Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2024 Publisher: Bayer plc, 400 South Oak Way, Reading RG2 6AD
Because of the risk of prolonged, disabling and potentially irreversible serious adverse drug reactions (see section 4.4 and section 4.8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where:
Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, 4.8 and 5.1):
Avelox 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).
Avelox 400 mg film-coated tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:
Avelox 400 mg film-coated tablets should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The recommended dose is one 400 mg film-coated tablet once daily.
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 adolescents (<18 years). Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Avelox 400 mg film-coated tablets should be used for the following treatment durations:
Avelox 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin structure infections). The recommended total duration of intravenous and oral treatment is 7-14 days for community-acquired pneumonia and 7-21 days for complicated skin and skin structure infections
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
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 moxifloxacin will reduce systemic availability of the drug by more than 80%. 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.
5 years.
Polypropylene/aluminium and polyvinyl chloride/polyvinylidene chloride/aluminium blisters:
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Aluminium/aluminium blisters:
Store in the original package in order to protect from moisture.
Cartons containing colourless transparent or white opaque polypropylene/aluminium blisters or colourless transparent polyvinyl chloride/polyvinylidene chloride/aluminium blisters:
The film-coated tablets are available in packs of 5, 7, and 10 tablets, in hospital packs containing 25 (5 x 5), 50 (5 x 10), 70 (7 x 10) film-coated tablets or in hospital multipacks containing 80 (5 packs of 16) or 100 (10 packs of 10) film-coated tablets.
Cartons containing aluminium/aluminium blisters are available in packs of one film-coated tablet.
Not all pack sizes may be marketed.
No special requirements.
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