L-Stafloxin 250

Rx

1. Complicated and uncomplicated skin and soft tissue infections.
2. Pyelonephritis.
3. Complicated and uncomplicated urinary tract infections pyelonephritis.
4. Chronic bacterial prostatitis.
5. Community-acquired pneumonia.
6. Acute bacterial exacerbations of chronic bronchitis.
7. Acute bacterial sinusitis.

Dosage:

L-Stafloxin 250 is used once or twice daily.

1. Complicated skin and soft tissue infections: 500 mg once or twice daily, 7 – 14 days; uncomplicated: 500 mg once daily, 7 – 10 days.
2. Inhalation anthrax: Post-exposure prophylaxis for Bacillus anthracis: 500 mg once daily, 8 weeks; Treatment: After intravenous therapy when the patients status allows, taking 500 mg once daily, 8 days.
3. Community-acquired pneumonia: 500 mg once or twice daily, 7 – 14 days.
4. Acute bacterial exacerbations of chronic bronchitis: 500 mg once daily, 7 – 10 days.
5. Acute bacterial sinusitis: 500 mg once daily, 10 – 14 days.
6. Pyelonephritis: 500 mg once daily, 7 – 10 days.
7. Chronic bacterial prostatitis: 500 mg once daily, 28 days.
8. Complicated urinary tract infections pyelonephritis: 500 mg once daily, 7 – 14 days; Uncomplicated: 250 mg once daily, 3 days.
9. Complicated cystitis: 250 mg once daily, 3 days.

Patients with impaired renal function:

• Clcr = 20 – 49 ml/min: start with normal dosage, maintenance with a half of the normal amount;
• Clcr = 10 – 19 ml/min: start with normal dosage, maintenance with a quarter of the normal amount. If initial dosage is 250 mg every 24 hours, the maintenance dosage is 125 mg every 48 hours;
• Clcr < 10 (including hemodialysis and continuous peritoneal dialysis):
  • Initial with 250 mg every 24 hours, maintenance with 125 mg every 48 hours;
  • Initial with 500 mg every 24 hours, maintenance with 125 mg every 24 hours;
  • Initial with 500 mg every 12 hours, maintenance with 125 mg every 24 hours.

Usage:

L-Stafloxin 250 is administered orally without regard to meals. It is not recommended to use antacid containing aluminium and magnesium, products containing heavy metals like iron and zinc,  sucralfate, didanosine within 2 hours before and after taking levofloxacin.

• 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.

• Disabling and potentially irreversible serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects.
• Common: Nausea, diarrhea; increased liver enzymes; insomnia, headache.
• Uncommon: Dizziness, nervous, agitation, anxiety; abdominal pain, flatulence, dyspepsia, vomiting, constipation; increased blood bilirubin; vaginitis, vaginal Candida infection; pruritus, eruption.

• 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 older than 65 years of age, in patients using corticosteroids).
  • 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.
  • Hypoglycemia.
• Extreme caution should be exercised when use levofloxacin for:
  • Patients with myasthenia.
  • Patients with known or suspected CNS disorders e.g. seizures, cerebral arteriosclerosis
  • 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).
  • Diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glibenclamide) or with insulin. Careful monitoring of blood glucose is recommended.
• 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.