Levomac instructions

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Levomac

Levomac (made in India) is an antibacterial drug of the fluoroquinolone group with a wide spectrum of activity. The active ingredient is levofloxacin.

Release forms

Levomak is available in two forms:

Table of contents:

  • for oral use, film-coated tablets containing 250 mg, 500 mg levofloxacin;
  • for infusion administration, solution in bottles (volume - 100 ml, containing 5 mg of levofloxacin in 1 ml).

Use for cystitis

For the treatment of cystitis, Levomac is used at a dosage of 250 mg per day for three days, in the absence of complications; a complicated form of infection requires a longer course - up to 7 - 10 days or longer. If renal function is impaired, the dose is calculated individually.

The tablets are taken without chewing, regardless of meals.

Description

The active ingredient of the drug, levofloxacin, has a bactericidal effect (the ability to destroy bacteria) due to disruption of the normal course of biochemical processes in the bacterial cell.

Levofloxacin after administration is quickly and almost 100% absorbed into the blood. It is excreted by the kidneys in urine within two days, and in small quantities in feces for three days.

The drug is effective against most microorganisms, has little activity against spirochetes, and inhibits the growth of Mycobacterium tuberculosis. There are known cases of bacterial resistance to the active substance of the drug, which necessitates a preliminary determination of the sensitivity of the infectious agent.

Indications for use

  • Acute sinusitis and other diseases of the ENT organs;
  • Lower respiratory tract infections (bacterial pneumonia, including community-acquired pneumonia, exacerbation of chronic bronchitis);
  • Urinary tract infections (complicated, uncomplicated) – cystitis, pyelonephritis, etc.;
  • Infections of soft tissues and skin (complicated, uncomplicated);
  • Chronic prostatitis;
  • Multidrug-resistant tuberculosis.

Contraindications for use

  • Hypersensitivity to levofloxacin, as well as other antibacterial drugs of the fluoroquinolone group;
  • Epilepsy;
  • Tendon lesions caused by the use of fluoroquinolones;
  • Age less than 18 years;
  • Period of pregnancy, breastfeeding.

Use with caution when:

  • increased risk of developing tendinitis, including when taking corticosteroids and older age;
  • tendency to develop seizures;
  • mental disorders.

Side effects

Frequent (in 1-10 patients per 100):

  • nausea, diarrhea;
  • increased activity of liver enzymes.
  • skin redness, itching;
  • stomach ache;
  • vomit;
  • indigestion;
  • anorexia;
  • headaches and dizziness;
  • sleep disorders;
  • drowsiness;
  • weakness and some others.
  • photosensitivity;
  • bronchospasm;
  • hives;
  • pseudomembranous colitis;
  • bloody stools;
  • dyspepsia;
  • confusion;
  • anxiety;
  • convulsions;
  • tremor, numbness of extremities, tingling;
  • tendon damage;
  • pain in muscles and joints;
  • heartbeat;
  • lowering blood pressure and some others.
  • shock;
  • vascular collapse;
  • hypoglycemia;
  • hepatitis;
  • disturbance from the sensory organs;
  • depression, psychotic reactions;
  • muscle weakness;
  • Achilles tendon rupture;
  • renal dysfunction;
  • fever and some others.

In isolated cases, Stevens-Johnson and Lyell syndromes, hemolytic anemia, exudative erythema multiforme, etc. were noted.

special instructions

  • Levomac solution cannot be mixed with alkaline solutions and heparin;
  • Not prescribed concomitantly with medications that lower the seizure threshold;
  • Blood clotting parameters should be monitored when used together with vitamin K antagonists;
  • The half-life of the drug increases when taken together with cimetidine, cyclosporine and probenecid;
  • During the entire period of taking the drug and 3 days after the end, it is prohibited to sunbathe or be exposed to artificial UV irradiation due to the possible risk of skin burns;
  • During the period of treatment, you should avoid driving a car and operating machinery with potential danger.

Analogues of the drug

Levofloxacin, Levobax, Levoflox, Tavanic, Levolet, Giracin, Loxof, Levoprim, Lotor, etc.

Overdose

Using an excessive amount of the drug can provoke:

  • nausea;
  • dizziness;
  • disturbance of consciousness;
  • seizures;
  • erosive lesions of the mucous membranes.
  • monitor ECG;
  • carry out symptomatic therapy;
  • take measures to maintain normal functioning of the cardiovascular system.

What to do in case of overdose

  • monitor ECG;
  • carry out symptomatic therapy;
  • take measures to maintain normal functioning of the cardiovascular system.

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LEVOMAK INSTRUCTIONS

Prices for LEVOMAK

Levofloxacin is effective against infectious diseases caused by strains of Staphylococcus epidermidis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus agalactiae, Streptococcus pyogenes, Enterococcus faecalis, Enterobacter aerogenes, Enterobacter cloacae, Enterobacter sakazakii, Enterobacter agglomerans, Haemophilus parainfluenzae, Haem ophilus influenzae, Viridans group streptococci, Escherichia coli, as well as Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris and Proteus mirabilis.

In addition, levofloxacin is active against strains of Moraxella catarrhalis, Pseudomonas fluorescens, Pseudomonas aeruginosa, Legionella pneumopnia, Chlamydophila pneumoniae, Acinetobacter baumannii, Acinetobacter anitratus, Acinetobacter calcoaceticus, Citrobacter freundii, Citrobacter diversus, Mycoplasma pneumoniae, Bordetella pertussis , Morganella morganii, Providencia rettgeri et stuartii, Clostridium perfringens and Serratia marcescens.

Levofloxacin is not effective against spirochetes.

There have been cases of bacterial strains developing resistance to levofloxacin, so it is recommended to conduct a sensitivity test before starting therapy.

When administered orally, the active component of the drug Levomac is quickly absorbed from the intestines. When taken orally, peak plasma concentrations of levofloxacin are achieved within 60 minutes. The bioavailability of levofloxacin reaches 100%, the degree of binding to plasma proteins is about 40%. The active component of the drug Levomac penetrates well into the tissues and biological fluids of the body, but practically does not penetrate the blood-brain barrier. A small part of levofloxacin is metabolized in the liver. Levofloxacin is excreted mainly unchanged by the kidneys. In patients with normal renal function, the half-life of levofloxacin is 6 to 8 hours.

Levomac is used to treat patients suffering from infectious diseases caused by microflora sensitive to levofloxacin. In particular, Levomac is prescribed to patients suffering from sinusitis and other diseases of the ENT organs, bacterial pneumonia, infectious diseases of soft tissues and skin, as well as pyelonephritis and complicated diseases of the urinary system.

In addition, levofloxacin can be prescribed to patients with chronic bacterial prostatitis.

In severe forms of infectious diseases, Levomac should be prescribed in combination with other antimicrobial drugs.

Solution for infusion administration Levomac:

The drug is intended for intravenous drip administration. The daily dose of Levomac is usually administered at one time or divided into 2 administrations. As soon as the opportunity arises, you should switch from parenteral to oral form of the drug Levomac. Levomac infusion solution should be administered at a rate of at least 30 min/250 mg. The duration of therapy with levofloxacin and the dose of the drug are determined by the doctor.

