Discontinue simvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. (nih.gov)
Temporarily discontinue simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. (nih.gov)
Simvastatin is also available as a fixed combination with ezetimibe under the brand name Vytorin. (nih.gov)
No incremental benefit of ezetimibe and simvastatin tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. (nih.gov)
Ezetimibe and simvastatin tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. (nih.gov)
Due to the increased risk of myopathy, including rhabdomyolysis, use of the 10 mg/80-mg dose of ezetimibe and simvastatin should be restricted to patients who have been taking ezetimibe and simvastatin 10 mg/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. (nih.gov)
Patients who are currently tolerating the 10 mg/80-mg dose of ezetimibe and simvastatin who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction. (nih.gov)
Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10 mg/80-mg dose of ezetimibe and simvastatin, patients unable to achieve their LDL-C goal utilizing the 10 mg/40-mg dose of ezetimibe and simvastatin should not be titrated to the 10 mg/80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering. (nih.gov)
Ezetimibe and simvastatin should be discontinued immediately if myopathy is diagnosed or suspected. (nih.gov)
Chronically2
An 80 mg daily dosage of simvastatin tablets are restricted to patients who have been taking simvastatin tablets 80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. (nih.gov)
Up to 5% of patients taking simvastatin chronically may experience minor elevations in serum ALT levels during therapy, but confirmed elevations to above three times the upper limit of normal (ULN) occur in only 1% to 2% of patients. (nih.gov)
Tablets7
These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. (nih.gov)
Maximum recommended dosage is simvastatin tablets 40 mg once daily. (nih.gov)
For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving simvastatin tablets 40 mg daily, prescribe alternative LDL-C lowering treatment. (nih.gov)
See full prescribing information for simvastatin tablets dosage modifications due to drug interactions. (nih.gov)
Simvastatin is available generic forms and under the commercial name of Zocor in tablets of 5, 10, 20, 40 and 80 mg. the recommended dose is 5 to 80 mg daily based upon tolerability and lipid levels. (nih.gov)
Myopathy1
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing simvastatin dosage. (nih.gov)
Orally1
Simvastatin (sim" va stat' in) is an orally available inhibitor of hepatic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the major rate-limiting enzyme in cholesterol synthesis. (nih.gov)
Acute2
Simvastatin is a commonly used cholesterol lowering agent (statin) that is associated with mild, asymptomatic and self-limited serum aminotransferase elevations during therapy, and rarely with clinically apparent acute liver injury. (nih.gov)
Rare cases of acute liver failure and death have been attributed to simvastatin. (nih.gov)
Autoimmune1
Isolated cases of an autoimmune hepatitis-like syndrome associated with simvastatin therapy have been reported, some of which did not reverse completely with discontinuation, resulting in a chronic hepatitis requiring long term immunosuppressive therapy. (nih.gov)
Increases1
Coadministration with these agents may cause increases in simvastatin levels and potentiate its hepatic or muscle toxicity. (nih.gov)
Cholesterol1
Like other members of its class (the "statins"), simvastatin lowers total serum cholesterol and particularly low density lipoprotein (LDL) cholesterol concentrations, thereby reducing the risk of atherosclerosis and its complications - myocardial infarction and stroke. (nih.gov)
But in view of the wide use of simvastatin, clinically apparent liver injury is exceeding rare and is estimated to occur in 1 per 100,000 patient years of exposure. (nih.gov)
Simvastatin is metabolized to some extent in the liver (via CYP 3A4) and is excreted in bile. (nih.gov)
ALT elevations are clearly more frequent in patients taking higher doses of simvastatin (40 and 80 mg daily). (nih.gov)
In several studies, ALT elevations were no more frequent in patients taking 10 and 20 mg of simvastatin daily than in placebo recipients. (nih.gov)
Higher1
Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher simvastatin dosage. (nih.gov)
Therapy1
18 UPMC Cardiovascular Institute TNT and IDEAL Adverse events and treatment related drug discontinuation 40% more common in high dose atorvastatin Over twice as many subjects in the atorva 80mg group stopped therapy related to side effects compared to simva 20/40. (slideplayer.com)
Patients1
Current indications for simvastatin are hypercholesterolemia and reduction in risk for death from coronary, cerebrovascular and peripheral artery disease in patients with these diseases. (nih.gov)