Generic Name: Rosuvastatin calcium
For the treatment of:
- Hyperlipidemia and mixed dyslipidemia as adjunctive therapy to diet to reduce elevated Total-C, LDL-C,
ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.
- Pediatric patients 10 to 17 years of age with heterozygous familal hypercholesterolemia (HeFH) as 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 greater than 190 mg/dL or greater than 160 mg/dL and there is a positive family his tory of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
- Hypertriglyceridemia as adjunctive therapy to diet for the treatment of adult patients with
- Primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
- Homozygous familal hypercholesterolemia as adjunctive therapy to other lipid lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
- Slowing of the progression of atherosclerosis as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
- Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.