Crestor Tablet 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ROSUVASTATIN CALCIUM 5.2 mg EQV ROSUVASTATIN

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

C10AA07

Dosage:

5 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

ROSUVASTATIN CALCIUM 5.2 mg EQV ROSUVASTATIN 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

IPR Pharmaceuticals Inc (Canovanas)

Authorization status:

ACTIVE

Authorization date:

2005-11-07

Patient Information leaflet

11/AB/SG/CV.000-053-322.12.0 

CRESTOR
®

5 MG, 10 MG, 20 MG, 40 MG FILM-COATED TABLETS  

COMPOSITION

Each tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin as
rosuvastatin calcium. 

PHARMACEUTICAL FORM

5 mg film-coated tablet - round, biconvex 7 mm, yellow coloured. 
10 mg film-coated tablet - round, biconvex, 7 mm, pink coloured._ _
20 mg film-coated tablet - round, biconvex, 9 mm, pink coloured._ _
40 mg film-coated tablet - oval, biconvex, 11.4 x 6.9 mm, pink
coloured. 
Tablets are impressed with ‘ZD4522’ and the tablet strength.  

THERAPEUTIC INDICATIONS

CRESTOR is indicated for patients with primary hypercholesterolaemia
and mixed 
dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous
familial 
hypercholesterolaemia) as an adjunct to diet when response to diet
and exercise is inadequate. 

CRESTOR is indicated to treat patients with primary
dysbetalipoproteinaemia (Fredrickson 
Type III hyper lipoproteinaemia) as an adjunct to diet when response
to diet and exercise is 
inadequate. 

CRESTOR reduces elevated LDL-cholesterol, total cholesterol and
triglycerides and increases 
HDL-cholesterol, thereby enabling most patients to achieve relevant
treatment guidelines. 

1
CRESTOR also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C,
total 
C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I.  

CRESTOR is also indicated in patients with homozygous familial
hypercholesterolaemia, either 
alone or as an adjunct to diet and other lipid lowering treatments
(e.g. LDL apheresis).  

Primary prevention of cardiovascular disease: CRESTOR is indicated
in individuals without 
clinically evident coronary heart disease but with an increased risk
of cardiovascular disease 
based on age ≥ 50 years old in men and ≥ 60 years old in
women, hsCRP ≥ 2 mg/L, and the 
presence of at least one additional cardiovascular disease
risk factor such as hypertension, low 
HDL-C, smoking, or

Summary of Product characteristics

CRESTOR

(ROSUVASTATIN)
1.
NAME OF THE MEDICINAL PRODUCT
CRESTOR

5 mg, 10 mg, 20 mg, 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin as
rosuvastatin calcium.
3.
PHARMACEUTICAL FORM
5 mg film-coated tablet - round, biconvex, 7 mm, yellow coloured.
10 mg film-coated tablet - round, biconvex, 7 mm, pink coloured.
_ _
20 mg film-coated tablet - round, biconvex, 9 mm, pink coloured.
_ _
40 mg film-coated tablet - oval, biconvex, 11.4 x 6.9 mm, pink
coloured.
Tablets are impressed with ‘ZD4522’ and the tablet strength.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CRESTOR is indicated for patients with primary hypercholesterolaemia
and mixed dyslipidaemia
(including Fredrickson Type IIa, IIb; and heterozygous familial
hypercholesterolaemia) as an
adjunct to diet when response to diet and exercise is inadequate.
CRESTOR is indicated to treat patients with primary
dysbetalipoproteinaemia (Fredrickson Type
III hyper lipoproteinaemia) as an adjunct to diet when response to
diet and exercise is inadequate.
CRESTOR reduces elevated LDL-cholesterol, total cholesterol and
triglycerides and increases
HDL-cholesterol, thereby enabling most patients to achieve relevant
treatment guidelines.
CRESTOR also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C,
total
C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I.
CRESTOR is also indicated in patients with homozygous familial
hypercholesterolaemia, either
alone or as an adjunct to diet and other lipid lowering treatments
(e.g. LDL apheresis).
Primary prevention of cardiovascular disease: CRESTOR is indicated in
individuals without
clinically evident coronary heart disease but with an increased risk
of cardiovascular disease based
on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP
≥ 2 mg/L, and the presence of
at least one additional cardiovascular disease risk factor such as
hypertension, low HDL-C,
smoking, or a family history of premature c