Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
January 24, 2013
Health Canada has issued new restrictions concerning the use of Advicor (lovastatin - niacin). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Alcohol use: People who consume more alcohol than the daily suggested amounts should discuss with their doctor if any special monitoring is needed.
Blood sugar: People with diabetes may experience small increases in their blood sugar while taking this medication. Your doctor may need to adjust the medications you take to control your blood sugar. You should continue to monitor your blood sugar levels regularly while taking this medication.
Flushing: People may develop a warm, itchy feeling on their skin (face, neck, back, and chest) after starting lovastatin - niacin. This is caused by the niacin part of the medication. Flushing may last for several hours after taking this medication and will usually go away after several weeks of taking the medication. Taking the medication at bedtime will help you deal with flushing by making it more likely to happen while you are asleep. If you are woken up by flushing, get up slowly to minimize dizziness or fainting. Avoid alcohol or hot drinks around the time you take niacin extended release, as these may increase flushing. Taking acetylsalicylic acid (ASA) about 30 minutes before taking lovastatin - niacin may also help with the flushing; check with your doctor first to see if this is appropriate for you.
Grapefruit juice: Drinking grapefruit juice has been found to increase the blood levels of lovastatin - niacin. Let your doctor know if you drink this beverage regularly.
Kidney problems: People with decreased kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver effects: This medication may cause increases in laboratory test results called liver function tests. These increases may indicate harmful effects to the liver. When the medication is stopped, the laboratory tests usually slowly return to normal. Your doctor will likely monitor your liver function regularly while you are taking this medication. People with a history of liver disease should be closely monitored by their doctors while they are taking this medication. People with an active liver disease or with unexplained liver function tests should not take lovastatin - niacin.
Medical conditions and surgery: People with gout, ulcers, or heart problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication should be stopped a few days before elective surgery and during acute medical conditions or surgery.
Muscle effects: In rare cases, serious muscle damage has been associated with the use of lovastatin, especially at higher doses. Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever. The risk of experiencing these muscle effects is increased for people with kidney problems or who are taking certain medications (e.g., gemfibrozil, danazol, cyclosporine). Before taking this medication, tell your doctor or pharmacist if you:
- are over the age of 70
- are taking other cholesterol-lowering medications such as fibrates (gemfibrozil, fenofibrate) or niacin
- are taking other medications, including prescription, non-prescription, and natural health products, as drug interactions are possible
- do excessive physical exercise
- drink 3 or more alcoholic drinks daily
- have a family history of muscular disorders
- have diabetes
- have had any past problems with the muscles (pain, tenderness) after using a statin
- have kidney or liver problems
- have thyroid problems
- have undergone surgery or other tissue injury
Previous niacin use: If you were taking another form of niacin (e.g., immediate release), your doctor will change you to extended release niacin before starting this medication. When you are stabilized on a specific dose of extended release niacin and lovastatin taken separately, your doctor will be able to determine the appropriate dose of this combination medication for you. Do not substitute another form of niacin without consulting with your doctor first - doing so can cause severe liver disorders.
Pregnancy: The medication should not be used during pregnancy. This medication can cause serious injury to the fetus. An effective and reliable method of contraception should be used while taking lovastatin - niacin. If you become pregnant while taking this medication, stop taking the medication and contact your doctor immediately.
Breast-feeding: It is not known if this medication passes into breast milk. This medication should not be used by women who are breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.