LIPITOR TABLET 80 mg

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
25-07-2014

Bahan aktif:

ATORVASTATIN CALCIUM 86.80mg EQV ATORVASTATIN

Boleh didapati daripada:

PFIZER PRIVATE LIMITED

Kod ATC:

C10AA05

Dos:

80 mg

Borang farmaseutikal:

TABLET, FILM COATED

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

PFIZER PHARMACEUTICALS LIMITED (VEGA BAJA)

Tarikh kebenaran:

2002-06-24

Risalah maklumat

                                  
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
                                
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