LIPITOR TABLET 80 mg
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
25-07-2014
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ATORVASTATIN CALCIUM 86.80mg EQV ATORVASTATIN
Available from:
PFIZER PRIVATE LIMITED
ATC code:
C10AA05
Dosage:
80 mg
Pharmaceutical form:
TABLET, FILM COATED
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
PFIZER PHARMACEUTICALS LIMITED (VEGA BAJA)
Authorization date:
2002-06-24
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
Read the complete document
