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pravastatin sodium tablet

1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Pravastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 7. Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. ( 1.1 ) 8. Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. ( 1.1 ) 9. Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. ( 1.2 ) 10. Reduce elevated serum TG levels in patients with hypertriglyceridemia. ( 1.2 ) 11. Treat patients with primary dysbetalipoproteinemia who are not responding to diet. ( 1.2 ) 12. Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. ( 1.2 ) Limitations of use: 2. Pravastatin sodium has not been studied in Fredrickson Types I and V dyslipidemias. ( 1.3 ) 1.1 Prevention of Cardiovascular Disease In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to: • reduce the risk of myocardial infarction (MI). • reduce the risk of undergoing myocardial revascularization procedures. • reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. In patients with clinically evident CHD, pravastatin sodium is indicated to: 1. reduce the risk of total mortality by reducing coronary death. 2. reduce the risk of MI. 3. reduce the risk of undergoing myocardial revascularization procedures. 4. reduce the risk of stroke and stroke/transient ischemic attack (TIA). 5. slow the progression of coronary atherosclerosis. 1.2 Hyperlipidemia Pravastatin sodium tablets are indicated: • as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia ( Fredrickson Types IIa and IIb). 1 • as an adjunct to diet for the treatment of patients with elevated serum TG levels ( Fredrickson Type IV). • for the treatment of patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet. • as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present: a. LDL-C remains ≥190 mg/dL or • there is a positive family history of premature cardiovascular disease (CVD) or 1.3 Limitations of Use Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson Types I and V).

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2 years ago ROUND YELLOW PRA 20 APO pravastatin sodium tablet

ROUND YELLOW PRA 20 APO

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

PRAVASTATIN SODIUM Tablets, USP 10 mg are available for oral administration as light pink, round, unscored tablets, imprinted “APO” on one side and “PRA” over “10” on the other side. They are supplied as follows: Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-5891-61

PRAVASTATIN SODIUM Tablets, USP 20 mg are available for oral administration as off-white to light yellow, round, unscored tablets, imprinted “APO” on one side and “PRA” over “20” on the other side. They are supplied as follows: Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-5892-61

PRAVASTATIN SODIUM Tablets, USP 40 mg are available for oral administration as light green, round, unscored tablets, imprinted “APO” on one side and “PRA” over “40” on the other side. They are supplied as follows: Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-5893-61 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from light and moisture.

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