Levofloxacin, 10 pcs., 500 mg, film-coated tablets

Levofloxacin-Vista, solution for infusion, intended for the treatment of the following infectious diseases in adults:

• community-acquired pneumonia;
• complicated infections of the skin and soft tissues;
• acute pyelonephritis and complicated urinary tract infections;
• chronic bacterial prostatitis;
• pulmonary anthrax: post-exposure prophylaxis and radical treatment.

Official recommendations for the appropriate use of antibacterial agents should be considered.

Composition and release form

Tablets - 1 tablet:

• Active ingredients: levofloxacin hemihydrate - 512.46 mg (corresponding to the content of levofloxacin - 500 mg);
• Excipients: microcrystalline cellulose - 44.69 mg, crospovidone - 7.85 mg, sodium stearyl fumarate - 1.41 mg, croscarmellose sodium - 6.15 mg, colloidal silicon dioxide - 15.38 mg, maltodextrin - 24.6 mg, magnesium stearate - 2.46 mg;
• Shell composition: Opadry orange 20A230018 - 15 mg (hydroxypropyl methylcellulose 2910 [hypromellose 6cP] (E464) - 6.6 mg, titanium dioxide (E171) - 1.375 mg, talc - 3.150 mg, hyprolose [hydroxypropylcellulose, klucel EF] ( E463) - 3.851 mg, sunset yellow dye (E110) - 0.024 mg).

3/5/7/10 pcs. — contour packaging, cardboard packs.

Description of the dosage form

Film-coated tablets, pinkish-orange, oval, biconvex; When cut, it is white to light yellow in color.

pharmachologic effect

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones, containing levofloxacin, a 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.

Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.

Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I), Staphylococcus aureus methi-S, Staphylococcus epidermidis methi-S, Staphylococcus spp(CNS), Streptococci group C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I/S/R, Streptococcus pyogenes, Viridans streptococci peni-S/R.

Aerobic gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter spp, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp, Moraxela catarrhalis (3+/p-, Morganella morganii, Neisseria gonorrhoeae non PPNG/PPNG, Neisseria meningitidis, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp, Pseudomonas aeruginosa, Pseudomonas spp, Salmonella spp, Serratia marcescens, Serratia spp.

Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp, Clostridium perfringens, Fusobacterium spp, Peptostreptococcus, Propionibacterum spp, Veilonella spp.

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

Pharmacokinetics

Levofloxacin is rapidly and almost completely absorbed after oral administration. Food intake has little effect on the speed and completeness of absorption. The bioavailability of 500 mg levofloxacin after oral administration is almost 100%. After taking a single dose of 500 mg of levofloxacin, Cmax is 5.2-6.9 mcg/ml, the time to reach Cmax is 1.3 hours, T1/2 is 6-8 hours.

Bonding with plasma proteins is 30-40%. Penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, genitourinary organs, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages.

In the liver, a small portion is oxidized and/or deacetylated. It is excreted from the body primarily by the kidneys by glomerular filtration and tubular secretion. After oral administration, approximately 87% of the dose taken is excreted unchanged in the urine within 48 hours, less than 4% in the feces within 72 hours.

Indications for use of Levofloxacin

Infectious and inflammatory diseases caused by sensitive microorganisms:

• acute sinusitis;
• exacerbation of chronic bronchitis;
• community-acquired pneumonia;
• complicated urinary tract infections (including pyelonephritis);
• uncomplicated urinary tract infections;
• prostatitis;
• infections of the skin and soft tissues;
• septicemia/bacteremia associated with the above indications;
• intra-abdominal infection.

Contraindications to the use of Levofloxacin

• hypersensitivity to levofloxacin or other quinolones;
• renal failure (with creatinine clearance less than 20 ml/min. - due to the impossibility of dosing this dosage form);
• epilepsy;
• tendon lesions due to previous treatment with quinolones;
• childhood and adolescence (up to 18 years);
• pregnancy and lactation period.

It should be used with caution in the elderly due to the high likelihood of a concomitant decrease in renal function, as well as in cases of glucose-6-phosphate dehydrogenase deficiency.

Peculiarities

The drug should be avoided in patients who have had serious adverse reactions in the past with quinolones or fluoroquinolones. Treatment of these patients with levofloxacin should be initiated only in the absence of alternative treatment options and after a careful benefit/risk assessment.

Pregnant

Due to the lack of research and the possible damage of quinolones to articular cartilage in the body as it grows, the drug is contraindicated during pregnancy and lactation. If pregnancy occurs while using the drug, you should inform your doctor.

Children

Do not use in patients under 18 years of age.

Drivers

Some adverse reactions (eg, dizziness/vertigo, drowsiness, blurred vision) may impair the patient's ability to concentrate and react quickly and may therefore pose an increased risk in situations where these qualities are particularly important (eg, when managing vehicles or other mechanisms).

Use of Levofloxacin during pregnancy and children

The incidence of levofloxacin-related adverse reactions in Phase 3 clinical trials conducted in North America was 6.3%. Therapy was discontinued due to drug-related side effects in 3.9% of patients.

In clinical studies, the following side effects were considered likely to be related to levofloxacin: nausea (1.3%), diarrhea (1%), vaginitis (0.7%), insomnia (0.5%), abdominal pain (0. 4%), flatulence (0.4%), itching (0.4%), dizziness (0.3%), dyspepsia (0.3%), rash (0.3%), genital candidiasis (0. 2%), taste disturbance (0.2%), vomiting (0.2%), constipation (0.1%), fungal infection (0.1%), itching in the genital area (0.1%), headache pain (0.1%), thrush (0.1%), nervousness (0.1%), erythematous rash (0.1%), urticaria (0.1%).

In clinical studies, the following side effects were observed without taking into account the relationship with the drug.

From the nervous system and sensory organs: headache (6.4%), insomnia (4.6%), dizziness (2.7%), fatigue (1.2%), impaired taste sensitivity (1%); <1%: asthenia, incoordination, coma, convulsions, speech impairment, stupor, tremor, vertigo, confusion, aggression, agitation, anxiety, anorexia, delirium, depression, emotional lability, hallucinations, difficulty concentrating, mania, nervousness, paranoia, impaired thinking, unusual dreams, sleep disturbance, somnolence, diplopia, cerebrovascular disorders, tinnitus, hearing and vision impairment, conjunctivitis, parosmia.

From the cardiovascular system and blood <1%: hypertension, hypotension (including orthostatic), heart failure, circulatory failure, arrhythmia, bradycardia, tachycardia, blockade, cardiac arrest, supraventricular tachycardia, ventricular and atrial fibrillation, palpitation , angina pectoris, coronary thrombosis, myocardial infarction, thromboembolism, phlebitis, platelet pathology, epistaxis, purpura, thrombocytopenia, leukocytosis, leukopenia, lymphopenia, granulocytopenia, lymphadenopathy.

From the respiratory system: sinusitis (1.3%), rhinitis (1%); <1%: asthma, acute respiratory distress syndrome, cough, hemoptysis, dyspnea, hypoxia, pleural effusion, respiratory failure.

From the gastrointestinal tract: nausea (7.2%), diarrhea (5.6%), constipation (3.2%), abdominal pain (2.5%), dyspepsia (2.4%), vomiting (2 .3%), flatulence (1.5%); <1%: dry mouth, dysphagia, swelling of the tongue, gastroenteritis, gastrointestinal bleeding, pseudomembranous colitis, hepatic coma, increased LDH, jaundice, impaired liver function, cholelithiasis.

From the genitourinary system: vaginitis (1.8%); <1%: itching in the genital area, impaired ejaculation, impotence, increased serum creatinine, decreased renal function, acute renal failure, hematuria.

From the musculoskeletal system <1%: arthralgia, arthritis, arthrosis, muscle weakness, myalgia, osteomyelitis, synovitis, tendonitis, rhabdomyolysis, hyperkinesis, involuntary muscle contractions, increased muscle tone, paresthesia, paralysis.

From the skin: itching (1.3%), rash (1.2%); <1%: erythema nodosum, skin peeling, skin ulceration, urticaria, increased sweating.

Other: local reaction (3.5%), pain (1.7%) and inflammation (1.1%) at the injection site; pain (1.4%), chest pain (1.2%) and back pain (1.1%); <1%: hyperkalemia, hypokalemia, dehydration, hypoglycemia, hyperglycemia, worsening diabetes mellitus, weight loss, carcinoma, fever, facial edema, withdrawal syndrome.

