Niacor

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. Niacor and other medicines may affect each other causing side effects. Niacor may affect the way other medicines work, and other medicines may affect how Niacor 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.

Tell your doctor if you are breastfeeding or plan to breastfeed. Niacor is excreted into human breast milk. It is not known if Niacor will harm your nursing baby.

If you take too much Niacor, call your local Poison Control Center or seek emergency medical attention right away.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglycerides and if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

This medicine may cause you to feel dizzy or faint, especially when you get up from a lying or sitting position. Getting up slowly may help. This effect should lessen after a week or two as your body gets used to the medicine. However, if the problem continues or gets worse, check with your doctor.

Do not stop taking niacin without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take vitamins or other dietary supplements unless they have been discussed with your doctor. This especially includes vitamins or dietary supplements that contain niacin or similar ingredients.

The role of low-density lipoprotein (LDL) cholesterol in atherogenesis is supported by pathological observations, clinical studies, and many animal experiments. Observational epidemiological studies have clearly established that high total or LDL cholesterol and low high-density lipoprotein (HDL) cholesterol are risk factors for coronary heart disease. The Coronary Drug Project1, completed in 1975, was designed to assess the safety and efficacy of nicotinic acid and other lipid-altering drugs in men 30 to 64 years old with a history of myocardial infarction (MI). Over an observation period of five years, nicotinic acid showed a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions. The incidence of definite, nonfatal MI was 8.9% for the 1,119 patients randomized to nicotinic acid versus 12.2% for the 2,789 patients who received placebo (p< 0.004). Though total mortality was similar in the two groups at five years (24.4% with nicotinic acid versus 25.4% with placebo; p =N.S.), in a fifteenyear cumulative follow-up there were 11% (69) fewer deaths in the nicotinic acid group compared to the placebo cohort (52.0% versus 58.2%; p=0.0004)2.

The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a randomized, placebo-controlled, angiographic trial testing combined colestipol and nicotinic acid therapy in 162 non-smoking males with previous coronary bypass surgery3. The primary, per subject cardiac endpoint was global coronary artery change score. After two years, 61% of patients in the placebo cohort showed disease progression by global change score (N=82), compared with only 38.8% of drug-treated subjects (N=80), when both native arteries and grafts were considered (p<0.005). In a follow-up to this trial in a subgroup of 103 patients treated for four years, again, significantly fewer patients in the drug-treated group demonstrated progression than in the placebo cohort (48% versus 85%, respectively; p< 0.0001)4.

The Familial Atherosclerosis Treatment Study (FATS) in 146 men ages 62 and younger with apolipoprotein B levels ≥125 mg/dL, established coronary artery disease, and family histories of vascular disease, assessed change in severity of disease in the proximal coronary arteries by quantitative arteriography5. Patients were given dietary counseling and randomized to treatment with either conventional therapy with double placebo (or placebo plus colestipol if the LDL cholesterol was elevated); lovastatin plus colestipol; or nicotinic acid plus colestipol. In the conventional therapy group, 46% of patients had disease progression (and no regression) in at least one of nine proximal coronary segments. In contrast, progression (as the only change) was seen in only 25% in the nicotinic acid plus colestipol group. Though not an original endpoint of the trial, clinical events (death, myocardial infarction, or revascularization for worsening angina) occurred in 10 of 52 patients who received conventional therapy, compared with 2 of 48 who received nicotinic acid plus colestipol.

Nicotinic acid (but not nicotinamide) in gram doses produces an average 10-20% reduction in total and LDL cholesterol, a 30-70% reduction in triglycerides, and an average 20-35% increase in HDL cholesterol. The magnitude of individual lipid and lipoprotein responses may be influenced by the severity and type of underlying lipid abnormality. The increase in total HDL is associated with a shift in the distribution of HDL subfractions (as defined by ultra-centrifugation) with an increase in the HDL2:HDL3 ratio and an increase in apolipoprotein A-I content. The mechanism by which nicotinic acid exerts these effects is not entirely understood, but may involve several actions, including a decrease in esterification of hepatic triglycerides. Nicotinic acid treatment also decreases the serum levels of apolipoprotein B-100 (apo B), the major protein component of the very low-density lipoprotein (VLDL) and LDL fractions, and of lipoprotein a [Lp(a)], a variant form of LDL independently associated with coronary risk. The effect of nicotinic acid-induced changes in lipids/lipoproteins on cardiovascular morbidity or mortality in individuals without pre-existing coronary disease has not been established.

