Fluvastatin (floo-va-STAT-in)

Lowers high cholesterol and triglyceride levels in the blood. Helps keep atherosclerosis (hardening of the arteries) from getting worse. This medicine is a statin.

Brand Name(s):

Lescol XL

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the capsuleat the same time every evening. If you take this medicine twice a day, take it at the same time every morning and every evening. You may take the extended-release tablet at any time of the day.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it. Do not open the capsule before you take it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not take the capsule if it has been more than 12 hours since you missed your last dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how fluvastatin works. Tell your doctor if you are using any of the following:
  • Colchicine, cyclosporine, fluconazole, gemfibrozil, glyburide, niacin, phenytoin
  • Blood thinner (including warfarin)
  • Fibrate medicine

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, diabetes, muscle pain or weakness, seizures, thyroid problems, or a history of liver disease. Tell your doctor if you drink alcohol regularly.
• This medicine may cause the following problems:
  • Severe muscle problems (including myopathy, immune-mediated necrotizing myopathy), especially when used with other medicines
  • Rhabdomyolysis (severe muscle weakness) that could lead to kidney damage
  • Liver problems
  • High blood sugar levels
• Make sure any doctor or dentist who treats you knows that you use this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever
• Unexplained muscle pain, tenderness, or weakness
• Unusual tiredness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Stomach upset
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088