EFFIENT Tablet 5mg

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Prasugrel Hydrochloride 5.49mg eqv Prasugrel

Beschikbaar vanaf:

ELI LILLY (SINGAPORE) PTE LTD

ATC-code:

B01AC22

Dosering:

5mg/tablet

farmaceutische vorm:

TABLET, FILM COATED

Samenstelling:

Prasugrel Hydrochloride 5.49mg eqv Prasugrel 5 mg

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

Eli Lilly and Company

Autorisatie-status:

ACTIVE

Autorisatie datum:

2010-05-05

Bijsluiter

Page 1 of 18 
NAME OF THE MEDICINE 
Effient (prasugrel hydrochloride) 
The active ingredient is prasugrel hydrochloride. 

DESCRIPTION 
Effient,  an  adenosine  diphosphate  (ADP)  receptor  antagonist  of the  thienopyridine  class,  is  a  potent 
inhibitor  of  platelet  activation  and  aggregation  mediated  by  the  P2Y
12 
ADP  receptor.    Chemically, 
prasugrel  hydrochloride  is  (±)-2-[2-acetyloxy-6,7-dihydrothieno[3,2-_c_]pyridin-5(_4_H)-yl]-1-cyclopropyl-2-
(2-fluorophenyl)ethanone  hydrochloride.    The  empirical  formula  is  C
20
H
20
FNO
3
S•HCl  which 
corresponds to a molecular weight of 409.90.  The
chemical structure is: 

The CAS number for prasugrel hydrochloride is 389574-19-0. 

It is a white to light brown solid. Prasugrel hydrochloride is soluble at pH 2, slightly soluble at pH 3 to 
4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 
1- and 2-propanol and acetone. It is practically insoluble
in diethyl ether and ethyl acetate. 

Effient is available for oral  administration as a 5 mg or 10 mg double-arrow shaped, film-coated, not 
scored  tablet,  debossed  on  each  side.    Each  beige  10  mg  tablet  is  manufactured  with  10.98  mg 
prasugrel hydrochloride, equivalent to 10 mg of prasugrel and each yellow 5 mg tablet with 5.49 mg 
prasugrel  hydrochloride,  equivalent  to  5  mg  of  prasugrel.  Other  ingredients  include  mannitol, 
hypromellose,  croscarmellose  sodium,  cellulose  -  microcrystalline,  and  vegetable  magnesium 
stearate. The colour coatings contain lactose, hypromellose, titanium dioxide, glycerol  triacetate, iron 
oxide yellow CI77492, and iron oxide red CI77491. 

PHARMACOLOGY 

Productkenmerken

Page 1 of 18
NAME OF THE MEDICINE
Effient (prasugrel hydrochloride)
The active ingredient is prasugrel hydrochloride.
DESCRIPTION
Effient, an adenosine diphosphate (ADP) receptor antagonist of the
thienopyridine class, is a potent
inhibitor of platelet activation and aggregation mediated by the P2Y
12
ADP receptor. Chemically,
prasugrel hydrochloride is
(±)-2-[2-acetyloxy-6,7-dihydrothieno[3,2-_c_]pyridin-5(_4_H)-yl]-1-cyclopropyl-2-
(2-fluorophenyl)ethanone
hydrochloride.
The
empirical
formula
is
C
20
H
20
FNO
3
S•HCl
which
corresponds to a molecular weight of 409.90. The chemical structure
is:
The CAS number for prasugrel hydrochloride is 389574-19-0.
It is a white to light brown solid. Prasugrel hydrochloride is soluble
at pH 2, slightly soluble at pH 3 to
4, and practically insoluble at pH 6 to 7.5. It also dissolves freely
in methanol and is slightly soluble in
1- and 2-propanol and acetone. It is practically insoluble in diethyl
ether and ethyl acetate.
Effient is available for oral administration as a 5 mg or 10 mg
double-arrow shaped, film-coated, not
scored tablet, debossed on each side. Each beige 10 mg tablet is
manufactured with 10.98 mg
prasugrel hydrochloride, equivalent to 10 mg of prasugrel and each
yellow 5 mg tablet with 5.49 mg
prasugrel
hydrochloride,
equivalent
to
5
mg
of
prasugrel.
Other
ingredients
include
mannitol,
hypromellose,
croscarmellose
sodium,
cellulose
-
microcrystalline,
and
vegetable
magnesium
stearate. The colour coatings contain lactose, hypromellose, titanium
dioxide, glycerol triacetate, iron
oxide yellow CI77492, and iron oxide red CI77491.
PHARMACOLOGY
MECHANISM OF ACTION
Effient is an inhibitor of platelet activation and aggregation through
the irreversible binding of its active
metabolite to the P2Y
12
class of ADP receptors on platelets. A variety of drugs that inhibit
platelet
function have been shown to decrease morbid events in people with
established atherosclerotic
disease. Since platelets participate in the initiation and/or
evolution of thrombotic complication