Advicor (NIACIN EXTENDED-RELEASE/LOVASTATIN-ORAL)

GENERIC NAME: NIACIN EXTENDED-RELEASE/LOVASTATIN - ORAL (NYE-a-sin/LOW-vuh-stat-in)

BRAND NAME(S): Advicor

USES: This combination medication is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. Niacin is also known as vitamin B3 (nicotinic acid), one of the B vitamins. It works by reducing the amount of cholesterol made by the liver and by helping the body remove fats from the blood. Lovastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. This product is prescribed after the use of one drug (niacin or lovastatin) has not been fully successful at lowering cholesterol.In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, drinking less alcohol, losing weight if overweight, and stopping smoking. Consult your doctor for more details.Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Lowering triglycerides in people with very high triglyceride blood levels may also decrease the risk of pancreas disease (pancreatitis).

HOW TO USE: Take this medication by mouth with a low-fat snack as directed by your doctor,
usually once daily at bedtime. Taking this drug with food will increase its absorption and help reduce side effects (such as flushing, stomach upset).Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.To lessen the chance of flushing, avoid alcohol, hot beverages, and spicy foods near the time you take this medication. Taking a plain aspirin (non-enteric coated, 325 milligrams) or a nonsteroidal anti-inflammatory drug (such as ibuprofen, 200 milligrams) 30 minutes before taking this medication may help prevent flushing. Ask your doctor if this treatment is right for you (especially if you are also taking a "blood thinner" such as warfarin).The niacin in this product is an extended-release form. Your doctor may instruct you to take the individual extended-release niacin first until you reach the right dose and then switch you over to this combination product. Niacin is also available in other formulations (such as immediate- and sustained-release). Do not switch other strengths, brands, or forms of niacin with this product because doing so may cause severe liver problems.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 1 hour before or at least 4 hours after taking these medications. These products can react with this medication, preventing its full absorption.Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. If you have not taken this medication for an extended period (more than 7 days), consult your doctor or pharmacist for instructions on restarting it. You may need to restart your medication at a lower dose and slowly increase the dose over several weeks.It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick. It may take up to 4 weeks before you get the full benefit of this drug.

SIDE EFFECTS: Flushing (warmth/redness/itching/tingling of the skin, especially of the face/neck), sweating, headache, dizziness, or chills may occur within 2 to 4 hours after taking this medication. Flushing may persist for a few hours. These effects should improve or go away after several weeks as your body adjusts to the medication. Stomach upset, nausea, vomiting, or diarrhea may also occur. If any of these effects persist or worsen, 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 lovastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.Tell your doctor immediately if any of these unlikely but serious side effects occur: toe/joint pain, fainting, swelling ankles/feet/hands, shortness of breath, fast heartbeat, easy bruising/bleeding, black/tarry stools, vomit that looks like coffee grounds.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, persistent nausea/vomiting, severe stomach/abdominal pain.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.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to niacin or lovastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use, stomach/intestinal ulcer, bleeding problems (such as low platelets), low levels of phosphate in the blood, gout.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this medication. Ask your doctor or pharmacist for more information.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. This is especially important if you are also taking medication to lower your blood pressure.If you have diabetes, this medication may increase your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Older adults may be more sensitive to the side effects of this drug, especially muscle problems.This medication must not be used during pregnancy. Lovastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin), gemfibrozil, vitamin or dietary products that contain niacin or nicotinamide.Other medications can affect the removal of lovastatin from your body, which may affect how lovastatin works. Examples include certain azole antifungals (such as itraconazole, ketoconazole, posaconazole, voriconazole), colchicine, cyclosporine, delavirdine, dronedarone, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as lopinavir, ritonavir), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), telithromycin, among others.Do not take any red yeast rice products while you are taking niacin/lovastatin since those products may also contain lovastatin. Taking niacin/lovastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.This product may interfere with certain laboratory tests (such as urine or blood catecholamines, copper-based urine glucose tests). Make sure laboratory personnel and all your doctors know you use this medication.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, irregular heartbeat.

NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood cholesterol/triglyceride levels, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.


STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.