crestor rosuvastatin calcium tablet film coated
1 INDICATIONS AND USAGE CRESTOR is 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. CRESTOR is 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.
astrazeneca pharmaceuticals lp
ROUND PINK ZD4522 20
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16 HOW SUPPLIED/STORAGE AND HANDLING CRESTOR tablets are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 90 tablets 0310-0755-90 yellow, round, biconvex, coated tablets. debossed “CRESTOR” and “5” on one side 10 mg bottles of 90 tablets 0310-0751-90 pink, round, biconvex, coated tablets. debossed “CRESTOR” and “10” on one side 20 mg bottles of 90 tablets 0310-0752-90 pink, round, biconvex, coated tablets. debossed “CRESTOR” and “20” on one side 40 mg bottles of 30 tablets 0310-0754-30 pink, oval, biconvex, coated tablets. debossed “CRESTOR” on one side and “40” on the other side Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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