Product description

Zocor (Simvastatin)

High blood cholesterol is first treated with exercise, weight loss, and a diet low in cholesterol and saturated fats. When these measures fail, cholesterol-lowering medications such as simvastatin 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 cholesterol as well as the presence of other risk factors such as diabetes, hypertension, cigarette smoking, low HDL cholesterol level, and family history of early coronary heart disease. The effectiveness of the medication in lowering cholesterol is dose related. Blood cholesterol determinations are performed in regular intervals during treatment so that dosage adjustments can be made.

Take simvastatin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. Take each dose with a full glass of water. For the greatest effect, simvastatin is usually taken at bedtime or with an evening meal. Follow your doctor's instructions. Your doctor may want to monitor your liver function with blood tests before starting treatment with simvastatin and every six months after both the start of your treatment and any increase in dose. Depending on the results of these tests, your doctor can determine how much monitoring you will require. Grapefruit and grapefruit juice may interact with simvastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor. Eat a low-fat, low-cholesterol diet. To realize beneficial effects from simvastatin, avoid fatty, high-cholesterol foods. It is important to take simvastatin regularly to get the most benefit. Do not stop taking simvastatin without first talking to your doctor. Simvastatin may need to be taken on a long-term basis for the treatment of high cholesterol. Your doctor may want you to have blood tests or other medical evaluations during treatment with simvastatin to monitor progress and side effects.

Simvastatin is a cholesterol- lowering medicine. It inhibits the production of cholesterol by the liver. It lowers overall blood cholesterol as well as blood LDL cholesterol levels. LDL cholesterol is believed to be the "bad" cholesterol that is primarily responsible for the development of coronary artery disease. Lowering LDL cholesterol levels retards progression and may even reverse coronary artery disease.

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Tablets should be stored at room temperature in a tightly closed container.

Safety information

Grapefruit and grapefruit juice may interact with simvastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor. Alcohol and simvastatin can both be damaging to the liver. Alcohol should be used only in moderation. Discuss the use of alcohol with your doctor so that the potential for liver problems can be determined. Simvastatin is generally well- tolerated. The medication should be used with caution in patients with alcohol or other liver diseases. Persistently abnormal liver tests during treatment are rare, but may lead to a discontinuation of the medication. Rare cases of muscle inflammation (myositis) and breakdown have been reported with simvastatin. 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 isincreased when simvastatin is given together with other medications such as cyclosporine (Sandimmune), gemfibrozil (Lopid), erythromycin and nicotinic acid. Simvastatin may interact with cholestyramine (Questran), warfarin (Coumadin), and cimetidine (Tagamet) to alter the blood levels of these medicines. When Coumadin is given together with simvastatin, blood clotting times require monitoring to avoid excessive blood thinning and bleeding. Simvastatin should not be used in children. Simvastatin is not habit forming.

Side effects

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

• Rare cases of muscle problems and liver problems have been associated with the use of simvastatin and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle or liver problems.
• If you experience any of the following serious side effects, stop taking simvastatin and seek emergency medical attention or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased urine or rust-colored urine; or
  • blurred vision.
• Other, less serious side effects may be more likely to occur. Continue to take simvastatin and talk to your doctor if you experience
  • gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea;
  • cough;
  • headache; or
  • insomnia.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.