Levofloxacin: instructions for use, analogues and reviews, prices in Russian pharmacies. Levofloxacin solution for infusion "belmed preparations Levofloxacin in Latin

Broad-spectrum antimicrobial agent, fluoroquinolone. Acts bactericidal. Blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes.

Active regarding Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influenzae, Ha emophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulgar is, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Clostridium perfringens.

Pharmacokinetics

When taken orally, it is absorbed from the gastrointestinal tract quickly and almost completely. Food intake has little effect on the speed and completeness of absorption. Bioavailability is 99%. Cmax is achieved after 1-2 hours and when taking 250 mg and 500 mg is 2.8 and 5.2 mcg/ml, respectively. Plasma protein binding is 30-40%. Penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, genitourinary organs, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and/or deacetylated. Renal clearance accounts for 70% of the total clearance.

T1/2 - 6-8 hours. Excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. Unchanged in urine, 70% is excreted within 24 hours and 87% within 48 hours; 4% of the dose taken orally is found in feces within 72 hours. After an intravenous infusion of 500 mg over 60 minutes, Cmax is 6.2 mcg/ml. With single and multiple intravenous administration, the apparent Vd after administration of the same dose is 89-112 l, Cmax - 6.2 μg/ml, T1/2 - 6.4 hours.

Indications

Infections of the lower respiratory tract (chronic bronchitis, pneumonia), ENT organs (sinusitis, otitis media), urinary tract and kidneys (including acute pyelonephritis), genital organs (including urogenital chlamydia), skin and soft tissues (festering atheromas, abscess, boils).

Contraindications

Hypersensitivity, epilepsy, tendon damage due to previous treatment with quinolones, pregnancy, lactation, children and adolescents under 18 years of age.

Dosage

Use orally or intravenously.

For sinusitis - orally, 500 mg 1 time / day; for exacerbation of chronic bronchitis - 250-500 mg 1 time / day. For pneumonia - orally, 250-500 mg 1-2 times/day (500-1000 mg/day); IV - 500 mg 1-2 times a day. For urinary tract infections - orally, 250 mg 1 time / day or intravenously at the same dose. For infections of the skin and soft tissues - 250-500 mg orally 1-2 times a day or intravenously, 500 mg 2 times a day. After intravenous administration, after a few days it is possible to switch to oral administration at the same dose.

For kidney diseases, the dose is reduced in accordance with the degree of dysfunction: with CC = 20-50 ml/min - 125-250 mg 1-2 times a day, with CC = 10-19 ml/min - 125 mg 1 time in 12 -48 h, with CC

The drug Levofloxacin (also known as Tavanic) is an antibacterial drug created on the basis of ofloxacin. However, its antibacterial activity is significantly higher (about two times) than ofloxacin.

Levofloxocin is prescribed for the treatment of bacterial inflammation in adult patients. These are pyelonephritis, pneumonia, inflammatory processes in the urinary tract, soft tissue infections, chronic prostatitis of bacterial etiology).

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones, containing levofloxacin, the levorotatory isomer of ofloxacin, as an active substance. Levofloxacin blocks DNA gyrase, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes.

The drug has several release forms, each of which is optimized for the treatment of certain types of infections:

1. Tablets 250 mg and 500 mg. Tablet forms, depending on the dosage, are called: “Levofloxacin 250” and “Levofloxacin 500”.
2. Eye drops 0.5%.
3. Solution for infusion 0.5%.

Levofloxacin photo

Routes of administration: orally, intravenously, conjunctivally.

Eye drops are used for a narrow range of inflammatory diseases that are associated with the visual analyzer. And tablets and solution for infusion are used for a wide range of infectious and inflammatory diseases of various organs and systems.

Indications for use Levofloxacin

Levofloxacin for oral and intravenous administration is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of microorganisms in adult patients (18 years of age and older).

• Lower respiratory tract infections (exacerbation of chronic bronchitis, pneumonia),
• ENT organs (sinusitis, otitis media),
• Urinary tract, kidneys, genitals (acute pyelonephritis, urogenital chlamydia),
• Skin and soft tissues (atheromas, abscesses, boils).

Instructions for use Levofloxacin, dosage

Pills

Levofloxacin tablets are taken orally between meals or before meals. The daily dosage can be divided into 2 doses. The tablets must not be chewed. Take with 0.5-1 glasses of water.

The dosage for tablet forms ranges from 250 mg to 1000 mg/day and is prescribed only by the attending physician, depending on the severity of the patient’s condition and the characteristics of the pathological process.

Levofloxacin injections

Levofloxacin in the form of injections is used intravenously (depending on the severity of symptoms - from 0.25 g / once a day to 0.5 g / twice a day).

Drops

1. During the first two days, apply 1 to 2 drops into the eye every two hours, throughout the entire period of wakefulness. You can put drops in your eyes up to 8 times a day.

2. From the third to the fifth day, apply 1 – 2 drops 4 times a day to the eyes.

Features of application

Patients who drive vehicles or work with machines and mechanisms should take into account possible adverse reactions from the nervous system (dizziness, stupor, drowsiness, confusion, visual and hearing impairment, movement disorders, including while walking).

The antibiotic is incompatible with ethanol, so during therapy the consumption of any liquids containing alcohol is strictly contraindicated.

Various forms of Levofloxacin have restrictions for use in patients of a certain age category. Thus, drops to combat infections of the ENT organs and skin can be used by adults and children from 1 year of age. But severe pulmonary infections can only be treated with solution and tablets in adult patients (over 18 years of age).

Side effects and contraindications Levofloxacin

• itching and redness of the skin;
• anaphylactic or anaphylactoid reactions (sudden drop in blood pressure, urticaria, facial swelling, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exudative erythema multiforme);
• local reaction during intravenous use - pain, redness at the site of puncture with a needle;
• pain in the chest;
• headache;
• dizziness and weakness;
• states of fear and anxiety;
• impaired hearing, vision, smell and taste sensitivity (dry mouth), decreased tactile sensitivity;
• increased sweating;
• paresthesia of the hands;
• trembling, seizures;
• diarrhea;
• nausea, vomiting, digestive disorders.

Overdose:

• confusion;
• dizziness;
• loss of consciousness;
• convulsions;
• nausea;
• erosion of mucous membranes;
• changes on the cardiogram.

Treatment is symptomatic. In case of an overdose of Levofloxacin tablets, gastric lavage and administration of antacids to protect the gastric mucosa, as well as electrocardiogram monitoring, are indicated. Levofloxacin is not eliminated by dialysis. There is no specific antidote.

Contraindications

Contraindications, according to the instructions for use of the drug Levofloxacin, include: epilepsy, pregnancy, breastfeeding, age under 18 years, severe renal failure, a history of allergic reactions to the antibiotic levofloxacin, or any other component included in the drug.

Levofloxacin should not be used in the treatment of children and adolescents due to the likelihood of damage to articular cartilage.

Eye drops should not be used to treat pregnant women, breastfeeding women, hypersensitivity, or children under 1 year of age.

Levofloxacin analogs, list

1. Levofloxacin-Teva,
2. Levostar,
3. Leflobakt,
4. L-Optic Rompharm,
5. Signitsef,
6. Oftaquix,
7. Tavanik,
8. Eleflox,
9. Tsipromed,
10. Betaciprol,
11. Vitabakt,
12. Decamethoxin,
13. Lofox,
14. Okatsin,
15. Ofloxacin.

Important - instructions for use of Levofloxacin, price and reviews do not apply to analogues and cannot be used as a guide to the use of drugs of similar composition or action. All therapeutic prescriptions must be made by a doctor. When replacing Levofloxacin with an analogue, it is important to consult a specialist; you may need to change the course of therapy, dosages, etc. Do not self-medicate!

Medicine

Levofloxacin represents

antibiotic wide spectrum of action. This means that the drug has a detrimental effect on a wide range of pathogenic and opportunistic microorganisms that are causative agents of infectious and inflammatory processes. Since each infectious-inflammatory pathology is caused by certain types of microbes and is localized in specific organs or systems, antibiotics that have a detrimental effect on this group of microorganisms are most effective in treating the diseases they cause in the same organs.

Thus, the antibiotic Levofloxacin is effective for the treatment of infectious and inflammatory diseases of the ENT organs (for example, sinusitis, otitis), respiratory tract (for example, bronchitis or pneumonia), urinary organs (for example, pyelonephritis), genital organs (for example, prostatitis, chlamydia) or soft tissue (eg, abscesses, boils).

Release form Today, the antibiotic Levofloxacin is available in the following dosage forms:1. Tablets 250 mg and 500 mg.

2. Eye drops 0.5%.

3. Solution for infusion 0.5%.

Levofloxacin tablets, depending on the content of the antibiotic, are often designated “Levofloxacin 250” and “Levofloxacin 500”, where the numbers 250 and 500 indicate the amount of its own antibacterial component. They are colored yellow and have a round, biconvex shape. When cut through the tablet, two layers can be clearly distinguished. Tablets of 250 mg and 500 mg are available in packs of 5 or 10 pieces.

Eye drops are a homogeneous solution, transparent, practically uncolored. Available in bottles of 5 ml or 10 ml, equipped with a specially designed cap in the form of a dropper.

The solution for infusion is available in 100 ml bottles. One milliliter of solution contains 5 mg of antibiotic. A full bottle of solution for infusion (100 ml) contains 500 mg of antibiotic intended for intravenous administration.

Levofloxacin – group

According to the type of action, Levofloxacin is a bactericidal drug. This means that the antibiotic kills pathogens, affecting them at any stage. But bacteriostatic antibiotics can only stop reproduction

bacteria

That is, they can only affect dividing cells. It is precisely because of the bactericidal type of action that Levofloxacin is a very powerful antibiotic that destroys growing, dormant, and dividing cells.

According to the mechanism of action, Levofloxacin belongs to the group systemic quinolones, or fluoroquinolones. The group of antibacterial agents belonging to systemic quinolones is used very widely because it is highly effective and has a wide spectrum of action. Systemic quinolones, in addition to Levofloxacin, include such well-known drugs as Ciprofloxacin, Lomefloxacin, etc. All fluoroquinolones disrupt the process of synthesis of genetic material of microorganisms, preventing them from reproducing, and thereby leading to their death.