Adults with infectious diseases of various localizations are usually prescribed levofloxacin mg per day.

For mild forms of complicated urinary system infections, 250 mg of levofloxacin per day is allowed.

The maximum permissible single dose of levofloxacin is 500 mg.

For patients with impaired renal function, the dose of Levomac is calculated depending on creatinine clearance and the severity of the infection.

When creatinine clearance is from 20 to 50 ml/min, as a rule, 250 mg of levofloxacin is prescribed, after which they switch to levofloxacin at a dose of 125 mg per day. In case of severe infection, it is possible to increase the first dose to 500 mg of levofloxacin, after which they switch to administering levofloxacin at a dose of 250 mg twice a day.

When creatinine clearance is less than 20 ml/min, as a rule, 250 mg of levofloxacin is prescribed, after which they switch to levofloxacin at a dose of 125 mg every 48 hours. For severe infections, it is allowed to increase the first dose to 500 mg of levofloxacin, after which they switch to administering levofloxacin at a dose of 125 mg every hour.

The total duration of therapy with levofloxacin (including parenteral and oral forms) should be no more than 14 days. It is recommended to continue taking Levomac for 2 days after the disappearance of clinical symptoms of the disease or until negative results of microbiological tests are obtained.

The drug is taken orally regardless of food intake. Levomac tablets should not be chewed. The dose of levofloxacin, as well as the duration of treatment, is determined by the doctor.

For urinary tract infections and exacerbation of chronic bronchitis, 250 mg of levofloxacin per day is usually prescribed. If chronic bronchitis is complicated, the dose of levofloxacin can be increased to 500 mg of levofloxacin per day.

For acute sinusitis, prostatitis and intra-abdominal infections, 500 mg of levofloxacin per day is usually prescribed.

For community-acquired pneumonia, bacteremia and septicemia, as well as diseases of soft tissues and skin, 1000 mg of levofloxacin per day is usually prescribed (the dose should be divided into 2 doses with an interval of 12 hours).

The duration of treatment with levofloxacin is usually from 7 days. For uncomplicated urinary tract infections, the duration of treatment is 3 days, for prostatitis – 28 days.

For patients with reduced renal function, the dose of levofloxacin is calculated taking into account the severity of the disease and creatinine clearance.

When creatinine clearance is from 20 to 50 ml/min, levofloxacin is prescribed at a dose of 250 mg per day, starting from the second day of therapy, they switch to taking levofloxacin at a dose of 125 mg per day. In severe forms of the disease, it is allowed to increase the first dose of levofloxacin to 500 mg, after which they switch to taking levofloxacin at a dose of 250 mg twice a day.

When creatinine clearance is less than 20 ml/min, as a rule, levofloxacin is prescribed at a dose of 250 mg per day, starting from the second day of therapy, they switch to taking levofloxacin at a dose of 125 mg every 48 hours.

Levomac can cause the following adverse reactions in patients:

From the hepatobiliary system and digestive tract: loss of appetite, vomiting, nausea, pain and discomfort in the abdominal area, dyspepsia, stool disorders, decreased plasma glucose levels. In isolated cases, the use of levofloxacin can cause the development of pseudomembranous colitis, hepatitis, increased levels of liver enzymes, and hyperbilirubinemia.

From the nervous system: paresthesia, tremors of the limbs, headache, disturbances in sleep and wakefulness, confusion, decreased concentration, depressive states, psychotic reactions, convulsions. In isolated cases, when using levofloxacin, the development of decreased visual acuity, hallucinations, suicidal thoughts, disturbances of taste and smell was noted.

From the blood vessels, heart and blood system: cardiac arrhythmias (including increased QT interval, tachycardia), decreased blood pressure, orthostatic hypotension, leukopenia, eosinophilia, thrombocytopenia, pancytopenia and hemolytic anemia.

From the musculoskeletal system: myasthenia gravis, muscle and joint pain, tendonitis, Achilles tendon rupture, rhabdomyolysis.

Allergic reactions: urticaria, bronchospasm, Quincke's edema, anaphylactic shock, photosensitivity, Lyell's syndrome, Stevens-Johnson syndrome.

Others: oral or vaginal candidiasis, development of superinfection, increased body temperature, exacerbation of porphyria. With infusion administration of the drug Levomac, the development of phlebitis, pain and hyperemia at the site of injection of the solution is also possible.

If undesirable reactions develop, you should consult your doctor, since some adverse reactions of levofloxacin require discontinuation of the drug Levomac.

Levomac is not prescribed to patients with known hypersensitivity to levofloxacin or other drugs in the group of fluoroquinolone antibiotics.

Levomac is not used for the treatment of patients suffering from epilepsy, as well as patients with a history of tendon lesions associated with the use of fluoroquinolones.

Levofloxacin is not used in pediatric practice (due to the risk of damage to tendons and cartilage tissue during growth).

Caution should be exercised when prescribing Levomac to patients at increased risk of developing tendinitis (including elderly patients and patients receiving corticosteroids). If tendonitis develops or is suspected, discontinue levofloxacin therapy.

In addition, caution should be exercised when prescribing Levomac to patients prone to developing seizures, as well as patients with glucose-6-phosphate dehydrogenase deficiency and mental disorders (including a history).

You should avoid operating potentially unsafe mechanisms and driving a car during treatment with Levomac.

During pregnancy, the use of Levomac is prohibited due to the risk of damage to cartilage tissue in the fetus. Before starting therapy with Levomac in women of reproductive age, pregnancy should be excluded. During therapy with levofloxacin, it is recommended to use reliable contraception. If pregnancy occurs during treatment with Levomac, you should consult a doctor.

During lactation, levofloxacin can be prescribed only if breastfeeding is discontinued.

Levomac infusion solution must not be mixed with heparin and alkaline solutions.

Levofloxacin should not be prescribed to patients receiving therapy with drugs that lower the seizure threshold.

Probenecid, cyclosporine and cimetidine, when used in combination with Levomac, may increase the half-life of levofloxacin.

It is recommended to monitor blood clotting parameters when levofloxacin is used in combination with vitamin K antagonists.

The use of high doses of Levomac can lead to the development of nausea, disturbances of consciousness, dizziness, erosive lesions of the mucous membranes, as well as convulsive seizures. In addition, when using doses of levofloxacin that significantly exceed therapeutic doses, prolongation of the QT interval may develop.

A specific antidote is unknown. In case of an overdose of levofloxacin, an ECG should be monitored, as well as symptomatic therapy and measures aimed at maintaining the function of the cardiovascular system. The active component of the drug Levomac is not excreted from the body during hemodialysis and peritoneal dialysis.

Solution for infusion administration Levomac in 100 ml bottles, 1 bottle is included in a cardboard pack.

Tablets for oral use Levomak, packaged in 5 pieces in blister packs, 1 or 2 blister packs are included in a cardboard pack.

Levomak, regardless of its release form, can be used for 2 years after manufacture, provided that the drug is stored in rooms with a temperature not exceeding 25 degrees Celsius.

Levofloxacin, Levoflox, Levobax.

