This combination medication is used along with a proper diet to help lower "bad" cholesterol (e.g., LDL) and fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. Niacin is also known as vitamin B3 (nicotinic acid), one of the B-complex vitamins. It works by reducing the amount of cholesterol made by the liver and increasing the natural substance (an enzyme) that breaks down fats in 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 non-drug treatments (e.g., diet change, increase in exercise, weight loss if overweight) and the use of one drug (niacin or lovastatin) have not been fully successful at lowering cholesterol. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Lowering triglycerides may also help reduce the risk of pancreas problems (pancreatitis) in people at risk.

Take this medication by mouth with a low-fat snack, usually once daily at bedtime or as directed by your doctor. Taking this drug with food will increase its absorption and help reduce side effects (e.g., flushing, stomach upset).

Swallow this drug whole. Do not chew, crush, or break the medication. Doing so can destroy the long action of the drug and may increase side effects.

To lessen the chance of flushing, avoid alcohol and hot beverages near the time you take niacin. Taking a plain aspirin (non-enteric coated, 325 milligrams) or a nonsteroidal anti-inflammatory drug (e.g., ibuprofen, 200 milligrams) 30 minutes before taking niacin 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 should 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 (e.g., 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.

Dosage is based on your medical condition, response to treatment, and use of certain interacting medicines. Many of the drugs listed in the Drug Interactions section may increase the chances of muscle problems when used with this product. Consult your doctor or pharmacist for more details.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit juice can increase the amount of certain medications 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 4 to 6 hours before or after taking these medications.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It may take up to 4 weeks before you get the full benefit of this drug.

It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.

Do not stop taking this medicine unless directed by your doctor. If this product is stopped, you may need to return to your original dose and gradually increase it again. If you have not taken this medication for several days, consult your doctor or pharmacist for instructions on restarting it.

See also Precautions section.

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 after use. These effects should improve or go away after several weeks as your body adjusts to the medication. Stomach upset, nausea, 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness, fast/irregular heartbeat, swelling ankles/feet/hands, shortness of breath, unusual joint pain, vision problems.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, easy bruising/bleeding, yellowing eyes/skin, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

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.

Before taking this product, tell your doctor or pharmacist if you are allergic to niacin or lovastatin; or if you had a severe reaction to other "statins" (e.g., simvastatin); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current liver disease, current stomach/intestinal ulcer, serious bleeding problems (e.g., arterial bleeding).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, low blood pressure, gallbladder disease, glaucoma, bleeding problems (e.g., low platelets), alcohol use/abuse, history of liver disease, history of stomach/abdominal ulcers, low levels of phosphate in the blood, gout.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness.

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with lovastatin or niacin. Ask your doctor or pharmacist for more information.

To reduce 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 drug 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 anti-diabetic medication or diet may need to be adjusted.

Older adults may be more sensitive to the side effects of the 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 using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

See also How to Use section.

This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: certain azole antifungals (itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (e.g., ritonavir, amprenavir, lopinavir, nelfinavir), certain macrolide antibiotics (erythromycin, clarithromycin, troleandomycin), nefazodone, telithromycin.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: alpha blockers (e.g., prazosin), azithromycin, "blood thinners" (e.g., warfarin), daptomycin, drugs affecting liver enzymes that remove lovastatin from your body (such as azole antifungals including fluconazole/voriconazole/posaconazole, amiodarone, cyclosporine, danazol, diltiazem, verapamil, rifampin, St. John's wort, carbamazepine), drugs to treat high blood pressure (e.g., ACE inhibitors such as lisinopril, beta blockers such as atenolol), fibrates (e.g., gemfibrozil, fenofibrate), nitrates (e.g., isosorbide dinitrate), vitamin or dietary products that contain niacin or nicotinamide.

This product can affect the results of certain lab tests (e.g., urine or blood catecholamines, copper-based urine glucose tests). Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., 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.

For best results, this medication should be used along with exercise, a low-cholesterol/low-fat diet, and a weight loss program if you are overweight. To help reduce your risk of heart attacks and strokes, check your blood pressure regularly, seek medical treatment if your blood pressure is high, and stop smoking. Consult your doctor for more details.

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.

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.

Information last revised October 2008 Copyright(c) 2008 First DataBank, Inc.