Indicated for the treatment of adults (>18 years of age) with mild, moderate and severe infections due to levofloxacin-susceptible microorganisms: (a) acute bacterial sinusitis; (b) acute bacterial exacerbations of chronic bronchitis; (c) community acquired pneumonia; (d) complicated urinary tract infections including pyelonephritis; (e) chronic bacterial prostatitis; and (f) skin and soft tissue infections.

The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection. It may be taken on an empty stomach or with meals. The dosage should be determined according to the sensitivity of the causative organism and the severity of the infection. For patients with normal renal function (creatinine clearance >50 mL/min), the following daily dosages are recommended:

Acute bacterial exacerbations of chronic bronchitis: 500 mg for 7 days.
Nosocomial Pneumonia: 750 mg for 7-14 days.
Community-acquired Pneumonia: 500 mg for 7-14 days.
Acute Bacterial Sinusitis: 500 mg for 10-14 days.
Uncomplicated Skin and Skin Structure Infections: 500 mg for 7-10 days.
Complicated Skin and Skin Structure Infections: 750 mg for 7-14 days.
Chronic Bacterial Prostatitis: 500 mg for 28 days.
Uncomplicated Urinary Tract Infections: 500 mg for 3 days.
Complicated Urinary Tract Infections: 750 mg for 5 days.
Acute Pyelonephritis: 750 mg for 5 days.
Administration in renal impairment: Levofloxacin is administered with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced. In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance.

May be taken with or without food.

The use of LEVOFLOXACIN is contraindicated in: Previous hypersensitivity reaction to levofloxacin, other quinolones or any other ingredient; epilepsy; patients with history of tendon disorders associated with fluoroquinolone administration. Children or adolescents (under 18 years of age). Pregnancy and lactation.

THE SAFETY AND EFFICACY OF LEVOFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.
Caution should be exercised when using levofloxacin in patients: Prone to seizures, such as patients with pre-existing central nervous system lesions.
Being treated with fenbufen or non-steroidal anti-inflammatory medicines, using medicines which lower the cerebral seizure threshold, such as theophylline.
Driving or operating machinery, as the use of levofloxacin may alter the ability to drive or to operate machinery.
Being tested for tuberculosis as levofloxacin inhibit the growth of Mycobacterium tuberculosis and therefore may give false-negative results in the bacteriological diagnosis of tuberculosis.
Exposed to ultraviolet light such as sunlight through window glass or longer wavelength ultraviolet (UVA) from sunbeds, in order to prevent photosensitization.

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