Before Taking Zocor

You should not take Zocor if you are allergic to simvastatin, if you are pregnant or breast-feeding, or if you have liver disease.

If you have any of these other conditions, your doctor may need adjust the dose of Zocor or order special tests:

history of liver disease;
history of kidney disease;

diabetes;

a thyroid disorder; or

if you drink more than 2 alcoholic beverages daily.

In rare cases, 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). You may also be more likely to develop this condition if you are of Chinese descent and you take high-dose Zocor while also taking medication that contains niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

amiodarone (Cordarone, Pacerone);

danazol (Danocrine);

nefazodone (an antidepressant);

gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);

antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem) or verapamil (Calan, Covera, Isoptin, Verelan);

HIV medications such as atazanavir (Reyataz), ritonavir (Norvir), lopinavir/ritonavir (Kaletra), saquinavir (Invirase), and others;

medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); or

drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

FDA pregnancy category X. Zocor 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 Zocor. Simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking Zocor.

FDA Warns Against Zocor Risk

The Food and Drug Administration (FDA) on Wednesday restricted the use of high doses of the cholesterol-lowering drug simvastatin, which is sold in generic forms and under the brand names Zocor and Vytorin, because of concerns over muscle problems associated with the drug.

The agency recommends that no new patients start taking the highest dose, 80 mg, of the medication. However, those who are already safely taking that dose may continue to do so.

Statins, which lower cholesterol by inhibiting its production in the liver, are among the most commonly prescribed drugs in the U.S. Recent studies have shown that the medications can lower the risk of having a heart attack or dying from heart disease, but the drugs have also been linked to serious side effects.

The statin Baycol (cerivastatin) was recalled in 2001 after users reported elevated rates of muscle injury similar to the ones that led the FDA to restrict use of simvastatin. Concerns about simvastatin and its potential to cause muscle-weakening, known as myopathy, emerged last March when the FDA issued warnings about the risk.

Zocor (Simvastatin)

Simvastatin (INN) (play /ˈsɪmvəstætɨn/) is a hypolipidemic drug used to control elevated cholesterol, or hypercholesterolemia. Simvastatin is a member of the statin class of pharmaceuticals, is a synthetic derivate of a fermentation product of Aspergillus terreus. It is marketed under the trade names Zocor, Simlup, Simcard, Simvacor, and others, as well as generically.

Dose

Simvastatin is a powerful lipid-lowering drug that can decrease low density lipoprotein (LDL) levels by up to 50%. It is used in doses of 5 mg up to 80 mg. Higher doses (160 mg) have been found to be too toxic, while giving only minimal benefit in terms of lipid lowering.

In secondary prevention, 80 mg per day reduced major cardiovascular events by an absolute rate of 1.2% compared to 20 mg per day in a randomized controlled trial.

Uses

There is also evidence of raising high density lipoprotein (HDL) and lowering triglyceride (TG) levels.

Simvastatin and other statins may inhibit the progression of atherosclerosis beyond their effects on LDL. Many explanations have been proposed, for example its inhibitory effect on macrophages in the atherosclerotic plaque lesions.

In one non-randomized study, simvastatin halved the risk of developing dementia or Parkinson's disease.