Clopivid tablet 75 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOPIDOGREL HYDROGEN SULPHATE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

CLOPIDOGREL HYDROGEN SULPHATE

Unit dalam pakej:

30Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets; 30 Tablet Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CLOPIVID 75 MG TABLET_ _
CLOPIDOGREL (75MG)
1
WHAT IS IN THIS LEAFLET
1.
What Clopivid is used for
2.
How Clopivid works
3.
Before you use Clopivid
4.
How to use Clopivid
5.
While you are using Clopivid
6.
Side effects
7.
Storage and Disposal of Clopivid
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT CLOPIVID IS USED FOR
Clopivid is taken by adult to prevent
blood
clots
(thrombi)
forming
in
hardened
blood
vessels
(arteries),
a
process
known
as
atherothrombosis,
which
can
lead
to
atherothrombotic
events (such as stroke, heart attack, or
death).
You have been prescribed Clopivid to
help prevent blood clots and reduce the
risk of these severe events because:
- You have a condition of hardening of
arteries (also known as atherosclerosis),
and
- You have previously experienced a
heart attack, stroke or have a condition
known as peripheral arterial disease, or
- You have experienced a severe type of
chest pain known as ‘unstable angina’
or ‘myocardial infarction’ (heart attack).
For the treatment of this condition your
doctor may have placed a stent in the
blocked or narrowed artery to restore
effective blood flow. You may also be
given acetylsalicylic acid (a substance
present
in
many
medicines
used
to
relieve pain and lower fever as well as
to
prevent
blood
clotting)
by
your
doctor.
- You have experienced symptoms of a
stroke which go away within a short
period of time (also known as transient
ischemic attack) or an ischemic stroke
mild in severity. You may also be given
acetylsalicylic
acid
by
your
doctor
starting within the first 24 hours.
-
You
have
an
irregular
heartbeat,
a
condition called 'atrial fibrillation', and
you cannot take medicines known as
'oral
anticoagulants'
(vitamin
K
antagonists)
which
prevent
new
clots
from forming and prevent existing clots
from growing.
You should have been told that 'oral
anticoagulants' are more effective than
acetylsalicylic acid or the combined use
of Clopivid and a

Ciri produk

VICLO31-var (MY)3
CLOPIVID TABLET 75 MG
DESCRIPTION
Pink, round and bevel-edged with shallow convex faces
film-coated tablet
COMPOSITION
Each
tablet
contains
Clopidogrel
Hydrogen
Sulphate
equivalent to Clopidogrel 75 mg/tablet
PHARMACODYNAMICS
Clopidogrel acts by inhibiting platelet aggregation through
selective inhibition of binding of adenosine diphosphate
(ADP)
to
its
platelet
receptor,
and
the
subsequent
ADP-mediated
activation
of
the
GPIIb/IIIa
complex.
Biotransformation of clopidogrel is necessary to produce
inhibition of platelet aggregation.
Platelet aggregation induced by agonists other than ADP is
also inhibited by blocking the amplification of the platelet
activation by released ADP. The action of Clopidogrel in
modifying
the
platelet
ADP
receptor
is
irreversible.
Consequently, platelets exposed to clopidogrel are affected
for the remainder of their lifespan.
At steady state, which occurs within 3 to 7 days, the average
inhibition level observed with a dose of 75 mg per day was
between 40% and 60%. Platelet aggregation and bleeding
time gradually returned to baseline values, generally within 5
days after treatment was discontinued.
PHARMACOKINETICS
ABSORPTION
Clopidogrel is rapidly absorbed, after repeated doses of 75
mg per day. Absorption is at least 50%.
DISTRIBUTION
Plasma concentrations of the parent compound are very low
and below the quantification limit (0.00025 mg/l) beyond 2 hours.
METABOLISM
Clopidogrel is extensively metabolized by the liver to its main
metabolite, a carboxylic acid derivative. It represents about
85% of the circulating drug-related compounds and achieves
peak plasma level approximately 1 hour after dosing. Neither
the parent compound nor the carboxylic acid derivative has
platelet inhibiting effect.
Clopidogrel is a prodrug. The active metabolite, a thiol
derivative,
is
formed
by
oxidation
of
clopidogrel
to
2-oxoclopidogrel and subsequent hydrolysis. The oxidative
step is regulated primarily by Cytochrome P450 isoenzymes
2B6 and 3A4 and to a lesser extent by 1A1, 1A2 and 2