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, bleeding problems, or a stomach ulcer. Do not use this medicine if you also use the following medicines: boceprevir (Victrelis®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Nizoral®), or certain medicines to treat HIV/AIDS (such as atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®).

How to Use This Medicine:
Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• 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 triglycerides in your blood.

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 medicines (such as diltiazem, mecamylamine, nifedipine, verapamil, Cardizem®, Norvasc®), nitrate medicines (such as isosorbide, Imdur®, Isordil®), other medicine to lower cholesterol (such as cholestyramine, colestipol, fenofibrate, gemfibrozil, Colestid®, Lopid®, Questran®, Tricor®), or a blood thinner (such as warfarin, Coumadin®, Jantoven®).
• If you also take cholestyramine (Questran®) or colestipol (Colestid®), take it at least 4 to 6 hours before or after you take niacin/lovastatin.
• Tell your doctor if you regularly drink grapefruit juice.
• 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:

• 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.
• Make sure your doctor knows if you have kidney disease, liver disease, angina, diabetes, gout, low blood pressure, muscle pain or weakness, seizures, or an underactive thyroid. Tell your doctor if you drink alcohol regularly.
• Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These may be symptoms of a serious 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 or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
• 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, a major injury, or you develop other serious health problems.
• This medicine may make you dizzy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate
• Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in the upper stomach, yellow skin or eyes
• Fever
• Muscle pain, tenderness, or weakness
• Unusual tiredness

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

• Confusion or problems with memory
• Diarrhea
• Headache
• Warmth or redness in your face, neck, arms, or upper chest

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