Vobrax Capsules 200mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

Asumed Biotech Sdn. Bhd.

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

30 Capsules; 10 Capsules; 100 Capsules

Dikeluarkan oleh:

Chen Ho Pharmaceutical Co., Ltd. Sinying Plant

Risalah maklumat

_Consumer Medication Information Leaflet_ _(RiMUP) _
VOBRAX 200MG CAPSULES
_Celecoxib 200mg _
Page 1 of 4 pages
WHAT IS IN THIS LEAFLET:_ _
1.
What Vobrax is used for
2.
How Vobrax works
3.
Before you use Vobrax
4.
How to use Vobrax
5.
While you are using Vobrax
6.
Side effects
7.
Storage and disposal of Vobrax
8.
Product description
9.
Manufacturer
&
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT VOBRAX IS USED FOR
The name of your medicine is Vobrax
200mg Capsules (called ‘Vobrax’ in
this
leaflet).
Vobrax
contains
a
medicine called Celecoxib. Celecoxib
is used for the management of acute
pain in adults and for the treatment of
primary dysmenorrhea, relief of the
acute
and
chronic
pain
and
inflammation of rheumatoid arthritis
and osteoarthritis; relief of signs and
symptoms of ankylosing spondylitis;
and for the management of low back
pain.
HOW VOBRAX WORKS
Vobrax
belongs
to
a
group
of
medicinal
products
called
nonsteroidal anti-inflammatory drugs
(NSAID),
and
specifically
a
sub-
group known as (COX-2) inhibitors.
Your body makes prostaglandins that
may cause pain and inflammation. In
conditions, such as osteoarthritis and
rheumatoid arthritis your body makes
more
of
these.
Vobrax
acts
by
reducing
the
production
of
prostaglandins, thereby reducing the
pain and inflammation.
BEFORE YOU USE VOBRAX
WHEN YOU MUST NOT USE IT:
Do not take Vobrax unless you have
been prescribed Vobrax by your doctor
Do not take Vobrax:
•
If you have severe kidney disease.
•
If you are allergic to celecoxib or
any of the other ingredients of this
medicine
•
If you currently have an ulcer in
your
stomach
or
intestines,
or
bleeding
in
your
stomach
or
intestines.
•
If
as
a
result
of
taking
acetylsalicylic acid or any other
anti-inflammatory
and
pain-
relieving medicine (NSAID) you
have
had
asthma,
nose
polyps,
severe
nose
congestion,
or
an
allergic reaction such as an itchy
skin rash, swelling of the face,
lips, tongue or throat, breathing
difficulties or wheezing.
•
If you have severe liver disease.

Ciri produk

COMPOSITION
Each capsule contains:
Celecoxib 200mg
PRODUCT DESCRIPTION
#2 white capsules characterized with yellow ribbon ring
and CH91 on surface, filled with white to off white
granular powder inside for oral administration.
INDICATION
1)
For the management of acute pain in adults and for
the treatment of primary dysmenorrhoea.
2)
Relief
of
the
acute
and
chronic
pain
and
inflammation
of
rheumatoid
arthritis
and
osteoarthritis.
3)
Relief
of
signs
and
symptoms
of
ankylosing
spondylitis.
4)
For the management of low back pain
PHARMACOLOGICAL PROPERTIES
ATC code: M01AH01
Pharmacotherapeutic group: anti-inflammatory and anti-
rheumatic products, non-steroids, coxibs.
PHARMACODYNAMIC PROPERTIES
_MECHANISM OF ACTION: _
Celecoxib is an oral, selective,
cyclooxygenase2 (COX-2) inhibitor within the clinical
dose range (200-400 mg daily). No statistically significant
inhibition of COX-1 (assessed as ex vivo inhibition of
thromboxane B2 [TxB2] formation) was observed in this
dose range in healthy volunteers.
_ _
_PHARMACODYNAMIC _
_EFFECTS:_
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 human but its
relevance to ulcer healing has not been established.
The
difference
in
antiplatelet
activity
between
some
COX-1
inhibiting
NSAIDs
and
COX-2
selective
inhibitors may be of clinical significance in patients at
risk
of
thrombo-embolic
reactions.
COX-2
selective
inhibitors reduce the formation of systemic (and therefore
possibly