Rosuvastatin calcium 40 MG Oral Tablet
1 INDICATIONS AND USAGE Rosuvastatin tablets are indicated: 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) ā„2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce 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. 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) ā„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 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.
Aurobindo Pharma Limited
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Rosuvastatin calcium 40 MG Oral Tablet
Aurobindo Pharma Limited
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP 5 mg are pink, oval shaped, biconvex film-coated tablets debossed with āIā on one side and ā29ā on the other side. Bottles of 30 NDC 65862-293-30 Bottles of 90 NDC 65862-293-90 Bottles of 500 NDC 65862-293-05 Bottles of 1,000 NDC 65862-293-99 10 x 6 Unit-dose Tablets NDC 65862-293-06 Rosuvastatin tablets USP 10 mg are pink, round, biconvex film-coated tablets debossed with āIā on one side and ā30ā on the other side. Bottles of 30 NDC 65862-294-30 Bottles of 90 NDC 65862-294-90 Bottles of 500 NDC 65862-294-05 Bottles of 1,000 NDC 65862-294-99 10 x 6 Unit-dose Tablets NDC 65862-294-06 Rosuvastatin tablets USP 20 mg are pink, round, biconvex film-coated tablets debossed with āIā on one side and ā31ā on the other side. Bottles of 30 NDC 65862-295-30 Bottles of 90 NDC 65862-295-90 Bottles of 500 NDC 65862-295-05 Bottles of 1,000 NDC 65862-295-99 10 x 6 Unit-dose Tablets NDC 65862-295-06 Rosuvastatin tablets USP 40 mg are pink, oval shaped, biconvex film-coated tablets debossed with āIā on one side and ā32ā on the other side. Bottles of 30 NDC 65862-296-30 Bottles of 90 NDC 65862-296-90 Bottles of 500 NDC 65862-296-05 Bottles of 1,000 NDC 65862-296-99 10 x 10 Unit-dose Tablets NDC 65862-296-10 Storage Store at 20Ā° to 25Ā°C (68Ā° to 77Ā°F); excursions permitted to 15Ā° to 30Ā°C (59Ā° to 86Ā°F) [see USP Controlled Room Temperature]. Protect from moisture.
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