Niacin (extended-release tablet)

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# Overview
Niacin (extended-release tablet) is an antihyperlipidemic, nutriceutical, nutritive agent,  Vitamin B that is FDA approved for the treatment of hyperlipidemia, prevention of recurrence of myocardial infarction, reduce atheroesclerotic plaque in CAD and hypertriglyceridemia in patients with risk for pancreatitis.   Common adverse reactions include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Niacin extended-release tablets USP should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets USP must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in Table 1 below.

### Maintenance Dose
- The daily dosage of niacin extended-release tablets USP should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower niacin extended-release tablets USP doses than men.
- Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.
- If lipid response to niacin extended-release tablets USP alone is insufficient or if higher doses of niacin extended-release tablets USP are not well tolerated, some patients may benefit from combination therapy with a bile acid binding resin or statin.
- Tolerance to flushing of skin develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of niacin extended-release tablets USP ingestion.
- Equivalent doses of niacin extended-release tablets USP should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin. Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets USP titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.
- If niacin extended-release tablets USP therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).
- Niacin extended-release tablets USP should be taken whole and should not be broken, crushed or chewed before swallowing.

### Concomitant Therapy
- Patients already receiving a stable dose of lovastatin or simvastatin who require further TG-lowering or HDL-raising (e.g., to achieve NCEP non-HDL-C goals), may receive concomitant dosage titration with niacin extended-release tablets USP per niacin extended-release tablets USP recommended initial titration schedule. For patients already receiving a stable dose of niacin extended-release tablets USP who require further LDL-lowering (e.g., to achieve NCEP LDL-C goals), the usual recommended starting dose of lovastatin and simvastatin is 20 mg once a day. Dose adjustments should be made at intervals of 4 weeks or more. Combination therapy with niacin extended-release tablets USP and lovastatin or niacin extended-release tablets USP and simvastatin should not exceed doses of 2000 mg niacin extended-release tablets USP and 40 mg lovastatin or simvastatin daily.
- Use of niacin extended-release tablets USP in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablet USP is contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets USP should be used with caution in patients with renal impairment

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use

### Dietary Daily Recommended Allowance
- Dosage:
Males
913 years: 12 mg/dL RDA
1418 years: 18 mg/dL RDA
1930 years: 18 mg/dL RDA
31-50 years: 18 mg/dL RDA
50-70 years: 18 mg/dL RDA
 70 years: 18 mg/dL RDA
Females
913 years: 12 mg/dL RDA
1418 years: 14 mg/dL RDA
1930 years: 14 mg/dL RDA
31-50 years: 14 mg/dL RDA
50-70 years: 14 mg/dL RDA
 70 years: 14 mg/dL RDA
- Males
913 years: 12 mg/dL RDA
1418 years: 18 mg/dL RDA
1930 years: 18 mg/dL RDA
31-50 years: 18 mg/dL RDA
50-70 years: 18 mg/dL RDA
 70 years: 18 mg/dL RDA
- 913 years: 12 mg/dL RDA
- 1418 years: 18 mg/dL RDA
- 1930 years: 18 mg/dL RDA
- 31-50 years: 18 mg/dL RDA
- 50-70 years: 18 mg/dL RDA
- > 70 years: 18 mg/dL RDA
- Females
913 years: 12 mg/dL RDA
1418 years: 14 mg/dL RDA
1930 years: 14 mg/dL RDA
31-50 years: 14 mg/dL RDA
50-70 years: 14 mg/dL RDA
 70 years: 14 mg/dL RDA
- 913 years: 12 mg/dL RDA
- 1418 years: 14 mg/dL RDA
- 1930 years: 14 mg/dL RDA
- 31-50 years: 14 mg/dL RDA
- 50-70 years: 14 mg/dL RDA
- > 70 years: 14 mg/dL RDA

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Niacin in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Niacin (extended-release tablet) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use

### Dietary Daily Recommended Allowance
- Dosage:
06 months: 2 mg/dL RDA
712 months: 4 mg/dL RDA
- 06 months: 2 mg/dL RDA
- 712 months: 4 mg/dL RDA
- Dosage
13 years: 6 mg/dL RDA
48 years: 8 mg/dL RDA
- 13 years: 6 mg/dL RDA
- 48 years: 8 mg/dL RDA

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Niacin in pediatric patients.

# Contraindications
Niacin extended-release tablet is contraindicated in the following conditions:
- Active liver disease or unexplained persistent elevations in hepatic transaminases.
- Patients with active peptic ulcer disease
- Patients with arterial bleeding
- Hypersensitivity to niacin or any component of this medication.

