atorvastatin calcium 20 mg
1 INDICATIONS AND USAGE Atorvastatin Calcium Tablets are indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 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 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium tablet is an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
ScieGen Pharmaceuticals, Inc.
OVAL YELLOW SG 153
SG 153 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATORVASTATIN CALCIUM Tablets, USP are supplied as follows: Strength How Supplied NDC Tablet Description 10 mg of atorvastatin bottles of 90 50228-451-90 yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 152 on other side bottles of 1,000 50228-451-10 20 mg of atorvastatin bottles of 90 5022-452-90 yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 153 on other side bottles of 500 5022-452-05 40 mg of atorvastatin bottles of 90 50228-453-90 yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 154 on other side bottles of 1,000 50228-453-10 80 mg of atorvastatin bottles of 90 50228-454-90 yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 155 on other side bottles of 500 50228-454-05 Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.
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