofloxacin-VERTEX, instructions for use: method and dosage

Film-coated tablets Levofloxacin-VERTEX are taken orally, before meals or in the interval between meals, swallowing whole, without chewing or breaking, drinking a sufficient amount of liquid (from 100 to 200 ml). The frequency of admission is 1 or 2 times / day.

The dose of levofloxacin and the duration of the course of treatment are determined taking into account the nature and severity of the infection, as well as the sensitivity of the suspected pathogenic microorganism. In case of switching from intravenous infusion of levofloxacin to oral administration in the form of tablets, the course of therapy should be continued in doses similar to those administered during intravenous infusion.

If you accidentally skip the next dose of Levofloxacin-VERTEX, the missed dose should be taken as soon as possible, and then continue to use the agent as usual.

Recommended dosage regimen and duration of treatment in patients with normal renal function (CC> 50 ml / min):

• exacerbation of chronic bronchitis, pyelonephritis: 1 time / day, 500 mg, course - 7-10 days;
• acute sinusitis: 1 time / day, 500 mg, course - 10-14 days;
• community-acquired pneumonia, infectious lesions of the skin and soft tissues: 1–2 times / day, 500 mg, course - 7–14 days;
• chronic bacterial prostatitis: once a day Levofloxacin-VERTEX 500 mg, course - 28 days;
• uncomplicated cystitis: 1 time / day, 250 mg, course - 3 days;
• complicated urinary tract infections: 1 time / day, 500 mg, course - 7-14 days;
• anthrax with airborne infection (prevention / treatment): 1 time / day, 500 mg, course - up to 56 days;
• tuberculosis (complex therapy of drug-resistant forms): 1–2 times / day, 500 mg, course - up to 90 days.

After reaching normal body temperature or confirmed eradication of the pathogen, it is recommended to take Levofloxacin-VERTEX for another 48–78 hours.

