LEVOFLOXACIN 500MG TABLETS

Name of the medicinal product:

Levofloxacin 500mg Film-coated Tablets

Qualitative and quantitative composition:

Each film-coated tablet contains Levofloxacin Hemihydrate USP equivalent to anhydrous levofloxacin 500mg.

Therapeutic indications:

Levofloxacin 500mg Film-coated Tablets is indicated in adults for the treatment of the following infections:

• Acute bacterial sinusitis
• Acute exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Complicated skin and soft tissue infections For the above-mentioned infections Levofloxacin 500mg Film-coated Tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
• Pyelonephritis and complicated urinary tract infections.
• Chronic bacterial prostatitis
• Uncomplicated cystitis
• Inhalation Anthrax: post exposure prophylaxis and curative treatment
• Levofloxacin 500mg Film-coated Tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration:

Levofloxacin 500mg Film-coated Tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Levofloxacin 500mg Film-coated Tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin; given the bioequivalence of the parenteral and oral forms, the same dosage can be used.