Apo-Atorvastatin 80mg Tablet

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

ATORVASTATIN CALCIUM

Dostupné z:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Medzinárodný Name):

ATORVASTATIN CALCIUM

Počet v balení:

30tablet Tablets; 30tablet Tablets

Výrobca:

APOTEX INC

Príbalový leták

APO-ATORVASTATIN TABLET
Atorvastatin Calcium (20mg, 40mg, 80mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What APO-ATORVASTATIN is
used for
2.
How APO-ATORVASTATIN
works
3.
Before you use APO-
ATORVASTATIN
4.
How to use APO-
ATORVASTATIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of APO-
ATORVASTATIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-ATORVASTATIN IS USED
FOR
Atorvastatin is used to lower the levels of
cholesterol (particularly Low Density
Lipoprotein (LDL) cholesterol) and other
fats in the blood. This may help prevent
heart disease
is
caused by cholesterol
clogging the blood vessels or slow the
progression of atherosclerosis (hardening
of the arteries that nourish your heart),
so-called coronary heart disease (CHD).
HOW APO-ATORVASTATIN WORKS
APO-ATORVASTATIN inhibits an
enzyme that is necessary for the body to
make cholesterol. In this way, less
cholesterol is produced in the liver.
BEFORE YOU USE APO-
ATORVASTATIN
-
_When you must not use it _
Tell your physician if
•
You have previously taken
atorvastatin or any other
medication in the same class -
example, simvastatin, pravastatin
or fluvastatin and were allergic, or
had reacted badly to it.
•
You are pregnant or intend to
become pregnant. This medicine
should not be used during
pregnancy.
•
You are breast-feeding, or intend
to breast-feed.
•
You have other medical
conditions, especially liver
disease.
_ _
_Pregnancy and lactation _
Do not take APO-ATORVASTATIN if
you are pregnant, trying to get pregnant
or think you may be pregnant.
Do not take APO-ATORVASTATIN if
you are breast-feeding. Ask your doctor
or pharmacist for advice before taking
any medicine.
_ _
_ _
-
_Before you start use it _
APO-ATORVASTATIN may not be
suitable for you:
•
If you have kidney problems
•
If you have had repeated or
unexplained muscle aches or
pains, a personal history or family
history of muscle problems
•
If you have had previous muscula

Súhrn charakteristických

APO‐ATORVASTATIN TABLET 20MG, 40MG, 80MG
Atorvastatin calcium
PRODUCT DESCRIPTION
20
mg:
White,
oval,
biconvex
film‐coated
tablets.
Engraved
"APO" on one side, "ATV20" on the other side.
40
mg:
White,
oval,
biconvex
film‐coated
tablets.
Engraved
"APO" on one side, "ATV40" on the other side.
80
mg:
White,
oval,
biconvex
film‐coated
tablets.
Engraved
"APO" on one side, "ATV80" on the other side.
PHARMACODYNAMICS
Atorvastatin calcium is a synthetic lipid‐lowering agent, which is
an inhibitor of 3‐hydroxy‐3‐methylglutaryl‐coenzyme A (HMG‐
CoA) reductase. This enzyme catalyzes the conversion of HMG‐
CoA to mevalonate, an early and rate‐
limiting step in cholesterol
biosynthesis.
Atorvastatin is a selective, competitive inhibitor of HMG‐CoA
reductase, the rate‐limiting enzyme that converts 3‐hydroxy‐3‐
methylglutaryl‐coenzyme
A
to
mevalonate,
a
precursor
of
sterols, including cholesterol. In patients with homozygous and
heterozygous
familial
hypercholesterolemia
(FH),
nonfamilial
forms
of
hypercholesterolemia,
and
mixed
dyslipidemia,
atorvastatin
reduces
total‐C
(total
cholesterol),
LDL‐C
(low‐
density lipoprotein cholesterol), and apo B (apolipoprotein B).
Atorvastatin also reduces VLDL‐C (very‐low‐density lipoprotein
cholesterol)
and
TG
(triglycerides)
and
produces
variable
increases in HDL‐C (high‐density lipoprotein cholesterol).
Atorvastatin lowers plasma cholesterol and lipoprotein levels by
inhibiting HMG‐CoA reductase and cholesterol synthesis in the
liver and by increasing the number of hepatic LDL receptors on
the cell surface for enhanced uptake and catabolism of LDL.
Atorvastatin reduces LDL production and the number of LDL
particles.
Atorvastatin
produces
a
profound
and
sustained
increase
in
LDL
receptor
activity
coupled
with
a
beneficial
change in the quality of circulating LDL particles. Atorvastatin is
effective in reducing LDL in patients with homozygous
familial
hypercholesterolemia, a population
that
has
not
normally
responded
to lipid‐lowering