Niacin Extended-release/lovastatin (By mouth)

How to Use This Medicine

Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• It is best to take this medicine at bedtime, with a low-fat snack. Do not take it on an empty stomach.
• Ask your doctor about the correct dose if you are switching to this medicine from another form of niacin. The dose of niacin in this medicine and in other forms may not be the same.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is only part of a complete plan for lowering cholesterol and triglyceride levels.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

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, increased hunger or thirst
• Chest pain, fast or pounding heartbeat, lightheadedness, fainting, or increased sweating
• Dark-colored urine or pale stools
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Muscle pain, tenderness, or weakness
• Nausea, vomiting, loss of appetite, or pain in the upper stomach
• Unusual tiredness
• Warmth or redness in your face, neck, arms, or upper chest
• Yellow skin or eyes

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

• Confusion or problems with memory
• Headache
• Mild diarrhea

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

Introduction

Lovastatin (loe-va-STAT-in), Niacin (NYE-a-sin)

Lowers high cholesterol and triglyceride levels in the blood. Helps prevent heart attacks and strokes. Helps keep atherosclerosis (hardening of the arteries) from getting worse. This medicine is a combination of vitamin B3 (niacin) and an HMG-CoA inhibitor, also called a statin.

Brand Name(s)

Advicor

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Do not use this medicine if you have had an allergic reaction to lovastatin or niacin. Do not use this medicine if you are pregnant or breastfeeding or if you have active liver disease or a stomach ulcer. You should not use niacin extended-release/lovastatin if you also use the following medicines: boceprevir (Victrelis®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Biaxin®, Ery-Tab®, Ketek®, Nizoral®, Noxafil®, or Sporanox®), or certain medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Agenerase®, Crixivan®, Invirase®, Kaletra®, Lexiva®, Norvir®, Reyataz®, or Viracept®).

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you also use amiodarone (Cordarone®), aspirin, cimetidine (Tagamet®), colchicine (Colcrys®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), ranolazine (Ranexa®), spironolactone (Aldactone®), voriconazole (Vfend®), certain blood pressure medicine (such as diltiazem, mecamylamine, nifedipine, verapamil, Cardizem®, Inversine®, Norvasc®, or Tiazac®), nitrate medicines (such as isosorbide, Imdur®, or Isordil®), other medicine to lower cholesterol (such as cholestyramine, colestipol, fenofibrate, gemfibrozil, Colestid®, Lopid®, Questran®, or Tricor®), or a blood thinner (such as warfarin, Coumadin®).
• If you also take cholestyramine (Questran®) or colestipol (Colestid®), take it at least 4 to 6 hours before or after you take niacin/lovastatin.
• Do not drink more than 1 quart of grapefruit juice each day.
• Tell your doctor if you drink more than 2 glasses of alcohol per day.
• Talk to your doctor if you take vitamins that contain niacin or nicotinamide.
• Do not drink hot beverages or eat spicy foods at the same time that you take this medicine. These items together with the medicine may cause you to feel warm or flushed.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have kidney disease, liver disease, angina, diabetes, an electrolyte problem, an endocrine problem, gout, low blood pressure, a metabolic problem, a muscle problem, uncontrolled epilepsy (seizures), or an underactive thyroid. Tell your doctor if you drink alcohol on a regular basis.
• Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These may be symptoms of a muscle problem called myopathy.
• Call your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
• Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, or yellow eyes or skin. These could be symptoms of a serious liver problem.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery or a major injury.
• This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.