Levofloxacin – manufacturer

Levofloxacin is produced by various pharmaceutical concerns, both domestic and foreign. The following manufacturers of Levofloxacin are most often sold on the domestic pharmaceutical market:

• CJSC "Vertex";
• RUE "Belmedpreparaty";
• JSC "Tavanik";
• Teva Concern;
• OJSC "Nizhpharm", etc.

Levofloxacins from various manufacturers are often named by simply combining the name of the antibiotic with the manufacturer, for example, “Levofloxacin Teva”, “Levofloxacin-Stada”, “Levofloxacin-Tavanic”. Levofloxacin Teva is produced by the Israeli corporation Teva, Levofloxacin-Stada is produced by the Russian concern Nizhpharm, and Levofloxacin-Tavanic is a product of Aventis Pharma Deutschland GmbH.
Doses and composition

Tablets, eye drops and solution for infusion Levofloxacin contain as an active component the chemical substance of the same name -

levofloxacin. Tablets contain 250 mg or 500 mg of levofloxacin. And eye drops and solution for infusion contain levofloxacin 5 mg per 1 ml, that is, the concentration of the active substance is 0.5%.

Eye drops and solution for infusion contain the following substances as auxiliary components:

• sodium chlorine;
• disodium edetate dihydrate;
• deionized water.

Levofloxacin 250 mg and 500 mg tablets contain the following substances as auxiliary components:

• microcrystalline cellulose;
• hypromellose;
• primellose;
• calcium stearate;
• macrogol;
• titanium dioxide;
• iron oxide yellow.

Spectrum of action and therapeutic effects Levofloxacin is an antibiotic with a bactericidal type of action. The drug blocks the work of enzymes that are necessary for the synthesis of DNA in microorganisms, without which they are unable to reproduce. As a result of blocking DNA synthesis, changes occur in the bacterial cell wall that are incompatible with the normal life and functioning of microbial cells. This mechanism of action on bacteria is bactericidal, since microorganisms die, and not only lose their ability to reproduce.

Levofloxacin destroys pathogenic bacteria that cause inflammation in certain organs. As a result, the cause of inflammation is eliminated, and as a result of the use of an antibiotic, recovery occurs. Levofloxacin can cure inflammation in any organ caused by microorganisms sensitive to it. That is, if cystitis, pyelonephritis or bronchitis is caused by bacteria on which Levofloxacin has a detrimental effect, then all these inflammations in different organs can be cured with an antibiotic.

Levofloxacin has a detrimental effect on a wide range of gram-positive, gram-negative and anaerobic microbes, the list of which is presented in the table:

Indications for use Eye drops are used for a narrow range of inflammatory diseases that are associated with the visual analyzer. And tablets and solution for infusion are used for a wide range of infectious and inflammatory diseases of various organs and systems. Levofloxacin can be used to treat any infection caused by microorganisms on which the antibiotic has a detrimental effect. Indications for the use of drops, solution and tablets are shown in the table for convenience:

Levofloxacin - instructions for use Features of the use of tablets, drops and solution are different, so it would be advisable to consider the intricacies of using each dosage form separately.
Levofloxacin tablets (500 and 250)

Tablets are taken once or twice a day before meals. You can take the tablets between meals. The tablet should be swallowed whole, without chewing, but with a glass

clean water

If necessary, the Levofloxacin tablet can be broken in half along the dividing strip.

The duration of treatment with Levofloxacin tablets and dosage depend on the severity of the infection and its nature. Thus, the following courses and dosages of the drug are recommended for the treatment of various diseases:

• Sinusitis – take 500 mg (1 tablet) 1 time per day for 10 – 14 days.
• Exacerbation of chronic bronchitis - take 250 mg (1 tablet) or 500 mg (1 tablet) 1 time per day for 7 - 10 days.
• Pneumonia – take 500 mg (1 tablet) 2 times a day for 1 – 2 weeks.
• Infections of the skin and soft tissues (boils, abscesses, pyoderma, etc.) - take 500 mg (1 tablet) 2 times a day for 1 - 2 weeks.
• Complicated urinary tract infections (pyelonephritis, urethritis, cystitis, etc.) - take 500 mg (1 tablet) 2 times a day for 3 days.
• Uncomplicated urinary tract infections - take 250 mg (1 tablet) once a day for 7 - 10 days.
• Prostatitis - take 500 mg (1 tablet) once a day for 4 weeks.
• Intra-abdominal infection - take 500 mg (1 tablet) 1 time per day for 10-14 days.
• Sepsis - take 500 mg (1 tablet) 2 times a day for 10 - 14 days.

Solution for infusion Levofloxacin

The solution for infusion is administered once or twice a day. Levofloxacin must be administered dropwise only, with 100 ml of solution dripped no faster than 1 hour. The solution can be replaced with tablets in exactly the same daily dosage.

Levofloxacin can be combined with the following infusion solutions:1. saline.

2. 5% dextrose solution.

3. 2.5% Ringer's solution with dextrose.

4. solutions for parenteral nutrition.

The duration of intravenous antibiotic use should not exceed 2 weeks. It is recommended to administer Levofloxacin as long as the person is sick, plus another two days after the temperature has returned to normal.

The dosages and duration of use of Levofloxacin infusion solution for the treatment of various pathologies are as follows:

• Acute sinusitis– administer 500 mg (1 bottle 100 ml) 1 time per day for 10 – 14 days.
• Exacerbation of chronic bronchitis– administer 500 mg (1 bottle 100 ml) 1 time per day for 7 – 10 days.
• Pneumonia
• Prostatitis– administer 500 mg (1 bottle of 100 ml) once a day for 2 weeks. Then they switch to taking 500 mg tablets once a day for another 2 weeks.
• Acute pyelonephritis– administer 500 mg (1 bottle 100 ml) 1 time per day for 3 – 10 days.
• Biliary tract infections– administer 500 mg (1 bottle of 100 ml) 1 time per day.
• Skin infections– administer 500 mg (1 bottle 100 ml) 2 times a day for 1 – 2 weeks.
• Anthrax – administer 500 mg (1 bottle of 100 ml) once a day. After stabilization of the person’s condition, transfer to taking Levofloxacin tablets. Take 500 mg tablets once a day for 8 weeks.
• Sepsis– administer 500 mg (1 bottle 100 ml) 1 – 2 times a day for 1 – 2 weeks.
• Abdominal infection– administer 500 mg (1 bottle 100 ml) 1 time per day for 1 – 2 weeks.
• Tuberculosis - administer 500 mg (1 bottle of 100 ml) 1 - 2 times a day for 3 months.

When a person’s condition normalizes, it is possible to switch from intravenous administration of Levofloxacin solution to taking tablets in the same dosage. Take antibiotic tablets for the remainder of the course of treatment.
Tablets and solution

Levofloxacin should not be stopped in advance and the next dose should not be skipped. Therefore, if you miss another tablet or infusion, you should take it immediately, and then continue using Levofloxacin in the recommended regimen.

People suffering from severe renal impairment, in which creatinine clearance is less than 50 ml/min, must take the drug according to a specific regimen during the entire course of treatment. Levofloxacin is taken, depending on QC, according to the following regimens:

1. CC is above 20 ml/min and below 50 ml/min - the first dosage is 250 or 500 mg, then take half of the initial dose, that is, 125 mg or 250 mg every 24 hours.

2. CC is above 10 ml/min and below 19 ml/min - the first dosage is 250 mg or 500 mg, then take half of the primary dose, that is, 125 mg or 250 mg once every 48 hours.

Patients with liver disease and the elderly can take Levofloxacin as usual. That is, no dosage adjustment is required depending on age.

Severe pneumonia may require multiple antibiotics because Levofloxacin does not always work as expected. Patients with a history of damage to brain structures (for example, trauma or stroke, etc.) are capable of having seizures while taking Levofloxacin.

During the entire course of using Levofloxacin, you should avoid exposure to direct sunlight and do not visit the solarium.

In rare cases, Levofloxacin can lead to tendon inflammation - tendonitis, which can lead to tendon rupture. If tendinitis is suspected, use of the drug should be stopped and treatment of the inflamed tendon should be started immediately.

Levofloxacin can lead to hemolysis of red blood cells in people suffering from hereditary glucose-6-phosphate dehydrogenase deficiency. Therefore, the antibiotic should be used carefully in this category of patients, constantly monitoring bilirubin and hemoglobin.

The antibiotic negatively affects the speed of psychomotor reactions, as well as concentration. Therefore, during treatment with Levofloxacin, you should avoid all activities that require good concentration and high reaction speed, including driving a car or servicing various mechanisms.

Overdose

An overdose of Levofloxacin is possible and is manifested by the following:

symptoms

• confusion;
• dizziness;
• loss of consciousness;
• convulsions;
• nausea;
• erosion of mucous membranes;
• changes on the cardiogram.

Treatment of overdose must be carried out in accordance with the existing symptoms. It is necessary to eliminate pathological symptoms by using medications that act in this direction. Any dialysis options to accelerate the removal of Levofloxacin from the body are ineffective.
Interaction with other drugs

The combined use of Levofloxacin with Fenbufen, non-steroidal anti-inflammatory drugs (for example,

AspirinParacetamolIbuprofen

Nimesulide, etc.) and theophylline enhances the readiness of the central nervous system for convulsions.

The effectiveness of Levofloxacin is reduced when used simultaneously with Sucralfate, antacids (for example, Almagel, Rhenium, Phosphalugel, etc.) and iron salts. To neutralize the effect of the listed drugs on Levofloxacin, they should be taken 2 hours apart.

The combined use of Levofloxacin and glucocorticoids (for example, hydrocortisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, etc.) leads to an increased risk of tendon ruptures.

Taking alcoholic beverages together with Levofloxacin leads to increased side effects that develop from the central nervous system (dizziness, drowsiness, blurred vision, loss of concentration and poor reaction).

Levofloxacin eye drops

Drops are used exclusively topically for the treatment of inflammation of the outer membranes of the eye. In this case, adhere to the following antibiotic use regimen:

1. During the first two days, apply 1 to 2 drops into the eye every two hours, throughout the entire period of wakefulness. You can put drops in your eyes up to 8 times a day.

2. From the third to the fifth day, apply 1 – 2 drops 4 times a day to the eyes.

Levofloxacin drops are used for 5 days.

