AURO-CLOPIDOGREL

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

Clopidogrel hydrogen sulfate; Clopidogrel (as hydrogen sulfate)

Prieinama:

Aurobindo Pharma Australia Pty Ltd

Klasė:

Medicine Registered

Pakuotės lapelis

AURO-CLOPIDOGREL  

CONSUMER MEDICINE INFORMATION

Ver 1.3

Page 1 of 4 

AURO-CLOPIDOGREL 75  
Clopidogrel (as hydrogen sulfate) 
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about AURO-
CLOPIDOGREL.  

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 AURO-
CLOPIDOGREL, your doctor has 
weighed the risks of you taking 
AURO-CLOPIDOGREL against the 
expected benefits it will have for you.  

Always follow the instructions that 
your doctor and pharmacist give you 
about AURO-CLOPIDOGREL.  

IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST.  
_ _
WHAT AURO-CLOPIDOGREL 
IS USED FOR

AURO-CLOPIDOGREL CONTAINS 
THE MEDICINE CLOPIDOGREL.    AURO-
CLOPIDOGREL 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).  

AURO-CLOPIDOGREL 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 
AURO-CLOPIDOGREL 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 P

Prekės savybės

 
Product Information:   
AURO-CLOPIDOGREL (Clopidogrel Tablets 75 mg)  

   Ver 1.3 

Page 1 of 22 

PRODUCT INFORMATION 

AURO-CLOPIDOGREL 75 (75 MG CLOPIDOGREL AS HYDROGEN SULFATE) 

NAME OF MEDICINE  

The name of the medicine is clopidogrel as hydrogen sulfate. 

CHEMICAL NAME: (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]
pyridine-5(4H)-acetate 
sulfate (1:1). 
MOLECULAR FORMULA: C
16
H
16
ClNO
2
S.H
2
SO
4 
MOLECULAR WEIGHT: 419.90 
CAS REGISTRY NUMBER: _[120202-66-6] _

DESCRIPTION  
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 practically insoluble in ether. 

INACTIVE: Cellulose - microcrystalline,
mannitol, hydroxypropylcellulose (low-substituted, LH-11 
& LH-21), crospovidone, macrogol 6000, castor oil-hydrogenated and
opadry II Pink 32K14834 
(ARTG No. 12033). 

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 
acti