CELXIB 200mg Capsule

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

10 x 10 Capsules

Dikeluarkan oleh:

UNISON LABORATORIES CO.LTD

Risalah maklumat

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CELXIB 200MG CAPSULE
Celecoxib (200 mg) 1
WHAT IS IN THIS LEAFLET
1.
What Celxib 200 is used for
2.
How Celxib 200 works
3.
Before you use Celxib 200
4.
How to use Celxib 200
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Celxib 200
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CELXIB 200 IS USED FOR
Celxib 200 is used for
• Menstrual cramps or period pains.
• Relief symptoms of joint pain,
tenderness, swelling and stiffness in
rheumatoid arthritis and osteoarthritis.
• Relief of signs and symptoms of
ankylosing spondylitis (a chronic
inflammatory rheumatic disorder that
primarily affects, but is not limited to,
the spine).
• The management of low back pain
(100 mg and 200 mg only).
HOW CELXIB 200 WORKS
Celxib 200 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
rheumatoid arthritis and osteoarthritis
your body makes more of these.
Celxib 200 acts by reducing the
production of prostaglandins, thereby
reducing the pain and inflammation.
BEFORE YOU USE CELXIB 200
_- When you must not use it _
Tell your doctor if any of the following
are true for you as patients with these
conditions should not take Celxib 200.
•
if you are allergic to Celecoxib or
any of the other ingredients of this
medicine
•
if you have had an allergic reaction
to a group of medicines called
‘sulfonamide’ (e.g. some antibiotics
used to treat infections)
•
If as a result of taking
acetylsalicylic acid or any other
anti-inflammatory and pain-
relieving medicine (NSAID) you
have had asthma, , 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 been diagnosed with
a

Ciri produk

1 of 5
CELXIB 200 MG
CAPSULE
NON-STEROIDAL ANTI-INFLAMMATORY/ ANTIRHEUMATIC
Each capsule contains:
CELECOXIB 200 MG
PRODUCT DESCRIPTION:
White powder in opaque white capsule No. 1 with printed CC 200 in red
color
MECHANISM OF ACTION:
_PHARMACOLOGY_
Pharmacotherapeutic group: M01AH Coxibs
The mechanism of action of Celecoxib is via inhibition of
prostaglandin synthesis primarily by inhibition of COX-2. At
therapeutic concentrations in humans, Celecoxib does not
inhibit cyclooxygenase 1 (COX-1). COX-2 is induced in response to
inflammatory stimuli. This leads to the synthesis and accumulation of
inflammatory prostanoids, in particular
prostaglandin E2, causing inflammation, edema and pain. Celecoxib acts
as an anti-inflammatory, analgesic and antipyretic agent by blocking
the production of inflammatory
prostanoids via COX-2 inhibition.
Consequently at therapeutic doses Celecoxib has no effect on
prostanoids synthesized by activation of COX-1 thereby not interfering
with normal COX-1 related physiological
processes in tissues, particularly the stomach, intestine and
platelets.
_PHARMACOKINETICS _
Absorption
When given under fasting conditions Celecoxib is well absorbed
reaching peak plasma concentrations after approximately 2-3 hours.
Oral bioavailability from capsules is about 99%
relative to administration in suspension (optimally available oral
dosage form). Under fasting conditions, both peak plasma levels (C
max
) and area under the curve (AUC) are roughly
dose proportional up to 200 mg twice daily; at higher doses there are
less than proportional increases in C
max
and AUC.
Distribution
Plasma protein binding, which is concentration independent, is about
97% at therapeutic plasma concentrations and Celecoxib is not
preferentially bound to erythrocytes in the blood.
Metabolism
Celecoxib metabolism is primarily mediated via cytochrome P450 2C9.
Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been
identified in human plasma: A primary
alcohol, the corresponding carboxylic acid and its glucuronide
c