1 ml of solution for infusion of Levomac contains:

Levofloxacin (in the form of levofloxacin hemihydrate) – 5 mg;

Levofloxacin (in the form of levofloxacin hemihydrate) – 250 mg;

Levofloxacin (in the form of levofloxacin hemihydrate) – 500 mg;

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Levomak 500, Film-coated tablets

Medical instructions

use of the drug

International nonproprietary name

Film-coated tablets, 250 mg and 500 mg

One tablet contains

active substance - levofloxacin hemihydrate

equivalent to levofloxacin 250 mg and 500 mg,

excipients: microcrystalline cellulose, pregelatinized starch, polysorbate-80, crospovidone, microcrystalline cellulose (PH 302), purified talc, colloidal anhydrous silicon dioxide, magnesium stearate,

shell composition: hypromellose 15 cps, titanium dioxide E171, propylene glycol, diethyl phthalate, iron(III) oxide red E 172, iron(III) oxide yellow E 172.

Film-coated tablets are reddish-brown, round, biconvex, smooth on both sides (for a dosage of 250 mg).

Film-coated tablets are reddish-brown in color, capsule-shaped, biconvex, smooth on both sides (for a dosage of 500 mg).

Antibacterial drugs are quinolone derivatives. Fluoroquinolones

PBX code J01MA12

Pharmacokinetics

The active substance of the drug, levofloxacin, is quickly and almost completely absorbed after oral administration. Peak plasma concentrations are achieved one to two hours after oral administration. Absolute bioavailability is 99%. The binding to plasma proteins is 30-40%, the degree of binding does not depend on the concentration of the drug.

The average volume of distribution of levofloxacin was, indicating a wide distribution of the drug in body tissues. Peak levels of levofloxacin are achieved in skin tissue 3 hours after dosing. Levofloxacin penetrates well into the lung tissue. Concentrations of the drug in lung tissue are 2-5 times higher than plasma concentrations and range from 2.4 to 11.3 mcg/g 24 hours after taking a single oral dose of 500 mg. Levofloxacin remains stereochemically stable in plasma and urine and is not metabolized to its enantiomer. 87% is excreted in the urine as unchanged substance within 48 hours, less than 4% of the dose is excreted in feces within 72 hours, and less than 5% is excreted in urine in the form of metabolites. The average terminal half-life of levofloxacin from plasma is hours.

Pharmacodynamics

The mechanism of action of Levomac is the suppression of bacterial DNA gyrase. Levomac has a bactericidal effect when administered in a concentration equal to or slightly higher than the inhibitory concentration. Levomac has activity against a wide range of gram-positive and gram-negative microorganisms: Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes; Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa; Chlamydia pneumoniae, Mycoplasma pneumoniae.

Indications for use

  • acute sinusitis
  • exacerbation of chronic bronchitis
  • community-acquired pneumonia
  • uncomplicated skin and soft tissue infections (mild to moderate)
  • uncomplicated and complicated urinary tract infections (mild and
  • acute pyelonephritis (mild to moderate)

Directions for use and doses

The average daily dose is 250 mg or 500 mg, the maximum is 1.5 g.

Infection Duration Daily dose

chronic bronchitis 7-10 days 500 mg 1-2 times a day

depending on severity

Community-acquired pneumonia 7-10 days 500 mg 1-2 times a day

Acute sinusitis days 500 mg

skin and soft tissue days 750 mg

skin and soft tissue days 500 mg

urinary tract 7 days 250 mg 2 times a day

Acute pyelonephritis 7 days 250 mg

urinary tract 7 days 250 mg

If kidney function is impaired:

Exacerbation of chronic bronchitis, community-acquired pneumonia, acute sinusitis, uncomplicated skin and soft tissue infections:

(CC – creatinine clearance)

Kidney condition Initial dose Subsequent dose

QC from 50 to 80 ml/min No dose adjustment required

CC from 20 to 49 ml/min 500 mg 250 mg every 24 hours

CC from 10 to 19 ml/min 500 mg 250 mg every 48 hours

Hemodialysis 500 mg 250 mg every 48 hours

peritoneal dialysis 500 mg 250 mg every 48 hours

Complicated skin and soft tissue infections:

QC from 50 to 80 ml/min No dose adjustment required

CC from 20 to 49 ml/min 750 mg 750 mg every 48 hours

CC from 10 to 19 ml/min 750 mg 500 mg every 48 hours

Hemodialysis 750 mg 500 mg every 48 hours

peritoneal dialysis 750 mg 500 mg every 48 hours

Complicated urinary tract infections, acute pyelonephritis:

CC 20 ml/min No dose adjustment required

CC from 10 to 19 ml/min 250 mg 250 mg every 48 hours

- nausea, diarrhea, increased activity of liver enzymes (for example,

alanine aminotransferase and aspartate aminotransferase)

- pain and redness at the injection site, phlebitis

- loss of appetite, vomiting, abdominal pain, dyspepsia

- itching, rash and redness of the skin

- headache, dizziness, drowsiness, sleep disturbances

- increased levels of bilirubin and creatinine in the blood serum

- general weakness (asthenia)

— reproduction of fungal flora and resistant microorganisms

- urticaria, bronchospasm, shortness of breath

- bloody diarrhea

- paresthesia, tremor, restlessness, increased anxiety, depression,

seizures and confusion

- tachycardia, drop in blood pressure

- neutropenia; thrombocytopenia, which may be accompanied by increased

- tendonitis (for example, Achilles tendon), joint and muscle pain

- Quincke's edema, hypotension, shock, anaphylactoid reactions,

photosensitivity, allergic pneumonitis, vasculitis, fever

- hypoglycemia (especially in patients with diabetes)

- visual and hearing impairments, taste sensitivity disorders and

smell, hypoesthesia, hallucinations

- tendon rupture (for example, Achilles tendon - this adverse reaction

can be observed for 48 hours after the start of treatment and worn

bilateral), muscle weakness, which is of particular importance for

patients with myasthenia gravis

- hepatitis, enterocolitis, pseudomembranous colitis

- decreased renal function up to acute renal failure,

In some cases

- severe skin rashes with blistering, Stevens syndrome -

Johnson, toxic epidermal necrolysis (Lyell's syndrome) and

exudative erythema multiforme

- prolongation of the QT interval

- hemolytic anemia, pancytopenia

- extrapyramidal symptoms and other muscle coordination disorders

- acute attacks of porphyria in patients with porphyria

- mental reactions with auto-aggressive behavior, including

suicidal thoughts or actions

  • hypersensitivity to levofloxacin or other quinolones
  • epilepsy
  • tendon lesions observed with previous use of quinolones
  • children and teenagers up to 18 years of age
  • pregnancy, lactation period
Drug interactions

When administered simultaneously with antacids, sucralfate, metal cations, and multivitamin preparations, the absorption of Levomak from the gastrointestinal tract may decrease.

When Levomac is co-administered with theophylline, non-steroidal anti-inflammatory drugs or other drugs that lower the seizure threshold, the risk of seizures increases.

Levomac does not interact with calcium carbonate, digoxin and warfarin.

When administered together with probenecid, cimetidine, ranitidine and furosemide, the concentration of Levomac in the blood increases.

