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).

Fluvastatin is used to slow the build-up of plaque (fatty deposits) in your blood vessels.

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

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

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

You should not take fluvastatin 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 fluvastatin. Tell your doctor about all other medicines you use.

Fluvastatin comes as a capsule and an extended-release (long-acting) tablet to take by mouth. The capsule is usually taken with or without food once a day at bedtime or twice a day. The extended-release tablet is usually taken once a day with or without food. Take fluvastatin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of fluvastatin and gradually increase your dose, not more than once every 4 weeks.

Continue to take fluvastatin even if you feel well. Do not stop taking fluvastatin without talking to your doctor.

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.

Take this medicine with a full glass of water, with or without food.

Take the regular tablet or capsule at the same time(s) each day.

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

Follow your doctor's dosing instructions very carefully.

Swallow the pill whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing the pill.

You will need frequent medical 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.

Fluvastatin 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.

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

• you have active liver disease; or

• you are pregnant or breastfeeding.

Do not use if you are pregnant. fluvastatin can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.

Do not breastfeed while using this medicine.

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).

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

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Avoid eating foods high in fat or cholesterol, or fluvastatin 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; 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 side effects of fluvastatin 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 fluvastatin. 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).

Tell your doctor about all your current medicines. Many drugs can affect fluvastatin, 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.

Keep all appointments with your doctor and the laboratory. Your doctor may order laboratory tests during your treatment, especially if you develop symptoms of liver damage.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking fluvastatin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.