Clopistad (Clopidogrel Film-Coated Tablet 75mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOPIDOGREL BISULPHATE

Boleh didapati daripada:

STADPHARM SDN. BHD.

INN (Nama Antarabangsa):

CLOPIDOGREL BISULPHATE

Unit dalam pakej:

3x10'stablet Tablets

Dikeluarkan oleh:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CLOPISTAD
Clopidogrel (75 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Clopistad is used for
2.
How Clopistad works
3.
Before you take Clopistad
4.
How to take Clopistad
5.
While you are using Clopistad
6.
Side effects
7.
Storage and disposal of Clopistad
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CLOPISTAD
IS USED FOR
Clopidogrel is indicated for the
prevention of blood clot formation
inside blood vessels, such as:

You suffer from heart attack (from a
few days until less than 35 days),
stroke (from 7 days until less than 6
months) or condition known as artery
narrowing disease.

You have experienced a severe type of
chest pain known as unstable angina
or 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.
HOW CLOPISTAD WORKS
Clopidogrel tablets belong to a group of
medicines called antiplatelet. Platelets
are very small structures in the blood,
smaller than red or white blood cells,
which clump together during blood
clotting. By preventing this clumping,
antiplatelet medicinal products reduce
the chances of blood clots forming.
BEFORE YOU TAKE CLOPISTAD
_-When you must not take it_

If you are known to have
hypersensitivity to clopidogrel or any
ingredients in the formulation._ _

If you have severe liver impairment._ _

If you have a medical condition that is
currently causing bleeding such as a
peptic ulcer or bleeding within the
brain.
If you think any of these apply to you,
or if you are in any doubt at all,
consult your doctor before taking this
medication.
_ _
_-Before you start to take it_
If any of the situations mentioned below
apply to you, you should tell your
doctor before taking this medication:

If you have a risk of bleeding such as
serious injury, surgery, risk of internal
bleeding (such as stomach ulcer), a
blood disorder (bleeding inside any
tissues, organs or joints of your body)

Ciri produk

CLOPISTAD
COMPOSITION
Active ingredient:
One film- coated tablet contains clopidogrel 75 mg.
DESCRIPTION
Pink, round-shaped, biconvex film-coated tablet, engraved with
”75” on one side and plain on the other side.
PHARMACODYNAMICS
Clopidogrel selectively inhibits the binding of adenosine diphosphate
(ADP) to its platelet receptor and the
subsequent
ADP-mediated
activation
of
the
glycoprotein
GPIIb/IIIa
complex,
thereby
inhibiting
platelet
aggregation. Biotransformation of clopidogrel is necessary to produce
inhibition of platelet aggregation, but an
active metabolite responsible for the activity of the drug has not
been isolated. Clopidogrel also inhibits platelet
aggregation induced by agonists other than ADP by blocking the
amplification of platelet activation by released
ADP. Clopidogrel does not inhibit phosphodiesterase activity.
Clopidogrel
acts
by
irreversibly
modifying
the
platelet
ADP
receptor.
Consequently,
platelets
exposed
to
clopidogrel are affected for the remainder of their lifespan.
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.
PHARMACOKINETICS
Clopidogrel is rapidly but incompletely absorbed after oral
administration, absorption appears to be at least 50%.
It is a prodrug and is extensively metabolised in the liver, mainly to
the inactive carboxylic acid derivative. The
oxidative step is regulated primarily by Cytochrome P450 isoenzymes
2B6, 3A4, 1A1, 1A2 and 2C19. The active
metabolite appears to be a thiol derivative but has not been
identified in plasma. Clopidogrel and the carboxylic
acid derivative are highly pla