Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bayer plc, 400 South Oak Way, Reading RG2 6AD
Avelox is indicated for the treatment of:
Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The recommended dose is 400 mg moxifloxacin, infused once daily.
Initial intravenous treatment may be followed by oral treatment with moxifloxacin 400 mg tablets, when clinically indicated.
In clinical studies most patients switched to oral therapy within 4 days (CAP) or 6 days (cSSSI). The recommended total duration of intravenous and oral treatment is 7-14 days for CAP and 7-21 days for cSSSI.
No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
There is insufficient data in patients with impaired liver function (see section 4.3).
No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Moxifloxacin is contraindicated in children and growing adolescents. Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
For intravenous use; constant infusion over 60 minutes (see also section 4.4).
If medically indicated the solution for infusion can be administered via a T-tube, together with compatible infusion solutions (see section 6.6).
No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.
Polyolefine bag: 3 years.
Glass bottle: 5 years.
Use immediately after first opening and/or dilution.
Do not store below 15°C.
Polyolefine bags with polypropylene port sealed in aluminium foil overwrap. 250 ml pack available in cartons of 5 and 12 bags.
Colourless glass bottles (type 2) with a chlorobutyl or bromobutyl rubber stopper as closure. The 250 ml bottle is available in packs of 1 bottle and in multipacks containing 5 bottles (5 packs of 1 bottle).
Not all pack sizes may be marketed.
This product is for single use only. Any unused solution should be discarded.
The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion:
Water for injections, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, Ringer’s solution, Compound Sodium Lactate Solution (Hartmann’s Solution, Ringer-Lactate Solution).
Moxifloxacin solution for infusion should not be co-infused with other drugs.
Do not use if there are any visible particulate matter or if the solution is cloudy.
At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. It is therefore recommended not to store the infusion solution below 15°C.
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