AVELOX Film-coated tablet Ref.[6999] Active ingredients: Moxifloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bayer plc, 400 South Oak Way, Reading RG2 6AD

Product name and form

Avelox 400 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 × 7 mm, and marked with “M400” on one side and “BAYER” on the other side.

Qualitative and quantitative composition

1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).

Excipient with known effect: The film-coated tablet contains 68mg lactose monohydrate (=66.56 mg lactose) (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Moxifloxacin

Moxifloxacin, a fourth-generation fluoroquinolone, has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens. The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair.

List of Excipients

Tablet core:

Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate

Film-coat:

Hypromellose
Macrogol 4000
Ferric oxide (E172)
Titanium dioxide (E171)

Pack sizes and marketing

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 × 5), 50 (5 × 10), 70 (7 × 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.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading RG2 6AD

Marketing authorization dates and numbers

PL 00010/0291

13 March 2003/12 February 2010

Drugs

Drug Countries
AVELOX Austria, Cyprus, Ecuador, Estonia, Finland, Hong Kong, Ireland, Japan, Lithuania, Malta, Mexico, Nigeria, New Zealand, Romania, Singapore, Turkey, United Kingdom

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