Assign to adults for the treatment of infections caused by microorganisms sensitive to the drug: community-acquired pneumonia; complicated skin and soft tissue infections; (For the above-mentioned infections, Levofloxacin should only be used when the use of other antibacterial agents that are usually recommended for the initial treatment of these infections is impractical or impossible); pyelonephritis, complicated urinary tract infections; chronic bacterial prostatitis.
active substance: levofloxacin hemihydrate;
1 ml of solution contains levofloxacin hemihydrate in terms of levofloxacin 5 mg;
Excipients: sodium chloride, sodium hydroxide, concentrated hydrochloric acid, water for injections.
Levofloxacin-Novofarm Dosage form
Solution for infusion.
Main physical and chemical properties: clear solution of greenish-yellow color. Theoretical osmolarity – 302 mosmol / l.
Pharmacotherapeutic group. Antibacterial agents of the quinolone group. Fluoroquinolones.
ATX code J01M A12.
Levofloxacin-Novofarm Pharmacological properties.
Levofloxacin is a synthetic antibacterial agent from the group of fluoroquinolones, the S (-) enantiomer of a racemic mixture of the drug ofloxacin.
Mechanism of action
Levofloxacin as an antibacterial drug from the group of fluoroquinolones acts on the complex of DNA-DNA gyrase and topoisomerase IV.
Pharmacokinetic / pharmacodynamic ratio
The degree of bacterial activity of levofloxacin depends on the ratio of the maximum serum concentration (Cmax) or the area under the pharmacokinetic curve (AUC) and the minimum inhibitory (inhibitory) concentration (MIC).
Levofloxacin-Novofarm Mechanism of resistance
The main mechanism of resistance is due to mutations in gyr-A genes. In vitro, there is cross-resistance between levofloxacin and other fluoroquinolones. Due to the mechanism of action, there is usually no cross-resistance between levofloxacin and other classes of antibacterial agents.
The European Antimicrobial Susceptibility Testing Committee (EUCAST) recommended levofloxacin MIC limit values separating susceptible micro-organisms from intermediate-susceptible (moderately resistant) and intermediate-susceptible from resistant organisms are presented in Table 1 of the test.
Approximately 30-40% of levofloxacin is bound to serum protein. The mean volume of distribution of levofloxacin is about 100 l after a single and repeated dose of 500 mg, indicating its widespread distribution in body tissues.
Penetration into tissues and body fluids
Levofloxacin has the ability to penetrate the bronchial mucosa, epithelial lining fluid, alveolar macrophages, lung tissue, skin (blister content), prostate tissue and urine. However, levofloxacin is poorly absorbed into the cerebrospinal fluid.
Levofloxacin is metabolized to a very small extent, the metabolites being dimethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for less than 5% of the drug excreted in the urine. Levofloxacin is stereochemically stable and is not subject to inversion of the chiral structure.
After oral and intravenous administration, levofloxacin is excreted from the blood plasma relatively slowly (half-life is 6-8 hours). Excretion is usually carried out by the kidneys (more than 85% of the administered dose). The mean pronounced total clearance of levofloxacin after a single dose of 500 mg was 175 ± 29.2 ml / min. There is no significant difference in the pharmacokinetics of levofloxacin after oral and intravenous administration, indicating the interchangeability of these pathways (oral and intravenous).