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. Treatment time The duration of therapy varies according to the course of the disease (see table below).

As with antibiotic therapy in general, administration of Levofloxacin Tablets should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

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 (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 500 mg once daily 8 weeks Special Populations Impaired renal function (creatinine clearance ≤ 50 ml/min) Dosage regimenCreatinine clearance 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/24h 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 dosage 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 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), 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). 4). Other undesirable effects which have been associated with fluoroquinolone administration include: • attacks of porphyria in patients with porphyria.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

8). 3). Aortic aneurysm and dissection, and heart valve regurgitation/incompetence Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones.

8). Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease or congenital heart valve disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection or heart valve disease, or in presence of other risk factors or conditions predisposing.

g. g. g. infective endocarditis). The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids. In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

Patients should be advised to seek immediate medical attention in case of acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities.

Risks of resistance:

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 in 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.

Tendinitis and tendon rupture Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.

The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, in patients receiving daily doses of 1000 mg, and those treated concurrently with corticosteroids.

Therefore, concomitant use of corticosteroids should be avoided. g. painful swelling, inflammation) the treatment with levofloxacin should be discontinued and alternative treatment should be considered. g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.

8). The risk of myoclonus is increased in older patients, and in patients with renal impairment if the dose of levofloxacin is not adjusted as per the creatinine clearance. Levofloxacin should be discontinued immediately at the first occurrence of myoclonus and appropriate treatment should be initiated.

Clostridium difficile-associated disease Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with Levofloxacin (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD).

8). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with levofloxacin. If CDAD is suspected or confirmed, levofloxacin Tablets should be stopped immediately and appropriate treatment initiated without delay.

Medicinal products inhibiting the peristalsis are contraindicated in this clinical situation. Patients predisposed to seizures Quinolones may lower the seizure threshold and may trigger seizures. 5). In case of convulsive seizures (see section […]

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.