pravastatin sodium 40 mg
1 INDICATIONS AND USAGE Pravastatin sodium tablets are 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). 2. 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. 3. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. 4. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 5. As an adjunct to diet for the treatment of adults with: • Primary dysbetalipoproteinemia. • Hypertriglyceridemia. Pravastatin sodium tablets are 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.
Glenmark Pharmaceuticals Inc., USA
SQUARE GREEN G5 40
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAVASTATIN SODIUM Tablets, USP are supplied as: Strength How Supplied NDC Tablet Description 10 mg of
PRAVASTATIN SODIUM, USP bottles of 90 68462-195-90 yellow colored, circular shaped, flat faced tablets with “G5” debossed on one side and “10” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-195-05 20 mg of
PRAVASTATIN SODIUM, USP bottles of 90 68462-196-90 yellow, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “20” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-196-05 40 mg of
PRAVASTATIN SODIUM, USP bottles of 90 68462-197-90 green, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “40” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-197-05 80 mg of
PRAVASTATIN SODIUM, USP bottles of 90 68462-198-90 yellow, oval, biconvex tablets with “G5” debossed on one side and “80” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-198-05 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
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