Pharmacokinetics

Following an oral dose, the pharmacokinetic profile of nicotinic acid is characterized by rapid absorption from the gastrointestinal tract and a short plasma elimination half-life. At a 1 gram dose, peak plasma concentrations of 15 to 30 μg/mL are reached within 30 to 60 minutes. Approximately 88% of an oral pharmacologic dose is eliminated by the kidneys as unchanged drug and nicotinuric acid, its primary metabolite. The plasma elimination half-life of nicotinic acid ranges from 20 to 45 minutes.

Nicotinic acid is contraindicated in patients with a known hypersensitivity to any component of this medication; significant or unexplained hepatic dysfunction; active peptic ulcer disease; or arterial bleeding.

NDC 0245-0067-11

Niacor®
Niacin Tablets, USP

500 mg

100 Tablets
Rx only

UPSHER-SMITH

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Niacin is sometimes taken at bedtime with a low-fat snack. Follow your doctor's instructions.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Take niacin with a full glass of cold or cool water. Taking the medication with a hot drink may increase your risk of side effects such as flushing.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Niacin extended-release tablets and capsules contain higher strengths of the medicine than the regular niacin tablets. Take only the dose that is correct for the type of niacin tablet or capsule you are using.

Niacin can cause you to have unusual results with certain medical tests (urine tests). Tell any doctor who treats you that you are using niacin.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

While using niacin, you may need blood tests at your doctor's office. Your kidney or liver function may also need to be checked. Visit your doctor regularly.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Applies to niacin: oral capsule, oral capsule extended release, oral elixir, oral tablet, oral tablet extended release

Along with its needed effects, niacin (the active ingredient contained in Niacor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking niacin:

• Darkening of urine
• light gray-colored stools
• loss of appetite
• severe stomach pain
• yellow eyes or skin

Some side effects of niacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• cough
• diarrhea
• feeling of warmth
• flushing or redness of the skin, especially on the face and neck
• headache
• nausea or vomiting
• rash or itching
• runny nose
• sneezing
• stuffy nose

• Dizziness or faintness
• dryness of the skin
• fever
• frequent urination
• joint pain
• muscle aching or cramping
• side, lower back, or stomach pain
• swelling of the feet or lower legs
• unusual thirst
• unusual tiredness or weakness
• unusually fast, slow, or irregular heartbeat

Applies to niacin: compounding powder, oral capsule, oral capsule extended release, oral liquid, oral tablet, oral tablet extended release

Cardiovascular

Very common (10% or more): Flushing (i.e., warmth, redness, itching, and/or tingling) (up to 88%)
Frequency not reported: Tachycardia, palpitations, atrial fibrillation, other cardiac arrhythmias, syncope, hypotension, postural hypotension[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Frequency not reported: Sweating, skin burning sensation, maculopapular rash, dry skin
Postmarketing reports: Skin discoloration[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 14%), nausea (up to 11%)
Common (1% to 10%): Vomiting
Frequency not reported: Peptic ulcers, eructation, flatulence[Ref]

Hematologic

Postmarketing reports: Slight reductions in platelet counts, prothrombin time prolonged[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, vesiculobullous rash)[Ref]

Hepatic

Postmarketing reports: Hepatitis, jaundice[Ref]

Metabolic

Frequency not reported: Decreased glucose tolerance, gout[Ref]

Musculoskeletal

Frequency not reported: Myalgia, myopathy[Ref]

Nervous system

Frequency not reported: Dizziness, syncope
Postmarketing reports: Migraine, asthenia, paresthesia[Ref]

Ocular

Postmarketing reports: Blurred vision, macular edema[Ref]

Psychiatric

Postmarketing reports: Insomnia, nervousness[Ref]

Other

Frequency not reported: Chills, edema[Ref]

Respiratory

Common (1% to 10%): Cough increased
Frequency not reported: Dyspnea[Ref]

Some side effects of Niacor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.