LIXIANA

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

EDOXABEN TOSYLATE

MAH:

KALBE FARMA - Indonesia

INN:

EDOXABEN TOSYLATE

dosage:

30 MG

pharmaceutical_form:

TABLET SALUT SELAPUT

units_in_package:

DUS, 7 BLISTER @ 14 TABLET SALUT SELAPUT

manufactured_by:

DAICHI SANKYO EUROPE GmbH - Germany

authorization_date:

2018-10-15

SPC

1
LIXIANA
Compositions
Each film-coated tablet contains:
Edoxaban..................................................................................................................15
mg
Edoxaban..................................................................................................................30
mg
Edoxaban..................................................................................................................60
mg
PHARMACOLOGY
MECHANISM OF ACTIONS
Edoxaban is a highly selective, direct and reversible inhibitor of
factor Xa, the serine protease
located in the final common pathway of the coagulation cascade.
Edoxaban inhibits free factor
Xa, and prothrombinase activity. Inhibition of factor Xa in the
coagulation cascade reduces
thrombin generation, prolongs clotting time and reduces the risk of
thrombus formation.
Pharmacodynamic effects
Edoxaban
produces
rapid
onset
of
pharmacodynamic
effects
within
1-2
hours,
which
corresponds with peak edoxaban exposure (Cmax). The pharmacodynamic
effects measured
by anti-factor Xa assay are predictable and correlate with the dose
and the concentration of
edoxaban. As a result of FXa inhibition, edoxaban also prolongs
clotting time in tests such as
prothrombin time (PT), and activated partial thromboplastin time
(aPTT). Changes observed in
these clotting tests are expected at the therapeutic dose, however,
these changes are small,
subject to a high degree of variability, and not useful in monitoring
the anticoagulation effect of
edoxaban.
PHARMACOKINETICS
_Absorption _
Edoxaban
is
absorbed
with
peak
plasma
concentrations
within
1-2
hours.
The
absolute
bioavailability is approximately 62%. Food increases peak exposure to
a varying extent, but has
minimal effect on total exposure. Edoxaban was administered with or
without food in the
ENGAGE AF-TIMI 48 and the Hokusai-VTE studies. Edoxaban is poorly
soluble at pH of 6.0 or
higher.
Co-administration of
proton-pump
inhibitors
had no relevant
impact
on
edoxaban
exposure.
_Distribution _
Disposition is biphasic.