rosuvastatin calcium 10 mg
1 INDICATIONS AND USAGE Rosuvastatin tablets are indicated: Rosuvastatin tablets are indicated: Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (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 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 homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia.
glenmark pharmaceutials inc., usa
ROUND BROWN G D
G D ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin Tablets, USP are supplied as: Strength How Supplied NDC Tablet Description 5 mg Bottles of 30 with child-resistant closure 68462-261-30 pink colored, film-coated, circular tablets debossed with “G” on one side and “C” on the other side. Bottles of 50 with child-resistant closure 68462-261-50 Bottles of 90 with child-resistant closure 68462-261-90 Bottles of 100 with child-resistant closure 68462-261-01 Bottles of 1,000 68462-261-10 Carton unit-dose pack of 100 (10x10) 68462-261-11 10 mg Bottles of 30 with child-resistant closure 68462-262-30 pink colored, film-coated, circular tablets debossed with “G” on one side and “D” on the other side. Bottles of 50 with child-resistant closure 68462-262-50 Bottles of 90 with child-resistant closure 68462-262-90 Bottles of 100 with child-resistant closure 68462-262-01 Bottles of 1,000 68462-262-10 Carton unit-dose pack of 100 (10x10) 68462-262-11 20 mg Bottles of 30 with child-resistant closure 68462-263-30 pink colored, film-coated, circular tablets debossed with “G” on one side and “O” on the other side Bottles of 50 with child-resistant closure 68462-263-50 Bottles of 90 with child-resistant closure 68462-263-90 Bottles of 100 with child-resistant closure 68462-263-01 Bottles of 1,000 68462-263-10 Carton unit-dose pack of 100 (10x10) 68462-263-11 40 mg Bottles of 30 with child-resistant closure 68462-264-30 pink colored, film-coated, oval shaped tablets debossed with “G264” on one side and “40” on the other side. Bottles of 50 with child-resistant closure 68462-264-50 Bottles of 90 with child-resistant closure 68462-264-90 Bottles of 100 with child-resistant closure 68462-264-01 Bottles of 500 68462-264-05 Bottles of 1,000 68462-264-10 Storage Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); 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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