LIPITOR TABLET 80MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ATORVASTATIN CALCIUM

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

ATORVASTATIN CALCIUM

Unit dalam pakej:

30Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

PFIZER PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LIPITOR
®
TABLET
Crystalline atorvastatin calcium (10 mg, 20 mg, 40 mg or 80 mg)
1
WHAT IS IN THIS LEAFLET
1.
What LIPITOR is used for
2.
How LIPITOR works
3.
Before you use LIPITOR
4.
How to use LIPITOR
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of LIPITOR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT LIPITOR IS USED FOR
LIPITOR belongs to a group of
medicines known as statins, which are
lipid (fat) regulating medicines.
LIPITOR 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 lifestyle changes on their
own have failed.
LIPITOR 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.
LIPITOR 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 it 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 diseases or if you have
a family history of high cholesterol.
When you have high le

Ciri produk

1
LIPITOR
TABLETS
®
CRYSTALLINE ATORVASTATIN CALCIUM
1. TRADE NAME(S) OF THE MEDICINAL PRODUCT
LIPITOR
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: crystalline atorvastatin
The tablets for oral administration contain crystalline atorvastatin
calcium equivalent to 10 mg,
20 mg, 40 mg or 80 mg atorvastatin.
3. PHARMACEUTICAL FORM
Atorvastatin tablets for oral administration contain 10 mg, 20 mg, 40
mg or 80 mg crystalline
atorvastatin.
10 mg: White, round, film-coated tablets debossed “10” on one side
and “ATV” on the other
side.
20 mg: White, round, film-coated tablets debossed “20” on one side
and “ATV” on the other
side.
40 mg: White, round, film-coated tablets debossed “40” on one side
and “ATV” on the other
side.
80 mg: White, round, film-coated tablets debossed “80” on one side
and “ATV” on the other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atorvastatin is indicated as an adjunct to diet for the treatment of
patients with elevated total
cholesterol (total-C), low density lipoprotein cholesterol (LDL-C),
apolipoprotein B (apo B),
and triglycerides (TG) and to increase high density lipoprotein
cholesterol (HDL-C) in
patients
with
primary
hypercholesterolemia
(heterozygous
familial
and
nonfamilial
hypercholesterolemia), combined (mixed) hyperlipidemia (
_Fredrickson _
Types IIa and IIb),
elevated
serum
TG
levels
(
_Fredrickson _
Type
IV),
and
for
patients
with
dysbetalipoproteinemia (
_Fredrickson _
Type III) who do not respond adequately to diet.
Atorvastatin is also indicated for the reduction of total-C and LDL-C
in patients with
homozygous familial hypercholesterolemia.
_Prevention of Cardiovascular Disease_
In
adult
patients
without
clinically
evident
cardiovascular
disease
(CVD),
but
with
multiple
risk
factors
for
coronary
heart
disease
(CHD)
such
as
age,
smoking,
hypertension, low HDL-C, or a family history of early CHD, LIPITOR is
indicated to:
-
Reduce the risk of myocardial infarction (MI)
-
Reduce the risk of stroke
-
Reduce the risk