# Warnings
Niacin extended-release tablet preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to niacin extended-release tablets, therapy with niacin extended-release tablets should be initiated with low doses (i.e., 500 mg at bedtime) and the niacin extended-release tablets dose should then be titrated to the desired therapeutic response.
- Caution should also be used when niacin extended-release tablet is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.
- Niacin is rapidly metabolized by the liver, and excreted through the kidneys. Niacin extended-release tablet is contraindicated in patients with significant or unexplained hepatic impairment and should be used with caution in patients with renal impairment. Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during niacin extended-release tablets therapy.

### Mortality and Coronary Heart Disease Morbidity
- The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial was a randomized placebo-controlled trial of 3414 patients with stable, previously diagnosed cardiovascular disease. Mean baseline lipid levels were LDL-C 74 mg/dL, HDL-C 35 mg/dL, non-HDL-C 111 mg/dL and median triglyceride level of 163 to 177 mg/dL. Ninety-four percent of patients were on background statin therapy prior to entering the trial. All participants received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40 to 80 mg/dL, and were randomized to receive niacin extended-release tablets 1500 to 2000 mg/day (n=1718) or matching placebo (IR Niacin, 100 - 150 mg, n=1696). On-treatment lipid changes at two years for LDL-C were -12.0% for the simvastatin plus niacin extended-release tablets group and -5.5% for the simvastatin plus placebo group. HDL-C increased by 25.0% to 42 mg/dL in the simvastatin plus niacin extended-release tablets group and by 9.8% to 38 mg/dL in the simvastatin plus placebo group (P<0.001). Triglyceride levels decreased by 28.6% in the simvastatin plus niacin extended-release tablets group and by 8.1% in the simvastatin plus placebo group. The primary outcome was an ITT composite of the first study occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures.
- The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. The primary outcome occurred in 282 patients in the simvastatin plus niacin extended-release tablets group (16.4%) and in 274 patients in the simvastatin plus placebo group (16.2%) (HR 1.02 , P=0.79. In an ITT analysis, there were 42 cases of first occurrence of ischemic stroke reported, 27 (1.6%) in the simvastatin plus niacin extended-release tablets group and 15 (0.9%) in the simvastatin plus placebo group, a non-statistically significant result (HR 1.79, , p=0.071).  The on-treatment ischemic stroke events were 19 for the simvastatin plus niacin extended-release tablets group and 15 for the simvastatin plus placebo group.

### Skeletal Muscle
- Cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (1 g/day) of niacin and statins. Physicians contemplating combined therapy with statins and niacin extended-release tablets should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Periodic serum creatine phosphokinase (CPK) and potassium determinations should be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.
- The risk for myopathy and rhabdomyolysis are increased when lovastatin or simvastatin are coadministered with niacin extended-release tablets, particularly in elderly patients and patients with diabetes, renal failure, or uncontrolled hypothyroidism.

### Liver Dysfunction
- Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses.
- Niacin extended-release tablets should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver diseases or unexplained transaminase elevations are contraindications to the use of niacin extended-release tablets.
- Niacin preparations have been associated with abnormal liver tests. In three placebo-controlled clinical trials involving titration to final daily niacin extended-release tablets doses ranging from 500 to 3000 mg, 245 patients received niacin extended-release tablets for a mean duration of 17 weeks. No patient with normal serum transaminase levels (AST, ALT) at baseline experienced elevations to more than 3 times the upper limit of normal (ULN) during treatment with niacin extended-release tablets. In these studies, fewer than 1% (2/245) of niacin extended-release tablets patients discontinued due to transaminase elevations greater than 2 times the ULN.
- In three safety and efficacy studies with a combination tablet of niacin extended-release tablets and lovastatin involving titration to final daily doses (expressed as mg of niacin/ mg of lovastatin) 500 mg/10 mg to 2500 mg/40 mg, ten of 1028 patients (1.0%) experienced reversible elevations in AST/ALT to more than 3 times the ULN. Three of ten elevations occurred at doses outside the recommended dosing limit of 2000 mg/40 mg; no patient receiving 1000 mg/20 mg had 3-fold elevations in AST/ALT.
- Niacin extended-release and simvastatin can cause abnormal liver tests. In a simvastatin- controlled, 24 week study with a fixed dose combination of niacin extended-release tablets and simvastatin in 641 patients, there were no persistent increases (more than 3x the ULN) in serum transaminases. In three placebo-controlled clinical studies of extended-release niacin there were no patients with normal serum transaminase levels at baseline who experienced elevations to more than 3x the ULN. Persistent increases (more than 3x the ULN) in serum transaminases have occurred in approximately 1% of patients who received simvastatin in clinical studies. When drug treatment was interrupted or discontinued in these patients, the transaminases levels usually fell slowly to pretreatment levels. The increases were not associated with jaundice or other clinical signs or symptoms. There was no evidence of hypersensitivity.
- In the placebo-controlled clinical trials and the long-term extension study, elevations in transaminases did not appear to be related to treatment duration; elevations in AST levels did appear to be dose related. Transaminase elevations were reversible upon discontinuation of niacin extended-release tablets.
- Liver function tests should be performed on all patients during therapy with niacin extended-release tablets. Serum transaminase levels, including AST and ALT (SGOT and SGPT), should be monitored before treatment begins, every 6 to 12 weeks for the first year, and periodically thereafter (e.g., at approximately 6-month intervals). Special attention should be paid to patients who develop elevated serum transaminase levels, and in these patients, measurements should be repeated promptly and then performed more frequently. If the transaminase levels show evidence of progression, particularly if they rise to 3 times ULN and are persistent, or if they are associated with symptoms of nausea, fever, and/or malaise, the drug should be discontinued.

