EZIVAS (Ezetimibe Tablets 10mg)

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

EZETIMIBE

Dostępny od:

CAMBER LABORATORIES SDN. BHD.

INN (International Nazwa):

EZETIMIBE

Sztuk w opakowaniu:

3 x 10s Tablets

Wyprodukowano przez:

Hetero Labs Limited

Ulotka dla pacjenta

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
EZIVAS (EZETIMIBE TABLETS 10MG)_ _
Ezetimibe (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What EZIVAS is used for
2.
How EZIVAS works
3.
Before you take EZIVAS
4.
How to take EZIVAS
5.
While you are taking EZIVAS
6.
Side effects
7.
Storage and Disposal of
EZIVAS
8.
Product Description
9.
Manufacturer and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
1. WHAT EZIVAS_ _IS USED FOR
EZIVAS
is
a
tablet
that
contains
10mg
of
ezetimibe
as
the
active
ingredient.
- EZIVAS is a cholesterol-lowering
medicine.
-
EZIVAS
is
for
patients
whose
cholesterol levels are too high and
when diet alone cannot lower these
levels adequately.
-
EZIVAS
reduces
elevated
total
cholesterol, LDL (bad) cholesterol
and triglycerides and increases HDL
(good) cholesterol.
- EZIVAS may be taken with other
cholesterol-lowering
medicines
known as statins or alone, in addition
to diet.
-
EZIVAS
may
be
taken
with
fenofibrate,
another
cholesterol-
lowering
medicine,
in
addition
to
diet.
-
For
patients
with
heart
disease,
EZIVAS combined with cholesterol-
lowering
medicines
called
statins
reduces
the
risk
of
heart
attack,
stroke,
surgery
to
increase
heart
blood
flow,
or
hospitalisation
for
chest pain.
If
you
have
sitosterolemia,
your
doctor
has
prescribed
EZIVAS
to
lower the level of plant sterols in
your blood.
Sitosterolemia is a hereditary illness
that
increases
the
levels
of
plant
sterols in your blood.
2. HOW EZIVAS_ _WORKS
EZIVAS
works
by decreasing
the
absorption of cholesterol in the small
intestine.
Statins
and
fenofibrate
lower cholesterol in a different way;
they work in the liver.
EZIVAS
adds
to
the
cholesterol-
lowering
effect
of
statins
and
fenofibrate.
WHY
HAS
MY
DOCTOR
PRESCRIBED
EZIVAS?
Your doctor has prescribed EZIVAS
to reduce the amount of cholesterol
and triglycerides in your blood.
Cholesterol is one of several fatty
substances found in the bloodstream.
Your total cholesterol is made up
mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad”
cholester

Charakterystyka produktu

Font Size: 7
EZIVAS (EZETIMIBE TABLETS 10MG)
ACTIVE INGREDIENT
Each uncoated tablet contains 10mg of Ezetimibe.
DOSAGE FORM
Oral Tablets
PRODUCT DESCRIPTION
White to off white, capsule shaped, flat faced bevel edged tablets
debossed with ‘I’ on one side and ‘83’ on the
other side.
PHARMACODYNAMICS
Pharmacotherapeutic group: Other lipid modifying agents. ATC code:
C10A X09
Mechanism of action
EZIVAS is orally active and potent, with a unique 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).
PHARMACOKINETIC PROPERTIES
Absorption
After oral administration, ezetimibe is rapidly absorbed and
extensively conjugated to a pharmacologically active
phenolic glucuronide (ezetimibe-glucuronide). Mean maximum plasma
concentrations (Cmax) occur within 1 to 2
hours for ezetimibe-glucuronide and 4 to 12 hours for ezetimibe. The
absolute bioavailability of ezetimibe cannot
be determined as the compound is virtually insoluble in aqueous media
suitable for injection.
Concomitant food administration (high fat or non-fat meals) had no
effect on the oral bioavailability of ezetimibe
when administered as EZIVAS 10mg tablets. EZIVAS can be administered
with or without food.
Distribution
Ezetimibe and ezetimibe-glucuronide are bound 99.7% and 88 to 92% to
human plasma proteins, respectively.