Advicor: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• ADVICOR is used to improve blood cholesterol levels

  when the response to an appropriate diet and exercise has been inadequate.

• It is intended for patients treated with lovastatin who

  require further cholesterol-lowering and who may benefit from niacin added to their regimen or patients treated with niacin who require further cholesterol-lowering who may benefit from having lovastatin added to their regimen.

• You should have been on a cholesterol-lowering diet and

  exercise program before starting ADVICOR and should continue on this program as directed by your doctor.

This medicine is prescribed for the particular condition you have. Do not give this medicine to other people or use it for any other condition.

What it does:

• ADVICOR lowers Total Cholesterol and specific types

  of cholesterols such as, LDL-C (bad cholesterol) and triglyceride levels, and increases HDL-C (good cholesterol).

When it should not be used:

• ADVICOR should not be used by pregnant or nursing

  women.

• ADVICOR should not be used by anyone with allergies

  (hypersensitivity) to niacin, lovastatin, or any component of this medication or the container (See, “What the nonmedicinal ingredients are:”).

• ADVICOR should not be used by anyone with

  significant or unexplained liver problems, active stomach ulcers, or active bleeding.

What the medicinal ingredient is:

Extended-release niacin and lovastatin

What the nonmedicinal ingredients are:

FD&C yellow No 615 (750/20 tablet only), hydroxypropyl methylcellulose, iron oxide yellow (500/20 and 1000/20 tablets only), iron oxide red (500/20, 1000/20 and 1000/40 tablets only), iron oxide black (1000/20 tablet only), macrogol, povidone, polyethylene glycol, polysorbate 80 (500/20, 750/20 and 1000/20 tablets only), stearic acid, and titanium dioxide

What dosage forms it comes in:

Film coated tablets of 500/20 mg, 750/20 mg, 1000/20 mg and 1000/40 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• If you become pregnant while using ADVICOR, discontinue use and contact your doctor immediately.
• If you are a woman during your child-bearing years, use reliable contraception while taking ADVICOR.

• If you were previously taking another niacin

  (nicotinic acid) (nicotinamide) tablet, your doctor will start you on a lower dose of extended-release niacin tablet (NIASPAN^®) and gradually increase the dose before using ADVICOR.

• Do not substitute another form of niacin (nicotinic acid) (nicotinamide), used with lovastatin, for ADVICOR without consulting your doctor; improper substitution of niacin can cause severe liver disorders.
• Promptly report to your physician any symptoms of muscle pain or weakness, as this may be a sign of a rare, but serious side effect.

• Do not consume large quantities of alcohol while taking ADVICOR.

BEFORE you use ADVICOR talk to your doctor or pharmacist if:

• You are taking any other medications (prescription, non-prescription and natural health products) including other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate).
• You have significant or unexplained liver, kidney or thyroid problems, active peptic ulcer, bleeding, diabetes, unstable angina, heart problems, or if you are at risk for low levels of phosphorus in your blood.
• You have a past history of jaundice (yellow skin), liver problems, peptic ulcer, or gout.
• You are pregnant or nursing.
• You have undergone surgery or have had other tissue injury.
• You have a family history of muscular disorders.
• You have had any past problems with muscles (pain, tenderness) after using an HMG-CoA reductase inhibitor (“statin”) such as atorvastatin, fluvastatin, pravastatin,

rosuvastatin or simvastatin or have developed an allergy or intolerance to them.

• You are hypersensitive to niacin, lovastatin or any

  component of this medication.

INTERACTIONS WITH THIS MEDICATION

Drugs or food that may interact with ADVICOR are listed below. Tell you doctor and pharmacist if you are taking any of these medications.

• cyclosporine
• itraconazole
• ketoconazole
• niacin
• erythromycin
• clarithromycin
• nefazodone or HIV protease inhibitors
• antipyrine
• propranolol
• digoxin

• fibric acid derivatives (bezafibrate, fenofibrate and

  gemfibrozil)

• oral hypoglycemic agents (drugs which control

  diabetes)

• vasoactive drugs (drugs which affect blood vessels)
• acetylsalicylic acid
• bile-acid sequestrants (drugs which bind bile acids)

• anticoagulant drugs (drugs which prevent blood

  clotting) such as warfarin

• alcohol
• hot drinks

• vitamins or other nutritional supplements containing

  large doses of niacin (greater than 100 mg) or related compounds such as nicotinamide

• grapefruit juice

PROPER USE OF THIS MEDICATION

Usual dose:

ADVICOR is a combination product that supplies a fixed dose of extended-release niacin and lovastatin. Before taking ADVICOR, your doctor will have determined the right dose for you of each component (niacin and lovastatin) and helped you slowly increase your dose of each separately.

