Active material: Levofloxacin
When ATH: J01MA12
CCF: Fluoroquinolone antibacterial drug
When CSF: 06.17.02.01
Manufacturer: DR. REDDY`S LABORATORIES LTD. (India)
Solution for infusion a transparent or slightly opalescent light yellow.
| 1 ml | 1 fl. | |
| Levofloxacin gemigidrat | 5.12 mg | 512 mg, |
| which corresponds to the content of levofloxacin | 5 mg | 500 mg |
[Ring] dextrose, hydrochloric acid, Sodium hydroxide, water d / and.
100 мл – флаконы из полиэтилена низкой плотности (1) – пачки картонные.
Ftorxinolon, antimicrobial is a broad spectrum bactericidal action. Blocks of DNA gyrase (topoisomerase II) and topoisomerase IV, crosslinking violates supercoiling and DNA breaks, It inhibits DNA synthesis, It causes profound morphological alterations in the cytoplasm, cell wall and membranes. Effective 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 influеnzае, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus is wonderful, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter different, Citrobacter freundii, Morganella morganii, Proteus vulgaris, Rettgeri Providence, The providence of stewardship, Serratia wilting, Clostridium perfringens.
If ingestion is absorbed from the gastrointestinal tract rapidly and almost completely. Food intake has little effect on the rate and completeness of absorption. Bioavailability is 99%. Cmax
achieved through 1-2 hours and at the reception 250 mg 500 mg of 2.8 and 5.2 ug / ml, respectively. Plasma protein binding - 30-40%. Well into the organs and tissues: lungs, bronchial mucosa, sputum, organs of the urogenital system, polymorphonuclear leukocytes, alyveolyarnыe macrophages. In the liver, a small portion is oxidized and / or deacetylated. Renal clearance is 70% total clearance.T1/2 – 6-8 no. Excreted from the body mainly by the kidneys by glomerular filtration and tubular secretion. Less 5% Levofloxacin is excreted as metabolites. Unchanged in the urine within 24 h output 70% and for 48 ч – 87%; in coil 72 h detected 4% an oral dose. After the on / in Infusion 500 mg for 60 min Cmax – 6.2 ug / ml. The on / in single and repeated administration of the apparent Vd after administration of the same dose of 89-112 l, Cmax – 6.2 ug / ml, T1/2 – 6.4 no.
Infections of the lower respiratory tract (chronic bronchitis, pneumonia), ENT (sinusitis, otitis media), urinary tract and kidney (incl. acute pyelonephritis), genital (incl. urogenital chlamydiosis), skin and soft tissue (festering atheroma, abscess, boils).
Inside, before a meal or in between meals, without chewing, drinking plenty of fluids. B /, slowly. При синусите – внутрь, by 500 mg 1 time / day; при обострении хронического бронхита – по 250-500 mg 1 time / day. При пневмонии – внутрь, by 250-500 mg 1-2 times / day (500-1000 mg / day); в/в – по 500 mg 1-2 times / day. При инфекциях мочевыводящих путей – внутрь, 250 mg 1 times / day, or in / at the same dose. При инфекциях кожи и мягких тканей – по 250-500 mg orally 1-2 times / day, or on / in, by 500 mg 2 times / day. After the on / in a few days, a transition to the ingestion of the same dose.
When kidney disease dose reduced according to the degree of dysfunction: при КК=20-50 мл/мин – по 125-250 mg 1-2 times / day, при КК=10-19 мл/мин – 125 mg 1 once every 12-48 no, at CC<10 мл/мин – 125 mg after 24 or 48 no. Длительность лечения – 7-10 (to 14) days.
From the digestive system: nausea, vomiting, diarrhea, anorexia, abdominal pain, pseudomembranous enterocolitis, повышение активности “печеночных” трансаминаз, giperʙiliruʙinemija, hepatitis, dysbiosis.
Cardio-vascular system: decrease in blood pressure, vascular collapse, tachycardia.
Metabolism: gipoglikemiâ (increased appetite, Sweating, tremor).
From the central and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesia, anxiety, fear, hallucinations, confusion, depression, movement disorders, convulsions.
From the senses: visual impairment, hearing, olfactory, gustatory and tactile sensitivity.
On the part of the musculoskeletal system: arthralgia, myalgia, tendon rupture, muscular weakness, Tendinitis.
From the urinary system: giperkreatininemiя, interstitsialnyi Jade.
From the hematopoietic system: eozinofilija, gemoliticheskaya anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, gemorragii.
Dermatological reactions: photosensitivity, itch, swelling of the skin and mucous membranes, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
Allergic reactions: hives, bronchospasm, suffocation, anaphylactic shock, hypersensitivity pneumonitis, vasculitis.
Other: aggravation of porphyria, raʙdomioliz, persistent fever, development of superinfection.
Hypersensitivity, epilepsy, defeat tendons at the earlier treatment quinolones, pregnancy, lactation, childhood and adolescence up 18 years.
Levofloxacin is contraindicated during pregnancy and lactation (breast-feeding).
With careful use of levofloxacin in elderly patients (a high probability of having a concomitant decrease in renal function).
After normalization of temperature, it is recommended to continue treatment for at least 48-78 no. Duration / in infusion 500 mg (100 ml solution infuzioinogo) must be at least 60 m. During treatment should avoid sunlight and artificial UV radiation to prevent damage to the skin (photosensitivity). If signs of tendinitis levofloxacin immediately cancel. It will be appreciated, In patients with brain damage history (stroke, severe injury) may develop seizures, при недостаточности глюкoзo-6-фосфатдeгидpoгeназы – риск развития гемолиза.
Effects on ability to drive vehicles and management mechanisms
In the period of treatment should refrain from activities potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Levofloxacin increases T1/2 cyclosporine.
Effect of levofloxacin reduces preparations, suppress intestinal motility, sucralfate, magnesium- and aluminum-containing antacid and an iron salt (needed a break between the reception of at least 2 no).
With simultaneous use of NSAIDs, Theophylline increases convulsive, ГКС – повышают риск разрыва сухожилий.
Cimetidine and drugs, block tubular secretion, slow removal of levofloxacin.
Levofloxacin solution for i / v administration is compatible with 0.9% sodium chloride solution, 5% dextrose, 2.5% Ringer's dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).
Levofloxacin solution for i / v administration should not be mixed with Heparin and solutions, having an alkaline reaction.
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