Allpac Celecoxib Capsule 200 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

ALLPAC SOLUTIONS SDN. BHD.

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

1x10 Capsules; 10x10 Capsules; 3x10 Capsules

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ALLPAC CELECOXIB CAPSULE 200 MG
Celecoxib (200mg)
1
WHAT IS IN THIS LEAFLET
1.
What Allpac Celecoxib is used for
2.
How Allpac Celecoxib works
3.
Before you use Allpac Celecoxib
4.
How to use Allpac Celecoxib
5.
While you are using Allpac
Celecoxib
6.
Side effects
7.
Storage and Disposal of Allpac
Celecoxib
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ALLPAC CELECOXIB IS USED FOR
For the management of acute pain in
adults and as primary treatment for pain
associated with menstruation
(dysmenorrhea).
Relief of the acute and chronic pain and
inflammation of rheumatoid arthritis
and osteoarthritis (pain at joints).
Relief of signs and symptoms of
inflammation at spine and other areas
of the body (ankylosing spondylitis).
For relief of low back pain.
HOW ALLPAC CELECOXIB WORKS
Celecoxib is a nonsteroidal anti-
inflammatory drug (NSAID). It works
by reducing hormones that cause
inflammation and pain in the body.
BEFORE YOU USE ALLPAC CELECOXIB
_ _
_- When you must not use it _
Do not take this medicine if:
•
You are allergic to celecoxib or
any of the other ingredients of this
medicine.
•
You have an allergic reaction to a
group of medicines called
“sulfonamides” (e.g. some
antibiotics used to treat infections).
•
You currently have an ulcer in
your stomach or intestines, or
bleeding in your stomach or
intestines.
•
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.
•
You are pregnant. If you can
become pregnant during ongoing
treatment you should discuss
methods of contraception with
your doctor.
•
You are breast-feeding
•
You have severe liver disease
•
You have severe kidney disease.
•
You have an inflammatory disease
of the in

Ciri produk

ALLPAC CELECOXIB CAPSULE 200 MG
VICELxx-03
DESCRIPTION
White opaque/white opaque capsule with “CL200” printed on one end
and
“hovid” printed on the other end
Fill material: white to off white granules
Capsule size: size 0
COMPOSITION
Each capsule contains Celecoxib 200 mg.
PHARMACODYNAMICS
Mechanism of action: Celecoxib is an oral, selective, cyclooxygenase-2
(COX-2) inhibitor within the range (200-400 mg daily).
Pharmacodynamic effects: Cyclooxygenase is responsible for generation
of prostagladins. 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 endothelial)
prostacyclin without affecting platelet thromboxane.
Celecoxib is a diaryl-substituted pyrazole, chemically similar to
other
non-arylamine sulfonamides (e.g. thiazides, furosemide) but differs
from
arylamine
sulfonamides (e.g.
sulfamethoxizole
and other
sulfonamide
antibiotics).
A dose dependent effect on TxB2 formation has been observed after high
doses of celecoxib.
PHARMACOKINETICS
Absorption:
Celecoxib
is
well
absorbed
reaching
peak
plasma
concentrations after approximately 2-3 hours. Dosing with food (high
fat
meal) delays absorption of celecoxib by about 1 hour resulting in