Ecoxi-120 (Etoricoxib 120mg Film Coated Tablet)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Etoricoxib

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

Etoricoxib

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

USV Private Limited

Risalah maklumat

ECOXI FILM COATED TABLET
Etoricoxib Film Coated Tablets 60mg, 90mg & 120mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ECOXI tablet is used for
2.
How ECOXI tablet works
3.
Before you use
ECOXI tablet
4.
How to use
ECOXI tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ECOXI
tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ECOXI TABLET
IS USED FOR
Your doctor has prescribed ECOXI tablet
for:
•
treatment of osteoarthritis
•
treatment of rheumatoid arthritis
•
treatment of ankylosing spondylitis
•
treatment of acute pain after minor
dental procedures
•
treatment of menstrual pain
•
treatment of gout
Osteoarthritis is a joint disease. It results
from
the
gradual
breakdown
of
the
cartilage that cushions the ends of the
bones, resulting in pain, inflammation,
tenderness,
stiffness,
and
physical
disability.
Rheumatoid arthritis is a chronic disease
that causes pain, stiffness, swelling and
loss
of
function
in
the
joints
and
inflammation in other body organs.
Ankylosing
spondylitis
is
an
inflammatory disease of the spine and
large joints.
Gout
is
a
disorder
characterized
by
sudden,
recurring
attacks
of
pain
and
inflammation in one or more joints.
You may obtain further information from
your
doctor
or
pharmacist,
who
have
more detailed information.
HOW ECOXI TABLET WORKS
ECOXI tablet is a member of a group of
medicines
called
selective
COX-2
inhibitors that are used to reduce pain
and inflammation. ECOXI tablet is not a
narcotic.
BEFORE YOU USE ECOXI TABLET
-
_When you must not use it _
Do not use ECOXI tablet if:
•
are allergic to etoricoxib or any of
other ingredients of this medicine.
•
have had heart failure, a heart attack,
bypass surgery, chest pain, narrow
or
blocked
arteries
of
the
extremities, a stroke or mini stroke
•
have high blood pressure that has
not been controlled by treatment
-
_Before you start to use it _
Tell
your
doctor
about
any
medical
proble

Ciri produk

PHARMACOLOGY
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic
products, non-steroids,
coxibs, ATC code: M01 Ah05
Mechanism of Action
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
concentration (geometric mean Cmax = 3.6 μg/ml) was observed at
approximately 1 hour
(Tmax) after administration to fasted adults. The geometric mean area
under the curve
(AUC0-24hr) was 37.8 μghr/ml. The pharmacokinetics of etoricoxib are
linear across the
clinical dose range.
Dosing with food (a high-fat meal) had no effect on the extent of
absorption of etoricoxib
after administration of a 120-mg dose. The rate of absorption was
affected, resulting in a
36% decrease in Cmax and an increase in Tmax by 2 hours.These data are
not considered
clinically significant. In clinical trials, etoricoxib was
administered