AVELOX moxifloxacin 400 mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

moxifloxacin, Quantity: 400 mg (Equivalent: moxifloxacin hydrochloride, Qty 436.8 mg)

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; microcrystalline cellulose; hypromellose; ferric oxide; croscarmellose sodium; lactose monohydrate; magnesium stearate; macrogol 400

Administration route:

Oral

Units in package:

5 tablets, 1 tablet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AVELOX (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions. Acute bacterial sinusitis, Community acquired pneumonia, Acute exacerbations of chronic bronchitis. AVELOX IV (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults who require initial IV therapy for the treatment of infections in the conditions. Community acquired pneumonia (caused by susceptible organisms). Acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics. AVELOX IV (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents. (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with moxifloxacin may be initiated. in some conditions, before results of these tests are known. Once results become available, therapy should be continued with the most appropriate antibiotic therapy.

Product summary:

Visual Identification: Dull red, oblong, convex film coated tablet with BAYER on one side and M400 on the other.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-12-21

Patient Information leaflet

210621 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 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 belonging to the
quinolone family (e.g.
ciprofloxacin, norfloxacin,
nalidixic acid)
Some of the symptoms of an
allergic reaction may include:
• shortness of breath
• wheezing or difficulty breathing
•

Summary of Product characteristics

Avelox PI VX1.0; CCDS 23
1
AUSTRALIAN PRODUCT INFORMATION – AVELOX
 (MOXIFLOXACIN
HYDROCHLORIDE) TABLET AND IV SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Moxifloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 436.8 mg moxifloxacin hydrochloride, equivalent
to 400 mg moxifloxacin.
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.
3
PHARMACEUTICAL FORM
Avelox 400 mg tablets are dull red, oblong, convex film-coated tablets
with BAYER on one side
and M 400 on the other.
Avelox 400mg tablets contains lactose monohydrate.
Avelox IV is a sterile, preservative free aqueous solution of
moxifloxacin hydrochloride with pH
ranging from 4.1 to 4.6. The appearance of the intravenous solution is
yellow. The colour does
not affect, nor is it indicative of, product stability.
For the full list of excipients, see Section 6.1 List of excipients.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Avelox (moxifloxacin hydrochloride) tablets are indicated for the
treatment of adults with
infections caused by susceptible organisms in the conditions:
-
Acute bacterial sinusitis
-
Community acquired pneumonia
-
Acute exacerbations of chronic bronchitis
Avelox IV (moxifloxacin hydrochloride) intravenous solutions are
indicated for treatment of
adults who require initial IV therapy for the treatment of infections
in the conditions:
-
Community acquired pneumonia (caused by susceptible organisms)
-
Acute exacerbations of chronic bronchitis when caused by organisms
bacteriologically
proven to be resistant to other classes of antibiotics or when there
is intolerance to other
antibiotics
Avelox PI VX1.0; CCDS 23
2
-
Avelox IV (moxifloxacin hydrochloride) intravenous solutions are
indicated for treatment of
adults with severe and complicated skin and skin structure infections
who require initial
parenteral therapy, and who have intolerance to alternative