Description

Composition
Each film-coated caplet contains levofloxacin hemihydrate 512.5 mg equivalent to levofloxacin 500 mg.

Pharmacology
Levofloxacin, is the optical S-(-) isomer of ofloxacin. It has a wide spectrum antibacterial effect against gram positive and
gram negative bacteria, including anaerobes. Moreover, levofloxacin has shown antibacterial activity against Chlamydia
pneumoniae & Mycoplasma pneumoniae. The main mechanism of action is through the inhibition of DNA gyrase, a type II
topoisomerase, resulting in inhibition of bacterial DNA replication and transcription.

Microbiology
Levofloxacin  is active against these microorganisms ( in-vitro and  clinical infection ) :
Gram positive aerob : Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus
pyogenes.
Gram negative aerob : Enterobacter cloacae, E. coli, H. influenzae and para – influenzae,
Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa.
Other microorganism : Chlamydia pneumoniae, Mycoplasma  pneumonia

Pharmacokinetic
Levofloxacin is rapidly and completely absorbed after oral administration. Peak plasma concentration is usually attained 1 – 2
hours after oral dosing .  The absolute bioavailability of a 500 mg oral dose of levofloxacin is approximately 99 %.
Levofloxacin  is widely distributed throughout the body in high concentration. Levofloxacin also penetrates well into lung tissue.
Lung tissue concentrations were generally 2 to 3 fold higher than plasma concentrations and range from approximately  2.4 –
11.3 µg/g over a 24-hour period  after a single 500 mg oral dose.

Clearance of levofloxacin is reduced and plasma elimination half life is prolonged in patients with impaired renal function (
creatinine clearance < 80 ml / minute ), requiring dosage adjustment in such patients to avoid accumulation. The majority of
the drug is not metabolized in the body. About 85 % of the administered dose is excreted in urine as an unchanged form.

Indications
Infections caused by susceptible microorganisms e.g. :
acute maxillary sinusitis
acute bacterial exacerbations of chronic bronchitis
community acquired pneumonia
uncomplicated skin and skin structure infections
complicated urinary tract infections
acute pyelonephritis

Contra indications
Patients with hypersensitivity to levofloxacin
Pregnancy and nursing mothers
Adolescents < 18 years

Dosage
LECRAV ® 500 film-coated caplet could be taken with or without food, it’d better to take it with a lot of water.

Adults  :  250 – 500 mg (oral), once daily for 7 – 14 days depending on the severity of the disease (for patients with
normal renal function, creatinine clearance > 80 ml / minute) .
Patients with impaired renal function and chronic bronchitis with acute exacerbation, or community acquired pneumonia,
or acute maxillary sinusitis, or skin and skin structure infection.
Patients with impaired renal function and complicated urinary tract infection , or acute pyelonephritis .