Novexib 200mg Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

GoodScience Sdn. Bhd.

INN (Nama Antarabangsa):

CELECOXIB

Unit dalam pakej:

3x10 Capsules; 10x10 Capsules

Dikeluarkan oleh:

PT. Novell Pharmaceutical Laboratories

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NOVEXIB 200MG CAPSULES
Celecoxib
1
WHAT IS IN THE LEAFLET
1.
What
NOVEXIB 200MG CAPSULES
is used
for
2.
How
NOVEXIB 200MG CAPSULES
works
3.
Before you use
NOVEXIB 200MG
CAPSULES
4.
How to use
NOVEXIB 200MG CAPSULES
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NOVEXIB 200MG
CAPSULES
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT NOVEXIB 200MG CAPSULES IS USED FOR
• Management and treatment for of acute
pain in adults, primary dysmenorrhoea,
inflammation of arthritis, ankylosing
spondylitis and low back pain
HOW NOVEXIB 200MG CAPSULES WORKS
Celecoxib belongs to a group of medicines
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. Celecoxib acts by
reducing the production of prostaglandins,
thereby reducing the pain and inflammation.
BEFORE YOU USE NOVEXIB 200MG CAPSULES
-
_When you must not use it_
• 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 as a result of taking acetylsalicylic
acid or any other anti-inflammatory and
pain-relieving medicine (NSAIDs).
• If you are pregnant, trying to get pregnant
or think you may be pregnant. Breastfeeding
mothers also should not take this medication.
Please ask your doctor or pharmacist before
taking this medicine.
• If you are at known risk of heart disease
such as stroke or ischemic heart disease
-
_Before you start to use it_
Talk to your doctor or pharmacist before
taking
NOVEXIB 200MG CAPSULES
:
• If you are allergic to celecoxib or any other
ingredients of this product
• If you have had an allergic reaction to a
group of medicines called “sulfonamides”
(e.g., some antibiotics used to treat
infections)
• If you currently have an ulcer or bleeding
in your digestive tr

Ciri produk

NOVEXIB 200 MG CAPSULES
CELECOXIB
COMPOSITION
Each capsule contains 200 mg of Celecoxib.
Excipients: Croscarmellose sodium, Lactose monohydrate, Povidone,
Magnesium stearate, Sodium
lauryl sulphate, Purified water.
Description: Hard capsule color aqua blue (cap) and aqua blue (body),
white granules.
PHARMACODYNAMICS
Pharmacotherapeutic group: Non-steroidal anti-inflammatory and
antirheumatic drugs, NSAIDs,
Coxibs ATC Code : M01AH01
Mechanism of action
Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor
within the clinical dose range
(200-400 mg daily).
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 humans 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) prostacyc-
lin 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.
However, celecoxib may have no effect on platelet aggregation