Pravastatin Sodium 40 MG Oral Tablet
1 INDICATIONS AND USAGE Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Pravastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Aurobindo Pharma Limited
RECTANGLE YELLOW Y 39
Y 39 RECTANGLE YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAVASTATIN SODIUM tablets, USP are supplied as:
PRAVASTATIN SODIUM Tablets USP, 10 mg are yellow, rectangular shaped with rounded edges, biconvex, uncoated tablets debossed with βYβ on one side and β37β on the other side. Bottles of 90 NDC 65862-632-90 Bottles of 500 NDC 65862-632-05 Bottles of 1,000 NDC 65862-632-99
PRAVASTATIN SODIUM Tablets USP, 20 mg are white to off-white, rectangular shaped with rounded edges, biconvex, uncoated tablets debossed with βTβ on one side and β36β on the other side. Bottles of 90 NDC 65862-633-90 Bottles of 500 NDC 65862-633-05 Bottles of 1,000 NDC 65862-633-99
PRAVASTATIN SODIUM Tablets USP, 40 mg are yellow, rectangular shaped with rounded edges, biconvex, uncoated tablets debossed with βYβ on one side and β39β on the other side. Bottles of 90 NDC 65862-634-90 Bottles of 500 NDC 65862-634-05 Bottles of 1,000 NDC 65862-634-99
PRAVASTATIN SODIUM Tablets USP, 80 mg are yellow, oval shaped biconvex, uncoated tablets, debossed with βYβ on one side and β38β on the other side. Bottles of 90 NDC 65862-635-90 Bottles of 500 NDC 65862-635-05 Store at 20ΒΊ to 25Β°C (68Β° to 77Β°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
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