Levofloxacin for children

Levofloxacin should not be used to treat various pathological conditions in children and adolescents under the age of 18, since the antibiotic negatively affects cartilage tissue. During the period of active growth of children, the use of Levofloxacin can provoke damage to articular cartilage, which can lead to disruption of the normal functioning of the joints.

Use for the treatment of ureaplasma

Ureaplasma affects the genital organs and urinary tract in men and women, causing infectious and inflammatory processes in them. Treatment of ureaplasmosis requires some effort. Levofloxacin is harmful to ureaplasma, therefore it is successfully used to treat infections caused by this microorganism.

So, for the treatment of ureaplasmosis, uncomplicated by other pathologies, it is enough to take Levofloxacin tablets 250 mg once a day for 3 days. If the infectious process is prolonged, then the antibiotic is taken 250 mg (1 tablet) once a day, for 7–10 days.

More about ureaplasma

Treatment of prostatitis Levofloxacin can effectively treat prostatitis caused by various pathogenic bacteria. Prostatitis can be treated with Levofloxacin tablets or in the form of an infusion solution.

In case of severe prostatitis, it is better to start therapy with an infusion of an antibiotic of 500 mg (1 bottle 100 ml) once a day. Intravenous administration of Levofloxacin is continued for 7 to 10 days. After this, you need to switch to taking antibiotic tablets, which you drink 500 mg (1 piece) once a day. The tablets should be taken for another 18 to 21 days. The general course of treatment with Levofloxacin should be 28 days. Therefore, after several days of intravenous administration of the antibiotic, you must take tablets for the remaining time up to 28 days.

Prostatitis can only be treated with Levofloxacin tablets. In this case, the man should take the drug 500 mg (1 tablet) once a day for 4 weeks.

More about prostatitis

Levofloxacin and alcohol Alcohol and Levofloxacin are incompatible with each other. During the treatment period, you should avoid drinking alcoholic beverages. If a person needs to drink a certain amount of alcohol, then it should be borne in mind that Levofloxacin will increase the effect of drinks on the central nervous system, that is, intoxication will be stronger than usual. The antibiotic increases dizziness, nausea, confusion, impaired reaction speed and ability to concentrate caused by alcohol.
Contraindications

Tablets and solutions for infusion Levofloxacin

• hypersensitivity, allergy or intolerance to the components of the drug, including levofloxacin or other quinolones;
• renal failure with CC less than 20 ml/min;
• epilepsy;
• the presence of tendon inflammation in the past during treatment with any drugs from the quinolone group;
• age under 18 years;
• pregnancy;
• breast-feeding.

Relative contraindications to the use of Levofloxacin in tablets and solution are severe renal dysfunction and glucose-6-phosphate dehydrogenase deficiency. in such cases, the drug should be taken under close medical supervision of the person’s condition.

Levofloxacin eye drops contraindicated for use in the following cases:

• sensitivity or allergy to any drugs from the quinolone group;
• pregnancy;
• breast-feeding;
• age under 1 year.

Side effects

The side effects of Levofloxacin are quite numerous, and they develop in various organs and systems. All side effects of the antibiotic are divided by frequency of development:

1. Often - observed in 1-10 people out of 100.

2. Sometimes - observed in less than 1 person out of 100.

3. Rare - occurs in less than 1 in 1000 people.

4. Very rare - occurs in less than 1 person in 1000.

All side effects of tablets and solution for infusion, depending on the frequency of occurrence, are reflected in the table:

In addition to the listed side effects, Levofloxacin, like any other antibiotic, can lead to the development of dysbacteriosis, as well as increased proliferation of fungi. Therefore, it is recommended to take drugs containing bacteria of normal intestinal microflora, as well as antifungal agents, against the background of antibiotic therapy.

Levofloxacin eye drops can cause the following side effects:

• burning in the eye;
• decreased visual acuity;
• formation of mucous strands in the eyes;
• blepharitis;
• conjunctival chemosis;
• proliferation of papillae on the conjunctiva;
• swelling of the eyelid;
• discomfort in the eye;
• itching in the eye;
• eye pain;
• redness of the conjunctiva;
• development of follicles on the conjunctiva;
• erythema on the eyelids;
• eye irritation;
• contact dermatitis;
• photophobia;
• headache;
• runny nose;
• allergic reactions.

Levofloxacin - synonyms The antibiotic Levofloxacin has synonymous drugs. Synonyms for Levofloxacin are medications that also contain the antibiotic levofloxacin as an active ingredient.

Levofloxacin eye drops have the following synonymous drugs:

• Oftaquix - eye drops;
• Signicef ​​– eye drops;
• L-Optic Rompharm – eye drops.

Levofloxacin tablets and solution for infusion have the following synonymous drugs on the domestic pharmaceutical market:

• Vitalecin - tablets;
• Glevo – tablets;
• Ivacin – solution for infusion;
• Lebel - tablets;
• Levolet R – tablets and solution for infusion;
• Levostar – tablets;
• Levotek – tablets and solution for infusion;
• Levoflox – tablets;
• Levofloxabol – solution for infusion;
• Levofloripine – tablets;
• Leobeg – solution for infusion;
• Leflobakt – tablets and solution for infusion;
• Lefokcin - tablets;
• Leflox – solution for infusion;
• Loxof - tablets;
• Maklevo – tablets and solution for infusion;
• Remedia – tablets and solution for infusion;
• Tavanik – tablets and solution for infusion;
• Tanflomed – tablets;
• Flexid - tablets;
• Floracid - tablets;
• Hyleflox – tablets;
• Ecolevid – tablets;
• Eleflox - tablets and solution for infusion.

Analogs Analogs of Levofloxacin are drugs that contain as an active component another antibiotic that has a similar spectrum of antibacterial activity. For convenience, analogues of eye drops, tablets and solution for infusion are shown in the table:

Release form: Solid dosage forms. Pills.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Important! Get to know the treatment

Directions for use and dosage:

Features of application:

Side effects:

Interaction with other drugs:

Contraindications:

Overdose:

Storage conditions:

Store at a temperature not exceeding 30 °C. Keep out of the reach of children!

Shelf life - 3 years.

Vacation conditions:

On prescription

Package:

10 tablets in a blister. 1 blister in a cardboard pack.

Description

Yellow hard gelatin capsules, number 0.

Compound

For one capsule:

active substance: levofloxacin (in the form of levofloxacin hemihydrate) – 250 mg;

Vexcipients: lactose monohydrate, povidone (E-1201), colloidal silicon dioxide anhydrous, calcium stearate (E-470), potato starch.

Composition of the hard gelatin capsule: gelatin, titanium dioxide, quinoline yellow (E-104), sunset yellow (E-110).

Pharmacotherapeutic group

Antibacterial agents for systemic use. Fluoroquinolones.

ATS code: J01MA12.

pharmachologic effect

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones, containing the levorotatory isomer of ofloxacin as an active substance. Levofloxacin blocks the complex of DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes of microbial cells. Levofloxacin is active against most strains of microorganisms, both in conditions in vitro, so and in vivo.

The degree of bactericidal activity of levofloxacin depends on the ratio of the maximum serum concentration (Cmax) or area under the pharmacokinetic curve (AUC) and the minimum inhibitory concentration (MIC).

Mechanism of resistance

Resistance to levofloxacin develops through stepwise mutation of the target site in both topoisomerases: DNA gyrase and topoisomerase IV. Other resistance mechanisms may also be involved in changes in sensitivity to levofloxacin, such as changes in cell wall permeability (common in Pseudomonas aeruginosa) and efflux from the cell.

Cross-resistance has been observed between levofloxacin and other fluoroquinolones. However, due to the mechanism of action, cross-resistance between levofloxacin and other classes of antimicrobial agents is generally absent.

Limit values

The recommended EUCAST (European Committee on Antimicrobial Susceptibility Testing) MIC breakpoints for levofloxacin, which classify organisms as sensitive, moderately resistant and resistant, are presented in the table below.

Clinical EUCAST MIC breakpoints for levofloxacin (version 2.0, 2012-01-01):

1 Breakpoints for levofloxacin correspond to high-dose treatment.

2 Resistance to low levels of fluoroquinolones may develop (MIC for ciprofloxacin 0.12–0.5 mg/l), but there is no data to support the clinical significance of this resistance in the treatment of respiratory tract infections N.influenzae.

3 Strains with MIC values ​​above the indicated resistance breakpoints are very rare or have not yet been observed. Identification and antimicrobial susceptibility testing should be performed on such isolates and, if the results are confirmed, the isolate should be sent to a reference laboratory. Isolates with confirmed MICs above the specified resistance breakpoints should be reported as resistant until clinical response data are available for such isolates.

4 The breakpoints refer to an oral dose of 500 mg 1–2 times and an intravenous dose of 500 mg 1–2 times.

For updated information regarding susceptibility test interpretation criteria and associated test methods and quality control standards established by EUCAST for this medicinal product, see: eucast.org/clinical_breakpoints/

The prevalence of resistance in a given species may vary by geographic region and season, and local information on resistance is therefore desirable, especially when treating severe infections. In cases where resistance is so widespread that the suitability of the drug is questionable in at least some cases, it is advisable to seek advice from an expert body.

Sensitive microorganisms

Bacillus anthracis, Staphylococcus aureus methicillin-sensitive, Staphylococcus saprophyticus, Streptococci groups C andG, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.

Eikenella corrodens, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella oxytoca, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri.

Anaerobic microorganisms: Peptostreptococcus.

Other microorganisms: Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Mycoplasma hominis, Mycoplasma pneumoniae, Ureaplasma urealyticum.

Microorganisms that can become resistant

Aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococcus aureus methicillin-resistant, coagulase-negative Staphylococcus spp.

Aerobic gram-negative microorganisms: Acinetobacter baumanii, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens.

Anaerobic microorganisms: Bacteroides fragilis.

Levofloxacin-resistant microorganisms

Aerobic gram-positive microorganisms: Enterococcus faecium.

Levofloxacin is prescribed to adults to treat the following infections:

– acute bacterial sinusitis;

– exacerbation of chronic bronchitis;

– community-acquired pneumonia;

– complicated infections of the skin and soft tissues;

– uncomplicated cystitis;

Due to the risk of serious adverse reactions (see section "Precautions"), fluoroquinolones, including levofloxacin, should be used as reserve drugs in patients with the above diseases and only in cases whereThere are no alternative treatment options.