The following adverse effects have been reported in post-marketing studies: hypersensitivity pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphonia, abnormal EEG, encephalopathy, eosinophilia, erythema multiforme, hemolytic anemia, multiple organ failure, increased international normalized ratio (INR), Stevens-Johnson syndrome, rupture tendons, ventricular fibrillation, vasodilation.

Below are data from 29 pooled Phase 3 clinical trials (n=7537). The average age of patients is 50 years (approximately 74% of patients are younger than 65 years), 50% are male, 71% are Caucasian, and 19% are black. Patients received levofloxacin for the treatment of various infections at a dose of 750 mg once daily, 250 mg once daily, or 500 mg twice daily. The duration of therapy was usually 3–14 days (average 10 days).

The overall incidence, type, and distribution of adverse reactions were similar in patients receiving levofloxacin 750 mg once daily compared with patients receiving 250 mg once daily or 500 mg twice daily. Therapy was discontinued due to drug-related adverse events in 4.3% of patients overall, 3.8% of patients taking the 250 and 500 mg doses, and 5.4% of patients taking the 750 mg dose. The most common side effects leading to discontinuation of the drug at doses of 250 and 500 mg were gastrointestinal complaints (1.4%), nausea (0.6%), vomiting (0.4%), dizziness (0.3%) , headache (0.2%). The most common side effects leading to discontinuation of the drug at a dose of 750 mg were gastrointestinal disturbances (1.2%), nausea (0.6%), vomiting (0.5%), dizziness (0.3%), headache pain (0.3%).

The following are side effects noted in clinical trials and observed with an incidence of more than 0.1%.

From the nervous system and sensory organs: headache (6%), dizziness (3%), insomnia (4%); 0.1–1%: anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disturbances, anorexia, unusual dreams, tremors, convulsions, paresthesia, vertigo, hypertension, hyperkinesis, incoordination, drowsiness, fainting.

From the cardiovascular system and blood: 0.1–1%: anemia, arrhythmia, palpitations, cardiac arrest, supraventricular tachycardia, phlebitis, epistaxis, thrombocytopenia, granulocytopenia.

From the respiratory system: shortness of breath (1%).

From the gastrointestinal tract: nausea (7%), diarrhea (5%), constipation (3%), abdominal pain (2%), dyspepsia (2%), vomiting (2%); 0.1–1%: gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous colitis, liver dysfunction, increased levels of liver enzymes, increased alkaline phosphatase.

From the genitourinary system: vaginitis (1%); 0.1–1%: impaired renal function, acute renal failure, genital candidiasis.

From the musculoskeletal system: 0.1–1%: arthralgia, tendinitis, myalgia, skeletal muscle pain.

From the skin: rash (2%), itching (1%); 0.1–1%: allergic reactions, edema (1%), urticaria.

Other: candidiasis (1%), reaction at the IV injection site (1%), chest pain (1%); 0.1–1%: hypoglycemia/hyperglycemia, hyperkalemia.

The following side effects have been reported in post-marketing studies.

From the nervous system and sensory organs: isolated reports of encephalopathy, EEG abnormalities, peripheral neuropathy, psychosis, paranoia, isolated reports of suicide attempts and suicidal thoughts, visual impairment (including diplopia, decreased visual acuity, blurred vision, scotoma ), hearing loss, tinnitus, parosmia, anosmia, loss of taste, taste perversion, dysphonia.

From the cardiovascular system and blood: isolated reports of torsade de pointes, prolongation of the QT interval, tachycardia, vasodilation, increased INR, prolongation of prothrombin time, pancytopenia, aplastic anemia, leukopenia, hemolytic anemia, eosinophilia.

From the gastrointestinal tract: liver failure (including fatal cases), hepatitis, jaundice.

From the musculoskeletal system: tendon rupture, muscle damage, including rupture, rhabdomyolysis.

From the skin: bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity/phototoxicity reactions.

Allergic reactions: hypersensitivity reactions (sometimes fatal), incl. anaphylactic/anaphylactoid reactions, anaphylactic shock, angioedema, serum sickness; isolated reports of hypersensitivity pneumonitis.

Other: vasculitis, increased activity of muscle enzymes, hyperthermia, multiorgan failure, interstitial nephritis.

When using levofloxacin in the form of 0.5% eye drops, the most frequently observed effects were: 1-3% - transient decreased vision, transient burning, pain or discomfort in the eye, sensation of a foreign body in the eye, fever, headache, pharyngitis, photophobia; <1% - allergic reactions, swelling of the eyelids, dry eyes, itching in the eye.

Levofloxacin 5 mg/ml 100 ml solution for inf.

