Zocor can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism underactive thyroid.
FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not take Zocor if you are pregnant.
Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking this medicine. Simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking Zocor.
How should I take Zocor? The usual maximum dose for this medication is 40 milligrams a day. If you have been instructed by your doctor to take more than 40 milligrams, continue on that same dose. However, promptly talk with him or her about the risks and benefits of your higher dose.
Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise.
There was no evidence of hypersensitivity. Of the 1, simvastatin treated patients in 4S with normal liver function tests LFTs at baseline, 8 0. Among these 8 patients, 5 initially developed these abnormalities within the first year. In 2 controlled clinical studies in 1, patients, the month incidence of persistent hepatic transaminase elevation without regard to drug relationship was 0.
No patients developed persistent liver function abnormalities following the initial 6 months of treatment at a given dose. It is recommended that liver function tests be performed before the initiation of treatment, and thereafter when clinically indicated. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including simvastatin.
Active liver diseases or unexplained transaminase elevations are contraindications to the use of simvastatin. Moderate less than 3X ULN elevations of serum transaminases have been reported following therapy with simvastatin. These changes appeared soon after initiation of therapy with simvastatin, were often transient, were not accompanied by any symptoms and did not require interruption of treatment.
The incidence of adenomas of the liver was significantly increased in mid- and high-dose females. Drug treatment also significantly increased the incidence of lung adenomas in mid- and high-dose males and females.
Adenomas of the Harderian gland a gland of the eye of rodents were significantly higher in high-dose mice than in controls. The increased incidence of thyroid neoplasms appears to be consistent with findings from other statins. These treatment levels represented plasma drug levels AUC of approximately 7 and 15 times males and 22 and 25 times females the mean human plasma drug exposure after an 80 milligram daily dose.
No evidence of mutagenicity was observed in a microbial mutagenicity Ames test with or without rat or mouse liver metabolic activation. Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain. On March 19, , the FDA issued another statement regarding simvastatin, saying it increases the risk of muscle injury myopathy when taken at high doses or at lower doses in combination with other drugs.
These interactions are clinically important because increasing simvastatin serum levels above those normally provided by the maximum recommended dose increases the risk of muscle damage, including the otherwise rare and potentially fatal side effect of rhabdomyolysis. It should not be taken by people who are also taking the antifungal drugs fluconazole , itraconazole , or posaconazole ; the antibiotics erythromycin , clarithromycin , or telithromycin ; HIV protease inhibitors; the antidepressant nefazodone ; the cardiovascular drug gemfibrozil ; the immunosuppressant ciclosporin , or the endometriosis drug danazol.
Reduced maximum doses of simvastatin apply for patients taking certain other drugs, including the cardiovascular drugs verapamil , diltiazem , amiodarone , amlodipine , and ranolazine. Statins are more effective than other lipid-regulating drugs at lowering LDL -cholesterol concentration, but they are less effective than the fibrates in reducing triglyceride concentration.
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