AVELOX SOLUTION FOR INFUSION 400 mg/250 ml

4.1 Indications

Avelox 400 mg solution for infusion is indicated for the treatment of the following bacterial infection caused by susceptible strains:

• Community acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae or Moraxella catarrhalis.
• Complicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.

For full list of susceptible strains, please refer to Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.3 Contraindications

Known hypersensitivity to moxifloxacin or other quinolones or any of the excipients.

Pregnancy and lactation.

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. For reasons of drug safety, Avelox is therefore contraindicated in patients with:

• Congenital or documented acquired QT prolongation
• Electrolyte disturbances, particularly in uncorrected hypokalaemia
• Clinically relevant bradycardia
• Clinically relevant heart failure with reduced left-ventricular ejection fraction
• Previous history of symptomatic arrhythmias

Avelox should not be used concurrently with other drugs that prolong the QT interval (see also “Interactions with other medicaments and other forms of interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Moxifloxacin is contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase >5 fold ULN.

4.2 Dosage and method of administration

4.2.1 Method of administration

Solution for Infusion:

The infusion solution should be infused intravenously over 60 minutes.

The solution for infusion can be administered directly or via a T-tube together with compatible infusion solutions.

The following coinfusions were found to form stable mixtures over a period of 24 hours at room temperature with Avelox infusion solution, and can therefore be considered as compatible with Avelox solution for infusion:

• Water for Injections
• Sodium Chloride 0.9%
• Sodium Chloride 1 molar
• Glucose 5%
• Glucose 10%
• Glucose 40%
• Xylitol 20%
• Ringer’s Solution
• Lactated Ringer’s Solution

If Avelox infusion solution is to be given with another drug, each drug should be given separately (see “Pharmaceutical Particulars, Incompatibilities” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Only clear solutions are to be used.

4.2.2 Dosage regimen

Dose (adults):

The recommended dose for Avelox is 400 mg once-daily (250 mL solution for infusion) for the above-mentioned indication and should not be exceeded.

Duration of treatment:

The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations for the treatment of upper and lower respiratory tract infections and skin infections are made:

Therapy may be initial intravenous administration, followed by oral administration of film-coated tablets. When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Avelox IV may be switched to Avelox Tablets when clinically indicated at the discretion of the physician.

Pneumonia: community acquired pneumonia: The recommended total treatment duration for sequential administration (intravenous followed by oral) is 7–14 days.

Complicated skin and skin structure infections total treatment duration for sequential therapy (intravenous followed by oral therapy), 7 – 21 days.

The recommended duration of treatment for the indication being treated should not be exceeded.

Avelox 400 mg film-coated tablets and Avelox 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).

4.2.3 Missed dose

If a dose is missed it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose.

Double doses should not be taken to compensate for a missed dose.

4.2.4 Additional information on special populations

4.2.4.1 Children and adolescents

Efficacy and safety of Avelox in children and adolescents have not been established (see “Contraindications”).

4.2.4.2 Geriatric patients

No adjustment of dosage is required in elderly.

4.2.4.3 Ethnic differences

No adjustment of dosage is required in ethnic groups.

4.2.4.4 Patients with hepatic impairment

No dosage adjustment is required in patients with mild or moderate impaired liver function. The use of moxifloxacin is not recommended in patients with severe hepatic impairment (Child Pugh C) (see “Special warnings and precautions for use” in Child Pugh C patients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.4.5 Patients with renal impairment

No dose adjustment is required in patients with any degree of renal impairment (including creatinine clearance ≤ 30 mL/min/1.73m2) and in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis.