Levaxela coated tablets 500 mg. №5

Description

Levaxela Composition:

active substance:
levofloxacin;

1 tablet contains levofloxacin 250 mg or 500 mg in the form of levofloxacin hemihydrate;

excipients: microcrystalline cellulose, hydroxypropylcellulose, crospovidone (type A), magnesium stearate;

shell: hypromellose, titanium dioxide, macrogol 4000, yellow FCF (E 110), indigo carmine, iron oxide red, iron oxide yellow – only for 500 mg.

Levaxela Dosage form
Film-coated tablets.

Levaxela Basic physical and chemical properties:

250 mg tablets: pink, oblong, biconvex tablets with a line;

500 mg tablets: orange, oblong, biconvex tablets with a line.

Levaxela Pharmacotherapeutic group
Antibacterial agents for systemic use. Fluoroquinolones. Levofloxacin.

ATC code J01M A12.

Pharmacological properties
Pharmacodynamics

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 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. The main mechanism of resistance is due to mutations in genes
gyr-A.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.

Checkpoints

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 M / I test.

Indication.

Infections caused by drug-sensitive microorganisms:

– acute bacterial sinusitis;

– exacerbation of chronic bronchitis;

– community-acquired pneumonia;

– complicated skin and soft tissue infections;

For the treatment of the above infections, Levaxel® should be used only when it is considered inappropriate to use antibacterial agents, which are usually recommended for the initial treatment of these infections.

– complicated (including pyelonephritis) and uncomplicated (including cystitis) urinary tract infections;

– chronic bacterial prostatitis;

– pulmonary form of anthrax: prevention after contact and treatment.

Contraindication.

– Hypersensitivity to levofloxacin, other fluoroquinolones or to any ingredient of the drug;

– epilepsy;

– tendon damage associated with the use of fluoroquinolones;

– children’s age;

– pregnancy and breastfeeding.