Instructions for medical use of the drug (Insert leaflet) Trade name Levofloxacin International nonproprietary name Levofloxacin Dosage form, dosage Solution for infusion, 2 mg/ml, 3 mg/ml, 5 mg/ml Pharmacotherapeutic group Anti-infective drugs for systemic use. Antibacterial drugs for systemic use. Antimicrobial drugs are quinolone derivatives. Fluoroquinolones. Levofloxacin. ATC code J01MA12 INDICATIONS FOR USE ADULT PATIENTS FOR TREATMENT OF THE FOLLOWING INFECTIONS: - COMMUNITY-ACQUIRED PNEUMONIA - SKIN AND SOFT TISSUE INFECTIONS FOR THE ABOVE INFECTIONS LEVOFLOXACIN SHOULD BE USED ONLY IN THOSE WITH IN CASES WHEN THE IMPOSSIBILITY OF USE OF ANTIBACTERIAL MEDICINES WHICH ARE USUALLY RECOMMENDED AS INITIAL THERAPY FOR THESE INFECTIONS IS JUSTIFIED. — PYELONEPHRITIS AND COMPLICATED URINARY TRACT INFECTIONS — CHRONIC BACTERIAL PROSTATITIS — PULMONARY FORM OF ANTHRAX: POST-EXPOSURE PREVENTION AND TREATMENT. — OFFICIAL GUIDELINES FOR THE APPROPRIATE USE OF ANTIBACTERIALS SHOULD BE FOLLOWED. LIST OF INFORMATION REQUIRED BEFORE USING CONTRAINDICATIONS - HYPERSENSITIVITY TO LEVOFLOXACIN (INCLUDING OTHER DRUGS OF THE QUINOLONE GROUP) - TAKEN CLASS IA ANTIARRHYTHMIC DRUGS (QUINIDINE, PROCAINAMIDE) OR CLASS III SSA (AMIODARONE, SOTALOL) - LONGER QT INTERVAL - HYPOKALEMIA - TENDON DAMAGE OBSERVED DURING PREVIOUS USE OF FLUOROQUINOLONES - EPILEPSY - GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY - PREGNANCY, LACTATION - CHILDHOOD AND ADOLESCENCE UNDER 18 YEARS - TREATMENT OF INFECTIONS THAT ARE NOT ARE SEVERE AND MAY PASS UP WITHOUT ANTIBACTERIAL THERAPY (E.G. OROPHARYNX INFECTIONS) - TREATMENT NON-BACTERIAL INFECTIONS, E.G. NON-BACTERIAL (CHRONIC) PROSTATITIS - PREVENTING TRAVELER'S DIARRHEA OR REPEATED LOWER URINARY TRACT INFECTIONS (INFECTIONS THAT DO NOT SPREAD BEYOND THE BLADDER) - LE FOR MODERATE BACTERIAL INFECTIONS, WHEN OTHER USUALLY RECOMMENDED ANTIBACTERIAL MEDICATIONS CANNOT BE USED, NECESSARY MEASURES CANNOT BE USED PRECAUTIONS FOR USE FLUOROQUINOLONE ANTIBIOTICS SHOULD BE USED WITH EXTREME CAUTION, ESPECIALLY IN ELDERLY PEOPLE, PATIENTS WITH KIDNEY DISEASE; PATIENTS RECEIVING SYSTEMIC CORTICOSTEROID THERAPY; PATIENTS AFTER ORGAN TRANSPLANTATION. THESE PATIENTS HAVE AN INCREASED RISK OF TENDON INJURY THAT MAY RESULT FROM TREATMENT WITH FLUOROQUINOLONE AND QUINOLONE ANTIBIOTICS. INTERACTIONS WITH OTHER DRUGS THE PHARMACOKINETICS OF LEVOFLOXACIN DOES NOT CHANGE TO A CLINICALLY SIGNIFICANT EXTENT WHEN COMMON APPLICATION WITH THE DRUGS: CALCIUM CARBONATE, DIGOXIN, GLIBENCLAMIDE, RANITIDINE. SIMULTANEOUS USE OF QUINOLONES WITH THEOPHYLLINE, FENBUFEN, NON-STEROID ANTI-INFLAMMATORY DRUGS (NSAIDS) AND OTHER DRUGS THAT REDUCED THE SEIZURE THRESHOLD MAY RESULT IN A SIGNIFICANT REDUCTION IN THE CEREBRAL SEIZURE THRESHOLD, DESPITE THE LACK OF PHARMACOKINETIC INTERACTIONS OF LEVOFLOXACIN WITH THEOPHYLLINE. IN THE PRESENCE OF FENBUFEN, THE CONCENTRATION OF LEVOFLOXACIN INCREASES BY ALMOST 13%. PROBENECID AND CIMETIDINE HAVE A SIGNIFICANT INFLUENCE ON THE ELIMINATION OF LEVOFLOXACIN AND REDUCE THE RENAL CLEARANCE OF LEVOFLOXACIN (BY 24% AND 34%, RESPECTIVELY), SINCE BOTH DRUGS CAN BLOCK THE DUAL SECRETION OF LEVOFLOXACIN SACINA IN THE KIDNEYS. WITH SIMULTANEOUS APPLICATION OF MEDICINES AFFECTING RENAL TUBAL SECRETION, TREATMENT WITH LEVOFLOXACIN SHOULD BE CARRIED OUT WITH CAUTION, ESPECIALLY IN IMPAIRMENTS OF RENAL FUNCTION. THE HALF-LIFE OF CYCLOSPORINE INCREASES BY 33% WHEN APPLIED WITH LEVOFLOXACIN. TREATMENT WITH LEVOFLOXACIN IN COMBINATION WITH A VITAMIN K ANTAGONIST (E.G. WARFARIN) MAY RESULT IN AN INCREASE IN COAGULATION TEST PERFORMANCE (PROTHROMBIN TIME (PT) ACCORDING TO INTERNATIONAL NORMALIZED RATIO ( INR) AND/OR INCREASED BLEEDING, WHICH CAN BE SERIOUS. THOSE RECEIVING VITAMIN K ANTAGONISTS REQUIRE MONITORING OF COAGULATION TESTS MEDICINES CAPABLE OF PROLONGING THE QT INTERVAL (E.G. CLASS IA AND III ANTI-ARHYTHMICS, TRICYCLIC ANTIDEPRESSANTS, MACROLE IDEAS) SHOULD BE USED WITH CAUTION WHEN USE WITH LEVOFLOXACIN SPECIAL WARNINGS (SPECIAL INSTRUCTIONS) AT THE GREATEST IN SEVERE CASES OF PNEUMOCOCCAL PNEUMONIA, LEVOFLOXACIN MAY NOT BE THE MOST OPTIMAL THERAPY.There is a high likelihood that METHICILLIN-RESISTANT STAPHYLOCOCCUS AURUS WILL ALSO BE RESISTANT TO FLUOROQUINOLONES, INCLUDING LEVO FLOXACIN THEREFORE, LEVOFLOXACIN IS NOT RECOMMENDED FOR USE IN THE TREATMENT OF INFECTIONS CAUSED BY METHICILLIN-RESISTANT STAPHYLOCOCOCUS OR SUCH SUSPECTIONS EXIST IF THE RESULTS OF LABORATORY TESTS HAVE NOT CONFIRMED THE SENSITIVITY OF THE MICROORGANISM TO LEVOFLOXACIN (AND ALSO IF THE USE OF ANTIBACTERIAL DRUGS USUALLY PRESCRIBED IN THE TREATMENT OF INFECTIONS CAUSED BY METHICYL LIN-RESISTANT STAPHYLOCOCCUS IS CONSIDERED IMPOSSIBLE). RESISTANCE TO FLUOROQUINOLONES BY E. COLI, THE MOST COMMON PATHOGENE CAUSING URINARY TRACT INFECTIONS, VARIES AMONG THE EUROPEAN UNION. WHEN PRESCRIBING DRUGS, IT IS RECOMMENDED TO CONSIDER THE LOCAL PREVALENCE OF E. COLI RESISTANCE TO FLUOROQUINOLONES. PULMONARY ANTHRAX: USE IS BASED ON BACILLUS ANTHRACIS SENSITIVITY DATA AND PRE-CLINICAL STUDIES, ALSO WITH LIMITED AMOUNTS OF CLINICAL DATA. TREATING PHYSICIANS SHOULD REFER TO HARMONIZED NATIONAL AND/OR INTERNATIONAL DOCUMENTS REGARDING THE TREATMENT OF ANTHRAX. THE RECOMMENDED INFUSION DURATION SHOULD BE FOLLOWED, WHICH IS NOT LESS THAN 30 MINUTES FOR 250 MG (50 ML INFUSION SOLUTION) AND NOT LESS THAN 60 MINUTES FOR 500 MG (100 ML SOLUTION). DURING OFLOXACIN INFUSION, TACHYCARDIA AND A TEMPORARY REDUCTION IN BLOOD PRESSURE MAY DEVELOP. IN RARE CASES, ACUTE VASCULAR INSUFFICIENCY (CIRCULAR COLLAPSE) IS POSSIBLE AS A RESULT OF A SHARP REDUCTION IN BLOOD PRESSURE. IF THERE IS SIGNS OF A LOSS IN BLOOD PRESSURE DURING LEVOFLOXACIN (L-ISOMER OF OFLOXACIN) INFUSION, THE INFUSION SHOULD BE DISCONTINUED IMMEDIATELY. SODIUM CONTENT THIS MEDICATION CONTAINS 7.7 mmol (177 MG) SODIUM PER 50 ML DOSE AND 15.39 mmol (354 MG) PER 100 ML DOSE. MUST BE TAKEN INTO ATTENTION IN PATIENTS ON A CONTROLLED SODIUM DIET. IN RARE CASES, TENDINITIS IS POSSIBLE, MOST OFTEN IN THE ACHILLES TENDON, WHICH CAN LEAD TO ITS RUPTURE. THE RISK OF DEVELOPING TENDINITIS AND TENDON RUPTURE IS INCREASED IN OLDER AGE AND IN PATIENTS USING CORTICOSTEROID DRUGS. IF TENDINITIS IS SUSPECTED, TREATMENT WITH LEVOFLOXACIN SHOULD BE IMMEDIATELY DISCONTINUED AND APPROPRIATE TREATMENT OF THE AFFECTED TENDON (E.G. IMMOBILIZATION) SHOULD BE INITIATED TO REST. EPIDEMIOLOGICAL STUDIES HAVE REPORTED AN INCREASED RISK OF ANEURYSMS AND AORTIC DISTRIBUTION AFTER FLUOROQUINOLONE USE, ESPECIALLY IN ELDERLY PATIENTS. IN PATIENTS WITH A HISTORY OF AN ANEURYSM, OR HAVING AN AURYSM AND/OR AORTIC DISSELATION, AS WELL AS OTHER RISK FACTORS OR CONDITIONS PREDISPOSIBLE TO THE DEVELOPMENT OF ANEURYSMS AND AORTIC DISSELATION (E.G., MARFAN'S SYNDROME, EHLER'S SYNDROME SA-DANLO VASCULAR TYPE, TAKAYASU ARTERITIS, GIANT CELL ARTERITIS, BEHÇET'S DISEASE, ARTERIAL HYPERTENSION, ATHEROSCLEROSIS), FLUOROQUINOLONES SHOULD BE USED ONLY AFTER A CAREFUL BENEFITS-RISK EVALUATION AND CONSIDERATION OF OTHER POSSIBLE THERAPY OPTIONS. IN THE EVENT OF SUDDEN ABDOMINAL, CHEST OR BACK PAIN, PATIENTS SHOULD CONTACT A DOCTOR IMMEDIATELY AT THE EMERGENCY DEPARTMENT. PSEUDOMEMBRANOSUS COLITIS IF PSEUDOMEMBRANOSUS COLITIS IS SUSPECTED, LEVOFLOXACIN SHOULD BE DISCONTINUED IMMEDIATELY AND APPROPRIATE TREATMENT INITIATED. IN SUCH CASES, MEDICINES THAT INHIBIT INTESTINE MOTORS SHOULD NOT BE USED. PRESPOSIBILITY TO SEIZURES LEVOFLOXACIN IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF EPILEPSY. AS WITH OTHER QUINOLONES, CAUTION SHOULD BE EXERCISED IN PATIENTS PROPOSED TO EPILEPTIC SEIZURES, FOR EXAMPLE, PATIENTS WITH EXISTING CENTRAL NERVOUS SYSTEM LESIONS, WHILE TREATING WITH FENBUFEN AND THE SIMILAR AT THE SAME TIME AND, NON-STEROID ANTI-INFLAMMATORY DRUGS OR DRUGS THAT LOWER THE CEREBRAL SEIZURE THRESHOLD, SUCH AS THEOPHYLLINE. IN CASE OF CONVULSIVE SEIZURES, TREATMENT WITH LEVOFLOXACIN SHOULD BE DISCONTINUED. PATIENTS WITH GLUCOSO-6-PHOSPHATEDEHYDROGENASE DEFICIENCY PATIENTS WITH LATENT