Clopidogrel Sanofi

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Clopidogrel hydrogen sulfate

Dostępny od:

Sanofi-Aventis Australia Pty Ltd

Klasa:

Medicine Registered

Charakterystyka produktu

clopidogrel-sanofi-ccdsv17-piv7-31may13  
1 

PRODUCT INFORMATION 
CLOPIDOGREL SANOFI



NAME OF THE MEDICINE 

CLOPIDOGREL SANOFI
 

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 thiol derivative, is formed by oxidation
of clopidogrel to 2-oxoclopidogrel 
and subsequent hydrolysis.  The active metabolite of
clopidogrel selectively inhib