Rosuvastatin calcium 20 mg

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 ≥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 homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o primary dysbetalipoproteinemia. o Hypertriglyceridemia. Rosuvastatin 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 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

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] drug abuse` `[4] drug ineffective` `[5] fatigue` `[6] dyspnoea` `[7] pain` `[8] nausea` `[9] overdose` `[10] death`

1 year ago

ROUND PINK G O

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 1000 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 1000 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 1000 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 1000 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.