LIPITOR TABLET 40 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ATORVASTATIN CALCIUM 43.40mg EQV ATORVASTATIN

Available from:

VIATRIS PRIVATE LIMITED

ATC code:

C10AA05

Dosage:

40mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

ATORVASTATIN CALCIUM 43.40mg EQV ATORVASTATIN 40mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Pfizer Manufacturing Deutschland GmbH

Authorization status:

ACTIVE

Authorization date:

1997-11-28

Patient Information leaflet

  
Page 1 of 20 

LIPITOR
®
 TABLETS 
ATORVASTATIN CALCIUM 

1.   TRADE NAME(S) OF THE MEDICINAL PRODUCT 

LIPITOR 

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_ 

Lipitor 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  6, or premature
family history of coronary�

Summary of Product characteristics

Page 1 of 29
LIPITOR
® TABLETS
ATORVASTATIN CALCIUM
1.
NAME OF THE MEDICINAL PRODUCT
LIPITOR
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.
Page 2 of 29
_Prevention of Cardiovascular Disease_
Lipitor 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
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,
Lipitor is indicated to:
•
Redu