How does this medication work? What will it do for me?

Fluvastatin belongs to the family of medications known as cholesterol-lowering drugs. It is used in addition to diet and exercise to treat people with high cholesterol levels. It is also recommended for people who have had heart procedures such as angioplasty to help prevent complications after surgery, including heart attacks and death.

This medication works by blocking an enzyme needed to make cholesterol in the liver (HMG-CoA reductase). The result is that less cholesterol is made and levels of cholesterol in the blood are decreased. Reduction of cholesterol levels in the blood has been shown to reduce the risks associated with heart disease, such as heart attack.

This medication usually takes 4 weeks to have a significant effect on the cholesterol level in your blood. After this time, your doctor will likely send you for a lab test to check for changes in your cholesterol levels.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each yellow, round, slightly biconvex film-coated tablet with bevelled edges debossed with "LESCOL* XL" on one side and "80" on the other contains 80 mg fluvastatin (from 84.24 mg fluvastatin sodium). Nonmedicinal ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, potassium bicarbonate, povidone, magnesium stearate, iron oxide yellow, titanium dioxide, and polyethylene glycol 8000.

How should I use this medication?

Before starting fluvastatin, or at the same time as starting to take it, you should be placed on a cholesterol-lowering diet. If appropriate, your health care professionals will discuss an individualized program of weight control and physical exercise with you.

The recommended adult dose of fluvastatin ranges from 20 mg to 80 mg daily. Up to 60 mg daily can be taken as one dose in the evening or at bedtime. The 80 mg daily dose can be taken as one 40 mg capsule twice daily, with or after meals, or as one extended-release capsule taken once daily in the evening.

Fluvastatin may be taken with or without food, but it should be taken consistently with regard to food (always with food or always without food).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

For best results in lowering cholesterol, it is important that you closely follow the diet suggested by your doctor. This medication may not change how you feel, but it may help to prevent possible health problems in the future.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to fluvastatin or any ingredients of the medication
  • are breast-feeding
  • are pregnant
  • have active liver disease or unexplained increases in liver function tests

Do not give this medication to children under 9 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • belching
  • constipation
  • diarrhea
  • difficulty sleeping
  • dizziness
  • fatigue
  • gas
  • headache
  • heartburn
  • joint pain
  • nausea

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • rash; hives; swelling of the lips, eyes, or face
  • symptoms of liver damage such as:
    • abdominal pain
    • clay-coloured stools
    • dark urine
    • itching
    • loss of appetite
    • nausea and vomiting
    • yellow skin or eyes
  • symptoms of muscle damage (muscle pain, tenderness or weakness, brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)
  • symptoms of nerve damage such as:
    • decreased sensation in the hands and feet
    • loss of balance
    • muscle weakness
    • numbness
    • tingling or prickling sensations
  • symptoms of severe abdominal pain (inflamed pancreas)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
  • symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

HEALTH CANADA ADVISORY

January 24, 2013

Health Canada has issued new restrictions concerning the use of fluvastatin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.

Kidney disease: Fluvastatin is not recommended for people with severe kidney disease.

Liver effects: Lab tests show signs of harmful effects to the liver may occur for a small percentage of adults who take fluvastatin for long periods of time. When this medication is stopped, the laboratory tests usually slowly return to normal. If you take fluvastatin, your doctor will likely monitor your liver function. People with a history of liver disease should be closely monitored by their doctors while they are taking this medication.

Muscle effects: In rare cases, serious muscle damage been associated with the use of statin medications (i.e., cholesterol-lowering drugs whose names end in "statin," such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

  • are over the age of 70
  • are taking other cholesterol-lowering medications such as fibrates (gemfibrozil, fenofibrate) or niacin
  • are taking other medications, including prescription, non-prescription, and natural health products, as drug interactions are possible
  • do large amounts of physical exercise
  • have a family history of muscular disorders
  • have diabetes
  • have had any past problems with the muscles (pain, tenderness) after taking a statin
  • have kidney or liver problems
  • have thyroid problems
  • have undergone surgery or other tissue injury
  • regularly drink 3 or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: Fluvastatin should not be taken by pregnant women. If you become pregnant while taking fluvastatin, stop taking the medication immediately and contact your doctor.

Breast-feeding: It is not known whether fluvastatin passes into breast milk. Women taking fluvastatin should not breast-feed.

Children: There is limited experience with the use of this medication by children (under 10 years). The safety and effectiveness for children have not been established.

Seniors: If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects.

What other drugs could interact with this medication?

There may be an interaction between fluvastatin and any of the following:

  • alcohol
  • amiodarone
  • amlodipine
  • chlorpropamide
  • cholestyramine
  • cimetidine
  • colchicine
  • colestipol
  • corticosteroids
  • cyclosporine
  • daptomycin
  • digoxin
  • fibrates (e.g., bezafibrate, fenofibrate, gemfibrozil)
  • fluconazole
  • nefazodone
  • niacin
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., diclofenac)
  • omeprazole
  • phenytoin
  • ranitidine
  • rifampin
  • spironolactone
  • tolbutamide
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.