Basic Information
ROSUDEX FILM-COATED TABLET 10MG
TABLET, FILM COATED
Regulatory Information
SIN16625P
October 6, 2022
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XC10AA07
Company Information
Active Ingredients
Strength: 10mg
Detailed Information
Contraindications
**Contraindications:** - Rosuvastatin is contraindicated in patients with hypersensitivity to any component of this product. - Rosuvastatin is contraindicated in patients with active liver disease or unexplained, persistent elevations of serum transaminases. - Rosuvastatin is contraindicated during pregnancy, while breastfeeding and in women of childbearing potential not using appropriate contraceptive measures. - Rosuvastatin is contraindicated in patients receiving concomitant ciclosporin. - Rosuvastatin is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml/minute).
Indication Information
**Indications:** - Rosuvastatin is indicated for patients with primary hypercholesterolemia and mixed dyslipidemia (including Fredrickson type IIa, IIb; and heterozygous familial hypercholesterolemia) as an adjunct to diet when response to diet and exercise is inadequate. - Rosuvastatin is indicated to treat patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipoproteinemia) as an adjunct to diet when response to diet and exercise is inadequate. - Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol, and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. Rosuvastatin also lowers ApoB, non-HDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, non-HDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I. - Rosuvastatin is also indicated in patients with homozygous familial hypercholesterolemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g., LDL apheresis). - Primary prevention of cardiovascular disease: rosuvastatin 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 coronary heart disease, rosuvastatin is indicated to: - reduce the risk of stroke, - reduce the risk of myocardial infarction, - reduce the risk of arterial revascularization procedures. - Rosuvastatin is indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce total-C, LDL-C, and ApoB levels in adolescent boys and girls, who are at least one year postmenarche, 10–17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C >190 mg/dl or >160mg/dl and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Pediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.