BIOCOXIB 90MG Film Coated Tablet

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

ETORICOXIB

Verfügbar ab:

MEDISPEC (M) SDN.BHD

INN (Internationale Bezeichnung):

ETORICOXIB

Einheiten im Paket:

3 x 10 Tablets; 5x5 Tablets

Hergestellt von:

Biolab Co., Ltd

Gebrauchsinformation

BIOCOXIB 90MG/120MG FILM COATED
TABLET
Etoricoxib
(90mg, 120mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_BIOCOXIB_
_ _
is used for
2.
How
_BIOCOXIB_
_ _
works
3.
Before you use
_BIOCOXIB_
4.
How to use
_BIOCOXIB_
_ _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_BIOCOXIB_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _BIOCOXIB_
IS USED FOR
Your doctor has prescribed BIOCOXIB
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 attacks
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 _BIOCOXIB_
_ _
WORKS
Etoricoxib is a non-steroidal anti-
inflammatory drug (NSAIDs) which is
highly selective cyclo-oxygenase-2
(COX-2) inhibitor with anti-
inflammatory and analgesic properties.
BEFORE YOU USE _BIOCOXIB_
_ _
-
_When you must not use it _
Do not use
_BIOCOXIB_
_:_
•
If you are allergic to Etoricoxib or
any of the others ingredients
•
If you are allergic to NSAIDs,
including aspirin and COX-2
inhibitors
•
If you have stomach ulcer
•
If you have serious liver disease
•
If you have serious kidney disease
•
If you are under 16 years’ old
•
If you have inflammatory bowel
disease
•
If you have high blood pressure

Fachinformation

P. 1/11
LEAFLET
BIOCOXIB 90 MG AND 120 MG FILM COATED TABLET
COMPOSITION :
Each tablet contains :
Etoricoxib
90 mg, 120 mg
PRODUCT DESCRIPTION :
BIOCOXIB 90 MG Film Coated Tablet : Asymmetric hexagonal with rounded
corners, white
film-coated tablets, impressed “BC” on one side and
“90” on the other.
BIOCOXIB 120 MG Film Coated Tablet: Asymmetric hexagonal with rounded
corners, light
green film-coated tablets, impressed “BC” on one side
and “120” on the other.
PHARMACOLOGY :
_Pharmacodynamics _
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor
within the clinical dose
range. Etoricoxib produced dose-dependent inhibition of COX-2 without
inhibition of COX-1 at
doses up to 150 mg daily. It
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
Etoricoxib
is
well
absorbed
from
the
gastrointestinal
tract
after
oral
doses.
The
absolute
bioavailability is approximately 100%. Peak plasma concentrations are
reached in about 1 hour
in fasted adults. 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. Food delays absorption, resulting peak plasma
concentrations by about 2 hour