Levofloxacin (levofloxacinum) coated tablets 500 mg. №14


Manufacturer: Ukraine

Assign to adults for the treatment of infections caused by microorganisms sensitive to the drug: community-acquired pneumonia; complicated skin and soft tissue infections; (For the above-mentioned infections, Levofloxacin should only be used when the use of other antibacterial agents that are usually recommended for the initial treatment of these infections is impractical or impossible); pyelonephritis, complicated urinary tract infections; chronic bacterial prostatitis.



Levofloxacin coated Storage:

active substance: levofloxacin;

1 tablet contains levofloxacin 250 mg or 500 mg;

Excipients: crospovidone, microcrystalline cellulose, sodium stearyl fumarate, SeleCoatTM coating (hypromellose, polyethylene glycol 6000, titanium dioxide (E 171)).

Levofloxacin coated Dosage form

Coated tablets.

Main physical and chemical properties: oval tablets with a biconvex surface, coated with a white coating.

Levofloxacin coated Pharmacotherapeutic group

Antibacterial agents for systemic use. Fluoroquinolones.

ATX code J01M A12.

Levofloxacin coated Pharmacological properties


Levofloxacin-Astrapharm is a broad-spectrum quinolone antibiotic containing the active substance levofloxacin. Levofloxacin, like other fluorinated quinolones, blocks bacterial DNA gyrase, disrupting bacterial DNA function. Levofloxacin is active against gram-positive and gram-negative pathogens, including strains resistant to penicillins, cephalosporins and / or aminoglycosides. The development of resistance can significantly affect the sensitivity of the drug to local strains, so when prescribing the drug, it is desirable to take into account this information, especially in the treatment of severe infections. Levofloxacin has a broad spectrum of action against microorganisms both in vitro and in vivo: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiaeterobacterium, Virid sakazakii, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumopnia, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulgaris, Providencia rettgeri et stuartii, Serratia marcescens, Clostridium perfringens.

Like other fluoroquinolones, levofloxacin is inactive against spirochetes.


When administered orally, levofloxacin is rapidly and almost completely absorbed. The peak of its concentration in blood plasma is observed in 1 hour after application. Absolute bioavailability – almost 100%. Levofloxacin is subject to linear pharmacokinetics in the range of 50-600 mg. Eating has some effect on the absorption of the drug.

Approximately 30-40% of levofloxacin is bound to serum protein. The cumulative effect of levofloxacin at a dosage of 500 mg 1 time per day has no clinical significance. There is a small but expected accumulation at a dosage of 500 mg 2 times a day. Stable distribution rates are achieved within 3 days.

The maximum concentration of levofloxacin in the bronchial mucosa and bronchial epithelial secretion at doses above 500 mg per os was 8.3 and 10.8 mg / ml, respectively.

The maximum concentration of levofloxacin in lung tissue at a dose of more than 500 mg per os was approximately 11.3 mg / ml and was reached within 4-6 hours after administration. The concentration in the lungs consistently exceeded that in blood plasma.

The maximum concentration of levofloxacin in the blister fluid after administration of 500 mg 1-2 times a day was 6.7 mg / ml, respectively.

Levofloxacin does not get well into the cerebrospinal fluid.

Following oral administration of 500 mg levofloxacin once daily for 3 days, mean prostate tissue concentrations were 8.7 mg / g, 8.2 mg / g, and 2 mg / g at 2, 6, and 24 hours, respectively; the average ratio of concentration in the prostate / plasma is 1.84.

The mean concentration of levofloxacin for 8-12 hours after a single dose of 150 mg or 300 mg or 500 mg per os was 44 mg / ml, 91 mg / ml and 200 mg / ml, respectively.