Fluvastatin

Lescol XL (fluvastatin) is approved by the FDA as a prescription drug used to treat high cholesterol in the blood. Lescol XL belongs to a class of medications called statins. Statin drugs are lipid-lowering drugs that have been found to reduce cardiovascular disease (such as stroke) and coronary heart disease (such as heart attack) in high-risk patients.

Fluvastatin works by blocking the enzyme in the liver that is responsible for making cholesterol. The enzyme is called hydroxy-methylglutaryl-coenzyme A reductase (HMG-CoA reductase). Since statins like fluvastatin prevent the production of this enyme, fluvastatin is also referred to as an HMG-CoA reductase inhibitor.

Fluvastatin is also available under different brand names including Lescol and Lescol XL, and are available as 20 mg capsules, 40 mg capsules and 80 mg extended-release tablets. Other examples of statins that are approved for use in the U.S. include atorvastatin (Lipitor), fluvastatin (Lescol, Lescol XL), lovastatin (Mevacor, Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), and pitavastatin (Livalo).

• Patients start fluvastatin at 20 mg - 40 mg, taken orally every night at bedtime.
• Dosing ranges from 20 mg - 80 mg, taken orally every day.
• For patients requiring 80mg per day, doses should be divided into two 40 mg doses taken orally, every 12 hours.
• Sustained-release doses are taken at the full 80 mg, taken orally every day.

Dosage Considerations

Some patients requiring a reduction of 25% or less of low density lipoprotein cholesterol (LDL C) may have their doses adjusted from the standard dose of 20 mg taken orally every day.

Based on response and tolerance to therapy, these patients should not exceed 40 mg taken orally, every 12 hours (with immediate release capsules). These patients should not exceed 80 mg (extended-release tablets) per 24-hour period.

Patients with mild renal impairment should not exceed 40 mg per day.

Fluvastatin should not be taken by patients with active liver disease, or by patients with unexplained elevated liver enzymes.

Overdose

Overdose from fluvastatin may cause adverse reactions including nerve pain, diarrhea, elevated levels of potassium in the blood, muscle pain, muscle breakdown, kidney failure, elevated liver enzymes, and clouding of the lens of the eyes.

Common side effects associated with using Lescol XL are:

• Stomach upset
• Headache,
• Stomach upset
• Abdominal pain,
• Diarrhea,
• Muscle pain,
• Fatigue,
• Insomnia,
• Nausea,
• Sinusitis,
• Bronchitis,
• Urinary tract infection (UTI), and,
• Elevated liver enzymes.

Less common side effects associated with using Lescol XL may include:

• Rash,
• Back pain,
• Arthralgia,
• Myopathy,
• Rhabdomyolysis,
• Rupture of tendon
• Pharyngitis
• Rhinitis
• Cough
• Constipation
• Pancreatitis, and
• Dizziness

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.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Lescol XL may interact with

• stomach acid reducers,
• cholestyramine,
• danazol,
• diclofenac,
• glyburide,
• nefazodone,
• niacin,
• phenytoin,
• rifampin,
• gemfibrozil or
• fenofibrate,
• drugs that weaken your immune system such as:
  • cancer medicine or steroids,
  • cyclosporine,
  • tacrolimus, and
  • others;
• amiodarone,
• diltiazem, or
• verapamil,
• antibiotics,
• antifungals,
• blood thinners, or
• HIV /AIDS medicine

Tell your doctor all medications you area taking. Lescol XL must not be used during pregnancy. It can cause birth defects. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this drug is not recommended.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

This medication contains fluvastatin. Do not take Lescol XL if you are allergic to fluvastatin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Patients taking fluvastatin should not combine this drug with gemfibrozil or red yeast rice because of increased risk for muscle pain and muscle damage.

• Non-serious and reversible cognitive side effects may occur
• Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake
• Heavy alcohol use, history of liver disease, renal failure
• Myopathy, risk of myopathy may be increased by co-administration w/ fibrates, niacin, cyclosporine, macrolides, azole antifungals.
• Withhold or discontinue treatment if myopathy develops, renal failure, or transaminase levels >3 times the upper limit of normal
• Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serum creatine kinase that persist despite discontinuing statin
• Lipid-lowering effects additive with bile-acid binding resin or niacin
• Take 2 hours after bile acid sequestrant

Pregnancy and Lactation

Breastfeeding mothers should not use Lescol XL or fluvastatin. Because the risks outweigh the potential benefits of taking this drug, pregnant women should avoid Lescol XL (fluvastatin). Safer alternative are available.