### Laboratory Abnormalities
- Increase in Blood Glucose: Niacin treatment can increase fasting blood glucose. Frequent monitoring of blood glucose should be performed to ascertain that the drug is producing no adverse effects. Diabetic patients may experience a dose-related increase in glucose intolerance. Diabetic or potentially diabetic patients should be observed closely during treatment with niacin extended-release tablets, particularly during the first few months of use or dose adjustment; adjustment of diet and/or hypoglycemic therapy may be necessary.
- Reduction in platelet count: Niacin extended-release tablet has been associated with small but statistically significant dose-related reductions in platelet count (mean of -11% with 2000 mg). Caution should be observed when niacin extended-release tablet is administered concomitantly with anticoagulants; platelet counts should be monitored closely in such patients.
- Increase in Prothrombin Time (PT): Niacin extended-release tablet has been associated with small but statistically significant increases in prothrombin time (mean of approximately +4%); accordingly, patients undergoing surgery should be carefully evaluated. Caution should be observed when niacin extended-release tablet is administered concomitantly with anticoagulants; prothrombin time should be monitored closely in such patients.
- Increase in Uric Acid: Elevated uric acid levels have occurred with niacin therapy, therefore use with caution in patients predisposed to gout.
- Decrease in Phosphorus: In placebo-controlled trials, niacin extended-release tablet has been associated with small but statistically significant, dose-related reductions in phosphorus levels (mean of -13% with 2000 mg). Although these reductions were transient, phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia.

# Adverse Reactions

## Clinical Trials Experience
- In the placebo-controlled clinical trials database of 402 patients (age range 21 to 75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks. 16% of patients on niacin extended-release tablets and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with niacin extended-release tablets that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs. 0%), rash (2% vs. 0%), diarrhea (2% vs. 0%), nausea (1% vs. 0%), and vomiting (1% vs. 0%). The most commonly reported adverse reactions (incidence >5% and greater than placebo) in the niacin extended-release tablets controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus.
- In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for niacin extended-release tablets. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, 6% (14/245) of niacin extended-release tablets patients discontinued due to flushing. In comparisons of immediate-release (IR) niacin and niacin extended-release tablets, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received niacin extended-release tablets. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4-week period averaged 8.6 events per patient for IR niacin versus 1.9 following niacin extended-release tablets.
Other adverse reactions occurring in 5% of patients treated with niacin extended-release tablets and at an incidence greater than placebo are shown in Table 2 below.
Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH)
- In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40 to 80 mg/dL, and were randomized to receive niacin extended-release tablets 1500 to 2000 mg/day (n=1718) or matching placebo (IR Niacin, 100 to 150 mg, n=1696). The incidence of the adverse reactions of "blood glucose increased" (6.4% vs. 4.5%) and "diabetes mellitus" (3.6% vs. 2.2%) was significantly higher in the simvastatin plus niacin extended-release tablets group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus niacin extended-release tablets group and one (<0.1%) in the simvastatin plus placebo group.

## Postmarketing Experience
Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval use of niacin extended-release tablets:
- Anaphylaxis
- Angioedema
- Urticaria
- Flushing
- Dyspnea
- Tongue edema
- Larynx edema
- Face edema
- Peripheral edema
- Laryngismus
- Vesiculobullous rash
- Maculopapular rash
- Dry skin
- Tachycardia
- Palpitations
- Atrial fibrillation
- Arrhythmias
- Syncope
- Hypotension
- Postural hypotension
- Blurred vision
- Macular edema
- Peptic ulcers
- Eructation
- Flatulence
- Hepatitis
- Jaundice
- Decreased glucose tolerance
- Gout
- Myalgia
- Myopathy
- Dizziness
- Insomnia
- Asthenia
- Nervousness
- Paresthesia
- Migraine
- Chemistry: Elevations in serum transaminases, LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus.
- Hematology: Slight reductions in platelet counts and prolongation in prothrombin time.