OR MANIFESTING INSUFFICIENT GLUCOSE-6-PHOSPHATEDEHYDROGENASE ACTIVITY MAY BE PRODICED TO HEMOLYTIC REACTIONS DURING TREATMENT WITH QUINOL THEREFORE, CAUTION SHOULD BE USED WHEN USING LEVOFLOXACIN. PATIENTS WITH IMPAIRED RENAL FUNCTION DUE TO THE EXCRETION OF LEVOFLOXACIN PRIMARILY BY THE KIDNEYS, DOSE ADJUSTMENT SHOULD BE CARRIED OUT FOR PATIENTS WITH IMPAIRED RENAL FUNCTION HYPERSENSITIVITY REACTIONS LEVOFLOXACIN MAY CAUSE SERIOUS, POTENTIALLY FATAL HYPERSENSITIVITY REACTIONS, SUCH AS ANGIOEDEMA, BEFORE ANAPHYLACTIC SHOCK, SOMETIMES AFTER FIRST DOSE. PATIENTS SHOULD IMMEDIATELY STOP TREATMENT AND CONTACT THEIR PHYSICIAN OR EMERGENCY DOCTOR WHO WILL TAKE APPROPRIATE EMERGENCY MEASURES. HYPOGLYCEMIA WITH LEVOFLOXACIN, AS WITH ALL QUINOLONES, HYPOGLYCEMIA MAY OCCUR, USUALLY IN PATIENTS WITH DIABETES MELLITUS WHO ARE AT THE SAME TIME TREATED WITH ORAL HYPOGLYCEMIC DRUGS, E.G. GLI BENCLAMIDE OR INSULIN. IN SUCH PATIENTS, STRICT MONITORING OF BLOOD GLUCOSE LEVEL IS RECOMMENDED. PREVENTION OF PHOTOSENSITIZATION ALTHOUGH PHOTOSENSITIZATION IS RARE WITH TREATMENT WITH LEVOFLOXACIN, PATIENTS ARE ADVISED NOT TO UNNECESSARY EXPOSE THEMSELVES TO STRONG SUN LIGHT OR ARTIFICIAL UV RADIATION TECHNIQUES, E.G., SUNLIGHT LAMPS, SOLARIUM, TO AVOID PHOTOSENSITIZATION. PATIENTS UNDER TREATMENT WITH VITAMIN K ANTAGONISTS DUE TO A POSSIBLE INCREASE IN COAGULATION TEST PERFORMANCE (PROTHROMBIN TIME/INR) AND/OR INCREASED BLEEDING IN PATIENTS UNDER TREATMENT WITH LEVOFLOXACIN M IN COMBINATION WITH A VITAMIN K ANTAGONIST (E.G. WARFARIN), CLOTTING INDICATORS SHOULD BE MONITORED BLOOD WHEN USE OF THESE DRUGS AT THE SAME TIME. PSYCHOTIC REACTIONS IN PATIENTS USING QUINOLONES, INCL. LEVOFLOXACIN, PSYCHOTIC REACTIONS HAVE BEEN RECORDED. IN VERY RARE CASES THEY PROGRESS TO SUICIDAL THOUGHTS AND SELF-HARMING BEHAVIOR, SOMETIMES EVEN AFTER ONE SINGLE DOSE OF LEVOFLOXACIN. IN THE CASE OF DEVELOPMENT OF PSYCHOTIC REACTIONS IN A PATIENT, LEVOFLOXACIN SHOULD BE CANCELED AND APPROPRIATE MEASURES TAKEN. CAUTION IS RECOMMENDED WHEN PRESCRIBING LEVOFLOXACIN TO PATIENTS WITH PSYCHOSES OR A HISTORY OF MENTAL ILLNESS. QT INTERVAL PROLONGATION SHOULD BE CAUTION IN PATIENTS WITH KNOWN RISK FACTORS FOR QT INTERVAL PROLONGATION: ELDERLY AGE, ELECTROLYTE DISORDERS (HYPOKALEMIA, HYPOMAGNEMIA), CONGENITAL LONG QT INTERVAL SYNDROME, HEART DISEASES (HEART FAILURE, MYOCARDIAL INFARCTION, BRADYCARDIA), SIMULTANEOUS USE OF MEDICINES CAPABLE OF EXTENDING THE QT INTERVAL. PERIPHERAL NEUROPATHY SENSORY AND SENSOMOTOR PERIPHERAL NEUROPATHY HAVE BEEN RECORDED IN PATIENTS RECEIVED WITH FLUOROQUINOLONES, INCL. LEVOFLOXACIN, AND THEIR DEVELOPMENT WAS RAPID. LEVOFLOXACIN SHOULD BE DISCONTINUED WHEN NEUROPATHY SYMPTOMS APPEAR TO AVOID THE DEVELOPMENT OF AN IRREVERSIBLE CONDITION. OPIATES DETERMINATION OF OPIATES IN URINE MAY GIVE A FALSE POSITIVE RESULT WHEN TREATMENT WITH LEVOFLOXACIN. IT IS NECESSARY TO CONFIRM A POSITIVE RESULT FOR OPIATES BY ANOTHER, MORE SPECIFIC METHOD. LIVER AND BILIARY TRACT DISORDERS CASES OF LIVER NECROSIS, UP TO LIFE-THREATENING LIVER FAILURE, HAVE BEEN RECORDED IN CONNECTION WITH THE USE OF LEVOFLOXACIN, PRIMARILY IN PATIENTS WITH SEVERE UNDERLYING ILLNESS M, FOR EXAMPLE SEPSIS. PATIENTS SHOULD BE ADVISED TO STOP TREATMENT AND CONSULT A DOCTOR IF SIGNS AND SYMPTOMS OF LIVER DISEASE APPEAR, SUCH AS ANOREXIA, JAUNDICE, DARK DISCOLORATION OF URINE, ITCHING, ABDOMINAL PAIN. EXacERBATION OF MYASTHENIAS GRAVIS FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, HAVE NEUROMUSCULAR BLOCKING ACTIVITIES AND MAY INCREASE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIAS GRAVIS. SERIOUS ADVERSE REACTIONS, INCLUDING CASES OF DEATH AND THE REQUIREMENT OF SUPPORTIVE VENTILATION, THAT OCCURRED DURING POST-MARKETING SURVEILLANCE, HAVE BEEN ASSOCIATED WITH THE USE OF FLUOROQUINOLONES IN PATIENTS WITH STRAY GIVING MYASTHENIAS GRAVIS. IT IS NOT RECOMMENDED TO USE LEVOFLOXACIN IF THE PATIENT HAS A HISTORY OF MYASTHENIAS GRAVIS. VISUAL IMPAIRMENTS IF VISUAL IMPAIRMENTS OCCUR OR EFFECTS ON THE EYES ARE MANIFESTED BY TAKING THE DRUG, YOU SHOULD IMMEDIATELY CONTACT AN OPHTHALMOLOGIST. SUPERINFECTION USE OF LEVOFLOXACIN, ESPECIALLY OVER A LONG TIME, MAY RESULT IN EXCESSIVE GROWTH OF INSENSITIVE MICROORGANISMS. IF SUPERINFECTION OCCURS, APPROPRIATE MEASURES SHOULD BE TAKEN DURING THE TREATMENT PERIOD. LEVOFLOXACIN MAY INHIBIT THE GROWTH OF MYCOBACTERIUM TUBERCULOSIS AND THEREFORE BE A CAUSE OF FALSE NEGATIVE RESULTS IN BACTERIOLOGICAL DIAGNOSIS OF TUBERCULOSIS. SEVERE SKIN ADVERSE REACTIONS HAVE BEEN REPORTED WITHIN THE USE OF LEVOFLOXACIN THAT SEVERE SKIN ADVERSE REACTIONS (SCARS), INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN: ALSO KNOWN AS LYELL'S SYNDROME), STEVENS JOHNSON SYNDROME (SJS) AND DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS) WHICH CAN BE FATAL OR LIFE-THREAMING. WHEN PRESCRIBED WITH DRUGS CONTAINING LEVOFLOXACIN, PATIENTS SHOULD BE INFORMED OF THE SIGNS AND SYMPTOMS OF SEVERE SKIN REACTIONS AND CAREFULLY MONITORED THEIR CONDITION IN THE FUTURE. WHEN SIGNS AND SYMPTOMS INDICATING THESE REACTIONS APPEAR, LEVOFLOXACIN SHOULD BE DISCONTINUED IMMEDIATELY AND ALTERNATIVE TREATMENT SHOULD BE CONSIDERED. IF A PATIENT HAS A SERIOUS REACTION SUCH AS SJS, TEN, OR DRESS USING LEVOFLOXACIN, TREATMENT SHOULD NOT BE RESUME OR PRESCRIBED IN ANY CASE. USE WITH CAUTION IN ELDERLY PERSONS DUE TO THE HIGH POSSIBILITY OF A CONSOLIDATED REDUCTION IN RENAL FUNCTION, IN PATIENTS WITH DIABETES. PRECAUTIONS THE BOTTLE SHOULD BE INSPECTED BEFORE USE. ONLY A TRANSPARENT SOLUTION WITH NO INCLUSIONS MAY BE USED. LEVOFLOXACIN SOLUTION FOR INFUSION SHOULD BE USED IMMEDIATELY (WITHIN 3 HOURS) AFTER PLUG PERFORATION TO AVOID BACTERIAL CONTAMINATION. PROTECTION FROM LIGHT IS NOT NECESSARY DURING INFUSION. AS WITH ALL OTHER MEDICATIONS, ANY UNUSED MEDICINE SHOULD BE DISPOSED WITH WASTE ACCORDING TO LOCAL ENVIRONMENTAL REGULATIONS. PREGNANCY AND LACTATION LEVOFLOXACIN IS CONTRAINDICATED FOR PREGNANT AND LACTATING WOMEN DUE TO THE LACK OF CLINICAL STUDY DATA AND THE POSSIBLE RISK OF DAMAGE BY FLUOROQUINOLONES TO THE LOAD-BEARING CARTILAGE TISSUE OF THE GROWING OR GANISM. PECULIARITIES OF THE EFFECT OF THE MEDICINE ON THE ABILITY TO DRIVE A VEHICLE OR POTENTIALLY DANGEROUS MECHANISMS SIDE EFFECTS OF LEVOFLOXACIN SUCH AS Dizziness OR STUPIDITY, Drowsiness AND VISION DISORDERS MAY WORSE MAINTAIN QUICK REACTIONS AND CONCENTRATION OF ATTENTION, WHICH PRESENTS A CERTAIN RISK WHEN OPERATING VEHICLES OR POTENTIALLY DANGEROUS MECHANISMS, MAINTENANCE OF MACHINES AND MECHANISMS, PERFORMANCE OF WORK IN AN UNSTABLE POSITION. RECOMMENDATIONS FOR USE DOSAGE REGIME DOSAGE DEPENDS ON THE TYPE AND SEVERITY OF THE INFECTION AND THE SENSITIVITY OF THE ALLEGED CAUSE. THE DURATION OF ADMINISTRATION OF 250 MG (50 ML INFUSION SOLUTION) SHOULD BE AT LEAST 30 MIN, 500 MG (100 ML INFUSION SOLUTION) - AT LEAST 60 MINUTES, 1-2 TIMES A DAY. DEPENDING ON THE PATIENT'S CONDITION, AFTER A SEVERAL DAYS OF TREATMENT YOU CAN GO TO TAKEN THE DRUG ORALLY IN THE SAME DOSE, CONSIDERING THE EQUIVALENCE OF BOTH ROUTES OF ADMINISTRATION. THE DURATION OF TREATMENT DEPENDS ON THE TYPE AND SEVERITY OF THE DISEASE. TREATMENT WITH LEVOFLOXACIN, LIKE ANY OTHER ANTIBACTERIAL THERAPY, SHOULD BE CONTINUED FOR AT LEAST 48-72 HOURS AFTER THE SYMPTOMS OF ACUTE INFLAMMATION HAVE DECREASED AND THE TEMPERATURE NORMALIZED. DOSING OF THE DRUG IN PATIENTS WITH NORMAL RENAL FUNCTION (CREATININE CLEARANCE > 50 ML/MIN) INDICATIONS DAILY DOSE COMMUNITY PNEUMONIA 500 MG (100 ML SOLUTION) 1-2 TIMES DAILY URINARY TRACT INFECTIONS WITH COMPLICATIONS (INCLUDING PYELONEPHRITIS) 250 MG (50 ML SOLUTION ) 1 time per day (with severe course of the disease, the dose should be increased) chronic bacterial prostatitis 500 mg (100 ml of solution) once a day complicated skin and soft tissue infections of 500 mg (100 ml of solution) 1 - 2 times a day dosing of the drug in Patients with a impaired renal function (creatinine clearance ≤ 50 ml/min) Creatinine clearance, ml/min Dose for intravenous administration 