Lefokcin, 5 pcs., 500 mg, film-coated tablets

Lefokcin, 5 pcs., 500 mg, film-coated tablets

Inside,

1 or 2 times a day. Do not chew the tablets and take them with a sufficient amount of liquid (from 0.5 to 1 glass); they can be taken 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 (Cl creatinine >50 ml/min), the following dosage regimen is recommended.

Sinusitis (inflammation of the paranasal sinuses):

500 mg 1 time per day – 10–14 days.

Exacerbation of chronic bronchitis:

250 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 - 3 days.

Chronic bacterial prostatitis:

500 mg 1 time per day - 28 days.

Complicated urinary tract infections, including pyelonephritis:

250 mg 1 time per day - 7-10 days.

Skin and soft tissue infections:

250 mg once a day or 500 mg 1-2 times a day - 7-14 days.

Septicemia/bacteremia:

500 mg 1-2 times a day - 10-14 days (after IV administration to continue therapy).

Intra-abdominal infection:

500 mg 1 time per day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora, after IV administration to continue therapy).

The dosage regimen for patients with impaired renal function is presented in the table.

Table

No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). If liver function is impaired, no special dose selection is required, since levofloxacin is metabolized in the liver only to an extremely small extent.

For elderly patients, no change in dosage regimen is required, except in cases of low creatinine clearance. As with the use of other antimicrobial drugs, treatment with Lefokcin is recommended to be continued for at least 48–78 hours after the body temperature has normalized or after the pathogen has been effectively destroyed.

If you miss a dose of the drug, you should take the pill as soon as possible before the time for your next dose approaches. Then continue taking Lefoccin according to the schedule.

Lefoxin

Determination of the frequency of side effects: often - 1-10%; sometimes - <1%; rarely - <0.1%; very rarely - <0.01%; individual cases <0.01%.

From the digestive system:

often - nausea, diarrhea, increased activity of liver enzymes (ALT, AST); sometimes - loss of appetite, vomiting, abdominal pain, digestive disorders; rarely - diarrhea with blood (may be a sign of colitis and even pseudomembranous colitis), increased bilirubin levels in the blood serum; very rarely - liver reactions (hepatitis).

From the side of metabolism:

very rarely - hypoglycemia (of particular importance for patients with diabetes mellitus); Possible signs of hypoglycemia: significantly increased appetite, nervousness, perspiration, trembling. When using quinolones, there is a risk of exacerbation of porphyria, which cannot be excluded during treatment with Lefoccin.

From the central nervous system and peripheral nervous system:

sometimes - headache, dizziness and/or stupor, drowsiness, sleep disturbances; rarely - depression, anxiety, psychotic reactions (for example, with hallucinations), paresthesia in the hands, tremor, psychomotor agitation, confusion, convulsions, anxiety.

From the senses:

very rarely - visual and hearing impairment, impaired taste and smell, decreased tactile sensitivity.

From the cardiovascular system:

rarely - increased heart rate, 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), muscle weakness (of particular importance for patients with bulbar syndrome); in some cases - muscle damage (rhabdomyolysis).

From the urinary system:

rarely - increased serum creatinine levels; very rarely - deterioration of kidney function up to acute renal failure, for example, due to allergic reactions (interstitial nephritis).

From the hematopoietic system:

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.

Allergic reactions:

sometimes - itching and redness of the skin; rarely - anaphylactic and anaphylactoid reactions with symptoms such as urticaria, bronchospasm and possibly severe suffocation; very rarely - angioedema (for example, in the face and pharynx), sudden drop in blood pressure and shock, photosensitivity, allergic pneumonitis; vasculitis; in some cases - 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.

Other:

sometimes - general weakness (asthenia); very rarely - fever. Any antibiotic therapy can cause changes in the microflora (bacteria and fungi) that is normally present in humans. For this reason, there may be an increased proliferation of bacteria and fungi that are resistant to the antibiotic used (secondary infection and superinfection), which in rare cases may require additional treatment.

Levofloxacin

The frequency of a particular side effect is determined using the following table:

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 (see "Special Instructions"), 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 may be a sign of intestinal inflammation and even pseudomembranous colitis (see "Special Instructions").

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 tendonitis), 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 (see “Special Instructions”), 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.

Lefokcin tablet p/w film 500mg 10 pcs

Hospital-acquired infections caused by Pseudomonas aeruginosa may require combination treatment. The prevalence of acquired resistance in cultured strains of microorganisms may vary by geographic region and over time. Therefore, country-specific information on levofloxacin resistance 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. Staphylococcus aureus (methicillin-resistant strains). 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 organism to levofloxacin.

