Levolet coated tablets 750 mg. №10

Description

LEVOLET COMPOSITION
active substance: levofloxacin

1 coated tablet contains levofloxacin 250 mg or 500 mg, or 750 mg as levofloxacin hemihydrate

Excipients: microcrystalline cellulose, corn starch, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, Opadry white OY58900 (hypromellose, titanium dioxide (E 171), polyethylene glycols).

LEVOLET DOSAGE FORM
Film-coated tablets.

LEVOLET MAIN PHYSICAL AND CHEMICAL PROPERTIES

white capsule-like biconvex coated tablets, smooth on both sides (750 mg tablets).

LEVOLET PHARMACOLOGICAL GROUP
Antibacterial agents of the quinolone group. Fluoroquinolones. ATX code J01M A12.

PHARMACOLOGICAL PROPERTIES
Pharmacological.

Microorganisms sensitive to the drug

Gram-positive aerobes Enterococcus faecalis, Staphylococcus aureus methi-S, Streptococci group C, G, Streptococcus agalactiae, Streptococcus pneumoniae peni I / S / R, Streptococcus pyogenes.

Anaerobes: Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus.

Others: Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae, Ureaplasma, H. pylori.

Microorganisms that are not permanently sensitive to the drug

Gram-positive aerobes Staphylococcus aureus methi-R.

Gram-negative aerobes Burkholderia cepacia.

Anaerobes: Bacteroides ovatus, Bacteroides thetaiiotamicron, Bacteroides vulgaris, Clostridium difficile.

Microorganisms resistant to the drug

Gram-positive aerobes Staphylococcus aureus methi-R, Staphylococcus coagulase negative methi-S (1).

Like other fluoroquinolones, levofloxacin is inactive against spirochetes.

Pharmacokinetics.

Suction.

Orally administered levofloxacin is rapidly and almost completely absorbed. The peak plasma concentration is reached 1:00 after ingestion. Bioavailability is almost 100%. Levofloxacin is subject to linear pharmacokinetics in the range of 50 mg to 600 mg. Food intake has some effect on its absorption.

Distribution.

About 30-40% of levofloxacin binds to serum protein. The cumulative effect of levofloxacin at a dosage of 500 mg once a day has no clinical significance and can be disregarded. There is an insignificant, but supposed, its cumulation at a dosage of 500 mg 2 times a day. Stable distribution rates are achieved within 3 days.

Distribution in tissues and body fluids.

Distribution in the bronchial mucosa and secretions of the bronchial epithelium.

The maximum concentration of levofloxacin in the bronchial mucosa and the secretion of the bronchial epithelium at an oral dose of 500 mg was 8.3 and 10.8 μg / ml, respectively.

Distribution into lung tissue.

The maximum concentration of levofloxacin in the lung tissue at an oral dose of 500 mg was approximately 11.3 μg / ml and was reached within 4-6 hours after administration. The concentration in the lungs constantly exceeded that in the blood plasma.