Zocor

Simvastatin is used together with diet to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

Simvastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors.

Simvastatin is used in adults and children who are at least 10 years old.

Simvastatin may also be used for purposes not listed in this medication guide.

You should not take simvastatin if you are allergic to it, or if:

• you have active liver disease; or
• you are pregnant or breast-feeding.

Some medicines can cause unwanted or dangerous effects when used with simvastatin. Your doctor may change your treatment plan if you also use medicine such as:

• cyclosporine;
• danazol;
• gemfibrozil;
• imatinib;
• lomitapide;
• nefazodone;
• an antibiotic or antifungal medicine;
• tuberculosis medicine;
• heart or blood pressure medication; or
• antiviral medicine to treat hepatitis C or HIV/AIDS.

Tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• diabetes;
• a thyroid disorder;
• if you are of Asian descent; or
• if you drink more than 2 alcoholic beverages daily.

Simvastatin 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).

Do not use simvastatin if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine. Stop taking simvastatin and tell your doctor right away if you become pregnant.

It is not safe to breast-feed a baby while you are using this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Simvastatin is usually taken in the evening or at bedtime.

Take simvastatin oral suspension (liquid) on an empty stomach.

Shake the liquid for at least 20 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You may need to take simvastatin on a long-term basis. You may need to stop using simvastatin for a short time if you have surgery or a medical emergency. Do not stop taking this medicine unless your doctor tells you to.

Simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Do not refrigerate or freeze the liquid medicine. Throw away any liquid that has not been used within 1 month after you first opened the bottle.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with simvastatin and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid eating foods high in fat or cholesterol, or simvastatin will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing; or
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache;
• nausea, stomach pain, constipation; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• any other cholesterol medication--niacin, fenofibrate, fenofibric acid, and others; or
• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete and many other drugs may affect simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your pharmacist can provide more information about simvastatin.