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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.

Mylan Institutional Inc.


5 months ago ROUND GREEN TEVA 7202 Pravastatin Sodium 40 MG Oral Tablet

ROUND GREEN TEVA 7202

5 months ago ROUND GREEN TEVA 7202 Pravastatin Sodium 40 MG Oral Tablet

TEVA 7202 ROUND GREEN

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

PRAVASTATIN SODIUM tablets, USP are supplied as: 20 mg tablets: Light-yellow, unscored, round tablet, debossed “TEVA” on one side and “7201” on the other side. They are available as follows: NDC 51079-458-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 40 mg tablets: Light-green, unscored, round tablet, debossed “TEVA” on one side and “7202” on the other side. They are available as follows: NDC 51079-782-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Keep this and all medications out of the reach of children.


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