– pyelonephritis and complicated urinary tract infections;

– chronic bacterial prostatitis;

– pulmonary form of anthrax: post-exposure prophylaxis and treatment.

Levofloxacin may be used to continue treatment in patients who have shown improvement during initial treatment with intravenous levofloxacin.

Official guidelines on the appropriate use of antibacterial agents should be considered.

Directions for use and doses

Levofloxacin, capsules, taken orally once or twice a day. Capsules should be taken without chewing and with a sufficient amount of liquid (from 0.5 to 1 glass). The drug can be taken before meals or at any time between meals, since food intake does not affect the absorption of the drug.

The drug should be taken at least 2 hours before or 2 hours after taking antacids containing magnesium and/or aluminum, iron salts, zinc, didanosine (only dosage forms containing magnesium or aluminum salts as buffer components) or sucralfate.

The dosage regimen is determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. The duration of treatment varies depending on the course of the disease. As with other antibiotics, treatment with levofloxacin is recommended to be continued for at least 48–72 hours after body temperature has returned to normal or after the pathogen has been effectively eradicated.

Patients with normal renal function (creatinine clearance >50 ml/min):

– Acute bacterial sinusitis: 2 capsules of Levofloxacin 250 mg 1 time per day (corresponding to 500 mg of levofloxacin) – 10–14 days.

– Exacerbation of chronic bronchitis:

– Community-acquired pneumonia: 2 capsules of Levofloxacin 250 mg 1–2 times a day (respectively 500–1000 mg of levofloxacin) – 7–14 days.

– Pyelonephritis: 2 capsules of Levofloxacin 250 mg 1 time per day (respectively 500 mg of levofloxacin) – 7–10 days.

– Complicated urinary tract infections: 2 capsules of Levofloxacin 250 mg 1 time per day (respectively 500 mg of levofloxacin) – 7–14 days.

– Uncomplicated cystitis: 1 capsule of Levofloxacin 250 mg 1 time per day (respectively 250 mg of levofloxacin) – 3 days;

– Chronic bacterial prostatitis: 2 capsules of Levofloxacin 250 mg 1 time per day (corresponding to 500 mg of levofloxacin) – 28 days.

– Complicated skin and soft tissue infections: 2 capsules of Levofloxacin 250 mg 1–2 times a day (respectively 500–1000 mg of levofloxacin) – 7–14 days.

– Pulmonary anthrax: 2 capsules of Levofloxacin 250 mg 1 time per day (corresponding to 500 mg of levofloxacin) – 8 weeks.

Patients with functional impairmentkidneys (creatinine clearance≤ 50 ml/min)

Levofloxacin is excreted primarily through the kidneys, so when treating patients with reduced renal function, a reduction in the dose of the drug is required. Relevant dosing information for these patients is given in the table below:

1 No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Patients with liver dysfunction

If liver function is impaired, no dosage adjustment is required, since levofloxacin is metabolized in the liver to a small extent.

Elderly patients

For elderly patients with creatinine clearance >50 ml/min, no dosage adjustment is required.

Children

Levofloxacin is contraindicated in children and adolescents (under 18 years of age).

What to do if you miss one or more doses of the drug

If a dose of the drug is accidentally missed, it is necessary to take it as soon as possible and then continue taking levofloxacin according to the recommended dosage regimen. You should not double the dose of the drug to compensate for a missed dose.

Side effect

The following side effects are presented according to the following frequency categories: often (≥1/100,

Infections and infestations: infrequently– fungal infections, development of resistance of pathogenic microorganisms.

Blood and lymphatic system disorders: infrequently– leukopenia, eosinophilia; rarely– neutropenia, thrombocytopenia; frequency unknown– pancytopenia, agranulocytosis, hemolytic anemia.

Immune system disorders: rarely– angioedema, hypersensitivity reactions; frequency unknown– anaphylactic shock, anaphylactoid shock. Anaphylactic and anaphylactoid reactions can sometimes develop even after the first dose of the drug.

Metabolic and nutritional disorders: infrequently– anorexia; rarely– hypoglycemia, especially in patients with diabetes; frequency unknown– hyperglycemia, hypoglycemic coma.

Mental disorders* : often- insomnia; infrequently– irritability, anxiety, confusion; rarely– mental disorders (hallucinations, paranoia), depression, agitation, unusual dreams, nightmares; frequency unknown - mental and behavioral disorders with self-harm, including suicidal thoughts and suicide attempts.

Nervous system disorders* : often– headache, dizziness; infrequently– drowsiness, tremor, dysgeusia; rarely– paresthesia, convulsions; frequency unknown– peripheral sensory neuropathy, peripheral sensorimotor neuropathy, dyskinesia, extrapyramidal disorders, parosmia (disorder of the sense of smell, especially the subjective sensation of an objectively absent smell), including loss of smell, syncope, idiopathic intracranial hypertension.

Visual disorders* : rarely– visual disturbances such as blurred vision; frequency unknown– transient loss of vision.

Disorders of the hearing organ and labyrinth* : infrequently– vertigo; rarely– tinnitus; frequency unknown– hearing loss, hearing impairment.

Heart disorders: rarely– sinus tachycardia, rapid heartbeat; frequency unknown– ventricular tachycardia, which can lead to cardiac arrest, ventricular arrhythmia and “torsade de pointes” (reported mainly in patients with a risk factor for prolongation of the QT interval), prolongation of the QT interval.

Vascular disorders: rarely– decrease in blood pressure.

Respiratory, thoracic and mediastinal disorders: infrequently– dyspnea; frequency unknown– bronchospasm, allergic pneumonitis.

Gastrointestinal disorders: often– diarrhea, vomiting, nausea; infrequently– abdominal pain, dyspepsia, flatulence, constipation; frequency unknown – hemorrhagic diarrhea, which in very rare cases may be a sign of enterocolitis, including pseudomembranous colitis, pancreatitis.

Disorders of the liver and biliary tract: often– increased activity of “liver” enzymes in the blood (for example, ALT, AST); infrequently– increased concentration of bilirubin in the blood; frequency unknown– jaundice and severe liver failure, including cases of acute liver failure, especially in patients with severe underlying disease (for example, sepsis), hepatitis.

Skin and subcutaneous tissue disorders: infrequently– rash, itching, urticaria, excessive sweating; frequency unknown– toxic epidermal necrolysis, Stevens syndrome – Johnson, erythema multiforme, photosensitivity reactions, allergic vasculitis, stomatitis. Reactions from the skin and mucous membranes may develop within a few minutes after taking the first dose of the drug.

Muscle, skeletal and connective tissue disorders* : infrequently– arthralgia, myalgia; rarely– tendon damage, including tendinitis (eg, Achilles tendon), muscle weakness, which can be especially dangerous in patients with myasthenia gravis; frequency unknown– rhabdomyolysis, tendon rupture (eg Achilles tendon), ligament rupture, muscle rupture, arthritis.

Renal and urinary tract disorders: infrequently– increased serum creatinine concentration; rarely– acute renal failure (for example, due to the development of nephritis).

General disorders and reactions at the injection site* : infrequently– asthenia; rarely– increased body temperature; frequency unknown– pain (including pain in the back, chest and limbs).

Other possible adverse effects that apply to all fluoroquinolones: attacks of porphyria in patients already suffering from this disease.

*Very rare, long-term (lasting up to months or years), disabling, potentially irreversible serious adverse reactions affecting multiple, sometimes multiple, body systems and sensory organs have been reported (including adverse reactions such as tendinitis, tendon rupture, arthralgia, pain in the limbs, gait disturbance, neuropathies associated with paresthesia, depression, weakness, memory impairment, sleep, hearing, vision, taste and smell) associated with the use of quinolones and fluoroquinolones, in some cases, regardless of the presence of previous risk factors.

Message aboutsuspected adverse reactions

If you experience any side effects, tell your doctor. This also applies to any adverse reactions that are not listed in this leaflet. You can also report adverse reactions to the information database on adverse reactions (actions) to drugs, including reports of ineffectiveness of drugs (UE Center for Expertise and Testing in Healthcare, rceth.by). By reporting side effects, you can help provide more information about the safety of the drug.

Contraindications

– hypersensitivity to levofloxacin, other quinolones or any of the auxiliary components of the drug;

– epilepsy;

– tendon lesions associated with a history of fluoroquinolone use;

– childhood and adolescence (up to 18 years);

– pregnancy;

– lactation period.

Overdose

Symptoms The most likely symptoms of an overdose of levofloxacin are symptoms from the central nervous system (confusion, dizziness, impaired consciousness and seizure-like seizures, hallucinations and tremors). In addition, gastrointestinal disorders (for example, nausea) and erosive lesions of the mucous membranes may occur.

Clinical pharmacological studies conducted with supratherapeutic doses of levofloxacin have shown prolongation of the QT interval.

Measures to assist in case of overdose. In case of overdose, careful monitoring of the patient is required, including ECG monitoring. Treatment is symptomatic. In case of overdose of levofloxacin, gastric lavage and administration of antacids are indicated to protect the gastric mucosa. Levofloxacin is not eliminated by dialysis (hemodialysis, peritoneal dialysis and continuous peritoneal dialysis). There is no specific antidote.

Precautionary measures

The use of levofloxacin should be avoided in patients with a history of serious adverse reactions associated with taking quinolone or fluoroquinolone-containing drugs. Treatment of such patients with levofloxacin should be initiated only in the absence of alternative treatment options and after a careful benefit/risk assessment.

There have been reports of the development of very rare, long-term (lasting months or years), disabling, potentially irreversible serious adverse reactions affecting various, sometimes several, systems of the human body (musculoskeletal, nervous and mental systems, sensory organs) in patients treated with quinolones or fluoroquinolones, regardless of their age and previous risk factors. These reactions may develop within a few hours to several weeks after starting treatment with levofloxacin. If you notice the first signs and symptoms of any serious adverse reaction, stop taking levofloxacin immediately and contact your doctor.

Because the use of fluoroquinolones, including levofloxacin, has been associated with the above serious adverse reactions, levofloxacin should be used only as a reserve antibiotic in patients for whom there are no alternative treatment options for the following indications: acute sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia, complicated skin and soft tissue infections, uncomplicated cystitis.

