AVELOX

What it is

Moxifloxacin is an 8-methoxyfluoroquinolone antibiotic with a broad spectrum of activity and bactericidal action. The bactericidal action results from the inhibition of topoisomerase II or DNA gyrase and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination. Each film coated tablet contains 400 mg moxifloxacin (as hydrochloride monohydrate).

Approved indications

AVELOX is indicated for the treatment of adults with infections caused by susceptible organisms in the conditions: — acute bacterial sinusitis — community acquired pneumonia — acute exacerbations of chronic bronchitis

Dosing overview

The usual dose of moxifloxacin is 400 mg orally every 24 hours. The duration of therapy depends on the type of infection: acute bacterial sinusitis requires 10 days of oral therapy; acute bacterial exacerbations of chronic bronchitis require 5 days; and community acquired pneumonia requires 10 days of oral therapy or 7–14 days of sequential intravenous/oral therapy. Oral doses should be administered at least two hours before or four hours after antacids containing magnesium or aluminium, products containing iron or multivitamins containing zinc. The film coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.

Key safety warnings

Fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include serious adverse reactions involving the nervous system, the musculoskeletal system and psychiatric effects. Moxifloxacin is an inhibitor of the delayed rectifier potassium current of the heart and has been shown to prolong the QTc interval in some patients. The magnitude of this effect may increase with increasing concentrations of the drug. QTc prolongation may lead to an increased risk for ventricular arrhythmias (including torsade de pointes) and cardiac arrest. Tendonitis and tendon rupture (predominantly Achilles tendon), sometimes bilateral, that required surgical repair or resulted in prolonged disability have been reported with quinolone therapy including moxifloxacin. This may occur even within the first 48 hours of treatment, and cases occurring up to several months after completion of therapy have been reported. The risk of tendinopathy may be increased in elderly patients, during strenuous physical activity, in patients treated concomitantly with corticosteroids, in patients with renal impairment and in patients with solid organ transplants. Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias or weakness have been reported in patients receiving quinolones including moxifloxacin. Moxifloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness and/or weakness, in order to prevent the development of an irreversible condition. Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of psychiatric adverse reactions including toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations or paranoia; depression, or self-injurious behaviour such as attempted or completed suicide; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These reactions may occur following the first dose.

Contraindications

AVELOX is contraindicated in patients with known hypersensitivity to moxifloxacin, any other quinolones or to any of the excipients in this medicine. Because of an effect of moxifloxacin on the QTc interval of the electrocardiogram and a lack of clinical experience with the drug in the following patient populations, the drug is contraindicated in patients with known prolongation of the QTc interval, patients with uncorrected hypokalaemia and patients receiving Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic agents. The use of moxifloxacin in children is not recommended.

Regulatory history

AVELOX moxifloxacin 400 mg tablet was first registered on the ARTG on 21 December 2000.