Lescol XL

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 fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') 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.

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with fluvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Fluvastatin is an oral, cholesterol-lowering drug. It belongs to a class of drugs called HMG-CoA reductase inhibitors, commonly called "statins." Other statins include lovastatin (Mevacor), atorvastatin (Lipitor), simvastatin (Zocor), and rosuvastatin (Crestor). Statins reduce cholesterol by inhibiting an enzyme in the liver (HMG-CoA reductase) that is necessary for the production of cholesterol. In the blood, statins lower total and LDL ("bad") cholesterol as well as triglycerides. LDL cholesterol is believed to be an important cause of coronary artery disease. Lowering LDL cholesterol levels slows and may even reverse coronary artery disease. Statins also increase HDL ("good") cholesterol. Raising HDL cholesterol levels, like lowering LDL cholesterol, may slow coronary artery disease. The FDA approved fluvastatin in December 1993.

Stomach upset may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very small number of people taking fluvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.This drug may infrequently cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Lescol XL is a prescription medication used in people with heart disease to decrease the chances of heart problems by lowering high cholesterol and triglycerides levels.

Lescol XL belongs to a group of medications called statins (or HMG-CoA reductase inhibitors). It works by decreasing the rate of production of cholesterol in the body.

Lescol XL is available as an extended-release tablet and is taken once a day. Lescol XL tablet may be taken at any time of the day. Lescol XL can be taken with or without food. Common side effects include headache, nausea, stomach pain, and diarrhea.

The most common side effects of Lescol XL are headache, upset stomach and stomach pain, diarrhea, flu-like symptoms, muscle pain, sinus infection, tiredness, or trouble sleeping. These side effects are usually mild and may go away. The following additional side effects have been reported with Lescol XL: memory loss, and confusion.

Talk to your doctor or pharmacist if you have side effects that bother you or that will not go away.

These are not all the side effects of Lescol XL. Ask your doctor or pharmacist for a complete list.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Lescol XL, there are no specific foods that you must exclude from your diet when receiving this medication.

This medicine can harm an unborn baby or cause birth defects. Do not use fluvastatin if you are pregnant.

You should not take fluvastatin if you have liver disease, or if you are breast-feeding a baby.

Some medicines can cause unwanted or dangerous effects when used with fluvastatin. Tell your doctor about all other medicines you use.

This section provides information on the proper use of a number of products that contain fluvastatin. It may not be specific to Lescol XL. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

Take the capsule at the same time every evening. You may take the extended-release tablet at any time of the day.

You may take this medicine with or without food.

Take the capsule at the same time every evening or if you take it twice a day take it in the morning and evening. You may take the extended-release tablet at any time of the day.

Do not open the capsule before taking it. Swallow the extended-release tablet whole. Do not crush, break, or chew it.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Do not drink large amounts of alcohol while taking fluvastatin. This could cause liver damage.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For high cholesterol:
  • For oral dosage form (capsules):
    • Adults—At first, 20 or 40 milligrams (mg) once a day in the evening. Some patients may need 40 mg two times a day (one in the morning and one in the evening). Your doctor may increase your dose as needed.
    • Children 10 to 16 years of age—At first, 20 mg once a day in the evening. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg two times a day (one in the morning and one in the evening).
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Adults—80 milligrams (mg) once a day.
    • Children 10 to 16 years of age—80 mg once a day.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take this medicine if it has been more than 12 hours since you missed your last dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• It is used to lower bad cholesterol and raise good cholesterol (HDL).
• It is used to lower triglycerides.
• It is used to slow the progress of heart disease.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Belly pain.
• Upset stomach.
• Loose stools (diarrhea).
• Feeling tired or weak.
• Not able to sleep.
• Flu-like signs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

To date, there has been limited experience with overdosage of fluvastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.  The dialyzability of fluvastatin sodium and of its metabolites in humans is not known at present [see Warnings and Precautions (5)].

In the pediatric population, there have been reports of overdosage with fluvastatin sodium in children including a 2 year-old and the other 3 years of age, either of whom may have possibly ingested fluvastatin sodium. The maximum amount of fluvastatin sodium that could have been ingested was 80 mg (4 x 20 mg capsules). Vomiting was induced by ipecac in both children and no capsules were noted in their emesis. Neither child experienced any adverse symptoms and both recovered from the incident without problems.

In the postmarketing experience there have been reports of accidental ingestion of LESCOL tablets in infants up to 3 years of age. In one case, increased serum CPK values were noted. There have been reports of intentional overdose in adolescents with the development of hepatic enzyme elevations, convulsions and gastroenteritis/vomiting/diarrhea. One case of intentional overdose as suicide attempt in a 15 year-old female reported ingestion of 2,800 mg Lescol XL with hepatic enzyme elevation.

Applies to fluvastatin: oral capsule, oral tablet extended release

Along with its needed effects, fluvastatin (the active ingredient contained in Lescol XL) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluvastatin:

More common

• Chills
• diarrhea
• fever
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle aches and pain
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Bladder pain
• bloody or cloudy urine
• cough producing mucus
• dark-colored urine
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with moving
• difficulty with swallowing
• dizziness
• fast heartbeat
• frequent urge to urinate
• hives
• itching
• lower back or side pain
• muscle cramps, spasms, or stiffness
• muscular pain, tenderness, wasting, or weakness
• pain, swelling, or redness in the joints
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest

Some side effects of fluvastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• headache
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Less common

• Bloated or full feeling
• excess air or gas in the stomach or intestines
• pain or tenderness around the eyes and cheekbones
• passing gas
• unable to sleep