Advise patients at the first sign or symptom of any serious adverse reaction (eg, swelling or pain in the tendon area, joint and muscle pain, burning, tingling sensation, weakness or pain in the extremities, confusion, seizures, severe headache, or hallucinations) ) stop treatment immediately and consult a doctor.

Tendinitis and tendon rupture

Tendinitis and tendon rupture (especially the Achilles tendon), sometimes bilateral, can occur as early as 48 hours after starting treatment with quinolones and fluoroquinolones, and for several months after stopping treatment. The risk of developing tendinitis and tendon rupture increases in elderly patients, in patients with renal failure, solid organ transplantation, and concurrent corticosteroid therapy when taking levofloxacin at a daily dose of 1000 mg. Concomitant use of corticosteroids and fluoroquinolones should be avoided.

At the first sign of tendonitis (eg, painful swelling, inflammation), discontinue levofloxacin and consider alternative treatment. The affected limb(s) should be treated appropriately (eg, adequate immobilization). Corticosteroids should not be used if signs of tendinopathy occur.

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy leading to paresthesia, hypoesthesia (reduced sensitivity), dysesthesia, or weakness have been reported in patients taking quinolones and fluoroquinolones. Patients using levofloxacin should be advised to inform their physician if symptoms of neuropathy such as pain, burning, tingling, numbness or weakness develop before continuing treatment to prevent the development of potentially irreversible conditions.

The capsule contains dyes quinoline yellow (E-104) and sunset yellow (E-110), which can cause allergic reactions.

Methicillin-resistant S. aureus probably has co-resistance to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results confirm the organism is susceptible to levofloxacin (and generally recommended antibacterial agents for the treatment of MRSA infections are considered inappropriate).

Levofloxacin can be used to treat acute bacterial sinusitis and exacerbation of chronic bronchitis if these infections have been properly diagnosed.

Resistance E. coli, the most common causative agent of urinary tract infections, to fluoroquinolones varies. Prescribers are advised to consider the local prevalence of resistance E. coli to fluoroquinolones.

Hospital-acquired infections caused by certain pathogens (Pseudomonas aeruginosa), may require combination treatment.

Inhalational anthrax: use in humans based on susceptibility data Bacillus anthracis in vitro and on experimental data obtained in animals, together with limited data in humans. If it is necessary to use levofloxacin in patients with this pathology, the attending physician should be guided by national and/or international documents on the treatment of anthrax.

Levofloxacin should not be used to treat children and adolescents due to the likelihood of damage to articular cartilage.

In very severe pneumonia caused by pneumococci, levofloxacin may not provide an optimal therapeutic effect.

Patients predisposed to seizures

Like other fluoroquinolones, levofloxacin is contraindicated in patients with epilepsy. Treatment with levofloxacin should be carried out with extreme caution in patients predisposed to seizures, due to the possibility of developing an attack. Convulsive readiness may also increase with simultaneous use of fenbufen and similar non-steroidal anti-inflammatory drugs or theophylline. If seizures occur, treatment should be discontinued.

Pseudomembranous colitis associated withClostridium difficile

Diarrhea that develops during or after treatment with levofloxacin (including several weeks after treatment), especially severe, persistent and/or bloody, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. If pseudomembranous colitis is suspected, treatment with levofloxacin should be stopped immediately and specific antibiotic therapy (vancomycin, teicoplanin or oral metronidazole) should be started immediately. Drugs that inhibit peristalsis are contraindicated in this clinical situation.

Prevention of photosensitivity reactions

Although photosensitivity is very rare when taking levofloxacin, to prevent its development, it is recommended that patients not be exposed unnecessarily to strong solar or artificial ultraviolet radiation (for example, exposure to the sun at high altitudes or visiting a solarium) during treatment with levofloxacin and for 48 hours after stopping treatment.

Superinfection

The use of levofloxacin, especially for a long time, can lead to increased proliferation of microorganisms that are insensitive to it. During treatment, the patient's condition should be re-evaluated and, in the event of superinfection, appropriate measures must be taken.

Disorders of the heart and blood vessels

Very rare cases of QT prolongation have been reported in patients receiving fluoroquinolones, including levofloxacin. When using these drugs, caution should be exercised in patients with known risk factors for prolongation of the QT interval: elderly patients; patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); congenital long QT syndrome; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous use of medications that can prolong the QT interval (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides).

Elderly patients and women may be more sensitive to drugs that prolong the QT interval. Therefore, caution should be exercised when using fluoroquinolones, including levofloxacin, in such patients.

Epidemiological studies have reported an increased risk of aortic aneurysm and dissection after use of fluoroquinolones, especially in elderly patients.

In patients with a history of aneurysm or aortic aneurysm and/or dissection, and other risk factors or conditions predisposing to the development of aortic aneurysm and dissection (eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behçet, arterial hypertension, atherosclerosis), fluoroquinolones should be used only after a careful assessment of the benefit-risk ratio and consideration of other possible treatment options.

If patients experience sudden pain in the abdomen, chest, or back, they should contact their doctor immediately at the emergency room.

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with latent or manifest glucose-6-phosphate dehydrogenase deficiency are predisposed to hemolytic reactions when treated with quinolones, which should be taken into account when prescribing levofloxacin.

Patients with impaired renal function

Due to the fact that levofloxacin is excreted mainly in the urine, the dose of the drug should be changed in patients with impaired renal function.

Hypersensitive reactionsbness

Levofloxacin can cause serious hypersensitivity reactions, including fatal ones (angioedema and anaphylactic shock), including after the first dose of the drug. If hypersensitivity reactions occur, stop treatment immediately and consult a doctor.

Severe bullous reactions

Cases of severe bullous skin reactions have been reported with the use of levofloxacin, such as Stevens-Johnson syndrome or toxic epidermal necrolysis. Patients should be advised to consult a doctor immediately before continuing treatment if skin and/or mucous reactions occur.

Dysglycemia

As with other quinolones, cases of disturbances in blood glucose levels, including both hyperglycemia and hypoglycemia, have been reported with levofloxacin, usually in patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic agents (eg, glibenclamide) or insulin. Careful monitoring of blood glucose concentrations is required in these patients.

Exacerbations of pseudoparalytic myasthenia gravis(myasthenia gravis)

Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Severe adverse reactions reported post-marketing, including deaths and the need for mechanical ventilation, have been associated with the use of fluoroquinolones in patients with myasthenia gravis. Levofloxacin is not recommended in patients with a history of pseudoparalytic myasthenia gravis.

Liver failure

Cases of liver necrosis up to life-threatening conditions have been reported, especially in patients with severe pre-existing diseases (for example, sepsis). If symptoms of liver failure develop (anorexia, jaundice, dark urine, itching), patients are advised to stop taking the drug and consult their doctor.

Visual impairment

In case of visual disturbances or if any effects on the organ of vision occur, you should immediately consult an ophthalmologist.

Patients taking vitamin K antagonists

When levofloxacin is co-administered with vitamin K antagonists, monitor blood clotting due to an increased risk of bleeding.

Mental reactions

Cases of mental reactions have been reported with the use of fluoroquinolones and levofloxacin, among them. In very rare cases, reactions such as suicidal thoughts and life-threatening behavior have been noted (including after the first dose). Treatment should be stopped at the first sign of such reactions. Treatment of patients with mental disorders should be carried out with extreme caution.

Influence on the results of laboratory and diagnostic tests

In patients taking levofloxacin, testing for opiates in urine may give false-positive results. It may be necessary to confirm positive test results for the presence of opiates using more specific methods.

Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, lead to false negative results in the bacteriological diagnosis of tuberculosis.

Use during pregnancy and lactation

Pregnancy. There is limited data on the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect reproductive toxicity.

However, in the absence of human data and experimental data indicating that there is a risk of damage to growing cartilage due to exposure to fluoroquinolones, levofloxacin should not be used in pregnant women.

Lactation period. Levofloxacin is contraindicated in women during breastfeeding. There is insufficient information about the excretion of levofloxacin into breast milk. However, other fluoroquinolones pass into breast milk. In the absence of human data and because experimental evidence suggests a risk of damage to growing cartilage due to exposure to fluoroquinolones, levofloxacin should not be used in lactating women.

Impact on the ability to drive transport and other abilitiesby dangerous mechanisms

Side effects of levofloxacin, such as dizziness, drowsiness and blurred vision, may reduce psychomotor reactions and the ability to concentrate, which may pose a certain risk when driving vehicles or potentially dangerous machinery.

Interaction with other drugs

Iron salts, zinc salts, magnesium- or aluminum-containing antacids, didanosine

The absorption of levofloxacin is significantly reduced with concomitant administration of iron salts, magnesium- or aluminum-containing antacids, didanosine (only products with didanosine containing aluminum or magnesium as buffer substances). Taking fluoroquinolones with multivitamin preparations containing zinc appears to reduce their oral absorption. Preparations containing di- and trivalent cations, such as iron salts, zinc salts, magnesium- or aluminum-containing antacids, didanosine (only products with didanosine containing aluminum or magnesium as buffer substances) are recommended to be taken at least 2 hours before or after 2 hours after taking levofloxacin. Calcium salts have minimal effect on the oral absorption of levofloxacin.

Sucralfate

The bioavailability of levofloxacin is significantly reduced when used simultaneously with sucralfate. If simultaneous use of levofloxacin and sucralfate is necessary, it is recommended to take sucralfate 2 hours after taking levofloxacin.

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

Pharmacokinetic interactions of levofloxacin with theophylline were not identified in clinical studies. However, when quinolones are used in conjunction with theophylline, non-steroidal anti-inflammatory drugs and other drugs that reduce the threshold of convulsive readiness of the brain, a pronounced decrease in the threshold of convulsive readiness of the brain is possible.

Concentrations of levofloxacin during concomitant administration of fenbufen increased by 13% compared with concentrations when taking levofloxacin alone.

Probenecid and cimetidine

Probenicid and cimetidine had a statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin was reduced by cimetidine by 24% and probenecid by 34%. This is due to the fact that both of these drugs are able to block the secretion of levofloxacin in the renal tubules. However, given the doses used in the study, it is unlikely that this statistically significant kinetic difference would be clinically significant.

