EZETROL

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

EZETIMIBE

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

EZETIMIBE

Dosis:

10 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 3 BLISTER @ 10 TABLET

Diproduksi oleh:

MSD INTERNATIONAL GMBH (PUERTO RICO BRANCH) LLC - Puerto Rico

Tanggal Otorisasi:

2020-04-04

Karakteristik produk

EZETROL

Tablet
Ezetimibe
COMPOSITION
Each tablet of EZETROL for oral administration contains 10 mg
ezetimibe.
THERAPEUTIC CLASS
EZETROL is in a new class of
lipid-lowering compounds that
selectively inhibit
the
intestinal absorption of cholesterol and related plant sterols.
MECHANISM OF ACTIONS
Ezetimibe
has
a
mechanism of
action
that
differs
from other
classes
of
cholesterol-
reducing compounds (e.g.,
statins,
bile acid sequestrants [resins],
fibric
acid derivatives,
and plant
stanols).
The molecular
target
of
ezetimibe is the sterol
transporter,
Niemann-Pick C1-Like 1 (NPC1L1),
which is responsible for
the intestinal
uptake of cholesterol and phytosterols.
Ezetimibe localizes at the brush border of the small
intestine and inhibits the absorption
of
cholesterol,
leading to a decrease in the delivery of
intestinal
cholesterol
to the liver.
This causes a reduction of
hepatic cholesterol
stores and an increase in clearance of
cholesterol
from the blood. Ezetimibe does not increase bile acid excretion (like
bile acid
sequestrants) and does not inhibit cholesterol synthesis in the liver
(like statins).
In a 2-
week clinical
study in 18 hypercholesterolemic patients,
EZETROL inhibited
intestinal
cholesterol
absorption by 54 %,
compared with placebo.
By inhibiting the
absorption of
intestinal
cholesterol,
ezetimibe reduces the delivery of
cholesterol
to the
liver.
Statins
reduce
cholesterol
synthesis
in
the
liver.
Together
these
distinct
mechanisms provide complementary cholesterol reduction. EZETROL,
administered with
a statin,
reduces total-
C,
LDL-
C,
Apo B,
and TG and increases HDL-
C in patients
with hypercholesterolemia,
beyond either treatment
alone.
Administration of
EZETROL
with fenofibrate is effective in improving serum total-
C,
LDL-
C,
Apo B,
TG,
HDL-
C,
DISETUJUI OLEH BPOM : 17/06/2021
ID : EREG100373VR12100073
and non-
HDL-
C in patients with mixed hyperlipidemia. The effects of Ezetimibe
given
either
alone or
in addition to an HMG-CoA reductase inhibitor
or
fenofibrate on
cardiovascular morbidity an