ROSTAT

Generic Name
Rosuvastatin
Therapeutic Category
Cardiology
Dosage Form
Tablets
Strength
5mg, 10mg & 20mg
Pack Size
1 x 10
Registration Number
55729, 55730 & 55731

Product Description

ROSTAT (Rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration . The chemical name for rosuvastatin calcium is bis[(E)-7-4-(4-fluorophenyl)-6-isopropyl-2-[methyl (methylsulfonyl)amino] pyrimidin-5-yl-3,5- dihydroxyhept-6-enoic acid] calcium salt .

Indication

ROSTAT is an HMG Co-A reductase inhibitor indicated for :

  • Hyperlipidemia and Mixed Dyslipidemia: ROSTAT is indicated 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 .

  • Pediatric Patients with Familial Hypercholesterolemia: ROSTAT is indicated as an adjunct to diet to :

    • Reduce Total-C, LDL-C and ApoB levels in children and adolescents 8 to 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 along with a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors .

    • Reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (for example, LDL apheresis) .

  • Hypertriglyceridemia: ROSTAT is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia .

  • Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): ROSTAT is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) .

  • Adult Patients with Homozygous Familial Hypercholesterolemia: ROSTAT is indicated as adjunctive therapy to other lipid-lowering treatments (for example, 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 Atheroscleros is: ROSTAT is indicated 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 .

  • Primary Prevention of Card iovascular Disease: In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age greater than or equal to 50 years old in men and greater than or equal to 60 years old in women, hsCRP greater than or equal to 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, ROSTAT is indicated to :

    • Reduce the risk of stroke 

    • Reduce the risk of myocardial infarction 

    • Reduce the risk of arterial revascularization procedures 

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