Apo-Atorvastatin 40mg Tablet

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

ATORVASTATIN CALCIUM

متاح من:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

ATORVASTATIN CALCIUM

الوحدات في الحزمة:

60tablet Tablets; 30tablet Tablets

المصنعة من قبل:

APOTEX INC

نشرة المعلومات

NOT APPLICABLE

خصائص المنتج

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