Side effects

• lymphatic system and blood: infrequently - eosinophilia, leukopenia; rarely - thrombocytopenia, neutropenia; with an unknown frequency - pancytopenia, hemolytic anemia, agranulocytosis;
• cardiovascular system: rarely - a feeling of palpitations, decreased blood pressure, sinus tachycardia; with an unknown frequency - ventricular arrhythmias, prolongation of the QT interval, ventricular tachycardia of the "pirouette" type (with possible cardiac arrest);
• invasions and infections: infrequently - fungal lesions, increased resistance of pathogens to Levofloxacin-VERTEX;
• CNS: often - dizziness, headache; infrequently - taste perversion, drowsiness, tremor; rarely - paresthesia, convulsions; with an unknown frequency - ageusia (lack of taste), loss of smell, parosmia (painfully altered sense of smell, including olfactory illusions or hallucinations), pseudotumor of the brain, benign intracranial hypertension, dyskinesia, fainting, peripheral sensory / sensorimotor neuropathy (diagnostic neuropathy the first signs of neuropathy, to reduce the possible risk of developing irreversible changes, it is required to abandon the use of Levofloxacin-VERTEX), extrapyramidal disorders;
• kidneys and urinary tract: infrequently - an increase in serum creatinine levels in the blood; rarely - acute renal failure, including as a result of interstitial nephritis;
• respiratory system, organs of the chest and mediastinum: infrequently - shortness of breath; with an unknown frequency - allergic pneumonitis, bronchospasm;
• skin and subcutaneous tissues: infrequently - itching, rash, hyperhidrosis, urticaria; with an unknown frequency - stomatitis, photosensitization reactions (during the period of therapy and for 48 hours after its cancellation, ultraviolet irradiation should be avoided, including direct sunlight on the skin), exudative erythema multiforme, Stevens-Johnson syndrome, leukocytoclastic vasculitis, toxic epidermal necrolysis (adverse reactions from the mucous membranes and skin can sometimes occur even after receiving the initial doses);
• digestive tract: often - nausea, diarrhea, vomiting; infrequently - flatulence, dyspepsia, constipation, abdominal pain; with an unknown frequency - pancreatitis; hemorrhagic diarrhea, which in rare cases is a sign of enterocolitis, including pseudomembranous colitis (with the development of the latter, you should immediately stop taking Levofloxacin-VERTEX and begin specific antibiotic therapy, drugs that inhibit intestinal motility are contraindicated in this case);
• labyrinthine disorders and the organ of hearing: infrequently - vertigo; rarely - ringing in the ears; with an unknown frequency - hearing loss / loss;
• organ of vision: very rarely - visual impairment, including blurring of the visible image; with an unknown frequency - uveitis, temporary loss of vision;
• hepatobiliary system: often - increased activity of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and other liver enzymes; an increase in the level of gamma-glutamyltransferase (GGT) and / or alkaline phosphatase (ALP); infrequently - an increase in the content of bilirubin in plasma; with an unknown frequency - jaundice, hepatitis, severe liver failure, including episodes of acute liver failure with a possible fatal outcome, mainly against the background of sepsis or other serious underlying disease; in case of signs of liver damage, such as darkening of urine, jaundice, anorexia, abdominal pain and itching, it is necessary to stop taking the tablets and immediately consult a doctor;
• muscle, skeletal and connective tissue: infrequently - myalgia, arthralgia; rarely - tendon damage, including tendonitis; muscle weakness; with an unknown frequency - rupture of ligaments / muscles, rupture of tendons, including the Achilles tendon (this effect can be bilateral in nature and is fixed for 48 hours after the start of the course or several months after its completion), rhabdomyolysis, arthritis;
• psyche: often - insomnia; infrequently - anxiety and / or anxiety, confusion; rarely - sleep disturbances, agitation, mental disorders (paranoia, hallucinations), nightmares, depression; with an unknown frequency - disturbances in attention, nervousness, delirium, disorientation, mental disorders with behavioral disturbances and the desire to harm oneself, including suicidal ideation, attempts at suicide;
• immune system: rarely - anaphylactic edema; with an unknown frequency - anaphylactoid / anaphylactic shock; (anaphylactoid / anaphylactic reactions in some cases can be observed after the first dose);
• metabolism and nutrition: infrequently - anorexia; rarely - hypoglycemia, mainly in patients with diabetes mellitus; with an unknown frequency - hyperglycemia, severe hypoglycemia, up to the development of coma, mainly in elderly patients and patients with diabetes mellitus receiving insulin or oral antidiabetic agents; Symptoms of hypoglycemia include pallor, weakness, perspiration, tremors, dizziness, increased heart rate or palpitations, nervousness, ravenous appetite, confusion; patients with diabetes mellitus need monitoring of blood glucose;
• general disorders: infrequently - asthenia; rarely - pyrexia; with an unknown frequency - pain, including in the chest, back and limbs; extremely rare - attacks of porphyria in patients with porphyrin disease.

Overdose

The main symptoms of an acute overdose of Levofloxacin-VERTEX may include the following reactions: impaired consciousness (including confusion), tremors, convulsions, hallucinations. It is also possible the appearance of nausea, erosive defects of the mucous membrane of the gastrointestinal tract (GIT), prolongation of the QT interval.

In this condition, the patient requires careful observation, including monitoring the electrocardiogram, conducting symptomatic therapy. Against the background of an acute overdose, gastric lavage and antacids are necessary in order to protect the gastric mucosa. Levofloxacin-VERTEX is not excreted from the body using peritoneal dialysis, hemodialysis, and continuous ambulatory peritoneal dialysis (CAPD). There is no specific antidote.

special instructions

It is not recommended to use Levofloxacin-VERTEX for the treatment of diagnosed / suspected infections caused by methicillin-resistant Staphylococcus aureus, since this pathogen is characterized by insensitivity to fluoroquinolones, including to levofloxacin.

Combination therapy may be necessary for the treatment of nosocomial infections with Pseudomonas aeruginosa (Pseudomonas aeruginosa).

When treating severe infections or insufficient effect of the course, confirmation of the diagnosis is required by the results of a microbiological test, including the identification of the pathogen and determination of the degree of its sensitivity to levofloxacin.

The use of fluoroquinolones (including levofloxacin) has been associated in some cases with disability and irreversible severe complications. While taking the drug, the development of such adverse events as arthralgia, myalgia, tendon rupture (including the Achilles tendon), tendinitis, peripheral neuropathy, reactions from the central nervous system (depression, hallucinations, confusion) can be observed. These side effects can manifest themselves in people of any age, both in the presence and absence of risk factors, after the first administration of Levofloxacin-VERTEX for a period from 2-3 hours to 14 days or more. If the initial symptoms of any adverse severe adverse reactions develop, the pill should be stopped immediately.

