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Medication Written by Pharmacists Reviewed by Doctors

Pharmacy Author: Omudhome Ogbru, PharmD
Medical and Pharmacy Editor: Jay W. Marks, MD

GENERIC NAME: simvastatin

BRAND NAME: Zocor

DRUG CLASS AND MECHANISM: Simvastatin is a cholesterol-lowering drug. It belongs to a class of drugs called HMG-CoA reductase inhibitors, commonly called "statins." Other statins include lovastatin (Mevacor), atorvastatin (Lipitor), fluvastatin (Lescol), and rosuvastatin (Crestor). Statins reduce cholesterol by inhibiting an enzyme in the liver (HMG-CoA reductase) that is necessary for the production of cholesterol. In the blood, statins lower total and LDL ("bad") cholesterol as well as triglycerides. LDL cholesterol is believed to be an important cause of coronary artery disease. Lowering LDL cholesterol levels slows and may even reverse coronary artery disease. Statins also increase HDL ("good") cholesterol. Raising HDL cholesterol levels, like lowering LDL cholesterol may slow coronary artery disease. The FDA approved simvastatin in December 1991.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS:

  • Tablets: 5, 10, 20, 40, and 80 mg.
  • Oral disintegrating tablets: 10, 20, 40, and 80 mg.

STORAGE:

  • Tablets should be stored between 5-30 C (41-86 F).
  • Oral disintegrating tablets should be stored between 20-25 C (68-77 F).

PRESCRIBED FOR: Simvastatin is used for reducing total cholesterol, LDL cholesterol, and triglycerides, and for increasing HDL cholesterol. In patients with coronary heart disease, diabetes, peripheral vessel disease, or history of stroke or other cerebrovascular disease. Simvastatin is prescribed for reducing the risk of mortality by reducing death from coronary heart disease, reducing nonfatal myocardial infarction (heart attack) and stroke, and reducing the need for coronary and noncoronary revascularization procedures.

DOSING: The dose range for is 5-80 mg/day given preferably in the evening. The usual staring dose is 20-40 mg once daily. Dose adjustments are made at weekly intervals.

DRUG INTERACTIONS: Decreased elimination of simvastatin could increase the levels of simvastatin in the body and increase the risk of muscle toxicity from simvastatin. Examples of drugs that decrease elimination of simvastatin include erythromycin (E-Mycin), ketoconazole (Nizoral), itraconazole (Sporanox), clarithromycin (Biaxin), telithromycin (Ketek), cyclosporine (Sandimmune), nefazodone (Serzone), and HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir). Large quantities of grape fruit juice (>1 quart daily) also will increase blood levels of simvastatin.

Amiodarone (Cordarone), verapamil (Calan Verelan, Isoptin), danazol (Danocrine), cyclosporine, niacin (Niacor, Niaspan, Slo-Niacin), gemfibrozil (Lopid) and fenofibrate (Tricor) also may increase the risk of muscle toxicity when combined with simvastatin. Patients taking amiodarone or verapamil should not take more than 20 mg of simvastatin. Patients taking danazol or cyclosporine should not take more than 10 mg of simvastatin.

Simvastatin increases the effect of warfarin (Coumadin) and the blood concentration of digoxin (Lanoxin). Patients taking simvastatin and warfarin or digoxin should be monitored carefully for toxic effects of warfarin and digoxin.

Cholestyramine (Questran, Questran Light) decreases the absorption of simvastatin. Therefore, simvastatin should only be taken 2 hours before or at least 4 hours after cholestyramine administration.

PREGNANCY: Pregnant women should not use simvastatin because the developing fetus requires cholesterol for development, and simvastatin reduces the production of cholesterol. Simvastatin should only be administered to women of child bearing age if they are not likely to become pregnant.

NURSING MOTHERS: Because of the risk of adverse effects to the developing infant, simvastatin should not be administered to nursing mothers.

SIDE EFFECTS: The most common side effects of simvastatin are headache, nausea, vomiting, diarrhea, abdominal pain, muscle pain, and abnormal liver tests. Hypersensitivity reactions have also been reported. The most serious potential side effects are liver damage and muscle inflammation or breakdown.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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