Cardivix 75mg Film Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOPIDOGREL BESYLATE

Boleh didapati daripada:

Alpharme Plc Sdn. Bhd.

INN (Nama Antarabangsa):

CLOPIDOGREL BESYLATE

Unit dalam pakej:

30 Tablets; 100 Tablets

Dikeluarkan oleh:

Pharmathen S.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
_ _
CARDIVIX 75MG FILM COATED TABLET
_Clopidogrel Besylate 112.10mg equivalent to clopidogrel 75mg. _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Cardivix is used for
2.
How Cardivix works
3.
Before you use Cardivix
4.
How to use Cardivix
5.
While you are using Cardivix
6.
Side effects
7.
Storage and disposal of Cardivix
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT CARDIVIX IS USED FOR
Cardivix
is
taken
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 Cardivix 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)
-
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
should
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 an irregular heartbeat, a
condition called 'atrial fibrillation',
and
you
are
not
suitable
take
medicines
known
as
'oral
anticoagulants'
(vitamin
K
antagonists)
which
prevent
new
clots
from
forming
and
prevent
existing clots from growing
Your doctor should
have prescribed
Cardivix
plus
acetylsalicylic
acid
if
you cannot take 'oral anticoagulants'
and you do have a low bleeding risk to
prevent
atherothrombotic
and
thromboembolic
events,
including
stroke.
HOW CARDIVIX WORKS
Cardivix
belongs
to
a
group
of
medicines called antiplatelet medicinal
products.
Platelets
are
very
s

Ciri produk

1
CARDIVIX 75MG FILM COATED TABLET
PRODUCT NAME
Cardivix 75mg Film Coated Tablet
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each tablet contains clopidogrel besylate 112.10mg equivalent to
clopidogrel 75mg
PRODUCT DESCRIPTION
Cardivix 75mg film-coated tablets are presented as pink, round,
biconvex film-coated tablets
9.1mm ± 0.1mm in diameter and thickness 4.2mm ± 0.2mm.
PHARMACODYNAMICS
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation
inhibitors excl. heparin.
ATC Code: BO1AC/04.
_Mechanism of action _
Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of
platelet aggregation.
Clopidogrel must be metabolised by CYP450 enzymes to produce the
active metabolite that
inhibits platelet aggregation.
The active metabolite of clopidogrel selectively inhibits the binding
of adenosine diphosphate
(ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated
activation of the
glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet
aggregation. Due to the irreversible
binding, platelets exposed are affected for the remainder of their
lifespan (approximately 7-10
days) and recovery of normal platelet function occurs at a rate
consistent with platelet turnover.
Platelet aggregation induced by agonists other than ADP is also
inhibited by blocking the
amplification of platelet activation by released ADP.
Because the active metabolite is formed by CYP450 enzymes, some of
which are polymorphic or
subject to inhibition by other medicinal products, not all patients
will have adequate platelet
inhibition.
_ _
_Pharmacodynamic effects _
Repeated doses of 75 mg per day produced substantial inhibition of
ADP-induced platelet
aggregation from the first day; this increased progressively and
reached steady state between
Day 3 and Day 7. At steady state, 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.
2
PHARMACOKINET