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 â¥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 and pediatric patients aged 7 years and older with hom*ozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia. Rosuvastatin Calcium 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 â¥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 hom*ozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia.
remedyrepack inc.
FDA Reported Adverse Reactions
[1] drug ineffective [2] off label use [3] fatigue [4] nausea [5] pain [6] headache [7] dyspnoea [8] diarrhoea [9] vomiting [10] pyrexia
2 years ago
ROUND PINK R10
16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets, USP are supplied as: 20 mg, pink, round shaped, biconvex, film coated tablets debossed with "R20" on one side and plain on other side. NDC: 70518-1819-00 NDC: 70518-1819-01 NDC: 70518-1819-02 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 45 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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