Lovastatin; Niacin extended-release tablets

What are lovastatin; niacin extended-release tablets?

LOVASTATIN; NIACIN (Advicor™) blocks the body's ability to make cholesterol. Advicor™ can help lower your cholesterol level. The combination of lovastatin and niacin lowers the 'bad' cholesterol level (LDL) and increases the 'good' cholesterol level (HDL). By improving your cholesterol levels, you may decrease your risk of having a heart attack or stroke. This medicine is only for patients whose cholesterol levels are not controlled by diet and exercise alone. Generic tablets are not available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an alcohol problem

• blood salt imbalance

• diabetes or other hormone disorder

• gallbladder disease

• gout

• heart disease or a history of heart attack

• infection

• kidney disease

• liver disease

• low blood counts, low platelets, or bleeding problems

• low blood pressure or taking drugs to lower blood pressure

• muscle disorder or condition

• recent surgery or severe injury

• seizures (convulsions)

• ulcers of intestine or stomach

• an unusual or allergic reaction to lovastatin; niacin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Take Advicor™ (lovastatin; niacin) tablets by mouth. Follow the directions on the prescription label. Swallow the tablet with a drink of water. Do not crush, break, or chew the tablet. The tablet should be taken in the evening with a low-fat snack. Do not take Advicor™ with grapefruit juice, hot beverages, or alcohol-containing beverages. Take your doses at regular intervals. Do not take your medicine more often than directed. If skin flushing (skin warmth, redness) becomes a problem, ask your health care provider if you can take aspirin (or ibuprofen) before taking your Advicor™ doses. Taking one dose of aspirin (or ibuprofen) 30 minutes before taking Advicor™ can help to decrease the amount of flushing you experience.

If you also take resins such as cholestyramine (Questran®) or colestipol (Colestid®) to lower your cholesterol, you should take Advicor™ at least 1 hour before or 4 hours after a dose of these medications.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with lovastatin; niacin?

Do not take Lovastatin; Niacin with any of the following:

• alcohol-containing beverages

• amprenavir

• atazanavir

• clarithromycin

• delavirdine

• erythromycin

• grapefruit juice

• indinavir

• itraconazole

• ketoconazole

• lopinavir; ritonavir

• mibefradil

• nefazodone

• nelfinavir

• other niacin products

• red yeast rice

• ritonavir

• saquinavir

• troleandomycin

Lovastatin; Niacin may also interact with the following medications:

• amiodarone

• barbiturates (examples: phenobarbital, butalbital, primidone)

• bosentan

• carbamazepine

• cilostazol

• cyclosporine

• danazol

• diltiazem

• efavirenz

• imatinib, STI-571

• isradipine

• fluconazole

• medicines for diabetes

• medicines for high blood pressure or heart disease

• medicine used to stop early pregnancy (mifepristone, RU-486)

• nitroglycerin or nitrates (amyl nitrate, isosorbide dinitrate, isosorbide mononitrate)

• other medicines to lower cholesterol or triglycerides (cholestyramine, colestipol, fenofibrate, gemfibrozil)

• oxcarbazepine

• phenytoin

• rifampin, rifabutin, or rifapentine

• St. John's Wort

• telithromycin

• verapamil

• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking lovastatin; niacin?

Visit your prescriber or health care professional for regular checks on your progress. Do not take more Advicor™ than is prescribed. You will need to have regular tests to make sure your liver is working properly.

Lovastatin; niacin is only part of a total cholesterol-lowering program. Your physician or dietician can suggest a low-cholesterol and low-fat diet that will reduce your risk of getting heart and blood vessel disease. Avoid alcohol and smoking, and keep a proper exercise schedule.

Tell your prescriber or health care professional as soon as you can if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

Some medicines increase the risk of muscle side effects while taking Advicor™. Discuss your drug regimen with your health care provider if you are prescribed certain antibiotics or antifungals which are not recommended with Advicor™ (examples: clarithromycin, erythromycin, itraconazole, ketoconazole). Your prescriber may decide to temporarily stop taking Advicor™ while you are taking a short course of the antibiotic or antifungal therapy. Alternatively, your health care provider may prescribe another antibiotic or antifungal medicine for your condition.

You may get dizzy, faint, or have blurred vision; until you know how niacin affects you, do not drive, use machinery, or do anything that needs mental alertness. To avoid dizzy or fainting spells, do not stand or sit up quickly, especially if you are an older person.

Do not drink hot drinks or alcohol at the same time you take your niacin dose. Hot drinks and alcohol can increase the flushing caused by niacin, which can be uncomfortable. Alcohol also can increase possible dizziness.

If you are going to have surgery tell your prescriber or health care professional that you are taking lovastatin; niacin.

You may notice the empty shell of the tablet in your stool; this is no cause for concern.

This medicine should not be used by women who are pregnant or breast-feeding. There is a potential for serious side effects to an unborn child or to an infant. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from taking lovastatin; niacin?

Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare or uncommon:

• blurred vision

• breathing problems

• chest pain

• dark yellow or brown urine

• decreased urination, difficulty passing urine

• fever

• sexual problems

• unexplained muscle pain, tenderness, cramps, or weakness

• unusual or severe tiredness or weakness

• yellowing of the skin or eyes

More common:

• dizziness that does not go away or fainting spells

• increased blood sugar, especially if you have diabetes

• nausea, vomiting

• palpitations

• skin rash, hives, peeling or itching of the skin

• stomach pain, loss of appetite

• swelling of the body (e.g., legs, ankles, arms)

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• chills

• diarrhea or constipation

• difficulty sleeping

• dizziness (mild), lightheadedness

• flushing (skin redness), warmth, and burning or tingling of the skin

• gas

• headache

• stomach upset, discomfort, or bloating

• sweating

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at controlled room temperature between 20—25 degrees C (68—77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.