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Generic Name: fluvastatin (FLOO va sta tin)
Brand Names: Lescol, Lescol XL

What is Lescol XL (fluvastatin)?

Fluvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

Fluvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

Fluvastatin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Lescol XL (fluvastatin)?

In rare cases, fluvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not take fluvastatin if you are pregnant or breast-feeding, or if you have liver disease.

Before taking fluvastatin, tell your doctor if you have diabetes, underactive thyroid, kidney disease, a muscle disorder, or a blood disorder:

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

Avoid drinking alcohol while taking fluvastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking fluvastatin.

There may be other drugs that can affect fluvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Lescol XL (fluvastatin)?

Do not use this medication if you are allergic to fluvastatin, if you are pregnant or breast-feeding, or if you have liver disease.

Before taking fluvastatin, tell your doctor if you are allergic to any drugs, or if you have:

• diabetes;

• underactive thyroid;

• kidney disease; or

• a muscle disorder.

If you have any of these conditions, you may not be able to use fluvastatin, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use fluvastatin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether fluvastatin passes into breast milk. Do not take fluvastatin without telling your doctor if you are breast-feeding a baby. Fluvastatin is not for use in children younger than 10 years of age.

How should I take Lescol XL (fluvastatin)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take fluvastatin with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Fluvastatin is usually taken at bedtime or with an evening meal. If you take fluvastatin several times daily, take it with meals. Follow your doctor's instructions.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Fluvastatin 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 may need to take fluvastatin on a long-term basis for the treatment of high cholesterol.

Store fluvastatin at room temperature, protected from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of fluvastatin is not expected to produce life-threatening symptoms.

What should I avoid while taking Lescol XL (fluvastatin)?

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

Avoid drinking alcohol while taking fluvastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking fluvastatin.

Grapefruit and grapefruit juice may interact with fluvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Lescol XL (fluvastatin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using fluvastatin and call your doctor at once if you have any of these serious side effects:

• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Keep taking fluvastatin and talk to your doctor if you have any of these less serious side effects:

• mild stomach pain, gas, bloating, stomach upset, heartburn;

• nausea;

• constipation; or

• diarrhea.

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.

What other drugs will affect Lescol XL (fluvastatin)?

Before taking fluvastatin, talk to your doctor if you are using any of the following drugs:

• stomach acid reducers such as cimetidine (Tagamet), ranitidine (Zantac), or omeprazole (Prilosec);

• cyclosporine (Sandimmune, Neoral, Gengraf);

• danazol (Danocrine);

• diclofenac (Cataflam, Voltaren));

• gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);

• glyburide (glibenclamide, DiaBeta, Micronase);

• amiodarone (Cordarone), diltiazem (Cartia, Cardizem, Dilacor, Tiazac), or verapamil (Verelan, Calan, Isoptin);

• niacin (Nicolar, Nicobid, Slo-Niacin, others);

• erythromycin (E-Mycin, Ery-Tab, others), clarithromycin (Biaxin), or telithromycin (Ketek);

• cholestyramine (Questran) or colestipol (Colestid);

• an antifungal medication such as itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral);

• nefazodone (Serzone);

• phenytoin (Dilantin);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• a blood thinner such as warfarin (Coumadin); or

• HIV or AIDS medication such as amprenavir (Agenerase), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), lopinavir-ritonavir (Kaletra), or saquinavir (Invirase, Fortovase).

If you are using any of these drugs, you may not be able to take fluvastatin, or you may require a dosage adjustment or special monitoring.

There may be other drugs not listed that can affect fluvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has information about fluvastatin written for health professionals that you may read.

What does my medication look like?

Fluvastatin is available with a prescription under the brand names Lescol and Lescol XL. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Lescol 20 mg--brown/light-brown capsules

• Lescol 40 mg--brown/gold capsules

• Lescol XL 80 mt-round, yellow tablets

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 9.02. Revision Date: 03/07/2007 13:25:50.