Trixevas 90mg FC Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TICAGRELOR

Boleh didapati daripada:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Nama Antarabangsa):

TICAGRELOR

Unit dalam pakej:

3 x 10 Tablets; 6 x 10 Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
TRIXEVAS 90MG FC TABLET
Ticagrelor 90mg
Page 1 of 4
WHAT IS IN THIS LEAFLET
1.
What TRIXEVAS TABLET is
used for
2.
How TRIXEVAS TABLET works
3.
Before you take TRIXEVAS
TABLET
4.
How to take TRIXEVAS
TABLET
5.
While you are taking TRIXEVAS
TABLET
6.
Side effects
7.
Storage and Disposal of
TRIXEVAS TABLET
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT TRIXEVAS TABLET IS USED
FOR
TRIXEVAS
TABLET
contains
an
active substance called ticagrelor. This
belongs to a group of medicines called
anti-platelet agents.
TRIXEVAS TABLET in combination
with
acetylsalicylic
acid
(another
antiplatelet agent) is only to be used in
adults.
You
have
been
given
TRIXEVAS
TABLET
because
you
have had:
•
a heart attack, or
•
unstable angina (angina or chest pain
that is not well controlled).
TRIXEVAS
TABLET
reduces
the
chances
of
you
having
a
stroke
or
another heart attack or dying from a
disease related to your heart or blood
vessels.
HOW TRIXEVAS TABLET WORKS
TRIXEVAS
TABLET
affects
cells
called ‘platelets. Platelets are very small
cells in your blood.
These cells help
stop bleeding by clumping together to
plug tiny holes in blood vessels that are
cut or damaged.
However, clots can also form inside
a
damaged blood vessel. This can be very
dangerous because:
•
the clot can cut off the blood supply
completely; this can cause a heart
attack
(myocardial
infarction)
or
stroke.
•
the clot can partly block the blood
vessels to the heart - this reduces the
blood flow to the heart. This can
cause chest pain which comes and
goes (called ‘unstable angina’).
TRIXEVAS TABLET helps stop the
clumping of platelets. This reduces
the chance of a blood clot forming
that can block a blood vessel and
reduce blood flow.
Your doctor will usually also tell you
to take acetylsalicylic acid. This is a
substance present in many medicines
used to prevent blood clotting.
BEFORE YOU TAKE TRIXEVAS
TABLET
-
_When you must not take it _

Ciri produk

Page 1 of 7
TRIXEVAS 90MG FC TABLET
DESCRIPTION
TRIXEVAS is a round, biconvex, yellow, film-coated tablet marked
“T” on one side and plain on the other side.
COMPOSITION
TRIXEVAS Tablet: Each tablet contains 90 mg of ticagrelor.
PHARMACODYNAMICS
Pharmacotherapeutic group: Platelet aggregation inhibitors, ATC code:
B01AC24
MECHANISM OF ACTION
Ticagrelor is a member of the chemical class
cyclopentyltriazolopyrimidines (CPTP), which is an oral, direct
acting, selective and reversibly binding
P2Y12 receptor antagonist that prevents ADP-mediated P2Y12 dependent
platelet activation and aggregation. Ticagrelor does not prevent ADP
binding, but when bound to the P2Y12 receptor prevents ADP-induced
signal transduction. Since platelets participate in the initiation
and/or
evolution of thrombotic complications of atherosclerotic disease,
inhibition of platelet function has been shown to reduce the risk of
CV events
such as death, MI or stroke.
Ticagrelor also increases local endogenous adenosine levels by
inhibiting equilibrative nucleoside transporter-1 (ENT-1). Ticagrelor
has been
documented to augment the following adenosine-induced effects:
vasodilation, inhibition of platelet function and dyspnoea. However, a
link
between the observed increases in adenosine and clinical outcomes
(e.g., morbidity mortality) has not been clearly elucidated.
PHARMACODYNAMIC EFFECTS
_Onset of action _
In patients with stable coronary artery disease (CAD) on ASA,
ticagrelor demonstrates a rapid onset of pharmacological effect as
demonstrated by
a mean inhibition of platelet aggregation (IPA) for ticagrelor at 0.5
hours after 180 mg loading dose of about 41%, with the maximum IPA
effect of
89% by 2-4 hours post dose, and maintained between 2-8 hours. 90% of
patients had final extent IPA >70% by 2 hours post dose.
_Offset of action_
If a CABG procedure is planned, ticagrelor bleeding risk is increased
compared to clopidogrel when discontinued within less than 96 hours
prior to
procedure.
_Switching data_
Switching from clopidogrel 75 mg t