Rosuvastatin Calcium

Roswin®

Prescription Drug

Indications

Dyslipidemia

In adult patients, rosuvastatin is indicated to:

• Decrease elevated total cholesterol (total-C), LDL-cholesterol (LDL-C) and triglycerides (TG) and to increase high density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia (heterozygous familial and non familial) or mixed dyslipidemia (Fredrickson types IIa and IIb). Rosuvastatin also decreases Apo B, nonHDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL-C, nonHDL-C/HDL-C, and Apo B/Apo A-I ratios and increases Apo A-I.
• Treat isolated hypertriglyceridermia (Fredrickson type IV hyperlipidemia)
• Treat patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipoproteinemia)
• Decrease total-C and LDL-C in patients with homozygous familiar hypercholesterolemia as adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or alone if such treatments are unavailable
• Slow the progression of atherosclerosis as part of a treatment strategy to decrease total-C and LDL-C to target levels

In children and adolescent patients 10 to 17 years old, rosuvastatin is indicated to:

• Decrease total-C, LDL-C and Apo B levels in children and adolescents 1o to 17 years old (boys Tanner Stage II and above, and girls who are at least one year post-menarche) with heterozygous familial hypercholesterolemia if after trial of diet therapy the following findings are present:

LDL-C > 190 mg/dL or
LDL-C > 160 mg/dL and:

• There is a positive family history of premature cardiovascular disease or
• Two or more other cardiovascular risk factors are present in the patient

Primary Prevention of Cardiovascular Disease
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 >65 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:

Decrease the risk of stroke
Decrease the risk of myocardial infarction
Decrease the risk of arterial revascularization procedures

Dosage and Administration

For more information on safety, precaution and other information about this product, please see the Product Insert.