rosuvastatin 10 mg
1 INDICATIONS AND USAGE Rosuvastatin tablets are 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 ≥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 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 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 ≥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 homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia. Hypertriglyceridemia.
American Health Packaging
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP 5 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-234-01 Rosuvastatin tablets USP 10 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side. Unit dose packages of 50 (5 x 10) NDC 60687-245-65 Unit dose packages of 100 (10 x 10) NDC 60687-245-01 Rosuvastatin tablets USP 20 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-256-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
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