rosuvastatin calcium tablet film coated
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 20
RSV 20 ROUND BROWN
Related Pills
rosuvastatin calcium 5 mg
Sandoz Inc
rosuvastatin calcium tablet film coated
sandoz inc
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
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.
More pills like ROUND RSV 20