Levolet P pills 250 mg 10 pcs
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Active ingredients
Levofloxacin
Release form
Pills
Composition
1 tablet contains: levofloxacin 250 mg, excipients: MCC (Avicel PH 101), corn starch, colloidal silicon dioxide, crospovidone, hypromellose (15 cps), MCC (Avicel PH 102), magnesium stearate, shell: Opadry white OY 58900 (hypromellose 5 cR, titanium dioxide, macrogol 400)
Pharmacological effect
Antimicrobial agent for broad-spectrum fluoroquinolone. Bactericidal effect. It 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. It is active against 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, Haemophilus 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 vulgaris, Providencia rettgeri, Providcncia stuartii, Serratia marcescens, Clostridium perfringens.
Pharmacokinetics
When ingestion 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 in 1-2 hours and when taken 250 mg and 500 mg is 2.8 and 5.2 mcg / ml, respectively. Binding to plasma proteins - 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the urogenital system, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and / or deacetylated. Renal clearance is 70% of total clearance. T1 / 2 - 6-8 h. Excreted mainly by the kidneys by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% is excreted in the urine within 24 hours and 87% in 48 hours; in the feces for 72 hours, 4% of the ingested dose is detected. After intravenous infusion of 500 mg for 60 min. Cmax - 6.2 mcg / ml. For intravenous and repeated injections, the apparent Vd after administration of the same dose is 89-112 l, Cmax - 6.2 mcg / ml, T1 / 2 - 6.4 h.
Indications
Infectious and inflammatory diseases of mild and moderate severity caused by pathogens sensitive to the drug: Community-acquired pneumonia. Drug-resistant forms of tuberculosis (as part of complex therapy). Complicated infections of the kidneys and urinary tract, including pyelonephritis. . h.Bacterial. Septicemia / bacteremia associated with the above indications for use. Intraabdominal infection. Infections of lop-organs (acute sinusitis). Infections of the lower respiratory tract (exacerbation of chronic bronchitis). Infections of the skin and soft tissues
Contraindications
Hypersensitivity to levofloxacin or other quinolones. Hypersensitivity to auxiliary components of the lever. Epilepsy. Tendon lesions associated with a history of quinolone. Children and adolescents up to 18 years. Pregnancy. Lactation period (breastfeeding). With care: Elderly age (high probability of the presence of concomitant decline in kidney function). Deficiency of glucose-6-phosphate dehydrogenase.
Precautionary measures
On the part of the digestive system: nausea, vomiting, diarrhea, anorexia, abdominal pain, pseudomembranous enterocolitis, increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis. Since the cardiovascular system: lower blood pressure, vascular collapse, tachycardia. Metabolism: hypoglycemia (increased appetite, sweating, tremors). On the part of the central nervous system and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesias, anxiety, fear, hallucinations, confusion, depression, movement disorders, convulsions. From the senses: visual impairment, hearing, smell, taste and tactile sensitivity. On the part of the musculoskeletal system: arthralgia, myalgia, tendon rupture, muscle weakness, tendonitis. From the urinary system: hypercreatininemia, interstitial nephritis. On the part of the hematopoietic system: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.
Use during pregnancy and lactation
Levofloxacin is contraindicated for use during pregnancy and lactation (breastfeeding).
Dosage and administration
Inside, before a meal or in a break between meals, without chewing, drinking plenty of liquid. Sinusitis: 500 mg 1 time per day. The course of treatment is 10-14 days. Exacerbation of chronic bronchitis: 250–500 mg 1 time per day. The course of treatment is 10-14 days. Infections of the skin and soft tissues: 250 mg 1–2 times a day or 500 mg 1 time per day.The course of treatment is 7-14 days.
Side effects
The frequency of side effects is classified depending on the frequency of occurrence often (1–10%), sometimes (less than 0.1–1%), rarely (0.01–0.1%), very rarely (less than 0.01%) , including separate messages. On the part of the blood system and the blood-forming organs, sometimes - eosinophilia, leukopenia. rarely - neutropenia, thrombocytopenia. very rarely - pronounced agranulocytosis. in some cases - hemolytic anemia, pancytopenia. For the digestive system often - nausea, diarrhea, increased activity of ALT, ACT, dysbacteriosis. sometimes - loss of appetite, vomiting, abdominal pain, digestive disorders, hyperbilirubinemia. rarely, diarrhea mixed with blood (in very rare cases, it can be a sign of intestinal inflammation or pseudomembranous colitis). very rarely - hepatitis. Of the cardiovascular system, rarely - tachycardia, a decrease in blood pressure. very rarely - vascular collapse. in some cases - prolongation of the QT interval. From the side of the central and peripheral nervous system, sometimes - headache, dizziness, stiffness of movement, drowsiness, sleep disturbance. rarely - paresthesias in the hands, tremors, anxiety, states of fear, seizures, convulsions, confusion. very rarely - psychotic reactions such as hallucinations and depressions, movement disorders. For the sense organs, very rarely are visual and hearing impairments, olfactory, gustatory and tactile sensitivity. trembling). in some cases - the exacerbation of existing porphyria. From the urinary system rarely - hypercreatininemia. very rarely - deterioration of renal function up to acute renal failure (for example, due to allergic reactions - interstitial nephritis). For the musculoskeletal system, rarely - tendon lesions (including tendonitis), joint and muscle pain. very rarely - tendon ruptures (including Achilles, which can be bilateral and occur within 48 hours after the start of treatment), muscle weakness (is of particular importance for patients with myasthenia). in some cases - rhabdomyolysis. Allergic reactions sometimes - itching and redness of the skin.rarely - anaphylactic and anaphylactoid reactions (manifested by symptoms such as urticaria, bronchospasm and possible severe choking, and in rare cases - swelling of the face, larynx). very rarely - a sharp decrease in blood pressure, anaphylactic shock. in some cases, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme, allergic pneumonitis, vasculitis. Dermatological reactions are very rare - photosensitization. Other things are sometimes asthenia. very rarely - persistent fever, development of superinfection.
Interaction with other drugs
Levofloxacin increases T1 / 2 cyclosporine. The effect of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, magnesium- and aluminum-containing antacids and iron salts (a break between taking at least 2 hours is necessary). With simultaneous use of NSAIDs, theophylline increases convulsive readiness, GCS - increase the risk of tendon rupture. Cimetidine and drugs blocking tubular secretion, slow down the elimination of levofloxacin. Levofloxacin solution for iv administration is compatible with 0.9% sodium chloride solution, 5% dextrose solution, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). Levofloxacin solution for iv administration should not be mixed with heparin and solutions having an alkaline reaction.
special instructions
Levofloxacin is used with caution in elderly patients (there is a high probability of a concomitant decrease in renal function). After the temperature is normalized, it is recommended to continue treatment for at least 48-78 hours. The duration of intravenous infusion of 500 mg (100 ml of the infusion solution) should be at least 60 minutes. During treatment, it is necessary to avoid solar and artificial UV irradiation in order to avoid damage to the skin (photosensitization). When signs of tendinitis appear, levofloxacin is immediately discontinued. It should be borne in mind that in patients with a history of brain damage (stroke, severe injury), seizures may develop, and glucose-6-phosphate dehydrogenase may develop if there is a deficiency in hemolysis. Influence on the ability to drive motor vehicles and control mechanisms During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions.