CLOPI-75 (Clopidogrel Tablets USP 75 mg)

Country: Malaysia

Language: English

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

Active ingredient:

CLOPIDOGREL BISULPHATE

Available from:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

CLOPIDOGREL BISULPHATE

Units in package:

30 Tablets

Manufactured by:

Macleods Pharmaceuticals Limited

Patient Information leaflet

CLOPI- 75
(Clopidogrel Tablets USP 75mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Page 1 of 3
WHAT IS IN THIS LEAFLET
1.
What CLOPI-75 is used
for
2. How CLOPI-75 works
thrombosis).
BEFORE YOU USE CLOPI-75
_When you must not use it_
- if you are allergic
_Taking other medicines_
Some
other
medicines
may
influence
the
use
of
Clopidogrel
or
vice
versa.
Please tell your doctor or
3.
Before you use CLOPI-
(hypersensitive)
to
pharmacist if you are taking
75
clopidogrel or
any
of the
or have recently taken any
4. How to take CLOPI-75
other ingredients in Clopi-75;
other medicines, including
5.
While you
are
using
- if you
have a medical
medicines obtained without a
CLOPI-75
condition
that is currently
prescription.
6. Side effects
causing bleeding such as a
Clopidogrel is metabolized
7. Storage and Disposal of
8. CLOPI-75
9. Product Description
10. Manufacturer
and
Product
Registration
Holder
11. Date of revision
WHAT CLOPI-75 IS USED FOR
You
have
been
prescribed
Clopi-75
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.
Clopi-75 can help to 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.
HOW CLOPI-75 WORKS
Clopi-75 belongs to a group
of
medicines
called
antiplatelet
medicinal
products.
Platelets
are
very
small structures in the blood,
which clump together during
blood clotting. By preventing
this
clumping,
antiplatelet
medicinal products reduce
the
chances
of
blood
clots
forming (a process called
stomach ulcer or bleeding
within the brain;
- if
you suffer
from severe
liver disease;
If
you
think
any
of
these
apply to you, or if you are in
any doubt at all, consult your
doctor
before
taking
Clopidogrel.
_Before you start to use it_
Tell your doctor if you:
plan to have s

Summary of Product characteristics

WARNING
Clopidogrel and the main circulating metabolite bind reversibly in
vitro to human plasma proteins
(98% and 94%, respectively). The binding is nonsaturable in vitro up
to a concentration of 100
µg/ml.
PHARMACODYNAMIC EFFECT
CLOPI-75
Each film coated tablet contains:
Clopidogrel
USP
Bisulfate
COMPOSITION
PHARMACOLOGY
Prevention of atherothrombotic events in Patients suffering from MI
(from a few days until <35
days), ischemic stroke (from 7 days until <6 months) or established
peripheral arterial disease.
Patients suffering from Non-ST segment elevation acute coronary
syndrome (unstable angina
or non-Q-wave MI), including patients undergoing stent placement
following percutaneous
coronary intervention; ST segment elevation acute MI, in combination
with Acetylsalicylic acid in
medically treated patients eligible for thrombolytic therapy.
Dose dependent inhibition of platelet aggregation can be seen 2 hours
after single oral doses of
Clopidogrel. Repeated doses of 75mg 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
75mg 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.
CLOPIDOGREL TABLETS USP 75 MG
INDICATIONS
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
MECHANISM OF ACTION
Clopidogrel is an inhibitor of platelet aggregation. A variety of
drugs that inhibit platelet function
have been shown to decrease morbid events in people with established
atherosclerotic
cardiovascular disease as evidenced by stroke or transient ischemic
attacks, myocardial
infarction, or need for bypass or angioplasty. This indicates that
platelets participate in the
initiation and/or evolution of these events and that inhibiting them
can reduce the event rate.
Clopidogrel is rapidly absorbed after oral adminis