| Application: | Internal Medicine |
|---|---|
| Usage Mode: | For oral administration |
| Suitable for: | Elderly, Children, Adult |
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Levofloxacin 500mg Film-coated Tablets is indicated in adults for the treatment of the following infections:
• Acute bacterial sinusitis
• Uncomplicated cystitis
• Acute exacerbation of chronic obstructive pulmonary disease including bronchitis
• Complicated skin and soft tissue infections/complicated skin and skin structure infections
For the above-mentioned infections Levofloxacin 500mg Film-coated Tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
• Acute pyelonephritis and complicated urinary tract infections
• Chronic bacterial prostatitis
• Community-acquired pneumonia
• 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.
Posology
The following dose recommendations can be given for Levofloxacin 500mg Film-coated Tablets:
Dosage in patients with normal renal function
(creatinine clearance >50 ml/min)
|
Indication |
Daily dose regimen (according to severity) |
Duration of treatment (according to severity) |
|
Acute bacterial sinusitis |
500 mg once daily |
10 - 14 days |
|
Acute bacterial exacerbations of chronic obstructive pulmonary disease including bronchitis |
500 mg once daily |
7 - 10 days |
|
Community-acquired pneumonia |
500 mg once or twice daily |
7 - 14 days |
|
Acute pyelonephritis |
500 mg once daily |
7 - 10 days |
|
Complicated urinary tract infections |
500 mg once daily |
7 - 14 days |
|
Uncomplicated cystitis |
250 mg once daily |
3 days |
|
Chronic bacterial prostatitis |
500 mg once daily |
28 days |
|
Complicated skin and soft tissue infections |
500 mg once or twice daily |
7 - 14 days |
|
Inhalation Anthrax |
500mg once daily |
8 weeks |
Special populations
Impaired renal function
(creatinine clearance ≤50ml/min)
|
|
Dose regimen |
||
|
|
250 mg / 24 h |
500 mg / 24 h |
500 mg / 12 h |
|
Creatinine clearance |
first dose: 250 mg |
first dose: 500 mg |
first dose: 500 mg |
|
50-20 ml/min |
then: 125 mg / 24 h |
then: 250 mg / 24 h |
then: 250 mg / 12 h |
|
19-10 ml/min |
then: 125 mg / 48 h |
then: 125 mg / 24 h |
then: 125 mg / 12 h |
|
<10 ml/min (including haemodialysis and CAPD) 1 |
then: 125 mg / 48 h |
then: 125 mg / 24 h |
then: 125 mg / 24 h |
1 No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Impaired liver function
No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population
No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function.
Paediatric population
Levofloxacin 500mg Film-coated Tablets is contraindicated in children and growing adolescents.
Method of administration
Levofloxacin 500mg Film-coated Tablets tablets should be swallowed without crushing and with sufficient amount of liquid. They may be divided at the score line to adapt the dose. The tablets may be taken during meals or between meals. Levofloxacin 500mg Film-coated Tablets tablets should be taken at least two hours before or after iron salts, zinc salts, magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents), and sucralfate administration, since reduction of absorption can occur.
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