When taking the drug simultaneously with antidiabetic agents, strict monitoring of blood glucose levels is recommended.

Levomac should be taken two hours before or two hours after taking antacids containing magnesium and aluminum; sucralfate, metal cations (iron preparations); multivitamin preparations containing zinc; didanosine, chewable and buffered tablets or pediatric powders for oral solution.

Levomac should be used with caution in case of impaired renal function

and adjust the dose if necessary.

During treatment, it is necessary to avoid solar and artificial ultraviolet irradiation to avoid photosensitivity reactions.

Features of the effect of the drug on the ability to drive a car or potentially dangerous mechanisms

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

Symptoms: nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, prolongation of the QT interval on the ECG, confusion, dizziness, convulsions.

Treatment: gastric lavage, administration of activated carbon, adequate hydration, symptomatic treatment. Dialysis is ineffective.

Release form and packaging

5 tablets in a blister pack made of polyvinyl chloride film and aluminum foil.

1 blister pack together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack.

Store in a dry place, protected from light, at a temperature not exceeding 30 0 C.

Keep out of the reach of children!

Do not use after the expiration date.

MacLeods Pharmaceuticals Limited

304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai –, India.

Registration Certificate Holder

Macleods Pharmaceuticals Limited, India

Address of the organization receiving complaints from consumers regarding product quality

Representative office in the Republic of Kazakhstan "Macleods Pharmaceuticals Limited"

RK, Almaty, st. Tulebaeva 38, office 307/A

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Lavomax ®

Yellow to orange film-coated tablets The core of the tablet is orange.

Excipients: magnesium hydroxycarbonate (heavy magnesium carbonate) - 69 mg, povidone Kmg, calcium stearate - 2 mg.

Shell composition: sucrose - 158.11 mg, povidone K17 - 5.65 mg, copovidone - 0.44 mg, magnesium hydroxycarbonate (light magnesium carbonate) - 25.7 mg, titanium dioxide - 1.2 mg, colloidal silicon dioxide (Aerosil A-380) - 1 mg, dye quinoline yellow - 0.09 mg, sunset yellow dye - 0.01 mg, macrogolmg, beeswax - 0.15 mg, liquid paraffin - 0.15 mg, talc - 1.5 mg.

3 pcs. — cellular contour packages (1) — cardboard packs.

3 pcs. — contour cell packaging (2) — cardboard packs.

4 things. — cellular contour packages (1) — cardboard packs.

6 pcs. — cellular contour packages (1) — cardboard packs.

6 pcs. — contour cell packaging (2) — cardboard packs.

10 pieces. — cellular contour packages (1) — cardboard packs.

10 pieces. — contour cell packaging (2) — cardboard packs.

Antiviral and immunomodulatory drug. Lavomax ® stimulates the formation of α-, β-, γ-interferons in the body. In response to Lavomax administration, interferon is produced mainly by intestinal epithelial cells, hepatocytes, T-lymphocytes and neutrophils.

After taking the drug orally, the maximum production of interferon is determined in the sequence intestine-liver-blood after 4-24 hours. Lavomax ® has an immunomodulatory and antiviral effect. Stimulates bone marrow stem cells, depending on the dose, enhances antibody formation, reduces the degree of immunosuppression, restores the T-helper/T-suppressor ratio.

Effective against various viral infections, incl. against influenza viruses, other acute respiratory viral infections, hepatitis and herpes viruses, cytomegaloviruses and neurotropic viruses.

The mechanism of antiviral action is associated with inhibition of the translation of virus-specific proteins in infected cells, as a result of which viral reproduction is suppressed.

After taking the drug orally, tilorone is quickly absorbed from the gastrointestinal tract. Bioavailability is 60%.

Binding to blood plasma proteins is about 80%.

Metabolism and excretion

Tiloron does not undergo biotransformation and does not accumulate in the body. It is excreted almost unchanged in feces (about 70%) and urine (about 9%). T 1/2 is 48 hours.

The drug is used in adults as part of complex therapy:

— viral hepatitis A, B and C;

— infectious-allergic and viral encephalomyelitis;

- urogenital and respiratory chlamydia;

Treatment and prevention of influenza and other acute respiratory viral infections.

The drug is taken orally after meals.

When treating influenza and other acute respiratory viral infections - in the first two days of the disease - 125 mg, then - 125 mg every other day. Course dose of mg (per course of treatment - 6 tablets of 125 mg each).

For the prevention of influenza and other acute respiratory viral infections - 125 mg once a week for 6 weeks. For a course of treatment - 6 tablets. 125 mg each.

For the treatment of viral hepatitis A - the first day, 125 mg 2 times, then 125 mg every other day. The course dose is 1.25 g (per course of treatment - 10 tablets of 125 mg each).

For the treatment of acute hepatitis B - 125 mg on the first and second days, then 125 mg every other day. The course dose is 2 g (per course of treatment - 16 tablets of 125 mg each), for protracted hepatitis Vmg 2 times a day on the first day, then 125 mg every other day. The course dose is 2.5 g (per course of treatment - 20 tablets of 125 mg each).

For chronic hepatitis B - the initial phase of treatment (2.5 g) - the first two days, 250 mg, then 125 mg every other day. Continuation phase (from 1.25 g to 2.5 g) - 125 mg per week. The course dose of the drug Lavomax ® is from 3.75 to 5 g (per course of treatment - from 30 to 40 tablets of 125 mg), the duration of therapy is 3.5-6 months, depending on the results of biochemical, immunological, morphological studies, reflecting the degree of activity of the process.

For acute hepatitis C - 125 mg on the first and second days, then 125 mg every other day. The course dose is 2.5 g (per course of treatment - 20 tablets of 125 mg each).

For chronic hepatitis C - the initial phase of treatment (2.5 g) - the first two days, 250 mg, then every other day. Continuation phase (2.5 g) - 125 mg per week. The course dose of Lavomax ® is 5 g (per course of treatment - 40 tablets of 125 mg each). The duration of therapy is 6 months, depending on the results of biochemical, immunological, and morphological markers of the activity of the process.

For the treatment of herpetic and cytomegalovirus infections - the first two days, 125 mg, then every other day, 125 mg. The course dose is 2.5 g (per course of treatment - 20 tablets of 125 mg each).

For urogenital and respiratory chlamydia, non-gonococcal urethritis - the first two days, 125 mg, then every other day, 125 mg. The course dose is 1.25 g (per course of treatment - 10 tablets of 125 mg each).

As part of complex therapy for pulmonary tuberculosis - 250 mg for the first two days, then 125 mg every other day. The course dose is 2.5 g (per course of treatment - 20 tablets of 125 mg each).

As part of complex therapy for neuroviral infections, the dose is set individually, the course of treatment is 4 weeks.

Possible: short-term chills, allergic reactions, symptoms of dyspepsia.

- lactation period (breastfeeding);

- children and adolescents up to 18 years of age;

- sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (the drug contains sucrose);

- hypersensitivity to the components of the drug.

Contraindicated in children and adolescents under 18 years of age.

Impact on the ability to drive vehicles and operate machinery

The use of the drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

There are no known cases of overdose of Lavomax ®.

