CLAVIX 75MG TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOPIDOGREL BISULPHATE

Boleh didapati daripada:

ACCORD HEALTHCARE SDN.BHD.

INN (Nama Antarabangsa):

CLOPIDOGREL BISULPHATE

Unit dalam pakej:

90 Tablets; 30 Tablets

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CLAVIX 75MG TABLETS
Clopidogrel Tablets USP (75mg)
1
WHAT IS IN THIS LEAFLET?
1.
What CLAVIX 75mg
Tablets is used for
2.
How CLAVIX 75 works
3.
Before you use CLAVIX 75
4.
How to take CLAVIX 75
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
CLAVIX 75
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision.
11.
Serial Number
WHAT CLAVIX 75MG TABLET IS
USED FOR
You have been prescribed
CLAVIX 75 because you are at
risk for experiencing unwanted
blood clots (thrombi). These
blood clots can lead to
symptoms which present in
different manners, such as
strokes, unstable angina, heart
attacks, or peripheral arterial
disease (leg pain on walking or
at rest). CLAVIX 75 is taken to
prevent further blood clots from
forming thereby reducing the
risk of having unstable angina, a
heart attack or another stroke.
HOW CLAVIX 75 WORKS
CLAVIX 75 tablets belong to a
group of medicines called
antiplatelet drugs. Platelets are
very small structures in blood,
smaller than red or white blood
cells, which clump together
during blood clotting. By
preventing this clumping,
antiplatelet drugs reduce the
chances of blood clots forming
(a process called thrombosis).
BEFORE YOU USE CLAVIX 75
_-When you must not use it _
_ _
•
If you are allergic to any of
the substances contained in the
tablets.
•
If you have a medical
condition that is causing
bleeding, such as a stomach
ulcer.
•
If you have liver disease or
damage.
_ _
_ _
_-Before you start to use it _
Tell your doctor or pharmacist
if:
•
You are pregnant or become
pregnant on CLAVIX 75, or you
are breast-feeding
•
You have a recent serious
injury.
•
You have recently
undergone surgery (including
dental surgery).
•
You will be having surgery.
Your doctor may ask you to stop
taking CLAVIX 75 for 5-7 days
before your surgery.
•
You have a blood disorder
that makes you prone to internal
bleeding (bleeding inside any
tissues, organs or joints of your
body) or tend to bleed

Ciri produk

CLAVIX 75 MG TABLETS
(CLOPIDOGREL TABLETS USP 75 MG)
• NAME AND STRENGTH OF ACTIVE INGREDIENT Clopidogrel Bisulfate USP (Form I) equivalent to Clopidogrel
75 mg
• PRODUCT DESCRIPTION
Pink coloured, round, biconvex, film coated tablets, debossed
with “Cl” on one side and plain on other side.
• PHARMACODYNAMICS & PHARMACOKINETICS
_Pharmacodynamic properties_
Clopidogrel is a prodrug that is metabolized by CYP450
enzymes
to
the
active
thiol
derivative.
The
active
thiol
derivative, selectively and irreversibly binds to the adenosine
diphosphate (ADP) P2Y12 receptor on platelets. This prevents ADP from
binding
and activating the glucoprotein GPIIb/IIIa complex, which is necessary
for platelet
aggregation.
Additionally,
other
agonists
are
blocked
from
inducing
platelet
aggregation because they are dependent on platelet activation, which
is mediated
by ADP. The action is irreversible for the lifespan of the platelet (7
to 10 days).
Platelet aggregation induced by agonists other than ADP is also
inhibited by
blocking the amplification of platelet activation by released ADP.
Dose dependent inhibition of platelet aggregation can be seen 2 hours
after single
oral doses of clopidogrel. Repeated doses of 75 mg clopidogrel per day
inhibit
ADP-induced platelet aggregation on the first day, and inhibition
reaches steady
state between Day 3 and Day 7. At steady state, the average inhibition
level
observed with a dose of 75 mg clopidogrel per day was between 40% and
60%.
Platelet aggregation and bleeding time gradually return to baseline
values after
treatment is discontinued, generally in about 5 days.
_Pharmacokinetic properties_
_Absorption _
Based on urinary excretion of metabolites, after single and multiple
oral doses of
clopidogrel 75 mg/day, absorption is rapid and is at least 50%
(dose-limited). Food
has no effect on the absorption of clopidogrel.
_Distribution _
Clopidogrel and the carboxylic acid derivative (metabolite) are highly
protein bound.
_Metabolism _
Clopidogrel is extensively metabolised by the liver