Since the use of an antimicrobial agent, especially during a long course of treatment, can cause increased reproduction of bacteria and fungi resistant to it, and thereby lead to a change in the normal composition of microflora and the subsequent development of superinfection, during therapy it is necessary to re-evaluate the patient's condition.

Fluoroquinolones, as a result of the activity inhibiting neuromuscular conduction, can aggravate muscle weakness against the background of pseudoparalytic myasthenia gravis. During the post-marketing period, such side effects as respiratory failure (requiring mechanical ventilation) and death associated with the use of fluoroquinolones in patients with pseudoparalytic myasthenia gravis were reported. If this diagnosis has been confirmed, therapy with Levofloxacin-VERTEX is contraindicated.

In patients receiving levofloxacin, false positive results may be obtained when determining opiates in urine. Also, similar results due to the suppression of the growth of Mycobacterium tuberculosis by the drug can be recorded during the subsequent bacteriological diagnosis of tuberculosis.

Influence on the ability to drive vehicles and complex mechanisms

Due to the possible development of drowsiness, dizziness / vertigo or visual impairment during the period of taking Levofloxacin-VERTEX, patients are advised to refrain from driving and servicing other complex moving machines and mechanisms.

Application during pregnancy and lactation

For pregnant and lactating women, therapy with Levofloxacin-VERTEX is contraindicated, since when using the drug during pregnancy and lactation, there is a threat of damage to the epiphyseal plate, which is responsible for the growth of bones in the fetus / child.

Pediatric use

The antimicrobial agent is not prescribed for children and adolescents due to incomplete growth of the skeleton, since in this age category, the risk of damage to the cartilaginous growth zones cannot be completely excluded against the background of taking Levofloxacin-VERTEX.

With impaired renal function

As the impairment of renal function aggravates, the renal clearance (CLR) decreases and the renal elimination of levofloxacin decreases, and its T _1/2 increases.

Pharmacokinetics of Levofloxacin-VERTEX in patients with renal insufficiency after a single oral dose of 500 mg (CC in ml / min):

• CC <20: CLR - 13 ml / min, T _1/2 - 35 h;
• CC - 20–49: CLR - 26 ml / min, T _1/2 - 27 h;
• CC - 50-80: CLR - 57 ml / min, T _1/2 - 9 hours.

Patients with nephrological pathology (CC ≤ 50) require mandatory monitoring of renal function and a change in the dosage regimen, set depending on the CC values and the recommended dose of Levofloxacin-VERTEX for patients with normal or moderately reduced renal function.

Recommended correction of the dosage regimen, at the required dose of 250 mg / 24 h, if CC> 50 (CC in ml / min):

• CC - 50–20: 1st dose - 250 mg, further - 125 mg / 24 h;
• CC - 19–10: 1st dose - 250 mg, further - 125 mg / 48 h;
• CC <10, including hemodialysis and CAPD *: 1st dose - 250 mg, further - 125 mg / 48 hours.

Recommended correction of the dosage regimen, at the required dose of 500 mg / 24 h, if CC> 50:

• CC - 50–20: 1st dose - 500 mg, further - 250 mg / 24 h;
• CC - 19-10: 1st dose - 500 mg, further - 125 mg / 24 h;
• CC <10, including hemodialysis and CAPD *: 1st dose - 250 mg, then 125 mg / 24 hours.

Recommended correction of the dosage regimen, at the required dose of 500 mg / 12 h, if CC> 50:

• CC - 50–20: 1st dose - 500 mg, further - 250 mg / 12 h;
• CC - 19–10: 1st dose - 500 mg, further - 125 mg / 12 h;
• CC <10, including hemodialysis and CAPD *: 1st dose - 500 mg, further - 125 mg / 24 h.

* After hemodialysis and CAPD, there is no need to take additional doses.

When prescribing the drug in a dose of 125 mg, Levofloxacin-VERTEX 250 mg tablets with a dividing line should be used.

