rosuvastatin calcium 5 mg
1 INDICATIONS AND USAGE Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin calcium 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: o Reduce LDL-C in adults with primary hyperlipidemia. o Reduce low-density lipoprotein cholesterol (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 with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia. Rosuvastatin calcium 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 with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia.
Sandoz Inc
ROUND BROWN RSV 5
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rosuvastatin calcium tablet film coated
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin calcium tablets are supplied as: 5 mg: Light brown, round, film-coated tablets with "RSV 5" debossed on one side. NDC 0781-5400-31, bottles of 30 tablets NDC 0781-5400-92, bottles of 90 tablets NDC 0781-5400-34, bottles of 3000 tablets NDC 0781-5400-13, carton of 100 tablets (10 x 10 Unit-dose) 10 mg: brown, round, film-coated tablets with "RSV 10" debossed on one side. NDC 0781-5401-31, bottles of 30 tablets NDC 0781-5401-92, bottles of 90 tablets NDC 0781-5401-34, bottles of 3000 tablets NDC 0781-5401-13, carton of 100 tablets (10 x 10 Unit-dose) 20 mg: brown, round, film-coated tablets with "RSV 20" debossed on one side. NDC 0781-5402-31, bottles of 30 tablets NDC 0781-5402-92, bottles of 90 tablets NDC 0781-5402-34, bottles of 3000 tablets NDC 0781-5402-13, carton of 100 tablets (10 x 10 Unit-dose) 40 mg: brown, round, film-coated tablets with "RSV 40" debossed on one side. NDC 0781-5403-31, bottles of 30 tablets NDC 0781-5403-92, bottles of 90 tablets NDC 0781-5403-34, bottles of 3000 tablets NDC 0781-5403-13, carton of 100 tablets (10 x 10 Unit-dose) Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
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