rosuvastatin calcium 20 mg
1 INDICATIONS AND USAGE 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. Rosuvastatin is 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: reduce LDL-C in adults with primary hyperlipidemia. reduce 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 homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia.
sun pharmaceutical industries, inc.
ROUND PINK 584
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. 5 mg tablets: yellow colored, circular, biconvex, film-coated tablets with ‘S’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure..........................................................NDC 47335-582-83 Bottles of 90 with child-resistant closure..........................................................NDC 47335-582-81 Bottles of 1000..................................................................................................NDC 47335-582-18 10 mg tablets: pink colored, circular, biconvex, film-coated tablets with ‘583’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure ….........................................................NDC 47335-583-83 Bottles of 90 with child-resistant closure ….........................................................NDC 47335-583-81 Bottles of 1000 ………………………… ….........................................................NDC 47335-583-18 20 mg tablets: pink colored, circular, biconvex, film-coated tablets with ‘584’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure..............................................................NDC 47335-584-83 Bottles of 90 with child-resistant closure..............................................................NDC 47335-584-81 Bottles of 1000…………………………..............................................................NDC 47335-584-18 40 mg tablets: pink colored, oval, biconvex, film-coated tablets with ‘585’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure.............................................................NDC 47335-585-83 Bottles of 90 with child-resistant closure.............................................................NDC 47335-585-81 Bottles of 1000 ………………………….............................................................NDC 47335-585-18 Storage Store rosuvastatin tablets at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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