Rosuvastatin calcium 5 MG Oral Tablet
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: Reduce low-density lipoprotein cholesterol (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: primary dysbetalipoproteinemia. Hypertriglyceridemia. 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: 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: primary dysbetalipoproteinemia. Hypertriglyceridemia.
Amneal Pharmaceuticals NY LLC
ROUND YELLOW AA 92
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16 HOW SUPPLIED/STORAGE AND HANDLING
ROSUVASTATIN Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, coated tablets, debossed “AA†and “92†on one side and plain on the other side. They are available as follows: Bottles of 90: NDC 69238-1146-9
ROSUVASTATIN Tablets USP, 10 mg are supplied as pink colored, round, biconvex, coated tablets, debossed “AA†and “93†on one side and plain on the other side. They are available as follows: Bottles of 90: NDC 69238-1147-9
ROSUVASTATIN Tablets USP, 20 mg are supplied as pink colored, round, biconvex, coated tablets, debossed “AA†and “94†on one side and plain on the other side. They are available as follows: Bottles of 90: NDC 69238-1148-9
ROSUVASTATIN Tablets USP, 40 mg are supplied as pink colored, oval, biconvex, coated tablets, debossed “AA 95†on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 69238-1149-3 Bottles of 90: NDC 69238-1149-9 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
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