Rosuvastatin calcium 20 MG Oral Tablet
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 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 ≥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.
Novadoz Pharmaceuticals LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets, USP are supplied as: Strength How Supplied NDC Tablet Description 5 mg Bottle of 90 tablets 72205-027-90 white, round shaped, biconvex, film coated tablets debossed with "R5" on one side and plain on other side. Bottle of 500 tablets 72205-027-05 Bottle of 1000 tablets 72205-027-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-027-06 10 mg Bottle of 90 tablets 72205-003-90 pink, round shaped, biconvex, film coated tablets debossed with "R10" on one side and plain on other side. Bottle of 500 tablets 72205-003-05 Bottle of 1000 tablets 72205-003-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-003-06 20 mg Bottle of 90 tablets 72205-004-90 pink, round shaped, biconvex, film coated tablets debossed with "R20" on one side and plain on other side. Bottle of 500 tablets 72205-004-05 Bottle of 1000 tablets 72205-004-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-004-06 40 mg Bottle of 30 tablets 72205-005-30 pink, oval shaped, biconvex, film coated tablets debossed with "R" on one side and "40" on other side. Bottle of 90 tablets 72205-005-90 Bottle of 500 tablets 72205-005-05 Bottle of 1000 tablets 72205-005-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-005-06 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.
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