MOXIFLOXACIN APOTEX moxifloxacin (as hydrochloride monohydrate) 400 mg film coated tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

moxifloxacin hydrochloride monohydrate

Tersedia dari:

Apotex Pty Ltd

INN (Nama Internasional):

moxifloxacin hydrochloride

Status otorisasi:

Registered

Selebaran informasi

MOXIFLOXACIN APOTEX
_Contains the active ingredient moxifloxacin (as hydrochloride
monohydrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all 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 this medicine
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 THIS MEDICINE IS
USED FOR
This medicine contains 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.
Moxifloxacin will not work against
infections caused by viruses such as
colds or the flu.
It is used to treat infections of the
lungs, airways and sinuses in adults.
In certain infections, you may require
treatment with moxifloxacin
injection followed by a course of
moxifloxacin tablets e.g. severe and
complicated skin and skin structure
infections.
Even if you have read the Consumer
Medicine Information for
moxifloxacin injection, you should
read this leaflet as well as it contains
information specific to the tablets.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine should not be used in
children and adolescents under 18
years of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
moxifloxacin or other medicines
belonging to the quinolone family
(e.g. ciprofloxacin, norfloxacin or
n

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION
MOXIFLOXACIN APOTEX (MOXIFLOXACIN (AS
HYDROCHLORIDE MONOHYDRATE)) TABLET
1
NAME OF THE MEDICINE
Moxifloxacin (as hydrochloride monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 400 mg of moxifloxacin (as
hydrochloride monohydrate) as
the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
400 MG TABLET:
Reddish brown coloured, modified capsule-shaped, biconvex film coated
tablet engraved
“APO” on one side and “MX 400” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moxifloxacin 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
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.
Consideration should be given to available official guidance on the
appropriate use of
antibacterial agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
MOXIFLOXACIN APOTEX film coated tablets are intended for oral
administration.
DOSAGE
The usual dose of moxifloxacin is 400 mg orally or intravenously every
24 hours. The
recommended dose should not be exceeded. NOTE: a moxifloxacin
intravenous solution is not
available in this brand.
The duration of therapy depends on the type of infection as described
below.
2
INFECTION
DAILY DOSE
USUAL DURATION
Acute bacterial sinusitis
400 mg
10 days
(oral therapy)
Acute bacterial exacerbations of
chronic bronchitis
400 mg
5 days
(sequential IV/oral therapy*, oral therapy)
Community acquired pneumonia
400 mg
10 days
(oral therapy)