MOXIMAC 400MG TABLETS (MOXIFLOXACIN TABLET)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MOXIFLOXACIN HCL

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

MOXIFLOXACIN HCL

Unit dalam pakej:

1 x 5 Tablets; 2 x 5 Tablets

Dikeluarkan oleh:

Macleods Pharmaceuticals Ltd

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MOXIMAC 400MG TABLETS
MOXIFLOXACIN TABLETS
1
WHAT IS IN THIS LEAFLET?
1.
What
MOXIMAC
is used for
2.
How
MOXIMAC
works
3.
Before you use
MOXIMAC
4.
How to use
MOXIMAC
5.
While you are using
MOXIMAC
6.
Side effects
7.
Storage and Disposal of
MOXIMAC
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT MOXIMAC IS USED FOR
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.
You
must
use
Moxifloxacin
together
with other antibacterial agent.
HOW MOXIMAC WORKS
Moxifloxacin works by killing bacteria
that cause infections.
BEFORE YOU USE MOXIMAC
_- When you must not use it _
-
If
you
are
allergic
to
the
active
substance
moxifloxacin,
any
other
quinolone antibiotics or any of the other
ingredients of this medicine.
-
If you suffer from myasthenia gravis
(abnormal
muscle
fatigue
leading
to
weakness and in serious cases paralysis),
taking
moxifloxacin
may
worsen
the
symptoms of your disease. Avoid taking
moxifloxacin if you suffer from
myasthenia gravis.
_- Before you start to use it _
Talk
to
your
doctor
before
taking
Moxifloxacin
-
Moxifloxacin can change your heart’s
ECG, especially if you are female, or if
you
are
elderly.
If
you
are
currently
taking any medicine that decreases your
blood
potassium
levels,
consult
your
doctor before taking moxifloxacin.
-
If
you
suffer
from
epilepsy
or
a
condition
which
makes
you
likely
to
have
convulsions
ta

Ciri produk

FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR
A HOSPITAL OR A LABORATORY
MOXIMAC 400 MG TABLETS (MOXIFLOXACIN TABLET)
COMPOSITION:
Each film coated tablet contains:
Moxifloxacin Hydrochloride Ph. Eur Equivalent to Moxifloxacin
………. 400 mg
DESCRIPTION
Moxifloxacin hydrochloride is a synthetic broad spectrum antibacterial
agent. Chemically, Moxifloxacin is 1-
cyclopropyl-7-[(S,S)2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3
quinoline carboxylic
acid. Its molecular formula is C21H24FN3O4*HCl, and molecular weight
is 437.9.
PHARMACOLOGICAL CLASSIFICATION
Fluoroquinolones
PHARMACEUTICAL FORM
Brick red colored, capsule shaped, biconvex, film coated tablets with
plain surface on both the sides
PHARMACOLOGICAL ACTION
PHARMACOKINETICS
Absorption and Bioavailability
Following oral administration moxifloxacin is rapidly and almost
completely absorbed. The absolute bioavailability
amounts to approximately 91%.
Pharmacokinetics is linear in the range of 50 - 800 mg single dose and
up to 600 mg once daily dosing over 10 days.
Following a 400 mg oral dose peak concentrations of 3.1 mg/l are
reached within 0.5 - 4 h post administration. Peak and
trough plasma concentrations at steady-state (400 mg once daily) were
3.2 and 0.6 mg/l, respectively. At steady-state
the exposure within the dosing interval is approximately 30% higher
than after the first dose.
Distribution
Moxifloxacin is distributed to extravascular spaces rapidly; after a
dose of 400 mg an AUC of 35 m∙gh/l is observed.
The steady-state volume of distribution (Vss) is approximately 2 l/kg.
_In vitro _
and
_ex vivo _
experiments showed a
protein binding of approximately 40 - 42% independent of the
concentration of the drug. Moxifloxacin is mainly
bound to serum albumin.
The following peak concentrations (geometric mean) were observed
following administration of a single oral dose of
400 mg moxifloxacin:
TISSUE
CONCENTRATION
SITE: PLASMA RATIO
Plasma
3.1 mg/l
-
Saliva
3.6 mg/l
0.75 - 1.3
Blister fluid
1.6
1
mg/l
1.7
1
Bronch