Plavix

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Clopidogrel hydrogen sulfate

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

PLAVIX
®
 TABLETS

_Clopidogrel_
CONSUMER MEDICINE INFORMATION

Please read this leaflet carefully before you start taking Plavix. You
may wish to keep it to read again.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Plavix 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 Plavix,
your doctor has weighed the risks of
you taking Plavix against the
expected benefits it will have for
you.
Always follow the instructions that
your doctor and pharmacist give you
about Plavix tablets.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT IS PLAVIX USED
FOR
PLAVIX CONTAINS THE MEDICINE
CLOPIDOGREL. PLAVIX 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).
Plavix 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
Plavix 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).
•
YOU HAVE SUFFERED ACUTE
CORONARY SYNDROME (EITHER A
SEVERE TYPE OF CHEST PAIN CALLED
UNSTABLE ANGINA, OR A HEART
ATTACK). IN THIS CASE YOU MAY
ALSO BE PRESCRIBED ASPIRIN.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
Plavix is only available on a doctor's
prescription.
BEFORE YOU TAKE PLAVIX
_WHEN YOU MUST NOT TAKE IT_
YOU SHOULD NOT TAKE PLAVIX IF:
•
YOU ARE ALLE

Summary of Product characteristics

plavix-ccdsv17piv11-31may13 

1 

PRODUCT INFORMATION 
PLAVIX



NAME OF THE MEDICINE  
PLAVIX


Clopidogrel hydrogen sulfate 
DESCRIPTION 
Clopidogrel hydrogen sulfate is designated chemically as methyl (+)-(S)-

-(2-chlorophenyl)-6,7-
dihydrothieno[3,2-c] pyridine-5(4H)-acetate sulfate (1:1). 
The empirical formula of clopidogrel hydrogen sulfate is C
16
H
16
ClNO
2
S.H
2
SO
4
 and its molecular 
weight is 419.9. 
Clopidogrel hydrogen sulfate has the following chemical structure: 
_ _
C O
O
S
N
H
Cl
,H
2
SO
4
CH
3

CAS Number:   
120202-66-6  (Clopidogrel hydrogen sulfate), 
113 665-84-2  (Clopidogrel base). 
Clopidogrel hydrogen sulfate is a white to off-white powder.  It is practically insoluble in water at 
neutral  pH  but  freely  soluble  at  pH  1.  It  is  freely  soluble  in  methanol,  sparingly  soluble  in 
methylene chloride and is practically insoluble in ethyl ether. It has a specific optical rotation of 
about + 56

. 
Each  tablet  contains  mannitol,  macrogol  6000,  microcrystalline  cellulose,  hydrogenated  castor 
oil,  hydroxypropylcellulose.  The  coating  contains  lactose,  hypromellose,  titanium  dioxide, 
glycerol triacetate, iron oxide red and carnauba wax. 
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