rosuvastatin 5 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: ∘ 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. 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: ∘ primary dysbetalipoproteinemia. ∘ Hypertriglyceridemia.
Biocon Pharma Inc
ROUND YELLOW B 5
B 5 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP are supplied as: Manufacturer: Recipharm Pharmaservices Private Limited Manufacturer: Biocon Pharma Limited NDC 70377-006-11: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-006-11: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-006-12: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-006-12: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-006-13: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-006-15: 5 mg. yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 1000 tablets NDC 70377-007-11: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-007-11: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-007-12: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-007-12: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-007-13: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-007-15: 10 mg. pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 1000 tablets NDC 70377-008-11: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-008-11: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-008-12: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-008-12: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-008-13: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-008-15: 20 mg. pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 1000 tablets NDC 70377-009-11: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-009-11: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-009-12: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-009-12: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 90 tablets NDC 70377-009-13: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 500 tablets NDC 70377-009-15: 40 mg. pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture.
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