Avelox

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Moxifloxacin hydrochloride 436.8mg Equivalent to 400 mg moxifloxacin

Available from:

Bayer New Zealand Limited

INN (International Name):

Moxifloxacin hydrochloride 436.8 mg (Equivalent to 400 mg moxifloxacin)

Dosage:

400 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Moxifloxacin hydrochloride 436.8mg Equivalent to 400 mg moxifloxacin Excipient: Croscarmellose sodium Hypromellose Iron oxide red Lactose monohydrate Macrogol 4000 Magnesium stearate Powdered cellulose Titanium dioxide

Units in package:

Blister pack, Polypropylene-Aluminium Starter, 1 tablet

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Avelox tablets and solution for infusion is indicated for the treatment of the following bacterial infections caused by susceptible strains: · Bronchitis (acute exacerbations of chronic bronchitis)

Product summary:

Package - Contents - Shelf Life: Blister pack, Polypropylene-Aluminium Starter - 1 tablets - 5 years from date of manufacture stored at or below 25°C - Blister pack, Aluminium/Aluminium - 5 tablets - 5 years from date of manufacture stored at or below 25°C - Blister pack, Polypropylene-Aluminium - 5 tablets - 5 years from date of manufacture stored at or below 25°C

Authorization date:

1999-08-31

Patient Information leaflet

AVELOX
®
TABLETS NZ CMI – CCDS22
Page 1 of 5
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 women Avelox tablets can be
used to treat a condition called
pelvic inflammatory disease
which is an infection of the
female upper genital tract.
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, complicated
abdominal 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
fluoroquinolones. 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 TAKE AVELOX TABLETS IF
YOU HAVE AN ALLERGY TO:
•
moxifloxacin, the active
ingredient in Avelox
•
any of the ingredients listed
at the end of this leaflet
•
other medicines

Summary of Product characteristics

191001 Avelox Data Sheet
Page 1 of 26
NEW ZEALAND DATA SHEET
AVELOX® (MOXIFLOXACIN)
1
PRODUCT NAME
AVELOX 400 mg moxifloxacin film coated tablet
AVELOX 400 mg moxifloxacin solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 436.8 mg moxifloxacin hydrochloride, equivalent
to 400 mg
moxifloxacin.
Excipient
with
known
effect:
The
film-coated
tablet
contains
68
mg
lactose
monohydrate (= 66.56 mg lactose)
Each 250 mL solution for infusion contains 436.8 mg moxifloxacin
hydrochloride,
equivalent to 400 mg moxifloxacin in 0.8% sodium chloride. The
solution for infusion
(250 mL) contains 34 mmoL sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The film coated tablets are dull red, oblong and convex, 17 x 7 mm
with 10 mm
radius of curvature weighing 693.8 – 699.8 mg. They are marked
“Bayer” on one
side and “M 400” on the other side.
The IV infusion is available in either a polyolefin flexible bag or a
glass bottle filled
with a minimum of 250 mL clear, yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avelox tablets and solution for infusion are indicated for the
treatment of the
following bacterial infections caused by susceptible strains:

Bronchitis (acute exacerbations of chronic bronchitis)

Pneumonia (community acquired)

Sinusitis (acute)

Complicated skin and skin structure infections (including diabetic
foot infections)

Complicated intra-abdominal infections including polymicrobial
infections such
as abscesses
Avelox tablets are indicated for the treatment of the following
bacterial infections
caused by susceptible strains:

Uncomplicated pelvic inflammatory disease (i.e. infections of female
upper
genital tract, including salpingitis and endometritis)
191001 Avelox Data Sheet
Page 2 of 26
Consideration should be given to available official guidance on the
appropriate use
of antibacterial agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dose for Avelox is 400 mg onc