AVELOX

Posology (adults) The recommended dose is one 400 mg film-coated tablet once daily. e. 2 for more details). 3). Other special populations No adjustment of dosage is required in the elderly and in patients with low bodyweight. Paediatric population Moxifloxacin is contraindicated in children and adolescents (< 18 years).

3). Method of administration The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals. Duration of administration Avelox 400 mg film-coated tablets should be used for the following treatment durations: - Acute exacerbation of chronic obstructive pulmonary disease including bronchitis 5 - 10 days - Community acquired pneumonia 10 days - Acute bacterial sinusitis 7 days - Mild to moderate pelvic inflammatory disease 14 days Avelox 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.

Sequential (intravenous followed by oral) therapy In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin structure infections).

The recommended total duration of intravenous and oral treatment is 7 -14 days for community-acquired pneumonia and 7 - 21 days for complicated skin and skin structure infections The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.

Adverse reactions based on all clinical trials and derived from post-marketing reports with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed below: Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. 4) Anaphylaxis incl. 4) Allergic oedema / angiooedema (incl. 4) System Organ Class (MedDRA) Common Uncommon Rare Very Rare Not known Nervous system disorders* Headache Dizziness Par- and Dysaesthesia Taste disorders (incl.

ageusia in very rare cases) Confusion and disorientation Sleep disorders (predominantly insomnia) Tremor Vertigo Somnolence Hypoaesthesia Smell disorders (incl. anosmia) Abnormal dreams Disturbed coordination (incl. gait disturbances, esp.

due to dizziness or vertigo) Seizures incl. 4) Disturbed attention Speech disorders Amnesia Peripheral neuropathy and polyneuropathy Hyperaesthesia Eye disorders* Visual disturbances incl. 4) Ear and labyrinth disorders* Tinnitus Hearing impairment incl.

4) Vascular disorders** Vasodilatation Hypertension Hypotension Vasculitis Respiratory, thoracic and mediastinal disorders Dyspnea (including asthmatic conditions) System Organ Class (MedDRA) Common Uncommon Rare Very Rare Not known Gastrointestinal disorders Nausea Vomiting Gastrointestinal and abdominal pains Diarrhoea Decreased appetite and food intake Constipation Dyspepsia Flatulence Gastritis Increased amylase Dysphagia Stomatitis Antibiotic associated colitis (incl.

4) Hepatobiliary disorders Increase in transaminases Hepatic impairment (incl. LDH increase) Increased bilirubin Increased gamma- glutamyl- transferase Increase in blood alkaline phosphatase Jaundice Hepatitis (predominantly cholestatic) Fulminant hepatitis potentially leading to life- threatening liver failure (incl.

8). 3). The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section. 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. Moxifloxacin 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.

Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients. 4% compared to baseline. As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications.

Elderly patients may also be more susceptible to drug-associated effects on the QT interval. 5). Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.

3). The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded. If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.

1. 6). - Patients below 18 years of age. - Patients with a history of tendon disease/disorder related to quinolone treatment. Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation.

5). Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.