Niaspan (Sunovion Pharmaceuticals Canada, 500 mg, 1000 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• NIASPAN (extended-release niacin) is used to improve blood cholesterol levels when the response to an appropriate diet and exercise has been inadequate.
• You should have been on a cholesterol-lowering diet and exercise program before starting NIASPAN and should continue on this program as directed by your doctor.

What it does:

• NIASPAN 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:

• NIASPAN should not be used by anyone with hypersensitivity to niacin or any component of this medication (See, “What the important nonmedicinal ingredients are), significant or unexplained liver problems, active peptic ulcers, or bleeding.

• If you become pregnant while using NIASPAN, discontinue use and contact your doctor.

What the medicinal ingredient is:

Extended-release Niacin

What the important nonmedicinal ingredients are:

methylcellulose, povidone, stearic acid

What dosage forms it comes in:

500 mg or 1000 mg extended-release tablets

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• If you were previously taking another niacin (nicotinic acid) tablet, do not start NIASPAN (extended-release niacin) at the same dose. You must start with a lower dose of NIASPAN and gradually move up to a higher dose as directed by your doctor.
• Never substitute another niacin (nicotinic acid) product for your NIASPAN; improper substitution can cause severe liver disorders.

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

• you have significant or unexplained liver or kidney 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 are undergoing surgery.
• you are hypersensitive to niacin or any component of this medication.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with NIASPAN (extended-release niacin) include: statins (HMG-CoA reductase inhibitors -drugs which reduce serum cholesterol), vasoactive drugs (drugs which affect blood vessels e.g., some blood pressure medications, nitrates), acetylsalicylic acid, bile-acid sequestrants (drugs which prevent cholesterol reabsorption), anticoagulant drugs (drugs which prevent blood clotting), alcohol, hot drinks, vitamins or other nutritional supplements containing large doses of niacin (> 100 mg) or related compounds such as nicotinamide.

PROPER USE OF THIS MEDICATION

Dosage should be individualized according to patient’s response under direction of a doctor and should be taken at bedtime.

Usual Adult Starting Dose: 500 mg daily for the first 4 weeks.

Maintenance Dose: 1000-2000 mg per day for long-term benefits.

Dosage Increase: Increase to 1000mg daily for next 4 weeks (weeks 5-8).

Dosage Increase (if necessary): Increase to 1500 mg daily for next 4 weeks (weeks 9-12).

Dosage Increase (if necessary): Increase to 2000 mg daily (week 16).

Daily dose should not be increased more than 500 mg in a 4-week period. Doses above 2000 mg daily are not recommended.

Important Note: The tablet strengths of NIASPAN (extended-release niacin) 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.

Do not substitute an equivalent dose of another niacin (nicotinic acid) product for your NIASPAN (see Warnings and Precautions).

NIASPAN tablets are designed to be taken whole with a glass of water. Do not break, crush, or chew them.

This medication is prescribed for the particular condition you have. Do not give this medication to other people nor use it for any other condition.

OTHER HELPFUL HINTS:

• Always take NIASPAN in one dose at bedtime.
• To minimize the risk of stomach upset, take NIASPAN with a low-fat snack.
• Avoid spicy foods and hot or alcoholic beverages around the time of taking NIASPAN.
• 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 NIASPAN.
• Be sure to tell your doctor about any vitamins or other nutritional supplements containing niacin (nicotinic acid, niacinamide, nicotinamide) you are currently taking.

Overdose:

Seek medical attention.

Missed Dose:

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

If you stop taking NIASPAN 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 a natural reaction signalling that niacin is in the bloodstream.
• Most patients on NIASPAN (extended-release niacin) 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 NIASPAN.
• If flushing occurs, it usually does so within 2 to 4 hours after taking NIASPAN 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.
• If you are diabetic, inform your doctor if you notice any changes in your blood sugar.
• If you are taking another cholesterol lowering drug, you should inform your doctor if you experience any signs of muscle pain or weakness, as this may be a sign 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 and diarrhea; rash and itching also are occasionally observed.

HOW TO STORE IT

Store at room temperature (15-30°C).

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

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

http://www.sunovion.ca

or by contacting Sunovion Pharmaceuticals Canada Inc., at:

1-866-260-6291

Last revised: October 23, 2015