Fluvastatin

g. exercise, weight reduction) is inadequate. 1).

). The patient should be advised to inform subsequent physicians of the prior use of TEVA-FLUVASTATIN or any other lipid metabolism regulator. Endocrine and Metabolism Increases in fasting glucose and HbA1c levels have been reported with inhibitors of HMG-CoA reductase as a class.

For some patients, at high risk of diabetes mellitus, hyperglycemia was sufficient to shift them to the diabetes status. The benefit of treatment continues to outweigh the small increased risk. Periodic monitoring of these patients is recommended.

Muscle Effects Effects on skeletal muscle such as rare cases of myalgia, myopathy and, very rarely, rhabdomyolysis have been reported in patients treated with fluvastatin sodium. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with TEVA-FULVASTATIN and with other HMG-CoA reductase inhibitors.

Myopathy, defined as muscle pain or muscle weakness in conjunction with increases in creatine phosphokinase (CK) values to greater than ten times the upper limit of normal, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or a marked elevation of CK.

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. , hyperlipoproteinemia Types I, III, IV, or V). 1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia Fluvastatin capsules 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 to 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.