Leflok coated tablets 500 mg. №5

Description

Leflok tablets Composition
active substance: levofloxacin;

1 tablet contains: levofloxacin hemihydrate in terms of levofloxicin 250 mg or 500 mg;

excipients: microcrystalline cellulose, crospovidone, povidone, talc, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 4000, sunset yellow FCF (E 110).

Leflok tablets Dosage form
Film-coated tablets.

Basic physical and chemical properties:

tablets of 500 mg: oblong-shaped, film-coated tablets, light pink, with a biconvex surface, with a line.

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

Leflok tablets Pharmacodynamics
Levofloxacin, a synthetic antibacterial agent of the fluoroquinolone group, is the S-enantiomer of the racemic mixture of the drug ofloxacin.

Mechanism of action

As an antibacterial agent from the group of fluoroquinolones, levofloxacin acts on the DNA-DNA gyrase complex and topoisomerase IV.

Pharmacokinetics / pharmacodynamics 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 (suppressive) concentration (MIC (MIC)).

The mechanism of resistance. The main mechanism of resistance is a consequence of a mutation in the gyr-A genes. In vitro cross-resistance exists between levofloxacin and other fluoroquinolones. Due to its mechanism of action, there is usually no cross-resistance between levofloxacin and other classes of antibacterial agents.

The recommended European Committee for Antimicrobial Susceptibility Testing (EUCAST) MIC cut-off values ​​for levofloxacin, which separate susceptible organisms from organisms intermediate-susceptible (moderately resistant) and intermediate-susceptible from resistant organisms, are presented in the MIC test table below (mg / L).

Indications
Infectious and inflammatory diseases of mild and moderate severity caused by microorganisms sensitive to the drug: acute sinusitis, exacerbations of chronic bronchitis, pneumonia, complicated and uncomplicated infections of the urinary tract (including pyelonephritis), infections of the skin and soft tissues, chronic bacterial prostatitis.

Contraindications
Hypersensitivity to levofloxacin, other quinolones or any of the excipients. Epilepsy. The presence of complaints of adverse reactions from the tendons after the preliminary use of quinolones.