LEVOFLOXACIN 250

LEVOFLOXACIN 250
Packing10 blister packs of 10 tablets
Shelf life36 months
CompositionLevofloxacin 250 mg
Posology and pharmaceutical formFilm-coated tablet

Summary of product characteristic

Indications, posology and method of administration

THERAPEUTIC INDICATIONS
In adults, levofloxacin are indicated for the treatment of the following infections:

Acute pyelonephritis and complicated urinary tract infections.
Chronic bacterial prostatitis.
Inhalation anthrax: postexposure prophylaxis and curative treatment.
Uncomplicated cystitis.

Due to fluoroquinolone antibiotics, including levofloxacin, being associated with serious adverse reactions and uncomplicated urinary tract infections (cystitis) in some patients which may resolve on their own, levofloxacin should only be used in patients who have no alternative treatment options.
For the infections mentioned below, levofloxacin should only be prescribed when the antibiotics typically recommended for initial treatment of these infections are not suitable for use.

Complicated skin and soft tissue infections.
Community-acquired pneumonia.
Acute exacerbation of chronic obstructive pulmonary disease including bronchitis.
Acute bacterial sinusitis.

Due to the fluoroquinolone antibiotics, including levofloxacin, being associated with serious adverse reactions and the acute infection episodes of chronic bronchitis and acute bacterial sinusitis, which may resolve on their own in some patients, levofloxacin should only be used in patients who have no alternative treatment options.
The drug may be used to complete the treatment course in patients who show improvement after initial treatment with intravenous levofloxacin.
Consult official guidelines on the appropriate use of antibiotics.
POSOLOGY AND METHOD OF ADMINISTRATION
Levofloxacin are administered once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen.
Duration of treatment:
The duration of treatment may vary depending on the underlying cause of the disease. Similar to standard antibiotic therapy, levofloxacin should be continued for at least 48 – 72 hours after the patient is afebrile or there is evidence that the bacteria have been eradicated. The following dose recommendations can be given for levofloxacin:
Dosage in patients with normal renal function (creatinine clearance > 50ml / min):

*Indication*	*Daily dose regimen* *(according to severity)*	*Duration of treatment (according to severity)*
Complicated urinary tract infections	500 mg once daily	7 – 14 days
Pyelonephritis	500 mg once daily	7 – 10 days
Chronic bacterial prostatitis	500 mg once daily	28 days
Inhalation anthrax	500 mg once daily	8 weeks
Complicated skin and soft tissue infections	500 mg once or twice daily	7 – 14 days
Community-acquired pneumonia	500 mg once or twice daily	7 – 14 days
Uncomplicated cystitis	250 mg once daily	3 days
Acute bacterial exacerbations of chronic bronchitis	500 mg once daily	7 – 10 days
Acute bacterial sinusitis	500 mg once daily	10 – 14 days

Special populations:
Impaired renal function (creatinine clearance ≤ 50 ml / min)

*Creatinine clearance*	*Dose regimen*
	250 mg/24 h	500 mg/24 h	500 mg/12 h
	First dose: 250 mg	First dose: 500 mg	First dose: 500 mg
50 – 20 ml/min	Then: 125 mg/24 h	Then: 250mg/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 dosage 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 dosage is required in the elderly, other than that imposed by consideration of renal function.
Paediatric population:
Levofloxacin is contraindicated in children and growing adolescents (less than 18 years of age).
Method of administration:
Levofloxacin tablets should be swallowed without crushing and with sufficient amount of liquid. The tablets may be taken during meals or between meals. Levofloxacin 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.
CONTRAINDICATIONS
Levofloxacin must not be used:

Hypersensitive to levofloxacin or other quinolones or to any of the excipients.
Patients with epilepsy.
Patients with history of tendon disorders related to fluoroquinolone administration.
Children or growing adolescents.
Pregnancy and breast-feeding women.

This information is for reference only. Please read the leaflet inside.

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