Lescol belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins". Fluvastatin 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).

Lescol is used is used in adults and children who are at least 10 years old to lower high cholesterol and triglyceride (types of fat) levels in the blood and to slow the build-up of plaque (fatty deposits) in your blood vessels.

Lescol is also used to lower the risk of heart complications in certain people with coronary heart disease.

You should not take Lescol if you have liver disease, or if you are breastfeeding a baby.

Do not use if you are pregnant or breastfeeding.

Some medicines can cause unwanted or dangerous effects when used with Lescol. Tell your doctor about all other medicines you use.

Take Lescol exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Lescol is usually taken once or twice daily, with or without food.

Take this medicine with a full glass of water.

Do not crush, chew, break, or open a tablet or capsule. Swallow it whole. Tell your doctor if you have trouble swallowing the pill.

You can take an extended-release tablet at any time of day.

The regular tablet or capsule should be taken at the same time(s) each day. Follow your doctor's dosing instructions very carefully.

While using this medicine, you may need frequent blood tests.

It may take up to 4 weeks before your cholesterol levels improve. Keep using this medicine as directed, even if you feel well. High cholesterol usually has no symptoms.

Lescol is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

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

Usual Adult Dose for Hyperlipidemia:

Initial dose: 20 to 40 mg orally once a day at bedtime.
Maintenance dose: 20 to 80 mg/day.

Usual Pediatric Dose for Hyperlipidemia:

9 to 16 years:
Initial dose: 20 mg orally once a day at bedtime.
Maintenance dose: 20 to 80 mg/day.

You should not take Lescol if you are allergic to fluvastatin, or if:

• you have active liver disease; or

• you are pregnant or breastfeeding.

Lescol can harm an unborn baby. Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Use effective birth control to prevent pregnancy while you are taking fluvastatin.

Fluvastatin can pass into breast milk and may cause side effects in the nursing baby. Do not take fluvastatin if you are breastfeeding.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease;

• muscle pain or weakness;

• kidney disease;

• diabetes;

• a thyroid disorder; or

• if you drink more than 2 alcoholic beverages daily.

Fluvastatin 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).

Lescol is not approved for use by anyone younger than 10 years old.

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

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

Avoid eating foods that are high in fat or cholesterol. Lescol will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan.

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 to Lescol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, fluvastatin 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, or 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;

• signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

• liver problems - upper stomach pain, loss of appetite, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Lescol side effects may include:

• muscle pain;

• headache; or

• stomach pain, nausea, or indigestion.

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.

Some drugs can increase your risk of serious muscle problems if you take them together with Lescol. Your doctor may need to change your treatment plan if you use any of the following drugs:

• gemfibrozil, fenofibric acid, fenofibrate; or

• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

Many other drugs can interact with fluvastatin. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• other cholesterol medications;

• an antibiotic or antifungal medicine;

• diabetes medicine;

• heart medication;

• seizure medication; or

• medicine to treat excess stomach acid or stomach ulcer.

This list is not complete and many other drugs can interact with fluvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.