For violations of liver function

Patients with functional disorders of the liver do not need individual dose selection, since in the liver the drug is metabolized to an insignificant extent.

Use in the elderly

In elderly patients, the pharmacokinetics of Levofloxacin-VERTEX does not differ from that in younger patients, except for differences associated with changes in CC. Elderly patients with CC> 50 ml / min do not need to change the dosage regimen.

Drug interactions

• sucralfate (an agent that protects the gastric mucosa): there is a pronounced decrease in the effect of levofloxacin; it is recommended to use sucralfate 2 hours after the administration of levofloxacin;
• calcium salts: there is a minimal effect of calcium salts on the absorption of levofloxacin;
• fenbufen, theophylline or similar medicinal substances from the group of non-steroidal anti-inflammatory drugs (NSAIDs), which help to reduce the seizure threshold of the brain: there is no pharmacokinetic interaction of levofloxacin with theophylline, but it has been established that quinolones can increase the ability of these NSAIDs to reduce the seizure threshold; when combined with fenbufen, the concentration of levofloxacin increases by 13%;
• agents containing bivalent / trivalent cations, including iron or zinc salts (drugs for the treatment of anemia), magnesium and / or aluminum-containing drugs (antacids); dosage forms of didanosine containing magnesium / aluminum as a buffer: it is recommended to take levofloxacin at least 2 hours before or after oral administration of these agents;
• GCS: the threat of tendon rupture is aggravated;
• cyclosporine: there is an increase in T _{1/2 of} this substance by 33%, but since this increase is clinically insignificant, no dose adjustment of cyclosporine is required;
• cimetidine, probenecid (substances that disrupt renal tubular secretion): there is a slowdown in the excretion of levofloxacin under the action of probenecid and cimetidine by 34 and 24%, respectively; with this combination, care must be taken, especially in patients with renal insufficiency;
• indirect anticoagulants (vitamin K antagonists), including warfarin: there is an increase in the international normalized ratio (INR) or prothrombin time, and / or the occurrence of bleeding, including severe; requires regular monitoring of blood clotting indicators;
• glibenclamide, digoxin, warfarin, ranitidine: do not show a clinically significant effect on the pharmacokinetics of levofloxacin;
• antihistamines (terfenadine, ebastine, astemizole), tricyclic and tetracyclic antidepressants, class IA and III antiarrhythmics, antipsychotics, macrolides, antifungals, imidazole derivatives (drugs that prolong the QT interval): Levofloxacin should be used with these agents with caution.

Analogs

Levofloxacin-VERTEX analogs are Levofloxacin-KRKA, Lefoktsin, Glevo, Levofloxacin, Tavanik, Floracid, Eleflox, Levoflox, Levoximed, Remedia, etc.

Terms and conditions of storage

Store out of the reach of children, protected from light penetration, at a temperature not exceeding 25 ° C.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Levofloxacin-VERTEX

At the moment, there are a lot of reviews about Levofloxacin-VERTEX on specialized sites. Most often it is assessed as a strong antibacterial drug with a wide spectrum of action, which helps well with various complex infections. Domestic production of the drug, relative budgetary cost, and availability in pharmacies are noted. Experts most often warn that the tablets are heavy antibiotics, therefore, strict adherence to the dosage regimen prescribed by the doctor and the parallel intake of bifidobacteria to restore the intestinal microflora is required.

The disadvantages of Levofloxacin-VERTEX are most often indicated by a large list of adverse reactions that manifest themselves in different patients from a minor degree to severe complications that worsen the quality of life. Some of them complained of extreme weakness, a significant decrease in heart rate, decreased heart rate, surges in blood pressure, dizziness, distorted perception of reality, light-headedness, numbness of the skin on the hands and calves.

Price for Levofloxacin-VERTEX in pharmacies

The price of Levofloxacin-VERTEX, in the form of film-coated tablets, depends on the dosage:

• Levofloxacin-VERTEX 250 mg - 260 rubles. for 5 pcs.;
• Levofloxacin-VERTEX 500 mg - 380 rubles. for 5 pcs. and 620 rubles. for 10 pcs.

Levofloxacin-VERTEX: prices in online pharmacies

Drug name Price Pharmacy

Levofloxacin-VERTEX tablets p.p. 500mg 10 pcs 639 RUB 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!