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  • Simvastatin (Flolipid or Zocor) belongs to a class of drugs called statins and is currently the 10th most prescribed drug in America. (medika.life)
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  • 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)
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  • 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)
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  • [3-19-2010] Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor* (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. (fda.gov)
  • The risk of myopathy is also increased when simvastatin, especially at the higher doses, is used with certain drugs (see Simvastatin Dose Limitations below). (fda.gov)
  • Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared to lower doses of simvastatin and possibly other statin drugs. (fda.gov)
  • Follow the recommendations in the simvastatin label regarding drugs that may increase the risk for muscle injury when used with simvastatin (see Simvastatin Dose Limitations below). (fda.gov)
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  • The FDA has warned that the risk of Zocor side effects is also increased when Zocor simvastatin is combined with certain other drugs. (lawyersandsettlements.com)
  • In 2002, the FDA issued its first warning about the risk of rhabdomyolysis to healthcare professionals not to administer more than 20 mg/day of simvastatin to patients receiving heart drugs containing amiodarone such as Cordarone and Pacerone. (lawyersandsettlements.com)
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  • However, use of simvastatin in HIV-infected patients receiving highly active antiretroviral therapy (HAART) is limited by the potential for this drug to interact with antiretroviral medications, specifically drugs from the protease inhibitor class. (ebmconsult.com)
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  • ALT elevations are clearly more frequent in patients taking higher doses of simvastatin (40 and 80 mg daily). (nih.gov)
  • In June 2011, the US FDA announced a simvastatin warning update, alerting patients to the risk of muscle injury (myopathy) when simvastatin was used at the highest doses (80 mg) and especially within the first 12 months of taking the medication. (lawyersandsettlements.com)
  • The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury (see Data Summary below). (fda.gov)
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  • 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)
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  • Use of simvastatin is contraindicated in medications that are strong inhibitors of cytochrome P450 activity (such as cyclosporine, ketoconazole, diltiazem, ciprofloxacin or amiodarone), and dose adjustments are appropriate for its use with other agents that inhibit CYP 3A4. (nih.gov)
  • Use of simvastatin with protease inhibitors increases the risk of statin adverse effects such as liver enzyme elevations and even rhabdomyolysis. (ebmconsult.com)
  • The reason why simvastatin use is contraindicated with protease inhibitors is related to the pharmacokinetic properties of both protease inhibitors and simvastatin. (ebmconsult.com)
  • One key study showed a 3,059% increase in simvastatin exposure when coadministration with the protease inhibitor combo, saquinavir (Invirase) and ritonavir (Norvir).2 The mechanism for the interaction is potent inhibition of the cytochrome P450 3A4 enzyme by all known protease inhibitors. (ebmconsult.com)
  • Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. (fda.gov)
  • In general, all drug prices, not only Zocor, are more affordable to order from Canada because the price of both the brand and generic medication is regulated by the government. (canadapharmacyonline.com)
  • Your Zocor dosage is based on your medical condition, age, other medication taken and your response to treatment. (canadadrugwarehouse.com)
  • Simvastatin is a widely used cholesterol-lowering medication that is metabolized predominantly by CYP450 3A4. (ebmconsult.com)
  • The cholesterol-lowering medication simvastatin (Zocor) is considered a first line agent for the treatment of a variety of dyslipidemias and for the primary and secondary prevention of cardiovascular events. (ebmconsult.com)
  • But in August 2008, the FDA issued another warning because it continued to receive reports of the muscle disease in patients taking both simvastatin and amiodarone. (lawyersandsettlements.com)
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  • Simvastatin is available under the following different brand names: Flolipid, Zocor. (medika.life)
  • More serious Zocor side effects can include myopathy (muscle pain and tenderness), rhabdomyolysis (a breakdown of muscle cells), cardiomyopathy (a decrease in heart muscle function), and liver disease. (lawyersandsettlements.com)
  • Simvastatin works by reducing the production of cholesterol by the liver. (dokteronline.com)