250 mg/24 h 500 mg/24 h 500 mg/12 h the first dose: 250 mg first dose: 500 mg first Dose: 500 mg 50-20 further 125 mg/24 h further 250 mg/24 h further 250 mg/12 h 19-10 further 125 mg/48 h, further 125 mg/24 h further 125 mg/12 h <10 (including Hemodialysis and constant outpatient peritoneal dialysis) Further 125 mg/48 h, further 125 mg/24 h, further 125 mg/24 hours after hemodialysis or constant outpatient peritoneal dialysis, there is no need for an additional dose of the drug. Patients with impaired liver function: Dose correction is not required. Elderly patients: Dose adjustment is not required, with the exception of correction with impaired renal function. Children and adolescence up to 18 years: levofloxacin is contraindicated. Mixing with other infusion solutions. Levofloxacin, a solution for infusions is compatible with the following infusion solutions: 0.9 % sodium chloride solution, 5 % dextrose solution, a 2.5 % deconstruction solution in a Ringer solution, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). The incompatibility of levofloxacin, a solution for infusion is not subject to mixing with heparin and alkaline solutions (for example, sodium carbonate) and other drugs, with the exception of those indicated above. The method and path of administration intravenously, drip, slowly measures that need to be taken in case of an overdose of the symptoms: gastrointestinal disorders (nausea), erosive lesions of the mucous membrane of the gastrointestinal tract, change in the QT interval, confusion, dizziness, and cramps. Treatment: symptomatic therapy, dialysis is ineffective, specific antidote is unknown. Recommendations for consulting a medical worker to clarify the method of applying the drug to a description of unwanted reactions that are manifested with the standard use of the LP and measures that the information below should be taken in this case is based on the data of clinical studies, as well as on the experience of post -marketing observation. The side effects below are presented in accordance with the following gradations of the frequency of their occurrence: very often (≥ 1/10); Often (≥1/100 - <1/10); Infrequently (≥1/1000 - <1/100); Rarely (≥1/10000 - <1/1000); Very rarely (<1/10000); The unknown frequency (according to the data that has the frequency of occurrence, it is not possible to determine). Inside each group, formed depending on the frequency of occurrence, unwanted effects are presented in the order of reducing their severity. Often - insomnia - headache, mild dizziness - phlebitis - diarrhea, vomiting, nausea - increasing the level of hepatic enzymes (ALT/AST, alkaline phosphatase, GGT) - reaction at the place of introduction (pain, redness) infrequently - fungal infection, including infection, including infection Candida - pathogenic resistance - leukopenia, eosinophilia - anorexia, anxiety, increased excitability, a state of confusion - drowsiness, tremor, dyshevia (violation of taste) - vertigo (dizziness) - shortness of abdominal pain, dyspepsia, background - raising the level of bilirubin In the blood - a rash, itching, urticaria, hyperhidrosis - arthralgia, myalgia - an increase in the level of creatinine in the blood - asthenia is rare - thrombocytopenia, neutropenia - angioedema, hypoglycemia, especially in patients with diabetes - psychotic reactions (for example, with hallucinations, with hallucinations, with hallucinations. Paranoia) - depression, agitation - unusual dreams, nightmares - convulsions, paresthesia - visual disorders, such as visibility of vision - tinnitus - tachycardia, a rapid sensation of the heartbeat - hypotension - tendon diseases, including tendonitis (for example, Achilles tendon) - muscle weakness, muscle weakness, muscle weakness, muscle weakness, muscle weakness, muscle weakness, muscle weakness Which can be of particular importance in patients with miastenia gravis - acute renal failure (for example, due to interstitial nephritis) - pyrexia (hyperthermia) The frequency is unknown - nasopytopenia, agranulocytosis, hemolytic anemia - anaphylactic shock, anaphylactoid shock (anaphylactoid reactions can even occur After the first dose of the drug) - hyperglycemia, hypoglycemic coma - psychotic disorders with behavior that pose a danger to the patient himself, including suicidal thinking or an attempt by suicide - peripheral sensory neuropathy, peripheral sensorimotor neuropathy, passion, including anosmia, dyskinesia, extrapyramidal disorder, agency (agency (agency. Loss of taste), fainting, benign intracranial hypertension - temporary vision loss, uvel - hearing loss, hearing impairment - ventricular tachycardia, which can lead to cardiac arrest - ventricular tachycardia, which can lead to cardiac arrest, ventricular arrhythmia and bicariate ventricular tachycardia (observed Basically, patients with risk factors for extension of the QT interval), lengthening of QT interval on ECG - bronchospasm, allergic pneumonitis - hemorrhagic diarrhea, in very rare cases can indicate enterocolitis, including pseudomembranous colitis, pancreatitis and severe damage to the liver, including cases Acute liver failure with death, especially in patients in the presence of the underlying disease with a severe course, hepatitis is toxic epidermal necrolysis, Stevens-Johnson syndrome, polymorphic erythema, photosensitive reactions, leukocytic vasculitis, stomatitis-rabdomyolysis, rupture of tendons (for example, Achilles tendon tenders ), Ligaments, muscles - arthritis - pain (including pain in the back, chest and limbs) SOC: skin and subcutaneous diseases with frequency rarely: “Drug reaction with eosinophilia and system symptoms (Dress) SOC: Endocrine disorders with a frequency rarely: - - - - - Syndrome of inadequate secretion of antidiuretic hormone (SIADH). If unwanted drugs arise, contact a medical worker, a pharmaceutical worker or directly to an information database of unwanted reactions (actions) to drugs, including reports of the inefficiency of drugs (indicate an information database of unwanted reactions) of the RGP to the National Center for Expertise Medicines and medical devices »Committee for Quality and Safety Control of goods and services of the Ministry of Health of the Republic of Kazakhstan http://www.ndda.kz Additional information The composition of the drug 100 ml of the solution contain an active substance - Levofloxacin hydrochloride 232.0 mg, 348.0 mg or 580.0 mg ( Equivalent to levofloxacin 200 mg, 300 mg or 500 mg) excipients: sodium chloride, water for injection. Description, appearance, smell, transparent, greenish-yellow-yellow color Solution Form of release and packaging of 100 ml of the drug into a polypropylene bottles with a graduate of 100, with a loop with a holder, clipped with polypropylene lids with a rubber lining and a cap equipped with a torn ring for opening for opening , welded on the bottle. For 1 bottle, along with instructions for medical use in Kazakh and Russian languages, placed in a cardboard pack or 120 bottles along with instructions for use in Kazakh and Russian languages ​​are placed in a cardboard box (group). The shelf life of 2 years is not used after the shelf life of the storage condition to be stored in a place protected from light at a temperature of not higher than 25 ° C. DO NOT FREEZE. KEEP OUT OF THE REACH OF CHILDREN! Conditions of vacation from pharmacies according to the recipe information about (Kelun-Kazfarm), Kazakhstan, Almaty region, Karasai district, Eltai s/o, S. Kokuzek, 1147, tel/fax, e-mail holder of the registration certificate of Kelun-Kazpharm LLP ( Kelun-Kazfarm), Kazakhstan name, address and contact details (telephone, fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, which accepts claims (proposals) on the quality of medicines from consumers and responsible for the safety of the medicinal safety of Kelun- KazPHARM ”(Kelun-Kazfarm), Kazakhstan, Almaty region, Karasai district, Eltai s/o, S. Kokozek., Tel/fax: 8 (727) 312-14-01, e-mail

