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WHEN ZOCOR SHOULD NOT BE USED

Some people should not take ZOCOR. Discuss this with your doctor.

ZOCOR should not be used by patients who are allergic to any of its ingredients. In addition to the active ingredient simvastatin, each tablet contains the following inactive ingredients: cellulose, lactose, magnesium stearate, iron oxides, talc, titanium dioxide, and starch. Butylated hydroxyanisole is added as a preservative.

Patients with liver problems: ZOCOR should not be used by patients with active liver disease or repeated blood test results indicating possible liver problems. (See WARNINGS.)

Women who are or may become pregnant: Pregnant women should not take ZOCOR because it may harm the fetus. Women of childbearing age should not take ZOCOR unless it is highly unlikely that they will become pregnant. If a woman does become pregnant while on ZOCOR, she should stop taking the drug and talk to her doctor at once.

Women who are breast-feeding should not take ZOCOR.

WARNINGS

Muscle: Tell your doctor right away if you experience any unexplained muscle pain, tenderness, or weakness at any time during treatment with ZOCOR so your doctor c Triamcinolone side effectsan decide if ZOCOR should be stopped. Some patients may have muscle pain or weakness while taking ZOCOR. Rarely, this can include muscle breakdown resulting in kidney damage. The risk of muscle breakdown is greater in patients with kidney problems or diabetes.

If you have conditions that can increase your risk of muscle breakdown, which in turn can cause kidney damage, your doctor should temporarily withhold or stop ZOCOR. Also, since there are no known adverse consequences of briefly stopping therapy with ZOCOR, treatment should be stopped a few days before elective major surgery and when any major acute medical or surgical condition occurs. Discuss this with your doctor, who can explain these conditions to you.

The risk of muscle breakdown is greater in patients taking certain other drugs along with ZOCOR:

  • Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, the antidepressant nefazodone, or large quantities of grapefruit juice (>1 quart daily), particularly with higher doses of ZOCOR.
  • Gemfibrozil particularly with higher doses of ZOCOR.
  • Other lipid lowering drugs (other fibrates or > 1 g/day of niacin) that can cause myopathy when given alone.
  • Cyclosporine or danazol particularly with higher doses of ZOCOR.
  • Amiodarone or verapamil with higher doses of ZOCOR.

The risk of muscle breakdown is greater at higher doses of simvastatin.

Because the risk of muscle side effects is greater when ZOCOR is used with the products listed above, the combined use of these products should be avoided unless your doctor determines the benefits are likely to outweigh the increased risks.

The dose of ZOCOR should not exceed 10 mg daily in patients receiving gemfibrozil. The combined use of ZOCOR and gemfibrozil should be avoided, unless your doctor determines that the benefits outweigh the increased risks of muscle problems. Caution should be used when using ZOCOR with other fibrates or niacin because these can cause muscle problems when taken alone.

No more than 10 mg/day of ZOCOR should be taken with cyclosporine or danazol.

The combined use of verapamil or amiodarone with doses above ZOCOR 20 mg should be avoided unless your doctor determines the benefits outweigh the increased risk of muscle breakdown.

Your doctor should also carefully monitor for any muscle pain, tenderness, or weakness, particularly during the initial months of therapy and if the dose of either drug is increased. Your doctor also may monitor the level of certain muscle enzymes in your body, but there is no assurance that such monitoring will prevent the occurrence of severe muscle disease.

Drug Interactions Associated with Increased
Risk of Myopathy/Rhabdomyolysis
Interacting agents Prescribing Recommendations
Itraconazole Ketoconazole Erythromycin Clarithromycin Telithromycin HIV protease inhibitors Nefazodone Avoid simvastatin
Gemfibrozil Cyclosporine Danazol Do not exceed 10 mg simvastatin daily
Amiodarone Verapamil Do not exceed 20 mg simvastatin daily
Grapefruit juice Avoid large quantities of grapefruit juice (>1 quart daily)

Liver: About 1% of patients who took ZOCOR in clinical trials developed elevated levels of some liver enzymes. Patients who had these increases usually had no symptoms. Elevated liver enzymes usually returned to normal levels when therapy with ZOCOR was stopped.

In the ZOCOR Survival Study, the number of patients with more than 1 liver enzyme level elevation to greater than 3 times the normal upper limit was no different between the ZOCOR and placebo groups. Only 8 patients on ZOCOR and 5 on placebo discontinued therapy due to elevated liver enzyme levels. Patients were started on 20 mg of ZOCOR, and one third had their dose raised to 40 mg.

Your doctor should perform routine blood tests to check these enzymes before you start treatment with ZOCOR and thereafter when clinically indicated. Patients titrated to the 80-mg dose should receive an additional test at 3 months and periodically thereafter (eg, semiannually) for the first year of treatment. If your enzyme levels increase, your doctor should order more frequent tests. If your liver enzyme levels remain unusually high, your doctor should discontinue your medication.

Tell your doctor about any liver disease you may have had in the past and about how much alcohol you consume. ZOCOR should be used with caution in patients who consume large amounts of alcohol.

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