No clinically significant interaction of the drug Lavomax ® with antibiotics, standard therapy for viral and bacterial diseases, or alcohol has been identified.

Compatible with antibiotics and standard therapy for viral and bacterial diseases.

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25°C. Shelf life: 2 years.

The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug.

There are contraindications, consult your doctor.

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Source: http://health.yandex.ru/pills/lavomaks-5987

Levomac instructions

Group: quinolones, fluoroquinolones

— lower respiratory tract infections (exacerbation of chronic bronchitis, community-acquired pneumonia);

— infections of the ENT organs (acute sinusitis);

- urinary tract and kidney infections (including acute pyelonephritis);

- genital infections (including bacterial prostatitis);

- infections of the skin and soft tissues (festering atheromas, abscess, boils);

Hypersensitivity, epilepsy, pregnancy, lactation, children under 18 years of age. Levomac should be prescribed with caution to patients prone to seizures, as well as those suffering from glucose-6-phosphate dehydrogenase deficiency, renal and liver dysfunction, psychotic disorders, diabetes mellitus and photosensitivity. Tendon lesions due to previous treatment with quinolones.

From the digestive system: nausea, vomiting, diarrhea, digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis. Increased activity of liver transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis;

From the cardiovascular system: decreased blood pressure, vascular collapse, tachycardia, prolongation of the QT interval, extremely rarely - atrial fibrillation;

Metabolism: hypoglycemia (increased appetite, increased sweating, trembling);

From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, epileptic seizures (in predisposed patients);

From the senses: disturbances of vision, hearing, smell, taste and tactile sensitivity;

From the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis;

From the urinary system: hypercreatininemia, interstitial nephritis, acute renal failure;

From the hematopoietic organs: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages;

Allergic reactions: itching and redness of the skin, swelling of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, suffocation, anaphylactic shock, allergic pneumonitis, vasculitis;

Other: photosensitivity, asthenia, exacerbation of porphyria, persistent fever, development of superinfection;

Levomac is an antimicrobial drug with a pronounced bactericidal effect. Levomac contains the active component levofloxacin, a synthetic substance from the fluoroquinolone group. The mechanism of action of levofloxacin is associated with the effect on DNA gyrase and topoisomerase IV of bacteria.

Levomac is active against a wide range of gram-negative and gram-positive bacteria. In particular, strains of Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Enterobacter aerogenes, Enterobacter sakazakii, Enterobacter cloacae, Enterobacter agglomerans, Escherichia coli, Haemophilus parainfluenzae, Haemophilus influenzae, Viridans group streptococci, and also Proteus vulgaris, Proteus mirabilis, Klebsiella oxytoca and Klebsiella pneumoniae.

Strains of Pseudomonas fluorescens, Pseudomonas aeruginosa, Moraxella catarrhalis, Acinetobacter baumannii, Acinetobacter calcoaceticus, Acinetobacter anitratus, Legionella pneumoniae, Chlamydophila pneumoniae, Bordetella pertussis, Citrobacter freundii, Citrobacter diversus, Mycoplasma pneumoniae, Morganella morganii are also sensitive to levofloxacin , Clostridium perfringens, Providencia rettgeri et stuartii and Serratia marcescens.

Spirochetes are not sensitive to the action of levofloxacin.

Cross-resistance to levofloxacin and other fluoroquinolones is possible. As a rule, there is no cross-resistance to the drug Levomac and antimicrobial agents of other groups. When taken orally, the absolute bioavailability of levofloxacin reaches 100%. The peak plasma concentration of the active component of the drug Levomac is observed 60 minutes after oral administration. Food intake does not affect the rate of absorption and bioavailability of levofloxacin. About 40% of levofloxacin is bound to plasma proteins. The active component of the drug practically does not penetrate into the cerebrospinal fluid.

Levofloxacin creates high therapeutic concentrations in the tissues of the lungs, bronchi, urinary system, prostate, as well as urine and bronchial secretions.

The active component of the drug Levomac is metabolized in the liver and excreted mainly by the kidneys unchanged (about 5% of levofloxacin is excreted as metabolites). The half-life of levofloxacin is approximately 6-8 hours in patients with normal renal function. In case of renal failure, the half-life may increase (with creatinine clearance less than 20 ml/min, the half-life of levofloxacin may increase to 35 hours).

Directions for use and dosage:

Film-coated tablets:

The drug is taken orally regardless of food intake. Levomac tablets should not be chewed. The dose of Levomac, as well as the duration of treatment, is determined by the doctor.

For urinary tract infections and exacerbation of chronic bronchitis, 250 mg is usually prescribed. Levomaka per day. If chronic bronchitis is complicated, the dose of Levomac can be increased to 500 mg. Levomaka per day.

For acute sinusitis, prostatitis and intra-abdominal infections, 500 mg is usually prescribed. per day.

For community-acquired pneumonia, bacteremia and septicemia, as well as diseases of soft tissues and skin, 1000 mg is usually prescribed. Levomaka per day (the dose should be divided into 2 doses with an interval of 12 hours).

The duration of treatment with Levomac is from 7 days.

For uncomplicated urinary tract infections, the duration of treatment is 3 days, for prostatitis - 28 days.

For patients with reduced renal function, the dose of Levomak is calculated taking into account the severity of the disease and creatinine clearance.

When creatinine clearance is from 20 to 50 ml/min, Levomac is prescribed at a dose of 250 mg. per day, starting from the second day of therapy, switch to taking a dose of 125 mg. per day.

In severe forms of the disease, it is allowed to increase the first dose of Levomac to 500 mg, after which they switch to taking a dose of 250 mg. twice a day.

When creatinine clearance is less than 20 ml/min, Levomac is prescribed at a dose of 250 mg. per day, starting from the second day of therapy, switch to taking Levomac at a dose of 125 mg. every 48 hours.

In severe forms of the disease, it is allowed to increase the first dose of Levomac to 500 mg, after which they switch to a dose of 125 mg. everyhour.

Solution for infusion administration Levomac:

The drug is intended for intravenous drip administration. The infusion rate should not exceed 250 mg/30 minutes. If arterial hypotension develops during the administration of the solution, the infusion should be stopped immediately.

Depending on the patient’s condition, you should switch to taking the oral form of Levomac as soon as possible. The duration of therapy and dose are determined by the doctor.

For community-acquired pneumonia, chronic bacterial prostatitis and infections of soft tissues and skin, Levomac is prescribed at a dose of 500 mg. per day.

For community-acquired pneumonia and infections of soft tissues and skin, the daily dose may be increased to 1000 mg. (divided into 2 injections).

For urinary tract infections, 250 mg is prescribed. Levomaka per day.

The total duration of therapy with Levomac, including parenteral and oral use, should not exceed 14 days (excluding the chronic form of bacterial prostatitis, in which the duration of use can be increased to 28 days).

Regardless of the form of release of the drug Levomac, patients with impaired renal function require a dose adjustment of levofloxacin.

When creatinine clearance is from 20 to 50 ml/min, a dose of 250 mg is prescribed. Levomac on the first day, after which they switch to taking the drug at a dose of 125 mg. per day.

