What is Niaspan?

Niaspan is a prescription medicine used with diet and exercise to increase the good cholesterol (HDL) and lower the bad cholesterol (LDL) and fats (triglycerides) in your blood.

• Niaspan is also used to lower the risk of heart attack in people who have had a heart attack and have high cholesterol.
• In people with coronary artery disease and high cholesterol, Niaspan, when used with a bile acid-binding resin (another cholesterol medicine) can slow down or lessen the build-up of plaque (fatty deposits) in your arteries.
• In people with heart problems and well-controlled cholesterol, taking Niaspan with another cholesterol-lowering medicine (simvastatin) does not reduce heart attacks or strokes more than taking simvastatin alone.

It is not known if Niaspan is safe and effective in children 16 years of age and under.

Description

NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula:

NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.

Mechanism of Action

The mechanism by which niacin alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Niacin decreases the rate of hepatic synthesis of VLDL and LDL, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

Who should not take Niaspan?

Do not take Niaspan if you have:

• liver problems
• a stomach ulcer
• bleeding problems
• an allergy to niacin or any of the ingredients in Niaspan. See the end of this guide for a complete list of ingredients in Niaspan.

What should I tell my healthcare provider before taking Niaspan?

Before you take Niaspan, tell your doctor, if you:

• have diabetes. Tell your doctor if your blood sugar levels change after you take Niaspan.
• have gout
• have kidney problems
• are pregnant or plan to become pregnant. It is not known if Niaspan will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant while taking Niaspan.
• are breastfeeding or plan to breastfeed. Niaspan can pass into your breast milk. You and your doctor should decide if you will take Niaspan or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take Niaspan.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements or other nutritional supplements containing niacin or nicotinamide. Niaspan and other medicines may affect each other causing side effects. Niaspan may affect the way other medicines work, and other medicines may affect how Niaspan works.

Especially tell your doctor if you take:

• other medicines to lower cholesterol or triglycerides
• aspirin
• blood pressure medicines
• blood thinner medicines
• large amounts of alcohol

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Niaspan?

• Take Niaspan exactly as your doctor tells you to take it.
• Take Niaspan tablets whole. Do not break, crush or chew Niaspan tablets before swallowing.
• Take Niaspan 1 time a day at bedtime after a low-fat snack. Niaspan should not be taken on an empty stomach.
• All forms of niacin are not the same as Niaspan. Do not switch between forms of niacin without first talking to your doctor as severe liver damage can occur.
• Do not change your dose or stop taking Niaspan unless your doctor tells you to.
• If you need to stop taking Niaspan, call your doctor before you start taking Niaspan again. Your doctor may need to lower your dose of Niaspan.
• If you forget to take a dose of Niaspan, take it as soon as you remember.
• If you take too much Niaspan, call your doctor right away.
• Medicines used to lower your cholesterol called bile acid resins, such as colestipol and cholestyramine, should not be taken at the same time of day as Niaspan. You should take Niaspan and the bile acid resin medicine at least 4 to 6 hours apart.
• Your doctor may do blood tests before you start taking Niaspan and during your treatment. You should see your doctor regularly to check your cholesterol and triglyceride levels and to check for side effects.

What are the possible side effects of Niaspan?

Niaspan may cause serious side effects, including:

• severe liver problems. Signs of liver problems include:
  • increased tiredness
  • dark colored urine (tea-colored)
  • loss of appetite
  • light colored stools
  • nausea
  • right upper stomach (abdomen) pain
  • yellowing of your skin or whites of your eye
  • itchy skin

• unexplained muscle pain, tenderness or weakness
• high blood sugar level (glucose)

Call your doctor right away if you have any of the side effects listed above.

The most common side effects of Niaspan include:

• flushing
• diarrhea
• nausea
• vomiting
• increased cough
• rash

Flushing is the most common side effect of Niaspan. Flushing happens when tiny blood vessels near the surface of the skin (especially on the face, neck, chest and/or back) open wider. Symptoms of flushing may include any or all of the following:

• warmth
• redness
• itching
• tingling of the skin

Flushing does not always happen. If it does, it is usually within 2 to 4 hours after taking a dose of Niaspan. Flushing may last for a few hours. Flushing is more likely to happen when you first start taking Niaspan or when your dose of Niaspan is increased. Flushing may get better after several weeks.

If you wake up at night because of flushing, get up slowly, especially if you:

• feel dizzy or faint
• take blood pressure medicines

To lower your chance of flushing:

• Ask your doctor if you can take aspirin to help lower the flushing side effect from Niaspan. You can take aspirin (up to the recommended dose of 325 mg) about 30 minutes before you take Niaspan to help lower the flushing side effect.
• Do not drink hot beverages (including coffee), alcohol, or eat spicy foods around the time you take Niaspan.
• Take Niaspan with a low-fat snack to lessen upset stomach.

People with high cholesterol and heart disease are at risk for a heart attack. Symptoms of a heart attack may be different from a flushing reaction from Niaspan. The following may be symptoms of a heart attack due to heart disease and not a flushing reaction:

• chest pain
• pain in other areas of your upper body such as one or both arms, back, neck, jaw or stomach
• shortness of breath
• sweating
• nausea
• lightheadedness

The chest pain you have with a heart attack may feel like uncomfortable pressure, squeezing, fullness or pain that lasts more than a few minutes, or that goes away and comes back. Heart attacks may be sudden and intense, but often start slowly, with mild pain or discomfort.

Call your doctor right away if you have any symptoms of a heart attack.

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Niaspan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Niaspan

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. Do not use Niaspan for a condition for which it was not prescribed. Do not give Niaspan to other people, even if they have the same symptoms that you have. It may harm them.

This guide summarizes the most important information about Niaspan. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Niaspan that is written for health professionals.

For more information, go to www.NIASPAN.com or call AbbVie Inc. Medical Information at 1-800-633-9110.

How should I store Niaspan?

• Store Niaspan at 68ºF to 77ºF (20ºC to 25ºC).

Keep Niaspan and all medicines out of the reach of children.

What are the ingredients in Niaspan?

Active ingredient: niacin

Inactive Ingredients: hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.

Label

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