Fluvastatin Sodium Extended Release Tablets

【DOSAGE FORMS AND STRENGTHS】80mg

【INDICATIONS AND USAGE】

Fluvastatin sodium tablet XL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:

l Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia

l 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

l Reduce the risk of undergoing revascularization procedures in patients with clinically evident Coronary

Heart Disease (CHD) 

l Slow the progression of atherosclerosis in patients with CHD

【DOSAGE AND ADMINISTRATION】

l Fluvastatin sodium tablet XL can be taken with or without food and may be taken at any time of the day

l Do not break, crush or chew Fluvastatin sodium tablet XL tablets prior to administration

l Adults: the recommended starting dose is 80 mg (administered as one 80 mg  Fluvastatin sodium tablet XL once daily)

【WARNINGS AND PRECAUTIONS】

l Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with advanced age (≥ 65), uncontrolled hypothyroidism, renal impairment, and combination use with cyclosporine, or gemfibrozil . Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue Fluvastatin sodium tablet XL if myopathy is diagnosed or suspected

l Patients should be advised to report promptly any symptoms of myopathy.  Fluvastatin sodium tablet XL therapy should be discontinued if myopathy is diagnosed or suspected

l Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with imunosuppressive agents

l Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter