Frequently Asked Questions

What is Avelox®?

Avelox® (moxifloxacin) is a fourth generation synthetic fluoroquinolone antibiotic agent. It has in vitro activity against a wide range of Gram-positive, Gram-negative, atypical and anaerobic pathogens.

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How does Avelox® work?

The bactericidal action of Avelox® results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair. Pharmacodynamic investigations have demonstrated that moxifloxacin exhibits a concentration dependent killing rate.

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When is Avelox® indicated?

Avelox® * 400 mg film-coated tablets are indicated for the treatment of community acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB), acute bacterial sinusitis (ABS), uncomplicated and complicated skin and skin structure infections (uSSSI and cSSSI), mild to moderate pelvic inflammatory disease (PID), and complicated intra-abdominal infections (cIAI).

Avelox® * 400 mg intravenous (IV) formulation is indicated for the treatment of bacterial community acquired pneumonia, cSSSI, and cIAI.

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* Licensed indications differ from country to country, please ensure you consult your local prescribing information before prescribing Avelox®.

How is Avelox® administered?

Avelox® is available as film-coated tablets or IV solution for infusion.

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What is the recommended dose of Avelox®?

The recommended dose for Avelox® oral film-coated tablets or IV solution for infusion is 400 mg once daily (od) for all indications. The duration of therapy and route of administration is dependent upon the type and severity of infection.

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When is Avelox® contraindicated?

Avelox® is contraindicated in the following patients*:

• Patients with hypersensitivity to moxifloxacin, other quinolones or to any of the excipients
• Patients who are pregnant or lactating
• Patients below 18 years of age

* Contraindications may vary from country to country, please ensure you consult your local prescribing information before prescribing Avelox®.

For further information regarding the safety profile of Avelox®, as well as drug interactions and warnings and precautions, please see the Safety page.

Does Avelox® interact with other medicinal products?

Concomitant ingestion of Avelox® with antacids, minerals and multi-vitamins may result in impaired absorption of Avelox® due to formation of chelate complexes with the multi-valent cations contained in these preparations, leading to lower-than-desired concentrations of Avelox® in the blood.

No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed. However, cases of increased anticoagulant activity have been reported in patients receiving anticoagulants with antibiotics, including Avelox®.

The pharmacokinetics of digoxin are not significantly influenced by Avelox® and vice versa. After repeated dosing in healthy volunteers Avelox® increased the C_max of digoxin by approximately 30% at steady state without affecting AUC or trough levels.

For the following substances absence of a clinically relevant interaction with Avelox® was proven: atenolol, ranitidine, calcium supplements, theophylline, PO contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for these drugs.

Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to Avelox®, in the form of QT prolongation. For reasons of drug safety, treatment with Avelox® should be avoided in patients receiving class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sortalol) antiarrhythmic agents.

Treatment with Avelox® should be used with caution in patients receiving drugs that prolong the QT interval (e.g. cisapride, erythromycin, antipsychotics and tricyclic antidepressants).

For further information regarding the safety profile of Avelox®, as well as drug interactions and warnings and precautions, please see the Safety page or consult your local prescribing information.

What is the resistance profile of Avelox®?

In vitro studies have demonstrated that resistance to Avelox® develops slowly by multiple step mutations. A very low overall frequency of resistance has been demonstrated. Serial exposure of organisms to sub-MIC concentrations of Avelox® showed only a small increase in MIC values.

Resistance mechanisms which inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin. There is no cross resistance between Avelox® and these agents. Plasmid-mediated resistance has not been observed to date.

Cross resistance among quinolones has been observed. However, some Gram-positive and anaerobic organisms resistant to other quinolones are susceptible to Avelox®.

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Can Avelox® be used to treat MRSA?

Avelox® is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA treatment with an appropriate antibacterial agent should be started.

For further information regarding the safety profile of Avelox®, as well as drug interactions and warnings and precautions, please see the Safety page or consult your local prescribing information.

What are the most common side-effects with Avelox®?

Common adverse drug reactions were observed with a frequency below 3% with the exception of nausea and diarrhoea with a frequency of below 10% and are based on all clinical studies with Avelox® 400 mg (oral and sequential therapy; overall n=12,984, including n= 2,535 for sequential therapy studies). These are:

• Mycotic superinfections
• Headache
• Dizziness
• QT prolongation in patients with hypokalaemia
• Nausea
• Vomiting
• Gastrointestinal and abdominal pains
• Diarrhoea
• Increase in transaminases
• Injection and infusion site reactions (IV only)

For further information regarding the safety profile of Avelox®, including less common adverse events, as well as drug interactions, please see the Safety page.

My patients always ask if they can consume alcohol whilst on a course of antibiotics.

Alcohol consumption will not affect the efficacy of Avelox®, however it may exacerbate CNS side effects.

For further information regarding the safety profile of Avelox®, including less common adverse events, as well as drug interactions, please see the Safety page.

Does Avelox® need to be taken with food?

Avelox® can be taken independent from food intake, including dairy products.

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Does Avelox® need to be taken at the same time each day?

Although no specific guidelines are given, it is good clinical practice to give Avelox® at regular intervals for the prescribed period.

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What advantage does Avelox® have over other fluoroquinolones?

Avelox® may simplify treatment regimens in some patients compared with other fluoroquinolones.

Avelox® has similar efficacy and safety compared with levofloxacin in the treatment of CAP. However, 5 days treatment with Avelox® is comparable to 7 days treatment with levofloxacin in the treatment of AECB.

Avelox® efficacy is comparable to that of the dual therapy ofloxacin and metroindazole, and of the triple therapy doxycycline, metronidazole and ciprofloxacin in patients with mild to moderate PID. It was associated with less drug-related adverse events than the combination therapy ofloxacin and metronidazole in the trial.

Unlike levofloxacin and ciprofloxacin, Avelox® does not require dosage adjustments in patients with renal impairment.

Moxifloxacin has been shown to be en fold more actve in vitro against Streptococcus pneumoniae when compare with levofloxacin and ciprofloxacin. (Ref Fung-Tomc, et al. Antimicrobial Agents and Chemotherapy, Dec 2000, 3351-3356).

For further information regarding the efficacy and safety profile of Avelox® and comparators including other fluoroquinolones please see the Efficacy page.

How many patients has Avelox®’s efficacy and safety been studied in?

Avelox® v (moxifloxacin) has been extensively investigated in over 18,000 patients in clinical trials and 137,211 patients in post-marketing surveillance studies. In addition, there is extensive clinical experience with Avelox® with over 149 million patients treated worldwide.

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