Detailed Drug Information:

DRUG CLASS AND MECHANISM: Simvastatin is a cholesterol-loweringmedicine. It inhibits the production of cholesterol by the liver. Itlowers overall blood cholesterol as well as blood LDL cholesterol levels.LDL cholesterol is believed to be the "bad" cholesterol that isprimarily responsible for the development of coronary artery disease.Lowering LDL cholesterol levels retards progression and may even reversecoronary artery disease.

PREPARATIONS: tablets: 5 mg,10 mg, 20 mg, 40 mg

STORAGE: Tablets should be stored at room temperature in atightly closed container.

PRESCRIBED FOR: High blood cholesterol is first treated withexercise, weight loss, and a diet low in cholesterol and saturated fats.When these measures fail, cholesterol-lowering medications such assimvastatin can be added. The National Cholesterol Education Program(NCEP) has published treatment guidelines for use of these medications.These treatment guidelines take into account the level of LDL cholesterolas well as the presence of other risk factors such as diabetes,hypertension, cigarette smoking, low HDL cholesterol level, and familyhistory of early coronary heart disease. The effectiveness of themedication in lowering cholesterol is dose related. Blood cholesteroldeterminations are performed in regular intervals during treatment so thatdosage adjustments can be made.

DOSING: May be taken on an empty or full stomach.

DRUG INTERACTIONS: Simvastatin is generally well-tolerated. Themedication should be used with caution in patients with alcohol or otherliver diseases. Persistently abnormal liver tests during treatment arerare, but may lead to a discontinuation of the medication. Rare cases ofmuscle inflammation (myositis) and breakdown have been reported withsimvastatin. Muscle breakdown causes the release of muscle protein(myoglobin) into the blood and kidney tubules, resulting in acute kidney failure. The risk of muscle breakdown is increased when simvastatin isgiven together with other medications such as cyclosporine (Sandimmune),gemfibrozil (Lopid), erythromycin and nicotinic acid. Simvastatin mayinteract with cholestyramine (Questran), warfarin (Coumadin), andcimetidine (Tagamet) to alter the blood levels of these medicines. When Coumadin is given together with simvastatin, blood clotting times requiremonitoring to avoid excessive blood thinning and bleeding. Simvastatinshould not be used in children. Simvastatin is not habit forming.

PREGNANCY: Simvastatin should not be used by pregnant women.

NURSING MOTHERS: Simvastatin should not be used by nursingmothers because of potential adverse side effects to the nursing infant.

SIDE EFFECTS: Simvastatin is generally well-tolerated and sideeffects are rare. Minor side effects include constipation, diarrhea,fatigue, gas, heartburn, and headache. Major side effects includeabdominal pain or cramps, blurred vision, dizziness, easy bruising or bleeding, itching, muscle pain or cramps, rash, and yellowing of the skinor eyes.