In severe forms of disease, the dose may be increased to 500 mg. on the first day, after which they switch to taking the drug at a dose of 125 mg. every 12 hours.

When creatinine clearance is less than 20 ml/min, a dose of 250 mg is prescribed. Levomac on the first day, after which they switch to taking the drug at a dose of 125 mg. every 48 hours.

In severe forms of the disease, the dose of levofloxacin can be increased to 500 mg. per day, after which they switch to taking the drug at a dose of 125 mg. everyhour.

Film-coated tablets 250 mg, 500 mg. 5 tablets in a blister, 1 or 2 blisters in a cardboard box.

100 ml bottles containing 500 mg. active substance.

Interaction with other drugs:

There is a decrease in the bioavailability of Levomac when administered orally in combination with iron supplements, antacid drugs containing aluminum or magnesium, as well as sucralfate.

The simultaneous use of Levomak with ethyl alcohol is prohibited.

Levomac solution for infusion is prohibited from being mixed with alkaline solutions, heparin and other drugs for parenteral administration, excluding saline solution, 5% glucose solution and 2.5% dextrose solution in Ringer's solution.

Should not be used concomitantly with drugs that lower the seizure threshold. Fenbufen, cimetidine and probenecid, when used in combination, slightly increase plasma concentrations of Levomac. There is an increase in the half-life of cyclosporine when used simultaneously with Levomac. It is recommended to monitor coagulation parameters when prescribing Levomac and vitamin K antagonists simultaneously. Caution should be exercised when prescribing Levomac to patients receiving drugs that prolong the QT interval.

Attention! Before using Levomac, you should consult your doctor.

The instructions are provided for informational purposes only.

Source: http://www.antibiotic.in.ua/levomak.php

Levomac: instructions for use

Compound

active ingredient: levofloxacin;

1 tablet contains levofloxacin hemihydrate equivalent to levofloxacin 250 mg or 500 mg

Excipients: microcrystalline cellulose, corn starch, polysorbate 80, crospovidone, talc, colloidal silicon dioxide, magnesium stearate, titanium dioxide (E 171), red iron oxide (E172), yellow iron oxide (E 172), propylene glycol, diethyl phthalate.

Dosage form

Film-coated tablets.

Pharmacological group

Antibacterial agents for systemic use. Fluoroquinolones.

ATC code J01M A12.

Indications

For adults with mild or moderate infections, Levofloxacin is prescribed for the treatment of infections caused by microorganisms sensitive to levofloxacin: acute sinusitis, exacerbation of chronic bronchitis, pneumonia, complicated and uncomplicated urinary tract infections (including pyelonephritis), skin and soft tissue infections, chronic bacterial prostatitis.

Contraindications

Hypersensitivity to levofloxacin or other quinolones, to any component of the drug, epilepsy, complaints of adverse reactions from the tendons after prior use of quinolones.

Directions for use and doses

The drug is taken 1 or 2 times a day. The dose depends on the type and severity of the infection. The duration of treatment depends on the course of the disease. It is recommended to continue treatment with the drug for at least hours after normalization of body temperature or destruction of pathogens confirmed by microbiological tests.

Levofloxacin tablets should be swallowed without chewing, with plenty of liquid. If necessary, the tablet can be split along the distribution line. They can be taken with food or at other times.

Regarding dosing, the following recommendations should be followed for adult patients with normal renal function whose creatinine clearance is 50 ml/min:

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

1) After hemodialysis or chronic ambulatory peritoneal dialysis (CAPD), additional doses are not needed.

Since the tablet is not divided, if the drug is prescribed at a dose of less than 250 mg, levofloxacin preparations with the possibility of such dosing should be used.

Dosage for patients with impaired liver function. No dose adjustment is required since levofloxacin is slightly metabolized in the liver and is excreted primarily by the kidneys.

Dosing for elderly patients. If renal function is not impaired, there is no need for dose adjustment.

Adverse reactions

Infections and infestations: fungal infections, including fungi of the genus Candida, proliferation of other resistant microorganisms.

From the blood and lymphatic system: leukopenia, eosinophilia, neutropenia, agranulocytosis, pancytopenia, hemolytic anemia, thrombocytopenia, which may cause an increased tendency to hemorrhage or bleeding.

From the immune system: hypersensitivity reactions, including anaphylactic / anaphylactoid shock, angioedema (see section "Peculiarities of use"), anaphylactic and anaphylactoid reactions can sometimes occur even after the first dose.

Metabolic and nutritional disorders: anorexia, hypoglycemia, especially in patients with diabetes mellitus (see Section “Peculiarities of Use”), hyperglycemia, hypoglycemic coma. Signs of hypoglycemia may include increased appetite, nervousness, sweating, and trembling limbs.

From the psyche: insomnia, agitation, confusion, nervousness, mental disorders (including hallucinations, paranoia), depression, anxiety, restlessness, states of fear, pathological dreams, nocturnal delusions, psychotic reactions with self-destructive behavior, including suicidal tendencies thinking or action (see section “Features of application”).

From the nervous system: headache, dizziness, drowsiness, tremor, dysgeusia, convulsions, paresthesia, peripheral sensory or sensorimotor neuropathy, decreased sensation of touch, parosmia, including anosmia, ageusia, extrapyramidal disorders, other disorders of coordination of movements also during walking, fainting , benign intracranial hypertension.

From the organ of vision: visual disturbances, blurred vision, temporary loss of vision.

Hearing disorders: vertigo, tinnitus, hearing loss, hearing loss.

From the cardiovascular system: tachycardia, palpitations, ventricular tachycardia, which can lead to cardiac arrest, ventricular arrhythmia and arrhythmia of the torsade de pointes type (mainly in patients with risk factors for prolongation of the QT interval), prolongation of the QT interval on the ECG (see sections “Peculiarities of use” (Prolongation of the QT interval) and “Overdose”), hypotension, allergic vasculitis, collapse.

From the respiratory system: shortness of breath, bronchospasm, allergic pneumonitis.

From the digestive tract: diarrhea, nausea, vomiting, abdominal pain, dyspepsia, bloating, constipation, hemorrhagic diarrhea, which may indicate enterocolitis, including pseudomembranous colitis, pancreatitis.

Hepatobiliary system: increased activity of liver enzymes (ALT / AST, alkaline phosphatase, GGTP), bilirubin, hepatitis, jaundice and severe liver damage, including cases of acute liver failure, mainly in patients with severe underlying diseases (see Section "Peculiarities of application").

From the skin and subcutaneous tissues: rash, itching, urticaria, hyperhidrosis, exudative erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity, hypersensitivity to solar and ultraviolet radiation, leukocyplastic vasculitis, stomatitis. Such reactions may occur after the first dose and within minutes or hours after administration.

From the musculoskeletal system and connective tissue: arthralgia, myalgia, tendon lesions (see section “Peculiarities of use”), including their inflammation (tendinitis) (for example, Achilles tendon), muscle weakness, which may be of particular importance for patients severe myasthenia gravis, rhabdomyolysis, rupture of tendons, ligaments, muscles, arthritis.

