Axcel Etoricoxib-120mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ETORICOXIB

Boleh didapati daripada:

KOTRA PHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

ETORICOXIB

Unit dalam pakej:

30tablet Tablets; 100 Tablets

Dikeluarkan oleh:

KOTRA PHARMA (M) SDN. BHD.

Risalah maklumat

AXCEL ETORICOXIB -120MG
TABLET
_Etoricoxib 120mg _
_ _
_ _
_ _
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Etoricoxib-120mg
Tablet is used for.
2.
How
Axcel
Etoricoxib-120mg
Tablet works.
3.
Before
you
use
Axcel
Etoricoxib-120mg Tablet.
4.
How
to
use
Axcel
Etoricoxib-
120mg Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Etoricoxib-120mg Tablet.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
AXCEL
ETORICOXIB-
120MG TABLET IS USED FOR
It
helps
to
reduce
the
pain
and
swelling (inflammation) in the joints
and muscles of people with gout. It is
also use for the treatment of acute
pain,
including
that
of
primary
dysmenorrhea (menstrual cramp).
WHAT IS GOUT?
Gout is a disease of sudden, recurring
attacks of very painful inflammation
and redness in the joints. It is caused
by deposits of mineral crystals in the
joint.
HOW
AXCEL
ETORICOXIB-
120MG TABLET WORKS
Etoricoxib
is
one
of
a
group
of
medicines
called
selective
COX-2
inhibitors. These belong to a family
of
medicines
called
non-steroidal
anti-inflammatory
drugs
(NSAIDs),
that
exhibits
anti-inflammatory,
analgesic, and antipyretic activities.
BEFORE
YOU
USE
AXCEL
ETORICOXIB-120MG TABLET
WHEN YOU MUST NOT USE IT
You must not use Axcel Etoricoxib-
120mg Tablet if you:
•
if you are allergic (hypersensitive)
to etoricoxib or any of the other
ingredients of Axcel Etoricoxib-
120mg Tablet
•
if you are allergic to non-steroidal
anti-inflammatory drugs
(NSAIDs), including aspirin and
COX-2 inhibitors
•
if you have a current stomach
ulcer or bleeding in your stomach
or intestines
•
if you have serious liver disease
•
if you have serious kidney disease
•
if you are or could be pregnant or
are breast-feeding
•
if you are under 16 years of age
•
if you have inflammatory bowel
disease, such as Crohn’s Disease,
Ulcerative Colitis, or Colitis
•
if your doctor has diagnosed heart
problems including heart failure
(moderate or sev

Ciri produk

AXCEL ETORICOXIB - 90MG TABLET
COMPOSITION:
Each tablet contains:
Etoricoxib
90mg
PRESENTATION:
White
coloured,
round
shape
with
8.0mm
diameter, biconvex, embossed with ‘Kotra’ logo
on one side and breakline on the other side.
AXCEL ETORICOXIB - 120MG TABLET
COMPOSITION:
Each tablet contains
Etoricoxib 120mg
PRESENTATION:
Green
coloured,
round
shape
with
9.8mm
diameter, biconvex, embossed with ‘Kotra’ logo
on one side and breakline on the other side.
INDICATIONS:
For acute and chronic treatment of the signs and
symptoms of osteoarthritis (OA) and rheumatoid
arthritis
(RA).
Treatment
of
ankylosing
spondylitis (AS), acute gouty arthritis, and acute
pain,
including
that
related
to
primary
dysmenorrhoea and minor dental procedures.
The decision to prescribe a selective COX-2
inhibitor should be based on an assessment of
the individual patient's overall risks.
PHARMACOLOGY:
_Mechanism of Action:_
Etoricoxib is a nonsteroidal anti-inflammatory
drug (NSAID) that exhibits anti-inflammatory,
analgesic, and antipyretic activities in animal
models. Etoricoxib is a potent, orally active,
highly
selective
cyclooxygenase-2
(COX-2)
inhibitor
within
and
above
the
clinical
dose
range. Two isoforms of cyclooxygenase have
been identified: cyclooxygenase-1 (COX-1) and
cyclooxygenase-2
(COX-2).
COX-1
is
responsible for prostaglandin-mediated normal
physiologic
functions
such
as
gastric
cytoprotection
and
platelet
aggregation.
Inhibition of COX-1 by nonselective NSAIDs has
been
associated
with
gastric
damage
and
platelet inhibition. COX-2 has been shown to be
primarily
responsible
for
the
synthesis
of
prostanoid mediators of pain, inflammation, and
fever. Selective inhibition of COX-2 by etoricoxib
decreases these clinical signs and symptoms
with decreased GI toxicity and without effects on
platelet function.
_Pharmacokinetics:_
_Absorption:_
In studies specifically designated to measure the onset of
action of etoricoxib, the onset of action occurred as early as
24 minutes after dosing. Orally administered etoricoxib is well
a