Lebel coated tablets 500 mg. №7

Description

Lebel Composition
active substance: levofloxacin;

1 tablet contains levofloxacin 500 mg (as levofloxacin hemihydrate);

excipients: microcrystalline cellulose, hypromellose, crospovidone, sodium stearyl fumarate; Opadry Y1 7000 White coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 400.

Lebel Dosage form
Coated tablets.

Main physical and chemical properties: oblong, coated tablets, white, with a fracture line on one side.

Lebel Pharmacotherapeutic group
Antibacterial agents of the quinolone group. Fluoroquinolones. ATX code J01M A12.

Lebel Pharmacological properties
Pharmacodynamics.

Levofloxacin is a synthetic antibacterial agent from the group of fluoroquinolones, is 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 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).

Mechanism of resistance. Resistance to levofloxacin develops in a stepwise process due to mutations in the target site in both type II topoisomers, DNA gyrase and topoisomerase IV. Other mechanisms of resistance, such as the impermeable barrier (common in Pseudomonas aeruginosa) and the efflux mechanism, may also affect sensitivity to levofloxacin.

Due to the mechanism of action, there is usually no cross-resistance between levofloxacin and other classes of antibacterial agents.

Checkpoints. The MIC control points for levofloxacin recommended by the European Antimicrobial Susceptibility Testing Committee (EUCAST), which separate sensitive microorganisms from moderately susceptible microorganisms and moderately susceptible microorganisms from resistant microorganisms, are presented in the table below.

Indication
Levofloxacin is indicated for the treatment in adults of the following infections caused by levofloxacin-sensitive microorganisms:

acute bacterial sinusitis;
exacerbation of chronic obstructive pulmonary disease, including bronchitis;
community-acquired pneumonia;
complicated skin and soft tissue infections;
uncomplicated cystitis
(in the case of treatment of the above infections, the drug can be used only when the use of other antibacterial agents, which are usually prescribed for the initial treatment of these infections, is not possible);

acute pyelonephritis and complicated urinary tract infections;
chronic bacterial prostatitis;
pulmonary form of anthrax: post-exposure prophylaxis and treatment.
Levofloxacin in this dosage form (tablets) can be used to complete the course of therapy in patients who have shown improvement during the initial treatment with levofloxacin, solution for infusion.

Formal recommendations for the proper use of antibacterial agents should be considered.

Contraindication
Hypersensitivity to levofloxacin, other fluoroquinolones or to any component of the drug; epilepsy; tendon damage after previous use of fluoroquinolones; children’s age; period of pregnancy or breastfeeding.