From the kidneys and urinary system: increased serum creatinine, acute renal failure (for example, due to interstitial nephritis).

General disorders: asthenia, general weakness, fever, pain (including pain in the back, chest and limbs), as with the use of other fluoroquinolones, attacks of porphyria are possible in patients with porphyria.

Overdose

Symptoms: dizziness, disturbance/confusion, seizures, tremor, QT prolongation; reactions from the gastrointestinal tract, such as nausea and erosion of the mucous membranes, increased manifestations of other adverse reactions. In cases of overdose, careful monitoring of the patient, including an ECG, is necessary.

Treatment is symptomatic. In case of acute overdose, gastric lavage is prescribed. Antacids are used to protect the gastric mucosa.

Hemodialysis, including peritoneal dialysis or CAPD, is not effective in removing levofloxacin from the body. There are no specific antidotes.

Use during pregnancy or breastfeeding

Due to the lack of research and the possibility of quinolones damaging articular cartilage in the body as it grows, the drug should not be prescribed to pregnant or breastfeeding women. If pregnancy is diagnosed during treatment, you should inform your doctor.

Children (under 18 years of age) are contraindicated to use the drug, since damage to the articular cartilage is possible.

Features of application

For nosocomial infections caused by Ps. Aeruginosa, and in severe cases of pneumococcal pneumonia, combination therapy may be needed.

Methicillin-resistant Staphylococcus aureus (MRSA) is resistant to fluoroquinolones, including levofloxacin, and therefore levofoxacin is not recommended for the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA), unless the microorganism's sensitivity to levofloxacin has been confirmed.

A common causative agent of urinary tract infections can be levofloxacin-resistant E. coli, which should be taken into account when prescribing levofloxacin to patients with urinary tract diseases.

Tendinitis and tendon rupture.

Tendonitis may occur during treatment with quinolones, which can lead to tendon rupture, including the Achilles tendon. Tendinitis and tendon ruptures, sometimes bilateral, may occur 48 hours after use of levofloxacin, and also several months after discontinuation of levofloxacin. Patients most susceptible to tendonitis and tendon ruptures are those over the age of 60 years, patients receiving a daily dose of 1000 mg of levofloxacin, and those receiving corticosteroid treatment. The daily dose must be adjusted for elderly patients, taking into account creatinine clearance. Thus, it is necessary to monitor the condition of elderly patients by prescribing levofloxacin. If tendonitis is suspected, treatment with levofloxacin should be stopped immediately and appropriate treatment (eg immobilization of the tendon) initiated.

Diseases caused by Clostridium difficile.

Diarrhea, especially severe, persistent or bloody, during or after treatment (including several weeks after treatment) with levofloxacin may be a symptom of Clostridium difficile disease, the most severe form of which is pseudomembranous colitis. If pseudomembranous colitis is suspected, levofloxacin should be discontinued immediately and symptomatic and specific treatment (eg vancomycin) should be initiated without delay. In such a situation, drugs that suppress intestinal motility are contraindicated.

Patients prone to seizures.

Quinolones can lower the seizure threshold and provoke the development of seizures. Levofloxacin is contraindicated in patients with a history of epilepsy.

As with other quinolones, the drug should be used with extreme caution in patients prone to seizures, such as those with pre-existing central nervous system lesions, while being treated with fenbufen and similar non-steroidal anti-inflammatory drugs, or drugs that increase seizure readiness (lower the seizure threshold). such as theophylline (see section “Interaction with other medicinal products and other types of interactions”). If seizures occur, treatment with levofloxacin should be discontinued.

Patients with latent or overt deficiency of glucose-6-phosphate dehydrogenase activity may be prone to hemolytic reactions when treated with quinolone antibacterial drugs. Therefore, such patients should use levofloxacin with caution.

Levofloxacin is excreted primarily by the kidneys, so dose adjustment is required in patients with renal failure.

Levofloxacin may occasionally cause serious, potentially fatal hypersensitivity reactions (including angioedema, anaphylactic shock), even after the first use. If hypersensitivity reactions occur, stop taking levofloxacin, consult a doctor and begin appropriate treatment.

Severe bullous reactions.

Severe bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with the use of levofloxacin. If bullous reactions occur, you should immediately stop taking levofloxacin, consult a doctor and begin appropriate treatment.

Changes in blood glucose levels.

Changes in blood glucose levels (both hyperglycemia and hypoglycemia) have been reported when quinolones are used, especially in patients with diabetes mellitus concomitantly taking oral hypoglycemic agents (including glibenclamide) or insulin. Cases of hypoglycemic coma have been reported. In patients with diabetes, it is necessary to monitor blood sugar levels.

Prevention of photosensitivity reactions.

Photosensitivity has been reported during treatment with levofloxacin.

In order to prevent the occurrence of photosensitivity reactions, patients taking levofloxacin should avoid exposure to sunlight and UV rays (artificial ultraviolet radiation lamps, solarium) due to possible photosensitivity while taking levofloxacin or for 48 hours after discontinuation of levofloxacin.

Patients taking vitamin K antagonists should monitor coagulation parameters when taking levofloxacin and vitamin K antagonists (warfarin) concomitantly due to the potential risk of increased coagulation parameters (prothrombin time/INR) and/or bleeding.

Psychotic reactions have been observed in patients receiving quinolines, including levofloxacin. In rare cases, they have led to suicidal thoughts and self-destructive behavior - sometimes even after taking a single dose of levofloxacin. In the event that a patient experiences these reactions, levofloxacin should be discontinued and countermeasures initiated. It is recommended to use levofloxacin with caution in patients with psychotic disorders or patients with a history of mental illness.

Prolongation of the QT interval.

Cases of QT prolongation have been reported with fluoroquinolones. Caution should be exercised when taking fluoroquinolones, including levofloxacin, in patients with known risk factors for QT prolongation:

  • syndrome of congenital or acquired long QT interval;
  • with simultaneous use of drugs that prolong the QT interval (including antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotic drugs);
  • if there is an imbalance of electrolytes (including hypokalemia, hypomagnesemia)
  • heart disease (heart failure, myocardial infarction, bradycardia).

Elderly patients and women are more sensitive to drugs that prolong the QT interval. Therefore, fluoroquinolones, including levofloxacin, should be used with caution in this group of patients.

Cases of sensory or sensorimotor peripheral neuropathy, which may occur rapidly, have been reported in patients taking fluoroquinolones, including levofloxacin. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy to prevent the occurrence of an irreversible condition.

When using levofloxacin, cases of liver necrosis to life-threatening liver failure have been reported, mainly in patients with severe underlying diseases, such as sepsis (see section "Adverse reactions"). Patients should be advised to stop treatment and consult a doctor if signs and symptoms of liver disease such as anorexia, jaundice, dark urine, itching or abdominal pain occur.

Fluoroquinolones, including levofloxacin, block neuromuscular transmission and may cause muscle weakness in patients with myasthenia gravis. Serious adverse reactions have been reported with fluoroquinolones during the post-marketing period, including deaths and the need for respiratory support in patients with myasthenia gravis. Levofloxacin is not recommended for use in patients with a history of myasthenia gravis.