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 receiving drugs that lower the seizure threshold of the brain, such as fenbufen and other similar NSAIDs, or other drugs that lower the seizure threshold, such as theophylline (see “Interactions with other drugs”).

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 metronidazole orally) should be started immediately. Drugs that inhibit intestinal motility are contraindicated.

Tendinitis. Rarely observed, tendonitis with quinolones, including levofloxacin, can lead to rupture of tendons, including the Achilles tendon. This side effect can develop within 48 hours after starting treatment and can be bilateral. Elderly patients are more prone to developing tendinitis. The risk of tendon rupture may be increased when taking corticosteroids concomitantly. If tendinitis is suspected, treatment with Levofloxacin should be stopped immediately and appropriate treatment of the affected tendon should be initiated, for example by providing sufficient immobilization (see sections “Contraindications” and “Side effects”).

Hypersensitivity reactions. Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (angioedema, anaphylactic shock) even with initial doses (see section "Side effects"). Patients should immediately stop taking the drug and consult a doctor.

Severe bullous reactions. Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been observed while taking levofloxacin (see section "Side effects"). In case of development of any reactions from the skin or mucous membranes, the patient should immediately consult a doctor and not continue treatment until his consultation.

Disorders of the liver and biliary tract. 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 (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 renal failure. 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 experience impaired night 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 (bacteria and fungi) that are insensitive to it, 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, take appropriate measures.

Prolongation of the QT interval. Very rare cases of QT prolongation have been reported in patients taking fluoroquinolones, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for prolongation of the QT interval: in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital long QT syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval, such as antiarrhythmic drugs of classes IA and III, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, imidazole derivatives, some antihistamines, including astemizole, terfenadine, ebastine. 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”, “Side effects”, “Interaction with other drugs”).

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 treated 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, usually in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycemic drugs (for example, glibenclamide) or insulin preparations. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, monitoring of blood glucose concentrations is required (see “Side effects”).

Peripheral neuropathy. In patients taking fluoroquinolones, including levofloxacin. Sensory and sensorimotor peripheral neuropathy has been reported, the onset of which may be rapid. If the patient develops symptoms of neuropathy, use of Levofloxacin should be discontinued. This minimizes the possible risk of developing irreversible changes.

Exacerbation of pseudoparalytic myasthenia gravis (myasthenia gravis). Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may increase muscle weakness in patients with myasthenia gravis. 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”).

Application for airborne anthrax infection. The use of levofloxacin in humans for this indication is based on susceptibility data from Bacillus anthracis obtained from in vitro and experimental animal studies, as well as 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. With the use of quinolones, including levofloxacin, the development of psychotic reactions has been reported, which in very rare cases progressed to the development of suicidal thoughts and behavior disorders with self-harm (sometimes after taking a single dose of levofloxacin) (see section "Side effects"). If such reactions develop, treatment with Levofloxacin should be discontinued and appropriate therapy should be prescribed. The drug should be prescribed with caution to patients with psychosis or 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 taking levofloxacin, 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.

Impact on the ability to drive vehicles. Wed and fur. :

During therapy with levofloxacin, you should refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, as dizziness, drowsiness and visual disturbances may develop (see section “Side Effects”).

Lefoccin

Fluoroquinolone, a broad-spectrum antimicrobial bactericidal agent. Blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes of bacteria.

In vitro activity:

Sensitive microorganisms (minimum inhibitory concentration less than 2 mg/l).

Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative methicillin-sensitive/moderately sensitive strains), including Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Staphylococcus spp. (leukotoxin-containing); Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive/moderately sensitive/resistant strains), Streptococcus pyogenes, Streptococcus viridans group (penicillin-sensitive/resistant strains).

Aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter spp. (including Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (beta-lactamase producing and non-producing strains), Morganella morganii, Neisseria gonorrhoeae (penicillinase producing and non-producing strains), Neisseria meningitidis, Pasteurella spp. (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp. (including Serratia marcescens), Salmonella spp.

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

Dr. microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella spp. (including Legionella pneumophila), Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma hominis), Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Moderately sensitive microorganisms (minimum inhibitory concentration more than 4-8 mg/l):

Aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains).

Aerobic gram-negative microorganisms: Burkholderia cepacia, Campylobacter jejuni, Campylobacter coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp., Porphyromonas spp.

Resistant microorganisms (minimum inhibitory concentration more than 8 mg/l):

Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp. (coagulase-negative methicillin-resistant strains).

Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.

Dr. microorganisms: Mycobacterium avium.