LEVOFLOXACIN

Levofloxacin 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 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 tablets:

Dosage in patients with normal renal function (creatinine clearance > 50 ml/min) Indication Daily dose regimen Duration of treatment (according to severity) (according to severity) Acute bacterial sinusitis 500 mg once daily 10 - 14 days Acute bacterial exacerbations of chronic bronchitis 500 mg once daily 7 - 10 days Community-acquired pneumonia 500 mg once or twice daily 7 - 14 days Pyelonephritis 500 mg once daily 7-10 days Complicated urinary tract infections 500mg 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. 4 “Tendinitis and tendon rupture” and “QT interval prolongation”).

3). Method of administration Levofloxacin 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.

5).

The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. g. g. g. 4). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression.

There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. The frequency of these prolonged, disabling and potentially irreversible serious drug reactions cannot be estimated with precision using available data, but the reporting incidence from adverse drug reaction reports indicates the frequency is at minimum between 1/1,000 and 1/10,000 (corresponding to the Rare frequency category).

4). Other undesirable effects which have been associated with fluoroquinolone administration include: • attacks of […]

8). 3) Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).

Levofloxacin may be used in the treatment of Acute Bacterial Sinusitis and Acute Exacerbation of Chronic bronchitis when these infections have been adequately diagnosed. Resistance to fluoroquinolones of E. coli – the most common pathogen involved in urinary tract infections – varies across the European Union.

Prescribers are advised to take into account the local prevalence of resistance of E. coli to fluoroquinolones.

Inhalation Anthrax:

Use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

Prolonged, disabling and potentially irreversible serious adverse drug reactions Cases of prolonged (continuing for months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (including musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.

There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. Levofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice, so that symptoms can be appropriately investigated and to avoid further exposure which could potentially worsen adverse reactions.

1, • in patients with epilepsy, • in patients with history of tendon disorders related to fluoroquinolone administration, • in children or growing adolescents, • during pregnancy, • in breast-feeding women.