Side effects of Levofloxacin

Allergic reactions: sometimes – itching and redness of the skin; rarely - general hypersensitivity reactions (anaphylactic and anaphylactoid reactions) with symptoms such as urticaria, constriction of the bronchi and possibly severe suffocation; very rarely - swelling of the skin and mucous membranes (for example, in the face and throat), sudden drop in blood pressure and shock, increased sensitivity to solar and ultraviolet radiation, allergic pneumonitis, vasculitis; in some cases - severe skin rashes with blistering, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme. General hypersensitivity reactions may sometimes be preceded by milder skin reactions. The above reactions can develop after the first dose, a few minutes or hours after administration of the drug.

From the digestive system: often - nausea, diarrhea, increased activity of liver enzymes (for example, alanine aminotransferase and aspartate aminotransferase); sometimes - loss of appetite, vomiting, abdominal pain, digestive disorders; rarely - diarrhea mixed with blood, which in very rare cases can be a sign of intestinal inflammation and even pseudomembranous colitis.

On the metabolic side: very rarely - a decrease in the concentration of glucose in the blood, which is of particular importance for patients with diabetes (possible signs of hypoglycemia: increased appetite, nervousness, perspiration, trembling). Experience with the use of other quinolones suggests that they can cause exacerbation of porphyria in patients already suffering from this disease. A similar effect cannot be excluded when using the drug levofloxacin.

From the nervous system: sometimes - headache, dizziness and/or stupor, drowsiness, sleep disturbances; rarely - anxiety, paresthesia in the hands, trembling, psychotic reactions such as hallucinations and depression, agitation, convulsions and confusion; very rarely - impaired vision and hearing, impaired taste and smell, decreased tactile sensitivity.

From the cardiovascular system: rarely - increased heartbeat, decreased blood pressure; very rarely - vascular (shock-like) collapse; in some cases - prolongation of the QT interval.

From the musculoskeletal system: rarely - tendon damage (including tendinitis), joint and muscle pain; very rarely - tendon rupture (for example, Achilles tendon); this side effect can be observed within 48 hours after the start of treatment and can be bilateral in nature, muscle weakness, which is of particular importance for patients with bulbar syndrome; in some cases - muscle damage (rhabdomyolysis).

From the urinary system: rarely - increased levels of bilirubin and creatinine in the blood serum; very rarely - deterioration of kidney function up to acute renal failure, interstitial nephritis.

From the hematopoietic organs: sometimes - an increase in the number of eosinophils, a decrease in the number of leukocytes; rarely - neutropenia, thrombocytopenia, which may be accompanied by increased bleeding; very rarely - agranulocytosis and the development of severe infections (persistent or recurrent increase in body temperature, deterioration in health); in some cases - hemolytic anemia; pancytopenia.

Other: sometimes - general weakness; very rarely - fever.

Any antibiotic therapy can cause changes in the microflora that is normally present in humans. For this reason, increased proliferation of bacteria and fungi resistant to the antibiotic used may occur, which in rare cases may require additional treatment.

