EFFIENT prasugrel (as hydrochloride) 5 mg tablet

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

prasugrel hydrochloride

Dostopno od:

Eli Lilly Australia Pty Ltd

INN (mednarodno ime):

Prasugrel hydrochloride

Status dovoljenje:

Registered

Navodilo za uporabo

EFFIENT
®
_EF'-FEE-ENT_
_Prasugrel hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Effient.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.lilly.com.au. The updated
leaflet may contain important
information about this medicine and
its use that you should be aware of.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
this medicine against the benefits
they expect it will have for you.
ALWAYS FOLLOW THE INSTRUCTIONS THAT
YOUR DOCTOR OR PHARMACIST GIVE YOU
ABOUT EFFIENT.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EFFIENT IS USED
FOR
Effient is used to prevent blood cells
from clotting.
It contains the active ingredient,
prasugrel.
It is used by people who have had a
PCI (percutaneous coronary
intervention) because of unstable
angina or a heart attack.
PCI is a procedure where a balloon-
tipped tube is used to open a blocked
artery, with or without a stent being
placed in the artery.
Effient belongs to the group of
medicines called antiplatelet agents.
It works by reducing the ability of
blood cells to clot. By preventing
blood cells from clumping, it reduces
the chances of blood clots forming (a
process called thrombosis), thereby
decreasing or even stopping blood
supply to the heart muscle.
Effient is always taken with aspirin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another use. If you want
more

Lastnosti izdelka

vA11-1_30Nov16
SUPERCEDES: vD11-1_7Nov16
Page 1 of 24
EFFIENT
®
(prasugrel hydrochloride)
NAME OF THE MEDICINE
EFFIENT

(prasugrel hydrochloride)
The active ingredient is prasugrel hydrochloride.
DESCRIPTION
Prasugrel, 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.
Prasugrel 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
Prasugrel 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.