Rosuvastatin calcium 10 MG Oral Tablet
1 INDICATIONS AND USAGE Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: o reduce LDL-C in adults with primary hyperlipidemia. o reduce LDL-C and slow the progression of atherosclerosis in adults. o 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 homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia. Rosuvastatin tablets are indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o 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 homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia.
Torrent Pharmaceuticals Limited
ROUND PINK 1180
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP are supplied as: Rosuvastatin tablets USP, 5 mg are yellow colored, round, biconvex, film coated tablets debossed with '79' on one side and plain on other side. Bottles of 30 NDC 13668-179-30 Bottles of 90 NDC 13668-179-90 Bottles of 500 NDC 13668-179-05 Rosuvastatin tablets USP, 10 mg are light pink colored, round, biconvex, film coated tablets debossed with '1180' on one side and plain on other side. Bottles of 30 NDC 13668-180-30 Bottles of 90 NDC 13668-180-90 Bottles of 500 NDC 13668-180-05 Rosuvastatin tablets USP, 20 mg are light pink colored, round, biconvex, film coated tablets debossed with '1181' on one side and plain on other side. Bottles of 30 NDC 13668-181-30 Bottles of 90 NDC 13668-181-90 Bottles of 500 NDC 13668-181-05 Rosuvastatin tablets USP, 40 mg are light pink colored, oval shape, biconvex, beveled edge, film coated tablets debossed with '1182' on one side and plain on other side. Bottles of 30 NDC 13668-182-30 Bottles of 90 NDC 13668-182-90 Bottles of 500 NDC 13668-182-05 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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