VYTORIN

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

SIMVASTATIN, EZETIMIBE

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

SIMVASTATIN, EZETIMIBE

Dosis:

20 MG /10 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 3 BLISTER @ 10 TABLET

Diproduksi oleh:

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) - Singapore

Tanggal Otorisasi:

2021-07-17

Karakteristik produk

VYTORIN

Tablet
Ezetimibe/Simvastatin
COMPOSITION
Each
tablet
of
VYTORIN
contains
10 mg
of
ezetimibe
and
10 mg
of
simvastatin
(VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20).
Clinical testing has been conducted over the dose range 10 mg
ezetimibe/10 mg
simvastatin to 10 mg ezetimibe/80 mg simvastatin.
THERAPEUTIC CLASS
VYTORIN (ezetimibe/simvastatin) is a lipid-lowering product that
selectively inhibits the
intestinal absorption of cholesterol and related plant sterols and
inhibits the endogenous
synthesis of cholesterol.
MECHANISM OF ACTIONS
VYTORIN
Plasma cholesterol is derived from intestinal absorption and
endogenous synthesis.
VYTORIN
contains
ezetimibe
and
simvastatin,
two
lipid-lowering
compounds
with
complementary mechanisms of action. VYTORIN reduces elevated total-C,
LDL-C, Apo
B, TG, and non-HDL-C, and increases HDL-C through dual inhibition of
cholesterol
absorption and synthesis.
EZETIMIBE
Ezetimibe inhibits the intestinal absorption of cholesterol. Ezetimibe
is orally active and
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-PickC1-
Like 1 (NPC1L1), which is responsible for the intestinal uptake of
cholesterol and
phytosterols.
DISETUJUI OLEH BPOM : 14/06/2021
ID REG : EREG100373VR12100060;
EREG100373VR12100059.
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;
statins reduce cholesterol synthesis in the liver and together these
distinct mechanisms
provide complementary cholesterol reduction.
In a 2-week clinical study
in
18 hypercholesterolemic patients, Ezetimibe inhibited
intestinal cholesterol absorption by 54%, compared with placebo.
A series of preclinical studies was performed to determine the
selectivity of ezetimibe for
inhibiting cholesterol ab