PIL
AVELOX
®
TABLETS CMI
1
AVELOX
®
TABLETS
(AV·E·LOX)
_moxifloxacin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Avelox tablets.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Avelox
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT AVELOX IS USED
FOR
Avelox tablets are used in adults for
the treatment of infections of the
lungs, airways and sinuses.
In certain infections, you may
require treatment with Avelox IV
injection followed by a course of
Avelox tablets e.g. severe and
complicated skin and skin structure
infections.
Even if you have read the
Consumer Medicine Information
for Avelox IV, you should read this
leaflet as well as it contains
information specific to the tablets.
Avelox tablets contain the active
ingredient, moxifloxacin, which is
an antibiotic belonging to a group
of medicines called quinolones.
These antibiotics work by killing
the bacteria that are causing your
infection.
Avelox tablets will not work
against infections caused by viruses
such as colds or the flu.
Avelox tablets are available by
prescription only.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
AVELOX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TA
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SPC
111013 Avelox PI
Page 1 of 22
PRODUCT INFORMATION
AVELOX
®
(MOXIFLOXACIN HYDROCHLORIDE, BAYER)
NAME OF THE MEDICINE
Moxifloxacin hydrochloride (CAS number: 186826-86-8).
Its empirical formula is C
21
H
23
FN
3
O
4 *
HCl and has a molecular weight of 437.9. Moxifloxacin,
a fluoroquinolone, differs from other
quinolones in that it has a methoxy function at the
8-position and an _S,S_ configurated
diazabicyclononyl ring moiety at the 7-position. Its chemical name is 1-cyclopropyl-7-{(_S,S_)-2,8-
diaza-bicyclo[4.3.0]non-8-yl}-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
hydrochloride. It is a pale yellow substance. The substance
shows no melting point but it
decomposes above 250°C. It is sparingly soluble in water and methanol, slightly soluble in HCl
and ethanol, and practicably insoluble in acetone and toluene. It
has the following chemical
structure:
DESCRIPTION
Avelox (moxifloxacin hydrochloride) is a synthetic broad
spectrum antibacterial agent and is
available as Avelox tablets for oral administration, and
as Avelox IV infusion solution for
intravenous administration.
Avelox tablets are available as a 400 mg film-coated tablet. Besides the active ingredient,
Avelox tablets also contain the following excipients: microcrystalline cellulose, croscarmellose
sodium, lactose, magnesium stearate, ferric oxide, hypromellose,
macrogol 4000, and titanium
dioxide.
Avelox IV is available in ready-to-use 250 mL (containing 400 mg
of moxifloxacin) flexibags or
glass infusion bottles, as a sterile, preservative free
aqueous solution of moxifloxacin
hyd
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