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|Niacin Controlled-Release Tablets

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Niacin Controlled-Release Tablets

Generic Name: Niacin Controlled-Release Tablets (Antihyperlipidemic) (NYE-uh-sin)
Brand Name: Niaspan

Niacin Controlled-Release Tablets is used for:

Improving cholesterol levels, reducing the risk for a second heart attack, slowing or treating hardening of the arteries, and lowering very high serum triglyceride levels. It is used in combination with diet. It may also be used for other conditions as determined by your doctor.

Niacin Controlled-Release Tablets is an antihyperlipidemic. It works by reducing LDL ("bad") cholesterol and triglycerides and increasing HDL ("good") cholesterol.

Do NOT use Niacin Controlled-Release Tablets if:

you are allergic to any ingredient in Niacin Controlled-Release Tablets
If you have severe or unexplained liver problems, an active peptic ulcer, or a history of arterial bleeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Niacin Controlled-Release Tablets:

Some medical conditions may interact with Niacin Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of bleeding problems, chest pain, diabetes, gallbladder problems, glaucoma, gout, heart problems or a recent heart attack, kidney disease, liver problems, low blood pressure, severe muscle problems (rhabdomyolysis), or stomach problems (eg, peptic ulcers)
if you consume large amounts of alcohol

Some MEDICINES MAY INTERACT with Niacin Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because side effects such as bleeding may occur
Fibrates (eg, gemfibrozil, fenofibrate) or HMG-CoA reductase inhibitors ("statins") (eg, simvastatin) because side effects, such as muscle aches and weakness that may be a symptom of a serious medical condition called rhabdomyolysis, may occur
Medicine for high blood pressure (eg, clonidine, prazosin) because side effects, such as dizziness and very low blood pressure, may occur
Alcohol because toxic effects, such as delirium and lactic acidosis, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Niacin Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Niacin Controlled-Release Tablets:

Use Niacin Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To minimize flushing and upset stomach, take Niacin Controlled-Release Tablets at bedtime after a low-fat snack (eg, low-fat yogurt, banana, crackers with a glass of milk) unless your doctor directs otherwise. Do not take Niacin Controlled-Release Tablets with alcohol, a hot drink, or spicy foods.
Do not take bile acid sequestrants (eg, colestipol, cholestyramine) within 4 to 6 hours of taking Niacin Controlled-Release Tablets.
Swallow Niacin Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Niacin Controlled-Release Tablets and you are taking 1 dose daily at bedtime, skip the missed dose. Do not take the dose in the morning or 2 doses at once.

Ask your health care provider any questions you may have about how to use Niacin Controlled-Release Tablets.

Important safety information:

Niacin Controlled-Release Tablets may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Niacin Controlled-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Niacin Controlled-Release Tablets may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
Do not substitute Niacin Controlled-Release Tablets for any other type of niacin without talking with your doctor. Severe liver damage can occur.
If you stop taking Niacin Controlled-Release Tablets for an extended period, contact your doctor before you start taking it again. Your dose may need to be adjusted.
Flushing occurs with Niacin Controlled-Release Tablets and may last for several hours. Talk with your doctor if flushing becomes bothersome. Take Niacin Controlled-Release Tablets at bedtime so that flushing will occur during sleep. If you are awakened by flushing at night, get up slowly, especially if you feel dizzy or faint or if you are taking blood thinners. Take aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen) 30 minutes before taking Niacin Controlled-Release Tablets to lessen flushing.
Diabetes patients - Niacin Controlled-Release Tablets may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine
Do not take large doses of vitamins while you use Niacin Controlled-Release Tablets unless your doctor tells you to.
Lab tests, including liver function tests and serum creatine kinase tests, may be performed while you use Niacin Controlled-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Niacin Controlled-Release Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Niacin Controlled-Release Tablets while you are pregnant. Niacin Controlled-Release Tablets is found in breast milk. Do not breast-feed while taking Niacin Controlled-Release Tablets.

Possible side effects of Niacin Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; heartburn, indigestion, or upset stomach; nausea or vomiting; temporary skin redness, itching, tingling or feelings of warmth (flushing).

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; changes in vision; cloudy or blurred vision; decrease in urine or dark-colored urine; fainting; fast or irregular heartbeat; flu-like symptoms (nausea, vomiting, "not well" feeling); loss of appetite; muscle pain, tenderness, swelling, or weakness; numbness or persistent tingling of the skin; severe dizziness; stomach pain; swelling of the hands, legs, or feet; unusual bruising or bleeding; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include flushing.

Proper storage of Niacin Controlled-Release Tablets:

Store Niacin Controlled-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Niacin Controlled-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Niacin Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Niacin Controlled-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Niacin Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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