MOXIDOX

Posology 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 Moxidox 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 Moxidox 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 Moxidox 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 Moxidox 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 / angioedema (incl. 4) Nervous system disorders* Headache Dizziness Par- and Dysaesthesia Taste disorders (incl.

ageusia in very rare cases) Confusion and disorientation Sleep disorders (predominantl y insomnia) Hypoaesthes ia Smell disorders (incl. anosmia) Abnormal dreams Disturbed coordination (incl. gait disturbances , esp. due to Hyperaesthesia System Organ Class (MedDRA) Common Uncommon Rare Very Rare Not known Tremor Vertigo Somnolence dizziness or vertigo) Seizures incl.

4) Disturbed attention Speech disorders Amnesia Peripheral neuropathy and polyneuropa thy Eye disorders* Visual disturbances incl. 7) Ear and labyrinth disorders * Tinnitus Hearing impairment incl. e. 4) Vascular disorders ** Vasodilatation Hypertensio n Hypotension Vasculitis Respiratory, thoracic and mediastinal disorders Dyspnoea (including asthmatic conditions) System Organ Class (MedDRA) Common Uncommon Rare Very Rare Not known Gastrointestinal disorders Nausea Vomiting Gastrointestina l 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 (predominan tly cholestatic) Fulminant hepatitis potentially leading to life- threatening liver failure (incl.

8). 3). The benefit of Moxidox treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section. 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. Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions Moxidox 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). Moxidox should be used with caution in patients with ongoing pro-arrhythmic 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 Moxidox, 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, Moxidox is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5-fold ULN.