Duocoxib Film Coated Tablet 120mg

国家: 马来西亚

语言: 英文

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

有效成分:

ETORICOXIB

可用日期:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN（国际名称）:

ETORICOXIB

每包单位数:

30 Tablets

厂商:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

资料单张

DUOCOXIB FILM COATED TABLET
Etoricoxib Film Coated 90mg, 120mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Duocoxib tablet is used
for
2.
How Duocoxib tablet works
3.
Before
you
take
Duocoxib
tablet
4.
How to use Duocoxib tablet
5.
While you are taking Duocoxib
tablet
6.
Side effects
7.
Storage
and
Disposal
of
Duocoxib tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT DUOCOXIB TABLET IS USED FOR
Your doctor has prescribed Duocoxib
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 gouts
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 functions 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 DUOCOXIB TABLET WORKS
Duocoxib tablet is a member of a
group of medicines called selective
COX-2 inhibitors that are used to
reduce
pain
and
inflammation.
Duocoxib tablet is not a narcotic.
BEFORE YOU TAKE DUOCOXIB TABLET
-
_ When you must not take it _
Do not take Duocoxib tablet it you:
•
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

产品特点

[DUOPHARMA (MANUFACTURING) BANGI SDN BHD]
[REVISION DATE: 9.3.2022]
DUOCOXIB FILM
COATED TABLET
ETORICOXIB FILM COATED TABLE 120MG
DESCRIPTION:
Duocoxib Tablet 120mg: Apple shape, pale green, biconvex
with “120” marking on one side and plain on the other side,
film-coated tablet.
PHARMACODYNAMICS: Duocoxib is a nonsteroidal anti-
inflammatory drug (NSAID) that exhibits anti-inflammatory,
analgesic
and
antipyretic
activities
in
animal
models.
Duocoxib
is
a
potent,
orally
active
and
highly
selective
cyclooxygenase-2
(COX-2)
inhibitor.
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 shown to be primarily responsible for the synthesis of
prostanoid
mediators
of
pain,
inflammation
and
fever.
Selective inhibition of COX-2 by etoricoxib decreases GI
toxicity and without causes effects on platelet function. There
was no inhibition of _ ex vivo _ arachidonic acid- or collagen-
induced platelet aggregation at steady state with doses of
Duocoxib up to 150mg.
PHARMACOKINETICS:
ABSORPTION
Orally administered etoricoxib is well absorbed. A standard
meal had no effect on the extent or rate of absorption of a
dose of etoricoxib 120mg.
DISTRIBUTION
Etoricoxib is approximately 92% bound to human plasma
protein over the range of concentrations of 0.05 to 5 mcg/ml.
The
volume
of
distribution
at
steady
state
(V
dss
)
is
approximately
120
L
in
humans.
Etoricoxib
crosses
the
placenta in rats and rabbits and the blood-brain barrier in rats.
METABOLISM
Etoricoxib is extensively metabolized with <1% of a dose
recovered in urine as the parent drug. The major route of
metabolism
to
form
the
6’-
hydroxymethyl
derivative
is
catalyzed
by
cytochrome
P450
(CYP)
enzymes.
Five
metabolites
have
been
identified
in
man.
The
principal
metabo