MOXI 400 (MOXIFLOXACIN HYDROCHLORIDE TABLETS 400 MG)

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Thành phần hoạt chất:

MOXIFLOXACIN HCL

Sẵn có từ:

UNIMED SDN BHD

INN (Tên quốc tế):

MOXIFLOXACIN HCL

Các đơn vị trong gói:

1 x 5 Tablets; 10 x 10 Tablets

Sản xuất bởi:

Hetero Labs Limited

Tờ rơi thông tin

TABLET MOXI 400
®
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
(MOXIFLOXACIN HYDROCHLORIDE TABLET 400MG)
(Moxifloxacin Hydrochloride 400mg)
_WHAT IS IN THIS LEAFLET? _
1. WHAT _MOXI 400 _IS USED FOR?
2. HOW _MOXI 400 _WORKS?
3. BEFORE YOU USE _MOXI 400_
-
_When you must not use it?_
-
_Before you start to use it._
-
_Taking other medicines._
4. HOW TO USE _MOXI 400?_
-
_How much to use?_
-
_When to use it?_
-
_How long to use it?_
-
_If you forget to use it?_
-
_If you use too much (overdose)._
5. WHILE YOU ARE USING IT
-
_Things you must do._
-
_Things you must not do._
-
_Things to be careful of._
6. SIDE EFFECTS
7. STORAGE AND DISPOSAL OF _MOXI 400_
8. PRODUCT DESCRIPTION
-
_What it looks like?_
-
_Ingredients_
-
_MAL Registration Number_
9. MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10. DATE OF REVISION
11. SERIAL NUMBER
WHAT _MOXI 400 _IS USED FOR?
This
product
contains
moxifloxacin
as
the active ingredient which belongs to a
group
of
antibiotics
called
fluoroquinolones.
Moxifloxacin is used in patients aged 18
years
and
above
for
treating
the
following
bacterial
infections
when
caused
by
bacteria
against
which
moxifloxacin
is
active.
Moxifloxacin
should
only
be
used
to
treat
these
infections when usual antibiotics cannot
be used or have not worked:
Infection
of
the
sinuses,
sudden
worsening of long term inflammation of
the
airways
or
infection
of
the
lungs
(pneumonia)
acquired
outside
the
hospital (except severe cases).
Mild
to
moderate
infections
of
the
female
upper
genital
tract
(pelvic
inflammatory
disease),
including
infections
of
the
fallopian
tubes
and
infections
of
the
uterus
mucous
membrane. Moxifloxacin tablets are not
sufficient on their own for treating this
kind
of
infection.
Therefore,
another
antibiotic
in
addition
to
Moxifloxacin
tablets
should
be
prescribed
by
your
doctor for the treatment of infections of
the female upper genital tract.
If the following bacterial infections have
shown
improvement
during
initial
treatment with Moxifloxacin solution for
infusion, Moxifloxacin tablets

Đặc tính sản phẩm

_MOXI 400 TABLETS _
_(MOXIFLOXACIN HYDROCHLORIDE 400 MG TABLETS) _
_ _
DESCRIPTION AND COMPOSITION:
_DESCRIPTION: _
Pink colored, capsule shaped, biconvex, film coated tablets, debossed
with 80
on one side and I on the other side.
_COMPOSITION: _
Each film-coated tablet contains 436.8 mg of Moxifloxacin Hcl
equivalent to
400 mg of Moxifloxacin.
PHARMACODYNAMICS
_MECHANISM OF ACTION _
Moxifloxacin is a 8-methoxy-fluoroquinolone antibiotic (ATC Code J01MA
14) with a broad
spectrum of activity and bactericidal action. Moxifloxacin has in
vitro activity against a wide
range of Gram-positive and Gram-negative organisms, anaerobes,
acid-fast bacteria, and
atypicals e.g. Chlamydia spp., Mycoplasma spp., and Legionella spp.
The
bactericidal
action
results
from
the
interference
with
topoisomerase
II
and
IV.
Topoisomerases are essential enzymes which control DNA topology and
assist in DNA
replication,
repair
and
transcription.
Moxifloxacin
exhibits
concentration
dependent
bactericidal killing. Minimum bactericidal concentrations are
generally similar to minimum
inhibitory concentrations.
Moxifloxacin is effective against b-lactam and macrolide resistant
bacteria. Studies in animal
models of infection have demonstrated high in vivo activity.
_RESISTANCE _
Resistance
mechanisms
which
inactive
penicillins,
cephalosporins,
aminoglycosides,
macrolides and tetracyclines do not interfere with the antibacterial
activity of moxifloxacin.
There is no cross resistance between moxifloxacin and these agents.
Plasmid-mediated
resistance has not been observed to date.
It appears that the C8-methoxy moiety contributes to enhanced activity
and lower selection of
resistant mutants of Gram-positive bacteria compared to the C8-H
moiety. The presence of
the bulky bicycloamine substituent at the C-7 position prevents active
efflux, a mechanism of
fluoroquinolone resistance.
In vitro studies have demonstrated that resistance to Moxifloxacin
develops slowly by
multiple step mutations.
A very low overall frequency of resistance was demonstrated (1