Levofloxacin, 10 pcs., 500 mg, film-coated tablets

After normalization of body temperature, it is recommended to continue treatment for at least 48–78 hours.

Cases of photosensitivity have been reported when using levofloxacin. To prevent its development, patients are not recommended to be exposed to strong sunlight or artificial ultraviolet radiation during treatment and for 48 hours after cessation of therapy.

If signs of tendonitis appear, levofloxacin is immediately discontinued.

Hospital-acquired infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) may require combination treatment. The prevalence of acquired resistance among microbial strains may vary by geographic region and over time. Therefore, country-specific information on levofloxacin resistance is required. It is necessary to establish a microbiological diagnosis with isolation of the pathogen and determination of its sensitivity to levofloxacin.

There is a high probability that Staphylococcus aureus (methicillin-resistant strains) will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of established or suspected infections caused by Staphylococcus aureus (methicillin-resistant strains) unless laboratory tests have confirmed the sensitivity of this microorganism to levofloxacin.

As with the use of other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased proliferation of microorganisms insensitive to it (bacteria and fungi), which can cause changes in the microflora that is normally present in humans, and, accordingly, can lead to to the development of superinfection. Therefore, during treatment, it is imperative to re-evaluate the patient’s condition and, in the event of superinfection, appropriate measures should be taken.

If a patient experiences diarrhea while taking levofloxacin, drugs that inhibit intestinal motility are contraindicated, since it is necessary to keep in mind the possibility of developing pseudomembranous colitis. Treatment with antibacterial agents leads to modification of the normal flora of the large intestine and can lead to increased growth of clostridia. If a diagnosis of pseudomembranous colitis is established, levofloxacin should be discontinued and appropriate treatment initiated.

Fluoroquinolones, including levofloxacin, can block neuromuscular activity and increase muscle weakness in patients with myasthenia gravis. Post-marketing adverse reactions, including pulmonary failure requiring mechanical ventilation and death, have been associated with the use of fluoroquinolones in patients with myasthenia gravis. The use of levofloxacin in patients with an established diagnosis of myasthenia gravis is not recommended.

It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), seizures may develop; in patients with glucose-β-phosphate dehydrogenase deficiency, there is a risk of hemolysis.

In severe community-acquired pneumonia caused by Streptococcus pneumoniae, levofloxacin may not provide optimal therapeutic effect.

In patients using fluoroquinolones, including levofloxacin, cases of sensory and sensorimotor axonal polyneuropathy affecting small and/or large axons and leading to paresthesia, hypoesthesia, dysesthesia and weakness have been reported. Symptoms may appear soon after starting use and may be irreversible. If the patient develops symptoms of neuropathy, including pain, burning, tingling, numbness and/or weakness or other sensory disturbances, including touch, pain, temperature, vibration and position sense, Levofloxacin should be discontinued immediately.

Patients should immediately stop taking the drug and consult a doctor if serious, life-threatening hypersensitivity reactions develop, as well as at the first manifestations of the skin or mucous membranes.

Cases have been reported of the development of psychotic reactions, which in very rare cases progressed to the development of suicidal ideation and behavioral disorders with self-harm. If such events occur, you should stop taking levofloxacin. Levofloxacin should be used with caution in patients with psychosis or patients with a history of mental illness.

In cases of development of any visual impairment, immediate consultation with an ophthalmologist is necessary.

Since levofloxacin is excreted mainly through the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as adjustment of the dosage regimen (see section "Dosage and Administration"). When treating elderly patients, it should be borne in mind that patients in this group often have impaired renal function (see section “Dosage and Administration”).

Cases of hepatic necrosis, including the development of fatal liver failure, have been reported with the use of levofloxacin, mainly in patients with severe underlying diseases, such as sepsis. If signs and symptoms of liver damage appear, such as anorexia, jaundice, dark urine, itching and abdominal pain, discontinue treatment with the drug.

Very rare cases of QT prolongation have been reported in patients receiving fluoroquinolones, including levofloxacin.

When using fluoroquinolones, including levofloxacin, caution should be exercised in female patients, in elderly patients, in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia), in patients with known risk factors for prolongation of the QT interval: with congenital long QT interval syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.

There have been reports of cases of hyperglycemia and hypoglycemia, usually in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycemic drugs (for example, glibenclamide) or insulin preparations, when using levofloxacin, as well as cases of hypoglycemic coma.

When using levofloxacin, it should be taken into account that the determination of opiates in urine can lead to false-positive results, which should be confirmed by more specific methods.

Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false-negative results of the bacteriological diagnosis of tuberculosis.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. The potential for side effects such as dizziness, vertigo, drowsiness and visual disturbances should be taken into account. If the described adverse events occur, you should refrain from performing the above activities.

Drug interactions

There are reports of a pronounced decrease in the threshold of convulsive readiness with the simultaneous use of quinolones and substances that can, in turn, reduce the cerebral threshold of convulsive readiness. This also applies equally to the simultaneous use of quinolones and theophylline.

The effect of Levofloxacin is significantly weakened when used simultaneously with sucralfate. The same thing happens with the simultaneous use of magnesium or aluminum containing antacids, as well as iron salts. Levofloxacin should be taken at least 2 hours before or 2 hours after taking these medications. No interaction was detected with calcium carbonate.

When using vitamin K antagonists simultaneously, monitoring of the blood coagulation system is necessary.

The elimination (renal clearance) of levofloxacin is slightly slowed down by the action of cimetidine and probenecid. It should be noted that this interaction has virtually no clinical significance. However, with the simultaneous use of drugs such as probenecid and cimetidine, which block a certain excretion pathway (tubular secretion), treatment with levofloxacin should be carried out with caution. This applies primarily to patients with limited renal function.

Levofloxacin slightly increases the half-life of cyclosporine.

Taking glucocorticosteroids increases the risk of tendon rupture.

Levofloxacin dosage

The drug is taken orally 1 or 2 times a day. Do not chew the tablets and take a sufficient amount of liquid (from 0.5 to 1 glass); you can take them before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

For patients with normal or moderately reduced renal function (creatinine clearance > 50 ml/min.), the following dosage regimen is recommended: sinusitis: 500 mg 1 time per day - 10-14 days; exacerbation of chronic bronchitis: 250 mg or 500 mg 1 time per day - 7-10 days; community-acquired pneumonia: 500 mg 1-2 times a day - 7-14 days. uncomplicated urinary tract infections: 250 mg 1 time per day for 3 days; prostatitis: 500 mg - 1 time per day - 28 days; complicated urinary tract infections, including pyelonephritis: 250 mg 1 time per day - 7-10 days; infections of the skin and soft tissues: 250 mg 1 time a day or 500 mg 1-2 times a day - 7-14 days; septicemia/bacteremia: 250 mg or 500 mg 1-2 times a day for 10-14 days; intra-abdominal infection: 250 mg or 500 mg 1 time per day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

Patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis do not require additional doses.

Patients with impaired liver function do not require special dosing, since levofloxacin is metabolized in the liver only to an extremely small extent.

As with the use of other antibiotics, treatment with Levofloxacin is recommended to be continued for at least 48-78 hours after normalization of body temperature or after laboratory confirmed recovery.

Levofloxacin

Hospital-acquired infections caused by Pseudomonas aeruginosa may require combination treatment.

Risk of developing resistance.

The prevalence of acquired resistance in cultured strains of microorganisms may vary by geographic region and over time. In this regard, information on drug resistance in a specific country is required. For the treatment of severe infections or if treatment is ineffective, a microbiological diagnosis must be established with the isolation of the pathogen and determination of its sensitivity to levofloxacin.

Methicillin-resistant Staphylococcus aureus.

There is a high likelihood that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of known or suspected infections caused by methicillin-resistant Staphylococcus aureus unless laboratory tests have confirmed the sensitivity of this microorganism to levofloxacin.

Disability and potential irreversible serious adverse reactions associated with the use of fluoroquinolones.

When using fluoroquinolones, including levofloxacin, cases of disability and the development of irreversible serious adverse reactions from various body systems, which can develop simultaneously in the same patient, have been observed. Adverse reactions caused by fluoroquinolones include tendonitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and nervous system side effects (hallucinations, anxiety, depression, insomnia, headaches, and confusion). These reactions can develop from several hours to several weeks after the start of levofloxacin therapy in patients of any age, including those without previous risk factors. If the first signs or symptoms of any serious adverse reactions occur, use of levofloxacin should be discontinued immediately. Fluoroquinolones, including levofloxacin, should be avoided in patients who have previously experienced any of these serious adverse reactions.

