Prescription Drug Information: Niacin (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Niacin extended-release tablets 500 mg are supplied as light orange to orange colored, round shaped, film-coated tablets debossed with “AN 321” on one side and plain on the other side.

They are available as follows:

NDC 50268-584-13 (10 tablets per card, 3 cards per carton)

Niacin extended-release tablets 1000 mg are supplied as light orange to orange colored, capsule shaped, film-coated tablets debossed with “AN 323” on one side and plain on the other side.

They are available as follows:

NDC 50268-586-13 (10 tablets per card, 3 cards per carton)

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispensed in Blister Punch Material. For Institutional Use Only.

17 PATIENT COUNSELING INFORMATION

17.1 Patient Counseling

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP) recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised to inform other healthcare professionals prescribing a new medication that they are taking niacin extended-release.

The patient should be informed of the following:

Dosing Time

Niacin extended-release tablets should be taken at bedtime, after a low-fat snack. Administration on an empty stomach is not recommended.

Tablet Integrity

Niacin extended-release tablets should not be broken, crushed or chewed, but should be swallowed whole.

Dosing Interruption

If dosing is interrupted for any length of time, their physician should be contacted prior to restarting therapy; re-titration is recommended.

Muscle Pain

Notify their physician of any unexplained muscle pain, tenderness, or weakness promptly. They should discuss all medication, both prescription and over the counter, with their physician.

Flushing

Flushing (warmth, redness, itching and/or tingling of the skin) is a common side effect of niacin therapy that may subside after several weeks of consistent niacin extended-release use. Flushing may vary in severity and is more likely to occur with initiation of therapy, or during dose increases. By dosing at bedtime, flushing will most likely occur during sleep. However, if awakened by flushing at night, the patient should get up slowly, especially if feeling dizzy, feeling faint, or taking blood pressure medications. Advise patients of the symptoms of flushing and how they differ from the symptoms of a myocardial infarction.

Diet

Avoid ingestion of alcohol, hot beverages and spicy foods around the time of taking niacin extended-release to minimize flushing.

Supplements

Notify their physician if they are taking vitamins or other nutritional supplements containing niacin or nicotinamide.

Dizziness

Notify their physician if symptoms of dizziness occur.

Diabetics

If diabetic, to notify their physician of changes in blood glucose.

Pregnancy

Discuss future pregnancy plans with your patients, and discuss when to stop niacin extended-release if they are trying to conceive. Patients should be advised that if they become pregnant, they should stop taking niacin extended-release and call their healthcare professional.

Breastfeeding

Women who are breastfeeding should be advised to not use niacin extended-release. Patients, who have a lipid disorder and are breastfeeding, should be advised to discuss the options with their healthcare professional.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 07-2015-01

AV 09/17 (P)
AvPAK

PATIENT INFORMATION

Niacin (NYE-a-sin) Extended-Release Tablets

Read this information carefully before you start taking niacin extended-release tablet(s) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What are niacin extended-release tablet(s)?

Niacin extended-release tablet(s) are 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.

  • Niacin extended-release tablet(s) 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, niacin extended-release tablet(s), 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 niacin extended-release tablet(s) with another cholesterol-lowering medicine (simvastatin) does not reduce heart attacks or strokes more than taking simvastatin alone.

It is not known if niacin extended-release tablet(s) is safe and effective in children 16 years of age and under.

Who should not take niacin extended-release tablet(s)?

Do not take niacin extended-release tablet(s) if you have:

  • liver problems
  • a stomach ulcer
  • bleeding problems
  • an allergy to niacin or any of the ingredients in niacin extended-release tablet(s). See the end of this leaflet for a complete list of ingredients in niacin extended-release tablet(s).

What should I tell my doctor before taking niacin extended-release tablet(s)?

Before you take niacin extended-release tablet(s), tell your doctor, if you:

  • have diabetes. Tell your doctor if your blood sugar levels change after you take niacin extended-release tablet(s).
  • have gout
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if niacin extended-release tablet(s) will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant while taking niacin extended-release tablet(s).
  • are breast-feeding or plan to breast-feed. Niacin can pass into your breast milk. You and your doctor should decide if you will take niacin extended-release tablet(s) or breast-feed. You should not do both. Talk to your doctor about the best way to feed your baby if you take niacin extended-release tablet(s).

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. Niacin extended-release tablet(s) and other medicines may affect each other causing side effects. Niacin extended-release tablet(s) may affect the way other medicines work, and other medicines may affect how niacin extended-release tablet(s) 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 niacin extended-release tablet(s)?

  • Take niacin extended-release tablet(s) exactly as your doctor tells you to take it.
  • Take niacin extended-release tablet(s) whole. Do not break, crush or chew niacin extended-release tablet(s) before swallowing.
  • Take niacin extended-release tablet(s) 1 time a day at bedtime after a low-fat snack. Niacin extended-release tablet(s) should not be taken on an empty stomach.
  • All forms of niacin are not the same as niacin extended-release tablet(s). 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 niacin extended-release tablet(s) unless your doctor tells you to.
  • If you need to stop taking niacin extended-release tablet(s), call your doctor before you start taking niacin extended-release tablet(s) again. Your doctor may need to lower your dose of niacin extended-release tablet(s).
  • If you forget to take a dose of niacin extended-release tablet(s), take it as soon as you remember.
  • If you take too much niacin extended-release tablet(s), 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 niacin extended-release tablet(s). You should take niacin extended-release tablet(s) and the bile acid resin medicine at least 4 to 6 hours apart.
  • Your doctor may do blood tests before you start taking niacin extended-release tablet(s) 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 niacin extended-release tablet(s)?

Niacin extended-release tablet(s) 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 niacin extended-release tablet(s) include:

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

Flushing is the most common side effect of niacin extended-release tablet(s). 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 niacin extended-release tablet(s). Flushing may last for a few hours. Flushing is more likely to happen when you first start taking niacin extended-release tablet(s) or when your dose of niacin extended-release tablet(s) 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:

  • Do not drink hot beverages (including coffee), alcohol, or eat spicy foods around the time you take niacin extended-release tablet(s).
  • Take niacin extended-release tablet(s) 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 niacin extended-release tablet(s). 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 niacin extended-release tablet(s). 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.

How should I store niacin extended-release tablet(s)?

  • Store niacin extended-release tablets at 68ºF to 77ºF (20ºC to 25ºC).

Keep niacin extended-release tablet(s) and all medicines out of the reach of children.

General information about the safe and effective use of niacin extended-release tablet(s).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use niacin extended-release tablet(s) for a condition for which it was not prescribed. Do not give niacin extended-release tablet(s) to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about niacin extended-release tablet(s). If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about niacin extended-release tablet(s) that is written for health professionals.

For more information, go to www.avkare.com or call AvKARE, Inc. at 1-855-361-3993.

What are the ingredients in niacin extended-release tablet(s)?

Active ingredient:

Niacin, USP

Inactive Ingredients:

FD&C yellow #6/sunset yellow FCF aluminum lake, hydroxyethyl cellulose, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 400, stearic acid and titanium dioxide

This Patient Information has been approved by the U.S. Food and Drug Administration.

*All trademarks are the property of their respective owners.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 07-2015-01

AV 09/17 (P)
AvPAK

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