Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
ROSUVASTATIN CALCIUM 20.80 mg EQV ROSUVASTATIN
ASTRAZENECA SINGAPORE PTE LTD
C10AA07
20 mg
TABLET, FILM COATED
ROSUVASTATIN CALCIUM 20.80 mg EQV ROSUVASTATIN 20 mg
ORAL
Prescription Only
IPR Pharmaceuticals Inc (Canovanas)
ACTIVE
2002-12-26
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 Read the complete document
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 Read the complete document