Duration of infusions. You should strictly adhere to the recommended duration of drug administration, which should be at least 60 minutes (for 100 ml of infusion solution) or 30 minutes (for 50 ml of solution). Experience with levofloxacin shows that increased heart rate and a transient decrease in blood pressure may occur during infusion. In rare cases, vascular collapse may develop. If a significant decrease in blood pressure is observed during the infusion, the drug should be stopped immediately.

Patients predisposed to developing seizures. Like other quinolones, levofloxacin should be used with great caution in patients with a predisposition to seizures. Such patients include patients with previous lesions of the central nervous system, such as stroke, severe traumatic brain injury; patients simultaneously taking drugs that lower the seizure threshold of the brain, such as fenbufen and other similar non-steroidal anti-inflammatory drugs, or other drugs that lower the seizure threshold, such as theophylline (see section “Interaction with other drugs”). If seizures develop, treatment with levofloxacin should be discontinued.

Pseudomembranous colitis. Diarrhea that develops during or after treatment with levofloxacin, 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 intestinal motility are contraindicated.

Tendinitis and tendon rupture. Tendinitis (including bilateral tendonitis) has been reported rarely with the use of quinolones, including levofloxacin, and has sometimes resulted in tendon rupture, including the Achilles tendon. This side effect may occur within 48 hours of starting treatment or several months after completion of fluoroquinolone therapy. Elderly patients are more prone to developing tendinitis. The risk of developing tendinitis and tendon rupture may increase with the simultaneous use of fluoroquinolones and glucocorticosteroids, as well as in patients after transplantation, so caution is recommended when prescribing fluoroquinolones to this category of patients. In patients with impaired renal function, the daily dose should be adjusted based on creatinine clearance.

Patients should be advised to remain calm at the first sign of tendonitis or tendon rupture and to contact their healthcare provider. If tendonitis or tendon rupture is suspected, treatment with Levofloxacin should be stopped immediately and appropriate treatment of the affected tendon should be initiated, for example by providing adequate immobilization (see sections “Contraindications” and “Side Effects”).

Reactions and hypersensitivity.

Levofloxacin can cause serious, potentially life-threatening hypersensitivity reactions (angioedema, anaphylactic shock) (see section "Side effects"). If they develop, administration should be stopped immediately

drug and, if necessary, carry out appropriate therapy.

Severe bullous reactions. When using levofloxacin, cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been observed (see section "Side effects"). In case of development of any reactions from the skin or mucous membranes, the patient should immediately inform the doctor, who should decide on further use of the drug in the patient.

Disorders of the liver and biliary tract. Cases of hepatic necrosis, including fatal liver failure, have been reported with the use of levofloxacin, mainly in patients with severe underlying diseases, such as sepsis (see section "Side effects"). Patients should be warned to stop treatment and seek immediate medical attention if signs and symptoms of liver damage occur, such as anorexia, jaundice, dark urine, itching and abdominal pain.

Patients with impaired renal function. Since levofloxacin is excreted mainly through the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as adjustment of the dosage regimen (see section "Dosage and Administration"). When treating elderly patients, it should be taken into account that patients in this group often have impaired renal function (see section “Dosage and Administration”).

Preventing the development of photosensitivity reactions. Although photosensitivity develops very rarely with the use of levofloxacin, to prevent its development, patients are not recommended to be unnecessarily exposed to strong solar or artificial ultraviolet irradiation (for example, visiting a solarium) during treatment and for 48 hours after the end of treatment with levofloxacin.

Superinfection. As with the use of other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased proliferation of microorganisms that are insensitive to it (bacteria and fungi), which can cause changes in the microflora that is normally present in humans. As a result, superinfection may develop. Therefore, during treatment, it is imperative to re-evaluate the patient’s condition and, if superinfection develops during treatment, appropriate measures should be taken.

Prolongation of the QT . Very rare cases of QT prolongation have been reported in patients receiving fluoroquinolone therapy, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for prolongation of the QT interval: in elderly patients; in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital long QT syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); with simultaneous use of drugs that can prolong the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics. Elderly and female patients may be more sensitive to drugs that prolong the QT interval. Therefore, fluoroquinolones, including levofloxacin, should be used with caution (see sections “With caution”, “Dosage and administration”, “Side effects”, “Overdose” and “Interaction with other drugs”).

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

Hypo- and hyperglycemia (dysglycemia). As with the use of other quinolones, cases of hyperglycemia and hypoglycemia have been observed with the use of levofloxacin. During therapy with levofloxacin, dysglycemia occurred more often in elderly patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, glibenclamide) or insulin. When using levofloxacin in such patients, the risk of developing hypoglycemia up to hypoglycemic coma increases. It is necessary to inform patients about the symptoms of hypoglycemia (confusion, dizziness, ravenous appetite, headache, nervousness, palpitations or increased heart rate, pale skin, perspiration, trembling, weakness). If the patient develops hypoglycemia, treatment with levofloxacin should be stopped immediately and appropriate therapy should be initiated. In these cases, it is recommended to switch to therapy with an antibiotic other than a fluoroquinolone, if possible. When treating elderly patients with diabetes mellitus with levofloxacin, careful monitoring of blood glucose concentrations is recommended.

Peripheral neuropathy. In patients receiving fluoroquinolone therapy. including levofloxacin, cases of sensory and sensorimotor peripheral neuropathy have been reported, the onset of which may be rapid. If the patient develops symptoms of neuropathy, levofloxacin should be discontinued. This minimizes the possible risk of developing irreversible changes.

Patients should be informed to report any symptoms of neuropathy to their healthcare provider. Fluoroquinolones should not be prescribed to patients with a history of peripheral neuropathy.

Exacerbation of pseudoparalytic myasthenia gravis ( myasthenia gravis ).

Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may increase muscle weakness in patients with myasthenia gravis. Post-marketing adverse reactions, including pulmonary failure requiring mechanical ventilation and death, have been associated with the use of fluoroquinolones in patients with myasthenia gravis. The use of levofloxacin in patients with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended (see section "Side effects").

Prevention and treatment of anthrax through airborne transmission . The use of levofloxacin in humans for this indication is based on data on the sensitivity of Bacillus anthracis to it from in vitro and experimental studies in animals, as well as on limited data from the use of levofloxacin in humans. Treating physicians should refer to national and/or international documents that reflect the collectively developed point of view on the treatment of anthrax.

Psychotic reactions. Psychotic reactions, including suicidal ideation/attempts, have been reported in patients taking fluoroquinolones, including levofloxacin, sometimes after a single dose. In case of development of any side effects from the central nervous system, including mental disorders, treatment

Levofloxacin should be discontinued immediately and appropriate therapy instituted. In these cases, it is recommended to switch to therapy with an antibiotic other than a fluoroquinolone, if possible.

The drug should be prescribed with caution to patients with psychosis or to patients with a history of mental illness.

Visual impairment. If any visual impairment develops, immediate consultation with an ophthalmologist is necessary (see section “Side Effects”).

Effect on laboratory tests. In patients receiving levofloxacin therapy, the determination of opiates in urine may lead to false-positive results, which should be confirmed by more specific methods. Levofloxacin may

Inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false negative results of the bacteriological diagnosis of tuberculosis.

Precautions when handling the drug. To prevent bacterial contamination, the infusion solution should be used within 3 hours of piercing the rubber stopper of the bottle or container.

Other. Non-wetting of the inner surface of bottles and containers is not a contraindication to the use of the drug.

Overdose

Symptoms of an overdose of Levofloxacin appear at the level of the central nervous system (confusion, dizziness, disturbances of consciousness and seizures of the epileptic type). In addition, gastrointestinal disorders (for example, nausea) and erosive lesions of the mucous membranes, prolongation of the QT interval may occur.

Treatment should be symptomatic. Levofloxacin is not eliminated by dialysis (hemodialysis, peritoneal dialysis and continuous peritoneal dialysis). There is no specific antidote.

Note!

Description of the drug Levofloxacin-Vista solution for inf. 5mg/ml cont. 100ml on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.