Levofloxacin should be used with caution when concomitantly taking drugs that affect tubular secretion, such as probenecid and cimetidine, especially in patients with impaired renal function.

Cyclosporine

Levofloxacin, when used in combination with cyclosporine, increases the half-life of cyclosporine by 33%.

Vitamin K antagonists

In patients receiving levofloxacin in combination with a vitamin K antagonist (eg, warfarin), increased results of coagulation test (PT/MHO) and/or bleeding up to severe were observed. In this regard, when using indirect anticoagulants and levofloxacin simultaneously, regular monitoring of blood coagulation parameters is necessary.

Drugs that prolong the intervalQT

Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (for example, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).

Others

Pharmacokinetics of levofloxacin when used simultaneously with calcium carbonate, digoxin, glibenclamide, ranitidine does not change sufficiently to be of clinical significance. In a pharmacodynamic interaction study, levofloxacin had no effect on theophylline (which is a marker substrate of CYP1A2), indicating that levofloxacin does not inhibit CYP1A2.

Vacation conditions

On prescription.

Manufacturer:

RUE "Belmedpreparaty"

Republic of Belarus, 220007, Minsk,

st. Fabricius, 30, t./f.: (+375 17) 220 37 16,

Thank you

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. Consultation with a specialist is required!

Thus, the antibiotic Levofloxacin is effective for the treatment of infectious and inflammatory diseases of the ENT organs (for example, sinusitis, otitis), the respiratory tract (for example, bronchitis or pneumonia), the urinary organs (for example, pyelonephritis), and the genital organs (for example, prostatitis, chlamydia) or soft tissue (eg, abscesses, boils).

Release form

Levofloxacin tablets, depending on the content of the antibiotic, are often designated “Levofloxacin 250” and “Levofloxacin 500”, where the numbers 250 and 500 indicate the amount of their own antibacterial component. They are colored yellow and have a round, biconvex shape. When cut through the tablet, two layers can be clearly distinguished. Tablets of 250 mg and 500 mg are available in packs of 5 or 10 pieces.

Eye drops are a homogeneous solution, transparent, practically uncolored. Available in bottles of 5 ml or 10 ml, equipped with a specially designed cap in the form of a dropper.

The solution for infusion is available in 100 ml bottles. One milliliter of solution contains 5 mg of antibiotic. A full bottle of solution for infusion (100 ml) contains 500 mg of antibiotic intended for intravenous administration.

Levofloxacin – group

According to the mechanism of action, Levofloxacin belongs to the group systemic quinolones, or fluoroquinolones. The group of antibacterial agents belonging to systemic quinolones is used very widely because it is highly effective and has a wide spectrum of action. Systemic quinolones, in addition to Levofloxacin, include such well-known drugs as Ciprofloxacin, Lomefloxacin, etc. All fluoroquinolones disrupt the process of synthesis of genetic material of microorganisms, preventing them from reproducing, and thereby leading to their death.

Levofloxacin – manufacturer

• CJSC "Vertex";
• RUE "Belmedpreparaty";
• JSC "Tavanik";
• Teva Concern;
• OJSC "Nizhpharm", etc.

Doses and composition

Eye drops and solution for infusion contain the following substances as auxiliary components:

• sodium chlorine;
• disodium edetate dihydrate;
• deionized water.

• microcrystalline cellulose;
• hypromellose;
• primellose;
• calcium stearate;
• macrogol;
• titanium dioxide;
• iron oxide yellow.

Spectrum of action and therapeutic effects

Levofloxacin destroys pathogenic bacteria that cause inflammation in certain organs. As a result, the cause of inflammation is eliminated, and as a result of the use of an antibiotic, recovery occurs. Levofloxacin can cure inflammation in any organ caused by microorganisms sensitive to it. That is, if cystitis, pyelonephritis or bronchitis is caused by bacteria on which Levofloxacin has a detrimental effect, then all these inflammations in different organs can be cured with an antibiotic.

Levofloxacin has a detrimental effect on a wide range of gram-positive, gram-negative and anaerobic microbes, the list of which is presented in the table:

Indications for use

Levofloxacin - instructions for use

Levofloxacin tablets (500 and 250)

The duration of treatment with Levofloxacin tablets and dosage depend on the severity of the infection and its nature. Thus, the following courses and dosages of the drug are recommended for the treatment of various diseases:

• Sinusitis – take 500 mg (1 tablet) 1 time per day for 10 – 14 days.
• Exacerbation of chronic bronchitis - take 250 mg (1 tablet) or 500 mg (1 tablet) 1 time per day for 7 - 10 days.
• Pneumonia – take 500 mg (1 tablet) 2 times a day for 1 – 2 weeks.
• Infections of the skin and soft tissues (boils, abscesses, pyoderma, etc.) - take 500 mg (1 tablet) 2 times a day for 1 - 2 weeks.
• Complicated urinary tract infections (pyelonephritis, urethritis, cystitis, etc.) - take 500 mg (1 tablet) 2 times a day for 3 days.
• Uncomplicated urinary tract infections - take 250 mg (1 tablet) once a day for 7 - 10 days.
• Prostatitis - take 500 mg (1 tablet) once a day for 4 weeks.
• Intra-abdominal infection - take 500 mg (1 tablet) 1 time per day for 10-14 days.
• Sepsis - take 500 mg (1 tablet) 2 times a day for 10 - 14 days.

Solution for infusion Levofloxacin

Levofloxacin can be combined with the following infusion solutions:
1. saline.
2. 5% dextrose solution.
3. 2.5% Ringer's solution with dextrose.
4. solutions for parenteral nutrition.

The duration of intravenous antibiotic use should not exceed 2 weeks. It is recommended to administer Levofloxacin as long as the person is sick, plus another two days after the temperature has returned to normal.

The dosages and duration of use of Levofloxacin infusion solution for the treatment of various pathologies are as follows:

• Acute sinusitis– administer 500 mg (1 bottle 100 ml) 1 time per day for 10 – 14 days.
• Exacerbation of chronic bronchitis – administer 500 mg (1 bottle 100 ml) 1 time per day for 7 – 10 days.
• Pneumonia
• Prostatitis– administer 500 mg (1 bottle of 100 ml) once a day for 2 weeks. Then they switch to taking 500 mg tablets once a day for another 2 weeks.
• Acute pyelonephritis – administer 500 mg (1 bottle 100 ml) 1 time per day for 3 – 10 days.
• Biliary tract infections – administer 500 mg (1 bottle of 100 ml) 1 time per day.
• Skin infections– administer 500 mg (1 bottle 100 ml) 2 times a day for 1 – 2 weeks.
• Anthrax – administer 500 mg (1 bottle of 100 ml) once a day. After stabilization of the person’s condition, transfer to taking Levofloxacin tablets. Take 500 mg tablets once a day for 8 weeks.
• Sepsis– administer 500 mg (1 bottle 100 ml) 1 – 2 times a day for 1 – 2 weeks.
• Abdominal infection – administer 500 mg (1 bottle 100 ml) 1 time per day for 1 – 2 weeks.
• Tuberculosis - administer 500 mg (1 bottle of 100 ml) 1 - 2 times a day for 3 months.

Tablets and solution

Levofloxacin should not be stopped in advance and the next dose should not be skipped. Therefore, if you miss another tablet or infusion, you should take it immediately, and then continue using Levofloxacin in the recommended regimen.

People suffering from severe renal impairment, in which creatinine clearance is less than 50 ml/min, must take the drug according to a specific regimen during the entire course of treatment. Levofloxacin is taken, depending on QC, according to the following regimens:
1. CC is above 20 ml/min and below 50 ml/min - the first dosage is 250 or 500 mg, then take half of the initial dose, that is, 125 mg or 250 mg every 24 hours.
2. CC is above 10 ml/min and below 19 ml/min - the first dosage is 250 mg or 500 mg, then take half of the primary dose, that is, 125 mg or 250 mg once every 48 hours.

In rare cases, Levofloxacin can lead to tendon inflammation - tendinitis, which can lead to rupture. If tendinitis is suspected, use of the drug should be stopped and treatment of the inflamed tendon should be started immediately.

Levofloxacin can lead to hemolysis of red blood cells in people suffering from hereditary glucose-6-phosphate dehydrogenase deficiency. Therefore, the antibiotic should be used carefully in this category of patients, constantly monitoring bilirubin and hemoglobin.

The antibiotic negatively affects the speed of psychomotor reactions, as well as concentration. Therefore, during treatment with Levofloxacin, you should avoid all activities that require good concentration and high reaction speed, including driving a car or servicing various mechanisms.

Overdose

• confusion;
• dizziness;
• nausea;
• erosion of mucous membranes;
• changes on the cardiogram.

Interaction with other drugs

The effectiveness of Levofloxacin is reduced when used simultaneously with Sucralfate, antacids (for example, Almagel, Rhenium, Phosphalugel, etc.) and iron salts. To neutralize the effect of the listed drugs on Levofloxacin, they should be taken 2 hours apart.

The combined use of Levofloxacin and glucocorticoids (for example, hydrocortisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, etc.) leads to an increased risk of tendon ruptures.

Taking alcoholic beverages together with Levofloxacin leads to increased side effects that develop from the central nervous system (dizziness, drowsiness, blurred vision, loss of concentration and poor reaction).

Levofloxacin eye drops

Levofloxacin drops are used for 5 days.

Levofloxacin for children

Use for the treatment of ureaplasma

So, for the treatment of ureaplasmosis, uncomplicated by other pathologies, it is enough to take Levofloxacin tablets 250 mg once a day for 3 days. If the infectious process is prolonged, then the antibiotic is taken 250 mg (1 tablet) once a day, for 7–10 days.

Treatment of prostatitis

In case of severe prostatitis, it is better to start therapy with an infusion of an antibiotic of 500 mg (1 bottle 100 ml) once a day. Intravenous administration of Levofloxacin is continued for 7 to 10 days. After this, you need to switch to taking antibiotic tablets, which you drink 500 mg (1 piece) once a day. The tablets should be taken for another 18 to 21 days. The general course of treatment with Levofloxacin should be 28 days. Therefore, after several days of intravenous administration of the antibiotic, you must take tablets for the remaining time up to 28 days.

Prostatitis can only be treated with Levofloxacin tablets. In this case, the man should take the drug 500 mg (1 tablet) once a day for 4 weeks.

