24 HR fluvastatin 80 MG Extended Release Oral 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 non-pharmacologic measures alone has been inadequate. Fluvastatin sodium extended-release tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia ( 1.1 ) • Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy ( 1.1 ) • Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD ( 1.2 ) • Slow the progression of atherosclerosis in patients with CHD ( 1.2 ) Limitations of Use: • Fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V) ( 1.3 ) 1.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia Fluvastatin sodium extended-release tablets are indicated • as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). • as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present: ▪ LDL-C remains ≥ 190 mg/dL or ▪ LDL-C remains ≥ 160 mg/dL and: • there is a positive family history of premature cardiovascular disease or • two or more other cardiovascular disease risk factors are present The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below. Category Total-C (mg/dL) LDL-C (mg/dL) Acceptable < 170 < 110 Borderline 170-199 110-129 High ≥ 200 ≥ 130 Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals. 1.2 Secondary Prevention of Cardiovascular Disease In patients with clinically evident CHD, fluvastatin sodium extended-release tablets are indicated to: • reduce the risk of undergoing coronary revascularization procedures • slow the progression of coronary atherosclerosis 1.3 Limitations of Use Fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V).
Mylan Pharmaceuticals Inc.
ROUND RED M F21
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16 HOW SUPPLIED/STORAGE AND HANDLING Fluvastatin Sodium Extended-Release Tablets are available containing fluvastatin sodium, USP equivalent to 80 mg of fluvastatin. The 80 mg tablets are rust, film-coated, round, unscored tablets debossed with M on one side of the tablet and F21 on the other side. They are available as follows: NDC 0378-5121-93 bottles of 30 tablets NDC 0378-5121-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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