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) ≥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: 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: 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.
apotex corp.
OVAL PINK APO ROS40
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. 5 mg: yellow, round, biconvex film-coated tablets. Engraved "APO" on one side, "ROS" over "5" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4502-3) Bottles of 90 (NDC 60505-4502-9) Unit dose blisters of 100 (NDC 60505-4502-0) 10 mg: pink, round, biconvex film-coated tablets. Engraved "APO" on one side, "ROS" over "10" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4503-3) Bottles of 90 (NDC 60505-4503-9) Unit dose blisters of 100 (NDC 60505-4503-0) 20 mg: pink, round, biconvex film-coated tablets. Engraved "APO" on one side, "ROS" over "20" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4504-3) Bottles of 90 (NDC 60505-4504-9) Unit dose blisters of 100 (NDC 60505-4504-0) 40 mg: pink, oval, biconvex film-coated tablets. Engraved "APO" on one side, "ROS40" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4505-3) Bottles of 90 (NDC 60505-4505-9) Unit dose blisters of 100 (NDC 60505-4505-0) Storage Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.
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