MOXIFLOXACIN

Posology The recommended dose is 400 mg moxifloxacin, infused once daily. Initial intravenous treatment may be followed by oral treatment with moxifloxacin 400 mg tablets, when clinically indicated. In clinical studies most patients switched to oral therapy within 4 days (CAP) or 6 days (cSSSI).

The recommended total duration of intravenous and oral treatment is 7 - 14 days for CAP and 7 - 21 days for cSSSI. 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 growing adolescents. 3). 4). 6).

Adverse reactions observed in clinical trials and derived from post-marketing reports with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [IV/oral] and oral administration) 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 / angioedema (incl. 4) 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) 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 Jaundice Hepatitis (predominantly cholestatic) Fulminant hepatitis potentially leading to life- threatening liver failure (incl.

8). 3). 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.

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). 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. 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.

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. The magnitude of QT prolongation may increase with increasing plasma concentrations due to rapid intravenous infusion.

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.