ADVICOR is used for maintenance therapy once you have reached a stable dose of niacin and lovastatin.

Doses of ADVICOR greater than 2000/40 mg daily are not recommended. If ADVICOR therapy is discontinued for an extended period (>7 days), reinstitution of therapy should begin with the lowest dose of ADVICOR.

ADVICOR tablets are designed to be taken whole. Do not break, crush, or chew them.

Important Note: The tablet strengths of ADVICOR

(extended-release niacin/lovastatin) are not interchangeable and you should not alternate between different strengths to provide the same daily dosage. Your doctor will specify the tablet strengths that you should use.

This medication is prescribed for the particular condition you have. Do not give this medication to other people or use it for any other condition.

OTHER HELPFUL HINTS:

• Always take ADVICOR in one dose at bedtime.
• To minimize the risk of stomach upset, take ADVICOR with a low-fat snack.
• Avoid spicy foods and hot or alcoholic beverages around the time of taking ADVICOR.

• If the side effect flushing is bothersome, (see Side

  Effects and What to Do About Them, below), discuss it with your doctor, and your doctor may recommend that you take acetylsalicylic acid, if this is appropriate for you up to 30 minutes before taking ADVICOR. Be sure to tell your doctor about any vitamins or other nutritional supplements containing niacin you are currently taking.

Overdose:

Seek medical attention.

Missed Dose:

You should take ADVICOR every night at bedtime as prescribed. If you miss a dose, take your usual ADVICOR dose the next evening; do not make up for missed doses by taking extra tablets.

If you stop taking ADVICOR for a week or more, contact your doctor for instructions.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

What is flushing?

Niacin sometimes causes redness, warmth, itching, and/or a tingling sensation on the face, neck, chest and back. This is called “flushing”. This is a natural reaction signalling that niacin is in the bloodstream.

Most patients on ADVICOR will experience this sensation, usually at the start of therapy or when the dosing is increased. For most patients, the flushing occurs over the first 8 weeks of therapy and will become milder and less frequent as your body adjusts to ADVICOR.

If flushing occurs, it usually does so within 2 to 4 hours after taking ADVICOR and may last for a few hours.

In some patients, flushing may be more intense. Additional symptoms, such as rapid or pronounced heartbeat or dizziness, shortness of breath, sweating, chills, and/or

swelling may occur; on rare occasions, fainting may occur. If the flushing wakes you up and you wish to get out of bed, take your time and get up slowly – especially if you start to feel faint or dizzy, or if you take blood pressure medication.

Other important reactions to be aware of:

• Fever
• Blurred vision

• If you are diabetic, inform your doctor if you notice any

  changes in your blood sugar.

• You should inform your doctor immediately and stop

  taking ADVICOR if you experience any signs of muscle pain, tenderness or weakness as well as generalized weakness and/or brownish or discoloured urine, as these may be signs of a rare but serious adverse drug reaction.

Other than flushing, the side effects most often seen are gastrointestinal in nature, such as stomach upset, constipation, gas, nausea and diarrhea. Rash, itching, pain in the abdomen, headache and dizziness are also occasionally observed.

Most side effects generally do not require medical attention and may come and go during treatment. But if any effect persists or becomes troublesome, talk with your doctor or pharmacist right away.

Possible side effects reported with some statins:

• breathing problems including persistent cough and/or

  shortness of breath or fever

• erectile dysfunction

• mood related disorders including depression and sleep

  disturbances including insomnia and nightmares

HOW TO STORE IT

Store at room temperature (15 to 30°C).

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.sepracorpharma.ca

or by contacting, Sepracor Pharmaceuticals, Inc. at: 1-866-260-6291.

Last revised: October 29, 2010