CLOPIDOGREL-DRLA clopidogrel 75 mg tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Clopidogrel

Pieejams no:

Dr Reddys Laboratories Australia Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Clopidogrel

Lietošanas instrukcija

Clopidogrel-DRLA_CMI_V1_17032011
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CLOPIDOGREL-DRLA TABLETS
_Clopidogrel_
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
CLOPIDOGREL-DRLA. YOU MAY WISH TO KEEP IT TO READ AGAIN.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clopidogrel-DRLA
tablets.
It does not contain all the available
information. Some of the
information it contains may not
apply to you.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have benefits and risks.
In deciding to give you Clopidogrel-
DRLA, your doctor has weighed the
risks of you taking Clopidogrel-
DRLA against the expected benefits it
will have for you.
Always follow the instructions that
your doctor and pharmacist give you
about Clopidogrel-DRLA tablets.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT IS CLOPIDOGREL-
DRLA USED FOR
CLOPIDOGREL-DRLA CONTAINS THE
MEDICINE CLOPIDOGREL.
CLOPIDOGREL-DRLA BELONGS TO A
GROUP OF MEDICINES CALLED ANTI-
PLATELET MEDICINES.
Platelets are very small blood cells
which clump together during blood
clotting. By preventing this
clumping, anti-platelet medicines
reduce the chances of blood clots
forming (a process called
thrombosis).
Clopidogrel-DRLA is used to prevent
blood clots forming in hardened blood
vessels (a process known as
atherothrombosis) which can lead to
events such as stroke, heart attack or
death.
You may have been prescribed
Clopidogrel-DRLA to help
prevent blood clots forming and
to reduce the risk of stroke, heart
attack and death because:
•
YOU HAVE PREVIOUSLY SUFFERED A
HEART ATTACK, STROKE OR HAVE A
CONDITION KNOWN AS PERIPHERAL
ARTERIAL DISEASE (LEG PAIN ON
WALKING OR AT REST).
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
Clopidogrel-DRLA is only available
on a doctor's prescription
BEFORE YOU TAKE
CLOPIDOGREL-DRLA
_WHEN YOU MUST NOT TAKE IT _
YOU SHOULD NOT TAKE CLOPIDOGREL-
DRLA IF:
•
YOU ARE ALLERGIC TO CLOP

Produkta apraksts

Product Information
Clopidogrel-DRLA_V2
Page 1 of 13
CLOPIDOGREL-DRLA
NAME OF THE MEDICINE
CLOPIDOGREL-DRLA
Clopidogrel
DESCRIPTION
Clopidogrel
is
designated
chemically
as
methyl (+)-(S)-α-(2-chlorophenyl)-6,7-
dihydrothieno[3,2-c] pyridine-5(4H)-acetate.
The empirical formula of clopidogrel is C
16
H
16
CINO
2
S and its molecular weight is 321.83.
Clopidogrel has the following chemical structure:
CAS Number: 113 665-84-2 (Clopidogrel base).
Clopidogrel is a viscous gum. It is practically insoluble in water at
neutral pH but is more soluble
in acidic media, showing maximum solubility at pH 1.
Each
tablet
contains
cellulose-microcrystalline,
mannitol,
silicon
dioxide,
croscarmellose
sodium,
sodium stearylfumarate, lactose anhydrous and butyl hydroxylanisole.
The coating contains polyvinyl
alcohol, talc, titanium dioxide, macrogol 3350, lecithin and iron
oxide red.
PHARMACOLOGY
PHARMACODYNAMICS
Clopidogrel is a specific and potent inhibitor of platelet
aggregation. Platelets have an established role in
the pathophysiology of atherosclerotic disease and thrombotic events.
Long term use of anti-platelet
drugs has shown consistent benefit in the prevention of ischaemic
stroke, myocardial infarction and
vascular death in patients
at
increased risk of such
outcomes, including
those
with
established
atherosclerosis or a history of atherothrombosis.
The active metabolite, a thiol derivative, is formed by
oxidation
of
clopidogrel
to
2-oxoclopidogrel
and
subsequent
hydrolysis.
The
active
metabolite
of
clopidogrel selectively inhibits the binding of ADP to its platelet
P2Y12.receptor and the subsequent ADP-
mediated
activation of the GPIIb/IIIa complex, thereby inhibiting platelet
aggregation. Clopidogrel also
inhibits platelet aggregation induced by other agonists by blocking
the amplification of platelet activation
by released ADP. Due to the irreversible binding, platelets exposed
are affected for the remainder of
their lifespan and recovery of normal platelet function occurs at a
rate consistent with platelet turnover
(