1 INDICATIONS AND USAGE Rosuvastatin calcium tablets is indicated: To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP â¥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with hom*ozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin is an HMG Co-A reductase inhibitor (statin) indicated: (1) To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP â¥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. As an adjunct to diet to reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with hom*ozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia. Hypertriglyceridemia.
tris pharma inc
FDA Reported Adverse Reactions
[1] drug ineffective [2] fatigue [3] nausea [4] pain [5] dyspnoea [6] headache [7] diarrhoea [8] off label use [9] vomiting [10] arthralgia
4 years ago
ROUND PINK CY 5
16 HOW SUPPLIED/STORAGE AND HANDLING
ROSUVASTATIN CALCIUM tablets are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 90 tablets bottles of 500 tablets NDC 27808-155-01 NDC 27808-155-03 pink, round, biconvex, coated tablets. debossed as âCYâ on one side and â5â on other side 10 mg bottles of 90 tablets bottles of 500 tablets NDC 27808-156-01 NDC 27808-156-03 yellow, round, biconvex, coated tablets. debossed as âCYâ on one side, and â10â on other side 20 mg bottles of 90 tablets bottles of 500 tablets NDC 27808-157-01 NDC 27808-157-03 yellow, round, biconvex, coated tablets. debossed as âCYâ on one side, and â20â on other side 40 mg bottles of 30 tablets bottles of 500 tablets NDC 27808-158-01 NDC 27808-158-03 pink, round, biconvex, coated tablet. debossed as âCYâ on one side, and â40â on other side Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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