Compositon/Ingredients: Levofloxacin

• Pyelonephritis.
• Complicated urinary tract infections pyelonephritis.
• Uncomplicated urinary tract infections.
• Chronic bacterial prostatitis.
• Community-acquired pneumonia.
• Acute bacterial exacerbations of chronic bronchitis.
• Acute bacterial sinusitis.
• Skin and soft tissue infections.

• In patients hypersensitive to levofloxacin or other quinolones or any of the excipients.
• In patients with epilepsy.
• Patients with known G6PD deficiency.
• In patients with history of tendon disorders related to fluoroquinolone administration.
• Children under 18 years of age.
• Pregnancy and lactation.

• Pyelonephritis: 500mg once daily, 7 – 10 days. Renal impairment: Clcr ≥ 20ml/min: start with 250mg, maintenance dosage 250mg every 24 hours; Clcr = 10 – 19ml/min: start with 250mg, maintenance dosage 250mg every 48 hours.
• Complicated urinary tract infections pyelonephritis: 500mg once daily, 7 – 14 days. Renal impairment: Clcr ≥ 20ml/min: start with 250mg, maintenance dosage 250 mg every 24 hours; Clcr = 10 – 19ml/min: start with 250mg, maintenance dosage 250mg every 48 hours.
• Uncomplicated urinary tract infections: 250mg once daily, 3 days.
• Chronic bacterial prostatitis: 500mg once daily, 28 days.
• Community-acquired pneumonia: 500mg once or twice daily, 7 – 14 days.
• Acute bacterial exacerbations of chronic bronchitis: 500mg once daily, 7 – 10 days.
• Acute bacterial sinusitis: 500mg once daily, 10 – 14 days.
• Skin and soft tissue infections: 500mg once or twice daily, 7 – 14 days.

Dosage for other indications in patients with impaired renal function:

• Clcr = 20 – 49ml/min: start with 500mg, maintenance dosage 250mg every 24 hours.
• Clcr = 10 – 19ml/min: start with 500mg, maintenance dosage 125mg every 24 hours.
• Patients with hemodialysis and continuous peritoneal dialysis: start with 500mg, maintenance dosage 125mg every 24 hours.

Avoid the use of fluoroquinolones in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones. Discontinue this medicine immediately at the first signs or symptoms of any serious adverse reactions.

Treatment with levofloxacin must be halted immediately if:

• There are first signs of hypersensitivity reactions.
• Tendinitis is suspected (the risk of tendinitis and tendon rupture is increased in the elderly, in patients using corticosteroids and in patients receiving daily dose of 1000mg).
• The adverse reaction effects on the central nervous system (CNS) (such as mental disorder, increased intracranial pressure, CNS stimulation, which may lead to convulsions, tremor, restlessness, headache, insomnia, depression, confusion, hallucinations, nightmares, and, rarely, suicidal thoughts or acts.
• Pseudomembranous colitis is suspected (symptoms: diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin).

Extreme caution should be exercised when use levofloxacin for:

• Patients with myasthenia.
• Patients with G6DP deficiency.
• Patients predisposed to seizures (such as patients with pre-existing central nervous system lesions).
• Patients with known or suspected CNS disorders e.g. seizures, cerebral arteriosclerosis
• Diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glibenclamide) or with insulin. Careful monitoring of blood glucose is recommended.
• Patients with known risk factors for prolongation of the QT interval: Congenital long QT syndrome, concomitant use of class IA and III antiarrhythmic, tricyclic antidepressants, macrolides), uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesaemia), elderly, cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).

Patients should avoid direct exposure to sunlight during treatment and 48 hours following treatment.

Patients should be aware of how they react to drug before driving or operating machinery. Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient’s ability to concentrate and react.

Store at temperature below 30°C. Avoid direct sunlight and moisture.