Avelox® information for Healthcare Professionals

Avelox® Administration

Avelox® Recommended Dose and Dosage Adjustment

The recommended dose for Avelox® (moxifloxacin) film-coated tablets and Avelox® intravenous (IV) solution for infusion is 400mg once daily (od) for all indications. The duration of therapy and route of administration is dependent upon the type and severity of infection as described in the Table 1.


Table 1. Dosage and Administration Information for Approved Indications*

InfectionDaily DoseRoute of AdministrationUsual Duration
Community Acquired Pneumonia (CAP) (Mild/Moderate) 400mg PO 10 days
Acute Exacerbation of Chronic Bronchitis (AECB) 400mg PO 5-10 days
Acute Bacterial Sinusitis (ABS) 400mg PO 7 days
Mild to Moderate Pelvic Inflammatory Disease (PID) 400mg PO 14 days
Community Acquired Pneumonia (CAP) 400mg IV/PO 7-14 days
Complicated Skin and Skin Structure Infections (cSSSI) 400mg IV/PO 7-21 days
Complicated Intra-abdominal Infections (cIAI) 400mg IV/PO 5-14 days
Table Key

PO Oral administration
IV Intravenous administration

The recommended dosage and duration of treatment for the indication should not be exceeded.

Dosage for Special Populations

Gender

Dosage adjustments based on gender are not necessary.

Elderly

Dosage adjustments based on age are not necessary. Also adult patients with lower body weight do not need dose adjustment.

Hepatic Impairment

Based on the pharmacokinetic data, no dosage adjustment is required for patients with mild or moderate hepatic insufficiency (Child Pugh Classes A and B). Due to limited clinical data, the use of Avelox® is not recommended in patients with severe hepatic insufficiency (Child Pugh Class C).

Renal Impairment

No dosage adjustment is required in patients with renal impairment (including creatinine clearance ≤ 30 ml/min/1.73m2) and in patients on chronic dialysis (i.e. haemodialysis or continuous ambulatory peritoneal dialysis).

Administration

Oral Administration

Avelox® film-coated tablets should be swallowed whole with sufficient liquid and may be taken with or without food. Do not crush or chew the tablets. The recommended dose should not be exceeded. Antacids, anti-retroviral drugs, and other preparations containing magnesium or aluminium, sucralfate and agents containing iron or zinc should be administered at least 4 hours before or 2 hours after ingestion of an oral moxifloxacin dose.

Intravenous Administration

Avelox® IV solution for infusion should be administered over a period of 60 minutes by direct infusion or through a Y-type IV infusion set with compatible infusion solutions, which may already be in place.

Rapid or bolus IV infusion must be avoided. Avelox® IV solution for infusion is not intended for intramuscular, intrathecal, intraperitoneal or subcutaneous administration.

The recommended duration of infusion should not be shortened and the recommended dose should not be exceeded.

Sequential Intravenous / Per Oral Therapy

When switching from IV to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is initiated with Avelox® IV solution for infusion may be switched to Avelox® film-coated tablets when clinically indicated at the discretion of the physician.


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

For further information on using Avelox® in the management of bacterial infections, please consult your local country specific prescribing information.

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