If blurred vision or other effects on the eyes are observed, you should immediately consult an ophthalmologist (see section “Adverse reactions”, “The ability to influence the reaction rate when driving vehicles or other mechanisms”).

When using levofloxacin, especially long-term, the development of opportunistic infections and the growth of resistant microorganisms is possible. If a secondary infection develops, appropriate measures must be taken.

In patients treated with levofloxacin, determination of opiates in urine may give a false-positive result. It may be necessary to confirm positive opiate results using specific methods.

Levofloxacin inhibits the growth of Mycobacterium tuberculosis and therefore a false negative result may occur during bacteriological testing in patients with tuberculosis.

The ability to influence the reaction rate when driving vehicles or other mechanisms

In some patients, the drug can cause headache, dizziness/vertigo, drowsiness, insomnia, blurred vision, confusion, therefore, while using it, you should refrain from driving vehicles and working with mechanisms that require increased attention and speed of psychomotor reactions.

Interaction with other drugs and other types of interactions.

Effect of other drugs on the drug

Iron salts, antacids containing magnesium and aluminum

The absorption of levofloxacin is significantly reduced when iron salts and antacids containing magnesium or aluminum are taken simultaneously with levofloxacin tablets. The drug should be taken at least 2:00 before or 2:00 after taking drugs containing divalent or trivalent cations, such as iron salts or antacids containing magnesium or aluminum (see section "Dosage and Administration"). No interaction with calcium carbonate was detected.

The bioavailability of levofloxacin tablets is significantly reduced when used simultaneously with sucralfate. If a patient must receive both sucralfate and levofloxacin, it is best to take sucralfate 2:00 after taking levofloxacin (see Dosage and Administration).

Theophylline, fenbufen or other similar non-steroidal anti-inflammatory drugs

There was no pharmacokinetic interaction between levofloxacin and theophylline. However, a significant reduction in the seizure threshold is possible with simultaneous use of quinolones with theophylline and nonsteroidal anti-inflammatory drugs and other agents that reduce the seizure threshold. The concentration of levofloxacin in the presence of fenbufen was approximately 13% higher than when taking levofloxacin alone.

Probenecid and cimetidine

Probenecid and cimetidine have a statistically significant effect on the excretion of levofloxacin.

The renal clearance of levofloxacin is reduced in the presence of cimetidine by 24% and probenecid by 34%. This is because both drugs are capable of blocking the tubular secretion of levofloxacin. However, at the doses tested in the study, it is not likely that statistically significant kinetic differences were clinically significant. Caution should be exercised in the simultaneous use of levofloxacin with drugs that affect tubular secretion, such as probenecid and cimetidine, especially in patients with renal failure.

Calcium carbonate, digoxin, glibenclamide, ranitidine do not cause any clinically significant effect on the pharmacokinetics of levofloxacin when used simultaneously.

Effect on other drugs

The half-life of cyclosporine increases by 33% when taken concomitantly with levofloxacin.

Vitamin K antagonists

Increased coagulation tests (IF/international normalization ratio) and/or bleeding, which may be severe, have been reported when used concomitantly with vitamin K antagonists (e.g. warfarin). Despite this, in patients receiving vitamin K antagonists in parallel, it is necessary to monitor coagulation parameters (see Section “Peculiarities of Application”).

Medicines that prolong the Q-interval

Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the Q-interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants and macrolides, antipsychotic drugs) (see section "Features" application" ("Prolongation of the QT interval")).

Other forms of interaction

No clinically significant food interactions were observed. Levofloxacin tablets can therefore be taken without regard to meals.

There is no clinically significant effect on the pharmacokinetics of levofloxacin when taking levofloxacin together with the following drugs: calcium carbonate, digoxin, glibenclamide, ranitidine.

The use of levofloxacin simultaneously with alcohol is not recommended.

When used simultaneously with GCS, the risk of developing tendon rupture increases.

Pharmacological properties

Levofloxacin, a synthetic antibacterial drug from the group of fluoroquinolones, is the S-enantiomer of the racemic mixture of the drug ofloxacin.

As an antibacterial drug from the group of fluoroquinolones, levofloxacin acts on the DNA-DNA gyrase complex and topoisomerase IV.

The European Committee on Antimicrobial Susceptibility Testing (EUCAST) recommended MIC cut-off values ​​for levofloxacin, separating sensitive from intermediate-susceptible (moderately resistant) organisms and intermediate-susceptible from resistant organisms, are presented in the MIC testing table below (mg/L).

EUCAST Clinical MIC Limit Values ​​for Levofloxacin (06/20/2006):

Recommended CLSI (Clinical and Laboratory Standards Institute, formerly NCCLS) MIC cut-off values ​​for levofloxacin separating susceptible from intermediately sensitive organisms and intermediately sensitive from resistant organisms are presented in the table below, for MIC testing (µg/ml) or disc diffusion method (zone diameter [mm] using levofloxacin 5 μg disc).

CLSI Recommended MIC and Disc Diffusion Limit Values ​​for Levofloxacin (M100-S17, 2007):

The prevalence of resistance may vary geographically and over time among selected species, and local information on resistance is desirable, especially when treating severe infections. If necessary, specialist advice should be sought when the local prevalence of resistance is such that the utility of the agent in some types of infections is questionable.

*Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications.

** natural intermediate sensitivity.

Hospital-acquired infections caused by P. aeruginosa may require combination therapy.

Levofloxacin is metabolized to a very small extent, the metabolites being dismethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for less than 5% of the amount of the drug that is excreted in the urine. Levofloxacin is stereochemically stable and is not subject to chiral structure inversion.

After administration and administration, levofloxacin is eliminated from blood plasma relatively slowly (half-life is 6-8 hours). It is usually excreted by the kidneys (85% of the administered dose).

There is no significant difference in the pharmacokinetics of levofloxacin after intravenous and oral administration, indicating that these routes (oral and intravenous) are interchangeable.

Levofloxacin has linear pharmacokinetics in the mg range.

Patients with kidney failure

The pharmacokinetics of levofloxacin is affected by renal failure. As renal function decreases, renal clearance and clearance decrease and half-life increases, as seen in the table below:

There are no significant differences in the pharmacokinetics of levofloxacin between young and elderly patients, other than differences associated with creatinine clearance.

A separate analysis of female and male patients demonstrated minor differences in the pharmacokinetics of levofloxacin depending on gender. There is no evidence that these differences are clinically significant.

Basic physical and chemical properties

round, biconvex, film-coated tablets, brown-red in color, smooth on both sides (250 mg)

capsule-shaped, biconvex, film-coated tablets, brown-red in color, smooth on both sides (500 mg).

Best before date

Storage conditions

Store at a temperature not exceeding 25 ° C in the original packaging.

Keep out of the reach of children.

Package

5 tablets in a blister, 1 or 2 blisters in a cardboard package; 5 tablets in a blister, 4 interconnected blisters, 5 such blisters in a cardboard package;

Vacation category

Manufacturer

McLeods Pharmaceuticals Limited

You should consult your doctor and read the instructions before use.

Source: http://lek.103.ua/19253-levomak-instruktsiya/