atorvastatin 10 MG Oral Tablet
1 INDICATIONS AND USAGE Atorvastatin calcium tablets is 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 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.
Accord Healthcare Inc.
OVAL WHITE FF1
FF1 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATORVASTATIN CALCIUM tablets USP 10 mg (10 mg of atorvastatin) : white to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF1†on one side and plain on other side. NDC 16729-044-10 bottles of 30’s count with a child-resistant closure NDC 16729-044-15 bottles of 90’s count with a child-resistant closure NDC 16729-044-01 bottles of 100’s count with a child-resistant closure NDC 16729-044-16 bottles of 500’s count NDC 16729-044-17 bottles of 1000’s count
ATORVASTATIN CALCIUM tablets USP 20 mg (20 mg of atorvastatin) : white to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF2†on one side and plain on other side. NDC 16729-045-10 bottles of 30’s count with a child-resistant closure NDC 16729-045-15 bottles of 90’s count with a child-resistant closure NDC 16729-045-01 bottles of 100’s count with a child-resistant closure NDC 16729-045-16 bottles of 500’s count NDC 16729-045-17 bottles of 1000’s count
ATORVASTATIN CALCIUM tablets USP 40 mg (40 mg of atorvastatin) : white to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF3†on one side and plain on other side. NDC 16729-046-10 bottles of 30’s count with a child-resistant closure NDC 16729-046-15 bottles of 90’s count with a child-resistant closure NDC 16729-046-01 bottles of 100’s count with a child-resistant closure NDC 16729-046-16 bottles of 500’s count NDC 16729-046-17 bottles of 1000’s count
ATORVASTATIN CALCIUM tablets USP 80 mg (80 mg of atorvastatin) : white to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF4†on one side and plain on other side. NDC 16729-047-10 bottles of 30’s count with a child-resistant closure NDC 16729-047-15 bottles of 90’s count with a child-resistant closure NDC 16729-047-01 bottles of 100’s count with a child-resistant closure NDC 16729-047-16 bottles of 500’s count NDC 16729-047-17 bottles of 1000’s count Storage Store at controlled room temperature 20 o C to 25 o C (68 o F to 77 o F).
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