Levofloxacin and alcohol

Contraindications

• hypersensitivity, allergy or intolerance to the components of the drug, including levofloxacin or other quinolones;
• renal failure with CC less than 20 ml/min;
• the presence of tendon inflammation in the past during treatment with any drugs from the quinolone group;
• age under 18 years;
• pregnancy;
• breast-feeding.

Relative contraindications to the use of Levofloxacin in tablets and solution are severe renal dysfunction and glucose-6-phosphate dehydrogenase deficiency. in such cases, the drug should be taken under close medical supervision of the person’s condition.

Levofloxacin eye drops contraindicated for use in the following cases:

• sensitivity or allergy to any drugs from the quinolone group;
• age under 1 year.

Side effects

All side effects of tablets and solution for infusion, depending on the frequency of occurrence, are reflected in the table:

often	Side effects encountered Sometimes	Side effects encountered rarely	Side effects encountered very rarely
Diarrhea	Itching	Anaphylactic reactions	Swelling on the face and throat
Nausea	Skin redness	Hives	Shock
Increased activity of liver enzymes (AST, ALT)	Loss of appetite	Bronchospasm, up to severe suffocation	A sharp decrease in blood pressure
	Digestive disorders (belching, heartburn, etc.)	Diarrhea with a small amount of blood	Increased sensitivity to sunlight and ultraviolet radiation
	Vomit	Exacerbation of porphyrias	Pneumonitis
	Stomach ache	Anxiety	Vasculitis
	Headache	Body trembling	Blisters on the skin
	Dizziness	Paresthesia on the hands (feeling like "pins and needles")	Toxic epidermal necrolysis
	Numbness	Hallucinations	Exudative erythema multiforme
	Drowsiness	Depression	Decrease in blood glucose concentration
	Sleep disorders	Excitation	Visual impairment
	Increased number of blood eosinophils	Convulsions	Taste disturbance
	Decrease in the total number of blood leukocytes	Confusion	Decreased ability to detect odors
	General weakness	Heartbeat	Decreased tactile sensitivity (sensation of touch)
		Pressure drop	Vascular collapse
		Tendinitis	Tendon rupture
		Muscle pain	Muscle weakness
		, as well as increased reproduction headache; allergic reactions. Levofloxacin - synonyms The antibiotic Levofloxacin has synonymous drugs. Synonyms for Levofloxacin are medications that also contain the antibiotic levofloxacin as an active ingredient. Levofloxacin eye drops have the following synonymous drugs: Oftaquix - eye drops; Signicef ​​– eye drops; L-Optic Rompharm – eye drops. Levofloxacin tablets and solution for infusion have the following synonymous drugs on the domestic pharmaceutical market: Vitalecin - tablets; Glevo – tablets; Ivacin – solution for infusion; Lebel - tablets; Levolet R – tablets and solution for infusion; Levostar – tablets; Levotek – tablets and solution for infusion; Levoflox – tablets; Levofloxabol – solution for infusion; Levofloripine – tablets; Leobeg – solution for infusion; Leflobakt – tablets and solution for infusion; Lefokcin - tablets; Leflox – solution for infusion; Loxof - tablets; Maklevo – tablets and solution for infusion; Remedia – tablets and solution for infusion; Tavanik – tablets and solution for infusion; Tanflomed – tablets; Flexid - tablets; Floracid - tablets; Hyleflox – tablets; Ecolevid – tablets; Eleflox - tablets and solution for infusion. Analogs Analogues of Levofloxacin are drugs that contain as an active component another antibiotic that has a similar spectrum of antibacterial activity. For convenience, analogues of eye drops, tablets and solution for infusion are shown in the table: Analogues of eye drops Analogues of tablets and solution for infusion Betaciprol Abaktal - tablets and solution for intravenous administration Vigamox Avelox Vitabact Basijen solution for infusion Dancil Gatispan tablets Decamethoxin Geoflox – tablets and solution for infusion Zimar Zanocin – tablets and solution for infusion Lofox Zarquin tablets Normax Zoflox – tablets and solution for infusion Okatsin Ificipro – tablets and solution for infusion Okomistin Quintor - tablets and solution for infusion Ofloxacin Xenaquin tablets Oftadek Loxon-400 tablets Ophthalmol Lomacin tablets Uniflox Lomefloxacin tablets Phloxal Lomflox tablets Ciloxane Lofox tablets Tsiprolet Moximac tablets Ciprolone Nolicin tablets Tsipromed Norbactin tablets Ciprofloxacin Norilet tablets Ciprofloxacin Bufus Normax tablets Ciprofloxacin-AKOS Norfacin tablets Oftocipro Norfloxacin tablets Moxifur Oflo – tablets and solution for infusion Oflox tablets Ofloxabol solution for infusion Ofloxacin – tablets and solution for infusion Ofloxin – tablets and solution for infusion Oflomac tablets Oflocid and Oflocid forte tablets Pefloxabol – solution and powder for infusion Pefloxacin – tablets and solution for infusion Plevilox tablets Procipro – tablets and solution for infusion Sparbact tablets Sparflo tablets Tarivid – tablets and solution for infusion Tariferid tablets Taricin tablets Faktiv tablets Ceprova tablets Ciplox - tablets and solution for infusion Cypraz tablets Cyprex tablets Tsiprinol - tablets, solution and concentrate for infusion Tsiprobay – tablets and solution for infusion Ciprobid – tablets and solution for infusion Ciprodox tablets Ciprolacare solution for infusion Tsiprolet – tablets and solution for infusion Cypronate solution for infusion Cipropane tablets Ciprofloxabol solution for infusion Ciprofloxacin – tablets and solution for infusion Cifloxinal tablets Tsifran – tablets and solution for infusion Tsifracid solution for infusion Ecocifol tablets Unikpef – tablets and solution for infusion Levofloxacin Compound Levofloxacin infusion Active ingredient (in 100 ml): levofloxacin hemihydrate 500 mg. Additional components: anhydrous glucose, hydrochloric acid, water for injection, sodium edetate. Levofloxacin 250 Active ingredient (in 1 tablet): levofloxacin hemihydrate 250 mg. Levofloxacin 500 Active ingredient (in 1 tablet): levofloxacin hemihydrate 500 mg. Additional components: 15 CPS hydroxypropyl methylcellulose, sodium starch glycolate, LF hydroxypropylcellulose, croscarmellose sodium, colloidal silicon dioxide, crospovidone, purified talc, titanium dioxide, magnesium stearate, microcrystalline cellulose 102, triacetin. pharmachologic effect An antibiotic belonging to the fluoroquinolone group. Has a wide spectrum of action. The active substance is the levorotatory active isomer of ofloxacin – levofloxacin hemihydrate. Due to its left-handed formula, it is more effective than ofloxacin. The mechanism of action is bactericidal: blockade of DNA gyrase of a microbial cell, interference with the cross-linking of breaks in deoxyribunocleic acids of bacteria and disruption of the process of DNA supercoiling. Due to this, irreversible structural changes in the membranes, cytoplasm and cell wall occur in the microbial cell. It acts both in vivo and in vitro against the prevailing number of microorganisms with aerobic metabolism. Some of them are gram-negative: ampicillin-resistant and ampicillin-sensitive strains of Haemophilus influenzae, Haemophilus ducreyi, Helicobacter pylori, Acinetobacter spp. (including Acinetobacter baumanii), Enterobacter spp. (including Enterobacter agglomerans, Actinobacillus actinomycetemcomitans, Eikenella corrodens, Enterobacter aerogenes, Enterobacter cloacae), Escherichia coli, Citrobacter freundii, non-producing and β-lactamase-producing strains of Moraxela catarrhalis, Haemophilus parainfluenzae, Morganella morganii, Gardnerella vaginalis, Kle bsiella spp. (including Klebsiella pneumoniae and Klebsiella oxytoca), resistant to penicillin, sensitive and moderately sensitive to penicillin Neisseria gonorrhoeae, Proteus mirabilis, Pasteurella spp. (including Pasteurella dagmatis, Pasteurella multocida, Pasteurella conis), Neisseria meningitidis, Salmonella spp., Providencia spp. (including Providencia stuartii, Providencia rettgeri), Proteus vulgaris, Pseudomonas spp. (including Pseudomonas aeruginosa) and Serratia spp. (including Serratia marcescens). Gram-positive: methicillin-sensitive strains (highly and moderately sensitive) and coagulase-negative Streptococcus agalactiae, Staphylococcus epidermidis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus spp. (types G and C), Staphylococcus spp.; strains resistant to penicillin (as well as moderately sensitive to penicillin and penicillin-sensitive) Streptococcus viridans, Streptococcus pyogenes; Listeria monocytogenes, Enterococcus spp. (including Enterococcus faecalis), Corynebacterium diphtheriae, Staphylococcus spp. Active against Mycobacterium spp. (including Mycobacterium tuberculosis, Mycobacterium leprae), Mycoplasma pneumoniae, Chlamydia pneumoniae, Chlamydia psittaci, Legionella spp. (including Legionella pneumophila), Rickettsia spp., Mycoplasma hominis, Chlamydia trachomatis, Bartonella spp., Ureaplasma urealyticum. Some microorganisms with anaerobic metabolism are also sensitive to levofloxacin: Bacteroides fragilis, Clostridium perfringens, Propionibacterum spp., Peptostreptococcus spp., Veilonella spp., Bifidobacterium spp., Fusobacterium spp. The active substance is almost completely rapidly absorbed from the digestive canal after oral administration. Bioavailability after internal use of 0.5 g of levofloxacin hemihydrate almost reaches 100%. The magnitude and rate of absorption are little affected by eating at the same time as the tablets. The affinity of levofloxacin hemihydrate for plasma proteins reaches 30-40%. After taking a single dose of 0.5 g of levofloxacin, the maximum concentration of the active substance in the blood plasma is from 5.2 to 6.9 mcg/ml, the half-life is about 6-8 hours, T(max) is 1.3 hours. Penetrates well into tissues and organs, especially into the lungs, pathological bronchial secretions, organs of the genitourinary system, prostate tissue, polymorphonuclear leukocytes, bronchial mucosa, cerebrospinal fluid, bone tissue and alveolar macrophages. A small portion of levofloxacin is deacetylated and/or oxidized in the liver. It is excreted from the body through secretion by the renal tubules and glomerular filtration. After internal use, about 87% of the taken levofloxacin is excreted unchanged in the urine within 2 days. Less than 4% of the substance is excreted in feces within 72 hours. After intravenous infusion of Levofloxacin solution at a dosage of 0.5 g, the maximum plasma concentration is 6.2 mcg/ml. After infusion of the same dosage (single or repeated), the half-life is 6.4 hours, the volume distribution is 89-112 L, and the maximum concentration is 6.2 mcg/ml. Indications for use Infectious-inflammatory pathology