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Zocor
Generic Name: Simvastatin
Drug Category: Statin
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 10 years old for a maximum duration of 6 years.
| Approved Uses |
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Indicated as an adjunctive therapy to diet for: Reductions in Risk of CHD Mortality and Cardiovascular Events: In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, ZOCOR is indicated to:
Hyperlipidemia: ZOCOR is indicated to:
Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH): As an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined. ZOCOR has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V). Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by elevated plasma levels of simvastatin and simvastatin acid. Predisposing factors for myopathy include advanced age (≥65 years), female gender, uncontrolled hypothyroidism, and renal impairment. Chinese patients may be at increased risk for myopathy. Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of ZOCOR should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. All patients starting therapy with ZOCOR, or whose dose of ZOCOR is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing ZOCOR. ZOCOR therapy should be discontinued immediately if myopathy is diagnosed or suspected. The risk of myopathy and rhabdomyolysis is increased by elevated plasma levels of simvastatin and simvastatin acid. Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which inhibit this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, posaconazole, voriconazole, the macrolide antibiotics erythromycin and clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, boceprevir, telaprevir, the antidepressant nefazodone, cobicistat-containing products, or grapefruit juice. Combination of these drugs with simvastatin is contraindicated. If short term treatment with strong CYP3A4 inhibitors is unavoidable, therapy with simvastatin must be suspended during the course of treatment. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including simvastatin. In patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored. Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including ZOCOR. Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg co-administered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day co-administered with lipid modifying doses of niacin-containing products. Chinese patients should not receive simvastatin 80 mg co-administered with lipid-modifying doses of niacin-containing products. There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. There have been rare reports of immune-mediated necrotizing myopathy (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 immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. ZOCOR is contraindicated with:
Caution should be used when prescribing other fibrates with simvastatin, as these agents can cause myopathy when given alone and the risk is increased when they are co-administered. Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin co-administered with colchicine, and caution should be exercised when prescribing simvastatin with colchicine. In patients taking Verapamil, Diltiazem, or Dronedarone the dose of ZOCOR should not exceed 10 mg/day. In patients taking Amiodarone, Amlodipine or Ranolazine the dose of ZOCOR should not exceed 20 mg/day. Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of ZOCOR should be reduced by 50% if initiating lomitapide. Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of ZOCOR should be reduced by 50% if initiating lomitapide. In one study, concomitant administration of digoxin with simvastatin resulted in a slight elevation in digoxin concentrations in plasma. ZOCOR is contraindicated in women who are or may become pregnant. Lipid lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. ZOCOR may cause fetal harm when administered to a pregnant woman. If ZOCOR is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. It is not known whether simvastatin is excreted in human milk. Because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not nurse their infants. |
| Off-label Uses |
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• Improve symptomatology and cardiac function in patients with non-ischemic dilated cardiomyopathy. GoToSource • Pulmonary arterial hypertension. GoToSource • Relapsing-remitting multiple sclerosis. GoToSource • Prevention of migraines. GoToSource • Reduction of incidence of dementia and newly-acquired parkinson’s disease. GoToSource • Increase hepatic blood flow and decrease hepatic sinusoidal resistance in patients with cirrhosis. GoToSource • Periodic fever syndrome. GoToSource • Rheumatoid arthritis. GoToSource • Idiopathic membranous nephropathy and nephrotic syndrome. GoToSource • Peripheral artery disease. GoToSource • Increase bone mineral density in postmenopausal women. GoToSource • Sickle cell disease. GoToSource • Polycystic ovary syndrome. GoToSource • Prevention of exacerbations in moderate-to-severe chronic obstructive pulmonary disease. GoToSource |
| Adverse Events |
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Myositis (muscle inflammation) and myalgia (muscle pain), peripheral neuropathy, gynecomastia (male breast enlargement), proteinuria (abnormal amount of protein in urine indicating damage to kidneys), hematuria (blood in urine), pulmonary fibrosis (scarring in lungs), atrial fibrillation (irregular, rapid heart rate) and bradycardia (slow heart rate). GoToSource Rhabdomyolysis (breakdown of muscle tissue). GoToSource Myopathy (diseases of skeletal muscle). GoToSource Erectile dysfunction. GoToSource Interstitial lung disease (disorders causing scarring of lungs). GoToSource Pollakiuria (urinary frequency) and nocturia (excessive urination at night). GoToSource Liver failure and cognitive impairment. GoToSource New onset diabetes. GoToSource |
| Litigation |
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Lawsuits filed for rhabdomyolysis. |
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