Niacor

Name: Niacor

Side Effects of Niacor

Niacor may cause serious side effects, including:

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


The most common side effects of Niacor include:

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

Flushing is the most common side effect of Niacor. 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 Niacor. Flushing may last for a few hours. Flushing is more likely to happen when you first start taking Niacor or when your dose of Niacor 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 Niacor. You can take aspirin (up to the recommended dose of 325 mg) about 30 minutes before you take Niacor to help lower the flushing side effect.
  • Do not drink hot beverages (including coffee), alcohol, or eat spicy foods around the time you take Niacor.
  • Take Niacor 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 Niacor. 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 or 911 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 Niacor. For more information, ask your doctor or pharmacist.

Niacor Precautions

Do not take Niacor if you have:

  • liver problems
  • a stomach ulcer
  • bleeding problems
  • an allergy to Niacor or any of the ingredients in Niacor

Niacor Dosage

Niacor is available as a tablet. Niacor is usually taken 2 to 3 times daily with meals. Take Niacor exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Other Requirements

  • Store Niacor at 15-30°C (59-86°F).
  • Keep Niacor and all medicines out of the reach of children.

Niacor Description

Niacin or nicotinic acid, a water-soluble B-complex vitamin and antihyperlipidemic agent, is 3-pyridinecarboxylic acid. It is a white, crystalline powder, sparingly soluble in water. It has the following structural formula:

Each Niacor® Tablet, for oral administration, contains 500 mg of nicotinic acid. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate and microcrystalline cellulose.

Indications and Usage for Niacor

I. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Types IIa and IIb)†, when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also the NCEP treatment guidelines6). Prior to initiating therapy with nicotinic acid, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total cholesterol, HDL cholesterol, and triglycerides.

II. Nicotinic acid is also indicated as adjunctive therapy for the treatment of adult patients with very high serum triglyceride levels (Types IV and V hyperlipidemia)† who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Such patients typically have serum triglyceride levels over 2000 mg/dL and have elevations of VLDL cholesterol as well as fasting chylomicrons (Type V hyperlipidemia)†. Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to develop pancreatitis. Therapy with nicotinic acid may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. Some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of nicotinic acid therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL. Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia7.

† Classification of Hyperlipoproteinemias

C = cholesterol, TG = triglycerides

LDL = low-density lipoprotein

VLDL = very low-density lipoprotein

IDL = intermediate-density lipoprotein

           Lipoproteins      Lipid Elevations      
     Type      Elevated      Major      Minor
     I (rare)      Chylomicrons      TG      ↑→ C
     IIa      LDL      C      .....
     IIb      LDL, VLDL      C      TG
     III (rare)      IDL      C/TG      .....
     IV      VLDL      TG      ↑→ C
     V (rare)      Chylomicrons, VLDL      TG      ↑→ C

Precautions

General

Before instituting therapy with nicotinic acid, an attempt should be made to control hyperlipidemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems (see INDICATIONS AND USAGE).

Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during nicotinic acid therapy. Frequent monitoring of liver function tests and blood glucose should be performed to ascertain that the drug is producing no adverse effects on these organ systems. Diabetic patients may experience a dose-related rise in glucose intolerance, the clinical significance of which is unclear. Diabetic or potentially diabetic patients should be observed closely. Adjustment of diet and/or hypoglycemic therapy may be necessary.

Caution should also be used when nicotinic acid is used in patients with unstable angina or in the acute phase of myocardial infarction, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.

Elevated uric acid levels have occurred with nicotinic acid therapy, therefore use with caution in patients predisposed to gout.

Drug Interactions

HMG-CoA Reductase Inhibitors : See WARNINGS, Skeletal Muscle.

Antihypertensive Therapy : Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

Aspirin : Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear.

Other : Concomitant alcohol or hot drinks may increase the side effects of flushing and pruritus and should be avoided at the time of drug ingestion.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Nicotinic acid administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The mice in this study received approximately 6-8 times a human dose of 3000 milligrams/day as determined on a milligram/square meter basis. Nicotinic acid was negative for mutagenicity in the Ames test. No studies on impairment of fertility have been performed.

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with nicotinic acid. It is also not known whether nicotinic acid at doses typically used for lipid disorders can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. If a woman receiving nicotinic acid for primary hypercholesterolemia (Types IIa or IIb) becomes pregnant, the drug should be discontinued. If a woman being treated with nicotinic acid for hypertriglyceridemia (Types IV or V) conceives, the benefits and risks of continued drug therapy should be assessed on an individual basis.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of nicotinic acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children and adolescents have not been established.

Overdosage

Supportive measures should be undertaken in the event of an overdose.

References

  1. The Coronary Drug Project Research Group. Clofibrate and Niacin in Coronary Heart Disease. JAMA 1975; 231:360-81.
  2. Canner PL et al. Fifteen Year Mortality in Coronary Drug Project Patients: Long-Term Benefit with Niacin. JACC 1986; 8(6):1245-55.
  3. Blankenhorn DH et al. Beneficial Effects of Combined Colestipol-Niacin Therapy on Coronary Atherosclerosis and Coronary Venous Bypass Grafts. JAMA 1987; 257(23):3233-40.
  4. Cashin-Hemphill et al. Beneficial Effects of Colestipol-Niacin on Coronary Atherosclerosis. JAMA 1990; 264(23):3013-17.
  5. Brown G et al. Regression of Coronary Artery Disease as a Result of Intensive Lipid-Lowering Therapy in Men with High Levels of Apolipoprotein B. NEJM 1990; 323:1289-98.
  6. Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol. Arch Int Med 1988; 148:36-69.
  7. Nikkila EA: Familial lipoprotein lipase deficiency and related disorders of chylomicron metabolism. In Stanbury JB et al. (eds.): The Metabolic Basis of Inherited Disease, 5th ed., McGraw-Hill, 1983, Chap. 30, pp. 622-642.

Manufactured by:
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447

Rev. 0200

What is Niacor (niacin)?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Niacin is used to treat and prevent a lack of natural niacin in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacin is sometimes used to treat coronary artery disease (also called atherosclerosis).

Niacin may also be used for purposes not listed in this medication guide.

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