Levox-500 coated tablets 500 mg. №10

Description

Levox Storage
active substance: levofloxacin;

1 tablet contains levofloxacin hemihydrate equivalent to levofloxacin anhydrous 500 mg or 750 mg;

Excipients: microcrystalline cellulose, hypromellose, croscarmellose sodium, crospovidone, colloidal anhydrous silica, purified talc, magnesium stearate, shell (coating Colorcoat FC4S-H (White), polyethylene glycol 6000, hypromellose (dipromeoxy), titanium).

Levox Dosage form
Film-coated tablets.

Levox Basic physical and chemical properties:

tablets of 500 mg: capsule-shaped, film-coated, with a line on one side, marked “500” on the other, white or almost white;

750 mg tablets: capsule-shaped, film-coated, scored on one side, marked “750” on the other, white or almost white.

Levox Pharmacotherapeutic group
Antibacterial agents for systemic use of quinolones, fluoroquinolones.

ATX code J01M A 12.

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.

As an antibacterial drug from the group of fluoroquinolones, levofloxacin 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).

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.

Absorption

Levofloxacin is rapidly and almost completely absorbed when taken orally, with peak plasma concentrations reached within 1 hour. The absolute bioavailability is approximately 100%.

Food has almost no effect on the absorption of levofloxacin.

Distribution

Approximately 30-40% of levofloxacin is bound to serum protein. The cumulative effect of levofloxacin with repeated use of 500 mg 1 time per day is almost absent. There is a small but predictable cumulative effect after doses of 500 mg twice daily. Stable state is reached within 3 days.

Penetration into tissues and body fluids

Penetration into the bronchial mucosa, bronchial secretion of lung tissue (BSTL)

The maximum concentration of levofloxacin in the bronchial mucosa and bronchial lung secretion after oral administration of 500 mg was 8.3 μg / g and 10.8 μg / ml, respectively. These values ​​were achieved within 1 hour after taking the drug.