Niaspan FCT - Consumer Medicine Information
|Manufacture:||Sunovion Pharmaceuticals Inc.|
|Condition:||High Cholesterol, Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL, Hyperlipoproteinemia Type IV, Elevated VLDL, Hyperlipoproteinemia|
|Class:||Miscellaneous antihyperlipidemic agents, Vitamins|
|Ingredients:||extended-release niacin, methylcellulose, povidone, stearic acid, polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, titanium dioxide, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, potassium hydroxide and black iron oxide|
About this Medication
What the medication is used for
- NIASPAN FCT (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 FCT and should continue on this program as directed by your doctor.
What it does
- NIASPAN FCT 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 FCT should not be used by anyone with allergies (hypersensitivity) to niacin or any component of this medication (See, “What the important nonmedicinal ingredients are), significant or unexplained liver problems, active stomach ulcers, or bleeding.
- If you become pregnant while using NIASPAN FCT, discontinue use and contact your doctor.
What the medicinal ingredient is
What the nonmedicinal ingredients are
Methylcellulose, povidone, stearic acid, polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, titanium dioxide, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, potassium hydroxide and black iron oxide.
What dosage forms it comes in
500 mg, 750 mg, or 1000 mg extended-release film coated tablets
Warnings and Precautions
|Serious Warnings and Precautions
- If you were previously taking another niacin (nicotinic acid) tablet, do not start NIASPAN FCT (extended-release niacin) at the same dose. You must start with a lower dose of NIASPAN FCT and gradually move up to a higher dose as directed by your doctor.
- Never substitute another niacin (nicotinic acid) product for your NIASPAN FCT; improper substitution can cause severe liver disorders.
BEFORE you use NIASPAN FCT talk to your doctor or pharmacist if:
- you have significant or unexplained liver or kidney problems, active stomach 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, stomach ulcer, or gout.
- you are pregnant or nursing.
- you are undergoing surgery.
- you are allergic to niacin or any component of this medication.
Interactions with this Medication
Drugs that may interact with NIASPAN FCT (extendedrelease 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.
Dosage Increase: Increase to 1000 mg daily for next 4 weeks (weeks 5-8).
Dosage Increase (if necessary): Increase to 1500 mg (1x500 mg plus 1x1000 mg or 3x500 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.
Maintenance Dose: 1000-2000 mg per day for long-term benefits.
|Important Note: Two 750 mg tablet strengths of NIASPAN FCT (extended-release niacin) are not interchangeable with three 500 mg tablets or one 500 mg tablet plus one 1000 mg tablet. 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 FCT (see Warnings and Precautions).
NIASPAN FCT 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 FCT in one dose at bedtime.
- To minimize the risk of stomach upset, take NIASPAN FCT with a low-fat snack.
- Avoid spicy foods and hot or alcoholic beverages around the time of taking NIASPAN FCT.
- 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 FCT.
- Be sure to tell your doctor about any vitamins or other nutritional supplements containing niacin (nicotinic acid, niacinamide, nicotinamide) you are currently taking.
In case of accidental overdose, call your doctor right away or go to the nearest emergency room/clinic or call your poison control centre.
You should take NIASPAN FCT only once per day in the evening or at bedtime after a low-fat snack as prescribed. If you miss a dose, take your usual NIASPAN FCT dose the next evening; do not make up for missed doses by taking extra tablets.
If you stop taking NIASPAN FCT 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 FCT (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 FCT.
- If flushing occurs, it usually does so within 2 to 4 hours after taking NIASPAN FCT 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:
- 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 stomach upset and diarrhea; rash and itching are occasionally observed.
How to Store it
Store at room temperature (15-30°C).
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and
Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at:
or by contacting Sunovion Pharmaceuticals Canada Inc., at: