Brand Name(s):

• Lescol®
• Lescol®XL

WHY is this medicine prescribed?

Fluvastatin is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Fluvastatin is also used to decrease the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. Fluvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Fluvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

HOW should this medicine be used?

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 at bedtime 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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking fluvastatin,

• tell your doctor and pharmacist if you are allergic to fluvastatin, any other medications, or any of the ingredients in fluvastatin capsules or extended release tablets..
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin; cimetidine (Tagamet); colchicine (Colcrys); cyclosporine (Neoral, Sandimmune); diclofenac (Cataflam, Voltaren); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); glyburide (DiaBeta, Glynase, Micronase); ketoconazole (Nizoral); omeprazole (Prilosec); other cholesterol-lowering medications such as fenofibrate (Tricor) and gemfibrozil (Lopid); phenytoin (Dilantin); ranitidine (Zantac); rifampin (Rifadin, Rimactane); and spironolactone (Aldactone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking cholestyramine (Questran), take it at least 4 hours before fluvastatin.
• tell your doctor if you have liver disease. Your doctor will order laboratory tests to see how well your liver is working even if you do not think you have liver disease.Your doctor will probably tell you not to take fluvastatin if you have liver disease or if the tests show that you may be developing liver disease.
• tell your doctor if you more than 2 alcoholic beverages per day and if you have ever had liver disease or have or ever had diabetes, low blood pressure, seizures, or thyroid or kidney disease.
• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking fluvastatin, stop taking fluvastatin and call your doctor immediately. Fluvastatin may harm the fetus.
• do not breast-feed while you are taking this medication.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fluvastatin. If you are hospitalized due to infection or serious injury, tell the doctor who treats you that you are taking fluvastatin.
• ask your doctor about the safe use of alcoholic beverages while you are taking fluvastatin. Alcohol can increase the risk of serious side effects.

What SPECIAL DIETARY instructions should I follow?

Eat a low-cholesterol, low-fat diet, which includes cottage cheese, fat-free milk, fish, vegetables, poultry, and egg whites. Use monounsaturated oils such as olive, peanut, and canola oils or polyunsaturated oils such as corn, safflower, soy, sunflower, cottonseed, and soybean oils. Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it has been more than 12 hours since your last dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 18, 2012.