that developed as a result of infection with bacteria sensitive to levofloxacin: Infections of the abdominal organs; exacerbation of chronic bronchitis; community-acquired pneumonia; inflammation of the prostate gland; acute sinusitis; uncomplicated urinary tract infections; bacteremia/septicemia (associated with the indications given in the description); complicated urinary tract infections (including pyelonephritis); infectious pathology of soft tissues and skin. Mode of application Levofloxacin tablets are taken orally between meals or before meals. The daily dosage can be divided into 2 doses. The tablets must not be chewed. Take with 0.5-1 glasses of water. Levofloxacin is used as an infusion intravenously (depending on the severity of symptoms - 0.5 g / 2 times a day). The regimen for using the drug depends on the severity of the disease, the sensitivity of microorganisms and the course of the pathological process. For adults with normal or slightly reduced renal function (creatinine clearance ≤50 ml/minute), the following treatment regimens are used: Sinusitis – 0.5 g once a day, course of treatment – ​​from 10 to 14 days; community-acquired pneumonia - -.5 g 1 or 2 times a day; duration of therapy – from 7 to 14 days; chronic bronchitis (exacerbation) - 0.5-0.25 g 1 time per day, course of treatment - from 7 to 14 days; prostatitis – 28 days, 0.5 g once a day; complicated urinary tract infections (including pyelonephritis) - 0.25 g once a day, course of treatment - from 7 to 10 days; uncomplicated urinary tract infections – 3 days, 0.25 g once a day; bacteremia or septicemia - treatment begins with an intravenous infusion of Levofloxacin, and then continues with the tablet form of Levofloxacin 0.5 or 0.25 g 1 or 2 times a day, the course of treatment is 1-2 weeks; infections of the skin and soft tissues - 0.25 g once a day for 1-2 weeks or 0.5 g 1 or 2 times a day for 1-2 weeks; abdominal infections 0.5 or 0.25 g 1 time per day, course of treatment – ​​1-2 weeks; treatment must be supplemented with other antimicrobial agents with activity against anaerobic pathogens. When taking the drug, you should adhere to the rule that applies to all antibacterial agents: taking tablets must be continued after reliable elimination of the pathogen or no less than 48-72 hours after normalization of body temperature. If the patient has impaired renal function, the dosage of the drug is changed: with creatinine clearance from 20 to 50 ml/min: when using a daily dose of 0.25 g in 1 dose, the starting dosage is 0.25 g, subsequently - 125 mg; when using a daily dose of 0.5 g in 1 dose, the starting dosage is 0.5 g, subsequently - 0.25 g; when using a daily dose of 1 g in 2 doses, the starting dosage is 0.5 g, subsequently - 0.25 g; with creatinine clearance from 10 to 19 ml/min: when using a daily dose of 0.25 g in 1 dose, the starting dosage is 0.25 g, subsequently - 125 mg every 48 hours; when using a daily dose of 0.5 g in 1 dose, the starting dosage is 0.5 g, subsequently - 125 mg 1 time per day; when using a daily dose of 1 g in 2 doses, the starting dosage is 0.5 g, subsequently - 125 mg every 12 hours; with creatinine clearance up to 10, as well as for dialysis patients (including outpatient continuous peritoneal dialysis): when using a daily dose of 0.25 g in 1 dose, the starting dosage is 0.25 g, subsequently - 125 mg every 48 hours; when using a daily dose of 0.5 g in 1 dose, the starting dosage is 0.5 g, subsequently - 125 mg 1 time per day; when using a daily dose of 1 g in 2 doses, the starting dosage is 0.5 g, subsequently - 125 mg 1 time per day. After continuous ambulatory peritoneal dialysis (CAPD) or hemodialysis, additional doses of Levofloxacin are not required. For elderly patients, no change in the usual dosage regimen of Levofloxacin is required, except in cases with low creatinine clearance. In case of liver dysfunction, special selection of the dose and dosage regimen of the drug is not required, since levofloxacin hemihydrate undergoes hepatic metabolism only to a small extent. Side effects Criteria for assessing the frequency of side effects: in 1-10 out of 100 patients - often, less than 1 out of 100 patients - sometimes, less than 1 out of 1000 - rare, patients - often, less than 1 out of 10000 - very rare, in 0.01% of patients and less – in some cases. From the digestive system: diarrhea, nausea, increased activity of liver enzymes, as determined by serum levels (often); rarely - an increase in bilirubin in the blood serum, severe diarrhea with blood in the stool (this symptom in rare cases can serve as a sign of both banal and pseudomembranous colitis); sometimes - loss or decreased appetite, abdominal pain, vomiting, dyspeptic disorders; very rarely - hepatitis. The immune system: sudden sharp decrease in blood pressure up to the development of shock, allergic pneumonitis, increased sensitivity to ultraviolet and solar radiation, vasculitis, swelling in the face and pharynx, other surfaces of the skin and mucous membranes (in very rare cases); skin redness and itching (sometimes); rarely - anaphylactic and anaphylactoid reactions (in the form of bronchospasm, severe suffocation, urticaria); in some cases - exudative erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome - epidermal toxic necrolysis. Sometimes general allergic manifestations were preceded by slightly milder skin reactions, which appeared after taking the starting dosage of Levofloxacin a few minutes or hours later. Metabolic disorders: very rarely - a decrease in blood glucose levels with subsequent possible signs such as nervousness, ravenous appetite, trembling, perspiration (this must be taken into account in patients with diabetes). From the urinary system: acute renal failure due to interstitial nephritis (very rare); rarely – increased serum creatinine levels. From the peripheral or central nervous system: sometimes - stupor, sleep disturbances, headache, dizziness, drowsiness; rarely - psychotic reactions (sometimes accompanied by hallucinations), tremor, anxiety, depression, various unpleasant sensations such as paresthesia of the hands, confusion, psychomotor agitation, anxiety, convulsive syndrome; very rarely - disturbances in vision, smell, hearing, taste sensitivity, deterioration in the sensitivity of tactile receptors. From the musculoskeletal system: tendon damage (including tendonitis), muscle and joint pain (rarely); rupture of tendons (usually Achilles), muscle weakness (this must be taken into account in patients with bulbar syndrome) - very rare; in some cases - rhabdomyolysis and other muscle lesions. Achilles tendon rupture may occur within the first 2 days of Levofloxacin therapy and is usually bilateral. From the cardiovascular system: prolongation of the QT interval on the ECG (in some cases), rarely - hypotension, increased heart rate; very rarely - vascular collapse. From the hematopoietic system: agranulocytosis (very rare); sometimes – a decrease in the level of leukocytes and eosinophils according to a clinical blood test, the development of severe infections (persistent increase in body temperature, relapse of fever, deterioration of health); thrombocytopenia (which may manifest as increased bleeding) and neutropenia (rarely); in some cases - pancytopenia or hemolytic anemia. Other side effects: very rarely - fever, sometimes - asthenia (general weakness). The use of Levofloxacin, like other antimicrobial drugs, can cause superinfection or secondary infection. Experience with other fluoroquinolones suggests that Levofloxacin, like other quinolone derivatives, can aggravate porphyria that the patient already has (so far, no exacerbation of porphyria while taking the drug has been recorded). Contraindications Pathological conditions of tendons after a history of use of other fluoroquinolones; childhood and adolescence (up to 18 years); epilepsy; lactation period (breastfeeding); pregnancy; individual hypersensitivity (allergy) to the components of Levofloxacin or to other quinolone derivatives. Prescribed with caution when: High risk of renal failure in geriatric patients; deficiency of glucose-6-phosphate dehydrogenase. Pregnancy Levofloxacin should not be administered to pregnant or nursing mothers. Drug interactions When taking aluminum- and magnesium-containing antacids, sucralfate, and iron-containing drugs simultaneously, the effectiveness of Levofloxacin is significantly weakened. Therefore, the interval between doses of these medications should be at least 2 hours. When taking drugs that reduce the seizure threshold in combination with Levofloxacin, a significant decrease in the seizure threshold is observed. The same applies to other quinolones. A decrease in the threshold is also observed when taking fenbufen, theophylline and other similar non-steroidal anti-inflammatory drugs. With the combined use of Levofloxacin with probenecid and cimetidine, a decrease in the renal clearance of Levofloxacin is observed. Clinically, this can only manifest itself when the patient has impaired renal function (prescribe with caution). The risk of tendon rupture increases significantly if the patient is taking glucocorticosteroid drugs. Monitoring of blood coagulation parameters is necessary if the patient takes indirect anticoagulants while taking Levofloxacin. The half-life of cyclosporine increases when taking Levofloxacin. Overdose An overdose is manifested by the following effects: vomiting, confusion or other disturbances of consciousness, dizziness, convulsions, nausea, erosive lesions of the mucous membranes. If the average therapeutic dosage of Levofloxacin is exceeded, it is also possible to prolong the QT interval on the ECG. There is no specific antidote, so the scope of treatment is symptomatic. The active substance is not eliminated by continuous peritoneal dialysis, peritoneal dialysis or hemodialysis. Release form Levofloxacin infusion 100 mg bottles containing 0.5 g of active ingredient. The solution in the bottle is yellow-green or yellow in color, transparent. Levofloxacin – 250 mg White or almost white tablets, round in shape, coated. There are 5 or 10 pieces in a package. Levofloxacin – 500 mg white or almost white tablets, scored on one side, coated, capsule-shaped. There are 5 or 10 pieces in a package. Storage conditions Shelf life - 3 years if storage conditions are met. Levofloxacin is available with a prescription. Store the drug in a dry place, protected from light, out of reach of children. Temperature conditions – no more than 25 degrees Celsius. Nosological classification (ICD-10) Chlamydial infections of the lower genitourinary tract (A56.0)