Pravastatin Sodium 40 MG Oral Tablet
1 INDICATIONS AND USAGE Pravastatin sodium tablet is 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 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.
Accord Healthcare Inc.
SQUARE GREEN PB 8
PB 8 SQUARE GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAVASTATIN SODIUM tablets, USP are supplied as: 10 mg tablets: pink coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘1’ on other side. They are supplied in bottles containing desiccant canister as follows. NDC Number Size 16729-008-15 Bottle of 90 tablets with child-resistant closure 16729-008-16 Bottle of 500 tablets 16729-008-17 Bottle of 1000 tablets 20 mg tablets: yellow coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘2’ on other side. They are supplied in bottles containing desiccant canister as follows. NDC Number Size 16729-009-15 Bottle of 90 tablets with child-resistant closure 16729-009-16 Bottle of 500 tablets 16729-009-17 Bottle of 1000 tablets 40 mg tablets: Light green coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘8’ on other side. They are supplied in bottles containing desiccant canister as follows. NDC Number Size 16729-010-15 Bottle of 90 tablets with child-resistant closure 16729-010-16 Bottle of 500 tablets 16729-010-17 Bottle of 1000 tablets 80 mg tablets: yellow coloured, mottled, oval shaped, uncoated tablets, debossed ‘PB’ on one side and ‘4’ on other side. They are supplied in bottles containing desiccant canister as follows. NDC Number Size 16729-011-15 Bottle of 90 tablets with child-resistant closure 16729-011-16 Bottle of 500 tablets 16729-011-17 Bottle of 1000 tablets Store at 25°C (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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