Eturion Tablet 40mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Atorvastatin Calcium43.40mg eqv Atorvastatin

可用日期:

VIATRIS PRIVATE LIMITED

ATC代码:

C10AA05

剂量:

40mg

药物剂型:

TABLET, FILM COATED

组成:

Atorvastatin Calcium43.40mg eqv Atorvastatin 40mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Viatris Pharmaceuticals LLC

授权状态:

ACTIVE

授权日期:

2007-06-22

资料单张

LIP-SIN-0413/1 
Date of Last Revision: March 2014 
Page 1 of 22 
ETURION
®
 TABLETS

ATORVASTATIN CALCIUM 

1.  TRADE NAME(S) OF THE MEDICINAL PRODUCT 

Eturion 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active Ingredient: atorvastatin. 

The tablets for oral administration contain atorvastatin calcium equivalent to 10, 20,
40, or 
80 mg atorvastatin. 

3.  PHARMACEUTICAL FORM 

Tablets: 10 mg, 20 mg, 40 mg, 80 mg. 

4.  CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

Atorvastatin is indicated as an adjunct to diet for reduction
of elevated total 
cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B,
and triglycerides 
in adults, adolescents and children aged 10 years or older with
primary 
hypercholesterolemia, heterozygous familial hypercholesterolemia,
or combined 
(mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated
serum triglyceride 
levels (Fredrickson Type IV), and for patients with
dysbetalipoproteinemia 
(Fredrickson Type III) when response to diet and
other non-pharmacological 
measures is inadequate. 

Atorvastatin also raises HDL-cholesterol and lowers the LDL/HDL and
total 
cholesterol/HDL ratios. 

Atorvastatin is also indicated to reduce total-C and LDL-C in
adults with 
homozygous familial hypercholesterolaemia as an adjunct to
other lipid-lowering 
treatments (e.g., LDL apheresis) or if such treatments are
unavailable. 

_Prevention of Cardiovascular Disease_ 

Eturion is indicated to reduce the risk of myocardial infarction in
adult hypertensive 
patients without clinically evident coronary heart disease,
but with at least three 
additional risk factors for coronary heart disease such as
age  55 years, male sex, 
smoking, left ventricular hypertrophy, other specified
abnormalities on ECG, 
microalbuminia or proteinuria, ratio of plasma
total cholesterol to HDL-cholesterol 

产品特点

Page 1 of 28
ETURION
® TABLETS
ATORVASTATIN CALCIUM
1.
NAME OF THE MEDICINAL PRODUCT
Eturion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: atorvastatin.
The tablets for oral administration contain atorvastatin calcium
equivalent to 10 mg, 20 mg,
40 mg, or 80 mg atorvastatin.
3.
PHARMACEUTICAL FORM
Tablets: 10 mg, 20 mg, 40 mg, 80 mg.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Atorvastatin is indicated as an adjunct to diet for reduction of
elevated total
cholesterol (total-C), low density lipoprotein cholesterol (LDL-C),
apolipoprotein B
(apo B), and triglycerides (TG) in adults, adolescents and children
aged 10 years or
older with primary hypercholesterolemia, heterozygous familial
hypercholesterolemia,
or combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb),
elevated serum
TG levels (Fredrickson Type IV), and for patients with
dysbetalipoproteinemia
(Fredrickson Type III) when response to diet and other
non-pharmacological measures
is inadequate.
Atorvastatin also raises high density lipoprotein cholesterol (HDL-C)
and lowers the
LDL/HDL and total-C/HDL ratios.
Atorvastatin is also indicated to reduce total-C and LDL-C in adults
with homozygous
familial hypercholesterolemia as an adjunct to other lipid-lowering
treatments (e.g.,
LDL apheresis) or if such treatments are unavailable.
_Prevention of Cardiovascular Disease_
Eturion is indicated to reduce the risk of myocardial infarction (MI)
in adult
hypertensive patients without clinically evident coronary heart
disease (CHD), but
with at least three additional risk factors for CHD such as age ≥55
years, male sex,
smoking, left ventricular hypertrophy, other specified abnormalities
on
Page 2 of 28
electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of
plasma total-C to
HDL-C ≥6, or premature family history of CHD.
In adults with type 2 diabetes and without clinically evident CHD, but
with multiple
risk factors for CHD such as retinopathy, albuminuria, smoking or
hypertension,
Eturion is indicated to:
•
Redu