Pravachol - Indications & Dosage

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40 mg tablets:

Green, rounded, rectangular-shaped, biconvex with a P embossed on one side and PRAVACHOL 40 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5194-10) and hospital unit-dose packages of 100 tablets (NDC 0003-5194-33). Bottles contain a desiccant canister.

80 mg tablets:

Yellow, oval-shaped, biconvex with BMS embossed on one side and 80 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5195-10), bottles of 500 (NDC 0003-5195-12), and hospital unit-dose packages of 100 tablets (NDC 0003-5195-33). Bottles contain a desiccant canister. STORAGE Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

REFERENCES

1 Shepherd J, et al. Prevention of coronary heart disease with pravastatin in men withhypercholesterolemia (WOS). N Engl J Med 1995; 333: 1301-7.

2 The Long-term Intervention with Pravastatin in Ischemic Disease Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels (LIPID). N Engl J Med 1998; 339: 1349-1357.

3 Sacks FM, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels (CARE). N Engl J Med. 1996; 335: 1001-9.

4 Pitt B, et al. Pravastatin Limitation of Atherosclerosis in the Coronary Arteries (PLAC I): Reduction in Atherosclerosis Progression and Clinical Events. J Am Coll Cardiol 1995; 26: 1133-9.

5 Jukema JW, et al. Effects of Lipid Lowering by Pravastatin on Progression and Regression of Coronary Artery Disease in Symptomatic Man With Normal to Moderately Elevated Serum Cholesterol Levels. The Regression Growth Evaluation Statin Study (REGRESS). Circulation1995; 91: 2528-2540.

6 Crouse JR, et al. Pravastatin, lipids, and atherosclerosis in the carotid arteries: design fea-tures of a clinical trial with carotid atherosclerosis outcome (PLAC II). Controlled Clinical Trials 1992; 13: 495.

7 Salonen R, et al. Kuopio Atherosclerosis Prevention Study (KAPS). A population-based primary preventive trial of the effect of LDL lowering on atherosclerotic progression in carotid and femoral arteries. Research Institute of Public Health, University of Kuopio, Finland. Circulation 1995; 92: 1758.

8 Fredrickson DS, et al. Fat transport in lipoproteinsÐ an integrated approach to mechanisms and disorders. N Engl J Med 1967; 276: 34-42, 94-102, 148-156, 215-224, 273-281.

9 Manson JM, Freyssinges C, Ducrocq MB, Stephenson WP. Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproductive Toxicology 1996; 10( 6): 439-446.

US Patent Nos.: 4,346,227; 5,030,447; 5,180,589; 5,622,985

D3-B0001-01-04 5154DIM-23 Revised November 2003