ERICOX 90mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ETORICOXIB

Boleh didapati daripada:

GENPHARMA SDN. BHD

INN (Nama Antarabangsa):

ETORICOXIB

Unit dalam pakej:

30 Tablets; 100 Tablets

Dikeluarkan oleh:

Alembic Pharmaceuticals Limited

Risalah maklumat

ERICOX TABLETS
_ _
Etoricoxib (60mg, 90mg, 120mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ERICOX Tablet is used for
2.
How ERICOX Tablet works
3.
Before you use ERICOX Tablet
4.
How to use ERICOX Tablet
5.
While you are using it
6.
Side effects
7.
Storage and disposal of ERICOX
Tablet
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ERICOX TABLET IS USED FOR
It
helps
to
reduce
the
pain
and
swelling (inflammation) in the joints
and
muscles
of
people
with
osteoarthritis,
rheumatoid
arthritis,
ankylosing spondylitis and gout. It is
also
use
for
the
treatment
of
acute
pain,
including
that
related
to
menstrual
pain
and
minor
dental
procedures.
_What is osteoarthritis? _
Osteoarthritis is a disease of the joints.
It results from the gradual breakdown
of cartilage that cushions the ends of
the
bones.
This
causes
swelling
(inflammation),
pain,
tenderness,
stiffness and disability.
_What _
_is _
_rheumatoid _
_arthritis? _
Rheumatoid
arthritis
is
a
longterm
inflammatory disease of the joints. It
causes
pain,
stiffness,
swelling,
and
increasing
loss
of
movement
in
the
joints
it
affects.
It
may
also
cause
inflammation
in
other
areas
of
the
body.
_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.
_What _
_is _
_ankylosing _
_spondylitis? _
Ankylosing
spondylitis
is
an
inflammatory disease of the spine and
large joints.
HOW ERICOX 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 ERICOX TABLET
_When you must not use it _
You must not use ERICOX Tablet if
you:
•
if you are allergic (hypersensitive)
to etoricoxib or any of the other
ingredients of ERICOX Tablet
•
i

Ciri produk

NAME OF THE MEDICINAL PRODUCT
_ERICOX 60mg Tablets_
_ERICOX 90mg Tablets_
_ERICOX 120mg Tablets_
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Etoricoxib 60mg
Etoricoxib 90mg
Etoricoxib 120mg
PRODUCT DESCRIPTION
Ericox 60mg Tablet:
Green, round, biconvex, film-coated tablets debossed with ‘444’
on one side and ‘L’
on other side.
Ericox 90mg Tablet:
White to off-white, round, biconvex, film-coated tablets debossed
with ‘445’ on one
side and ‘L’ on other side.
Ericox 120mg Tablet:
Pale-green, round, biconvex, film-coated tablets debossed with
‘446’ on one side
and ‘L’ on other side.
DOSAGE FORM
Tablet
PHARMACODYNAMICS
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic
products, non-
steroids, coxibs, ATC code: M01AH05
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor
within the
clinical dose range.
Across clinical pharmacology studies, Etoricoxib produced
dose-dependent
inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg
daily.
Etoricoxib did not inhibit gastric prostaglandin synthesis and had no
effect on
platelet function.
Cyclooxygenase is responsible for generation of prostaglandins. Two
isoforms,
COX-1 and COX-2, have been identified. COX-2 is the isoform of the
enzyme that
has been shown to be induced by pro-inflammatory stimuli and has been
postulated
to be primarily responsible for the synthesis of prostanoid mediators
of pain,
inflammation, and fever. COX-2 is also involved in ovulation,
implantation and
closure of the ductus arteriosus, regulation of renal function, and
central nervous
system functions (fever induction, pain perception and cognitive
function). It may
also play a role in ulcer healing. COX-2 has been identified in
tissue around gastric
ulcers in man but its relevance to ulcer healing has not been
established.
PHARMACOKINETICS
_Absorption_
Orally administered etoricoxib is well absorbed. The absolute
bioavailability is
approximately 100%. Following 120 mg once-daily dosing to steady
state, the peak
plasma concentrat