Atorv 20 mg Film-coated tablet

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

ATORVASTATIN CALCIUM TRIHYDRATE

Verfügbar ab:

AV MANUFACTURING SDN.BHD

INN (Internationale Bezeichnung):

ATORVASTATIN CALCIUM TRIHYDRATE

Einheiten im Paket:

7's x 4 Tablets

Hergestellt von:

AV MANUFACTURING SDN.BHD

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ATORV 20MG FILM-COATED TABLET
Crystalline atorvastatin calcium 20mg
1
WHAT IS IN THIS LEAFLET
1.
What Atorv is used for
2.
How Atorv works
3.
Before you take Atorv
4.
How to use Atorvastatin
5.
While you are using Atorv
6.
Side effects
7.
Storage and Disposal
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
1.
WHAT ATORV IS USED FOR
Atorv belongs to a group of medicines
known as statins, which are lipid (fat)
regulating medicines.
Atorv is used to lower lipids known as
cholesterol [total cholesterol, low
density lipoprotein cholesterol (LDL-
C)] and other fats (triglycerides) and to
increase high density lipoprotein
cholesterol (HDL-C) in the blood when
a low fat diet and life style changes on
their own have failed.
Atorv can lower the risk for heart
attack, stroke, certain types of heart
surgery, and chest pain in patients who
have heart disease or risk factors for
heart disease such as:

Age, smoking, high blood pressure,
low HDL-C, heart disease in the
family.
Atorv can lower the risk for heart attack
or stroke in patients with diabetes and
risk factors such as:

Eye problems, kidney problems,
smoking, or high blood pressure.
Cholesterol:
Everyone has cholesterol and
triglycerides in their blood. They are
types of blood fat needed by the body
for many things, including building cell
walls, making bile acids (which help to
digest food) and certain hormones.
However, too much cholesterol can be a
problem.
Your body makes cholesterol, but ut
also comes from food. Normally the
body balances the cholesterol it makes
with the cholesterol it gets from food.
This means if more cholesterol comes
from food, less is made by the body.
However, if you eat a diet high in fat,
your body may not keep this balance
and your cholesterol levels rise. High
cholesterol is more likely to occur with
certain disease or if you have a family
history of high cholesterol. When you
have high levels of cholesterol. When
you have high levels of

Fachinformation

ATORV 20MG FILM-COATED TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Crystalline Atorvastatin calcium 21.6 mg equivalent to atorvastatin 20
mg.
PRODUCT DESCRIPTION
White to off-white, round film-coated tablet debossed with “20”
and score line on one side, and plain 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 hyper- cholesterolemia, a population that has
not normally responded to lipid-lowering medication.
Atorvastatin and some of its metabolites are pharmacologically active
in humans. The primary site of action of atorvastatin is the liver,
which is
the p