PLAVIX (clopidogrel bisulfate) is an inhibitor
of A.P. induced
platelet aggregation acting by direct inhibition
of adenosine diphosphate
(ADP) binding to its receptor
and of the subsequent A.P.
mediated activation of the glycoprotein
GPIIb/ IIIa complex. Chemically it is methyl
(+)-( S)-a -(2-
chlorophenyl)-6,7-dihydrothieno[3,2-c] pyridine-5(4H)-acetate sulfate
(1:1). The empirical
formula of clopidogrel
bisulfate is C16H16Cl NO2SH2SO4
and its molecular weight
is a white to off-white
powder. It is practically insoluble in water
at neutral pH
but freely soluble at
pH 1. It also dissolves freely
in methanol, dissolves sparingly in methylene
chloride, and is practically insoluble in ethyl
ether. It has a specific
of about +56°.
PLAVIX for oral administration
is provided as pink, round, biconvex, engraved film- coated tablets
containing 97.875 mg of clopidogrel
bisulfate which is the molar
equivalent of 75
mg of clopidogrel base.
Each tablet contains
hydrogenated castor oil, microcrystalline cellulose, polyethylene
glycol 6000 and pregelatinized
starch as inactive ingredients.
The pink film coating contains
(red), hydroxypropyl methylcellulose 2910, polyethylene
glycol 6000 and titanium
dioxide. The tablets are polished with Carnauba wax.