  • Simvastatin is used to lower cholesterol in people who have high levels either due to genetics (familial hypercholesterolaemia) or as a result of diet and lifestyle. (dokteronline.com)
  • In these people simvastatin slows down hardening of the arteries, regardless of your cholesterol level. (dokteronline.com)
  • It is important to continue to follow a cholesterol-lowering diet and exercise regime while taking simvastatin. (dokteronline.com)
  • Simvastatin works by reducing the amount of cholesterol that is produced by the liver. (canadadrugwarehouse.com)
  • However, it is difficult to predict the increase in the cholesterol-reducing effect of simvastatin because of the many variables that can potentially interact with the drug metabolism and mechanism of action. (drugsdb.com)
  • The previous Zocor FDA warning in March 2010 is part of an ongoing investigation into Zocor and other cholesterol drug side effects. (lawyersandsettlements.com)
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  • 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)
  • 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)
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  • 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)
  • Coadministration with these agents may cause increases in simvastatin levels and potentiate its hepatic or muscle toxicity. (nih.gov)
  • 3000% increase in simvastatin concentrations, simvastatin should never be given concurrently with any protease inhibitor. (ebmconsult.com)
  • In particular, CYP450 3A4 is responsible for the vast majority of simvastatin metabolism and plasma clearance.3 Thus, protease inhibitor mediated inhibition of the CYP450 3A4 clearance pathway for simvastatin results in dangerously high concentrations of this statin. (ebmconsult.com)
  • Simvastatin can also be used to reduce the risk of coronary heart disease in people who have already had a heart attack, or who suffer from angina or diabetes. (dokteronline.com)
  • In patients with coronary heart disease (CHD) or at high risk of CHD, ZOCOR can be started simultaneously with diet. (druglib.com)
  • Review their medical history and current medications with their healthcare professional to determine if they should continue using simvastatin. (fda.gov)
  • Grapefruit products are known to interact with several medications, and one of which is simvastatin. (drugsdb.com)
  • In one clinically study, a 12-fold increase has been noted when simvastatin was taken together with a large amount of grapefruit juice. (drugsdb.com)
  • Clinically apparent liver injury due to simvastatin is rare. (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)
  • Zocor was also combined with Zetia as Merck and Schering-Plough Corp's Vytorin- which faced over one hundred Vytorin-Zetia class action lawsuits involving consumer fraud. (lawyersandsettlements.com)
  • We currently have the brand name Zocor from Canada, Australia and the United Kingdom manufactured by Merck. (canadapharmacyonline.com)
  • Zocor, a synthetic statin developed by Merck & Co., was the company's best-selling drug and the second most popular drug worldwide, with sales of $4.3 billion in 2005, the year Merck's patent expired. (lawyersandsettlements.com)
  • Simvastatin is an ingredient in Merck & Co's Zocor and Abbott Laboratories Inc's Simcor, and is now sold generically. (lawyersandsettlements.com)
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  • Rare cases of acute liver failure and death have been attributed to simvastatin. (nih.gov)
  • This enzyme system is chiefly responsible for the first-pass metabolism of simvastatin which transforms it into more usable chemicals in the body. (drugsdb.com)
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  • One study reported that 21% of HIV infected patients were receiving a contraindicated statin with their PI.11 Therefore, the combination of simvastatin and PIs should be avoided and other statin options (such as pravastatin which does not undergo CYP450 metabolism) are preferred.12 Use of simvastatin with nevirapine, efavirenz, or etravirine may be acceptable. (ebmconsult.com)
  • Since clinical studies show that even a glass of grapefruit juice, taken each day, can considerably increase simvastatin levels in the blood, it is best to avoid grapefruit products throughout the treatment. (drugsdb.com)
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  • The Zocor study reported muscle damage in nearly one percent of patients taking an 80 milligram dose of Zocor. (lawyersandsettlements.com)
  • According to the FDA, no new patients should be put on the 80 mg dose and patients currently on that dose should only continue if they have used simvastatin for more than a year without muscle pain. (lawyersandsettlements.com)
  • 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)
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  • Report any side effects with simvastatin to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box. (fda.gov)
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  • 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)
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