# Drug Interactions

### Statins
- Caution should be used when prescribing niacin ( 1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis. Combination therapy with niacin extended-release tablets and lovastatin or niacin extended-release tablets and simvastatin should not exceed doses of 2000 mg niacin extended-release tablets and 40 mg lovastatin or simvastatin daily.

### Bile Acid Sequestrants
- An in vitro study results suggest that the bile acid-binding resins have high niacin binding capacity. Therefore, 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of niacin extended-release tablets.

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

### Antihypertensive Therapy
- Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

### Other
- Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of niacin extended-release tablets.

### Laboratory Test Interactions
- Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niacin may also give false-positive reactions with cupric sulfate solution (Benedict's reagent) in urine glucose tests.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Animal reproduction studies have not been conducted with niacin or with niacin extended-release tablets. It is also not known whether niacin 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 niacin for primary hyperlipidemia becomes pregnant, the drug should be discontinued. If a woman being treated with niacin for hypertriglyceridemia conceives, the benefits and risks of continued therapy should be assessed on an individual basis.
- All statins are contraindicated in pregnant and nursing women. When niacin extended-release tablet is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and product labeling for the statin.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Niacin (extended-release tablet) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Niacin (extended-release tablet) during labor and delivery.

### Nursing Mothers
- Niacin is excreted into human milk but the actual infant dose or infant dose as a percent of the maternal dose is not known. 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. No studies have been conducted with niacin extended-release tablets in nursing mothers.

### Pediatric Use
- Safety and effectiveness of niacin therapy in pediatric patients (16 years) have not been established.

### Geriatic Use
- Of 979 patients in clinical studies of niacin extended-release tablets, 21% of the patients were age 65 and over. No overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

### Gender
- Data from the clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of niacin extended-release tablets.

### Race
There is no FDA guidance on the use of Niacin (extended-release tablet) with respect to specific racial populations.

### Renal Impairment
- No studies have been performed in this population. Niacin extended-release tablets should be used with caution in patients with renal impairment.

### Hepatic Impairment
- No studies have been performed in this population. Niacin extended-release tablets should be used with caution in patients with a past history of liver disease and/or who consume substantial quantities of alcohol. Active liver disease, unexplained transaminase elevations and significant or unexplained hepatic dysfunction are contraindications to the use of niacin extended-release tablets

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Niacin (extended-release tablet) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Niacin (extended-release tablet) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral.

### Monitoring
There is limited information regarding Niacin (extended-release tablet) Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Niacin (extended-release tablet) and IV administrations.

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

# Pharmacology

## 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.

## Structure
- Niacin extended-release tablets USP (film-coated), contain 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:

## Pharmacodynamics
- Niacin functions in the body after conversion to nicotinamide adenine dinucleotide (NAD) in the NAD coenzyme system. Niacin (but not nicotinamide) in gram doses reduces total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), and triglycerides (TG), and increases high-density lipoprotein cholesterol (HDL-C). The magnitude of individual lipid and lipoprotein responses may be influenced by the severity and type of underlying lipid abnormality. The increase in HDL-C is associated with an increase in apolipoprotein A-I (Apo A-I]]) and a shift in the distribution of HDL subfractions. These shifts include an increase in the HDL2:HDL3 ratio, and an elevation in lipoprotein A-I (Lp A-I, an HDL-C particle containing only Apo A-I). Niacin treatment also decreases serum levels of apolipoprotein B-100 (Apo B), the major protein component of the very low-density lipoprotein (VLDL) and LDL fractions, and of Lp(a), a variant form of LDL independently associated with coronary risk. In addition, preliminary reports suggest that niacin causes favorable LDL particle size transformations, although the clinical relevance of this effect requires further investigation. The effect of niacin-induced changes in lipids/proteins on cardiovascular morbidity or mortality in individuals without preexisting coronary disease has not been established.
- A variety of clinical studies have demonstrated that elevated levels of TC, LDL-C, and Apo B promote human atherosclerosis. Similarly, decreased levels of HDL-C are associated with the development of atherosclerosis. Epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the level of Total-C and LDL-C, and inversely with the level of HDL-C.
- Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate-density lipoprotein (IDL), and their remnants, can also promote atherosclerosis. Elevated plasma TG are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD). As such, total plasma TG has not consistently been shown to be an independent risk factor for CHD. Furthermore, the independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

## Pharmacokinetics

### Absorption
- Due to extensive and saturable first-pass metabolism, niacin concentrations in the general circulation are dose dependent and highly variable. Time to reach the maximum niacin plasma concentrations was about 5 hours following niacin extended-release tablets. To reduce the risk of gastrointestinal (GI) upset, administration of niacin extended-release tablets with a low-fat meal or snack is recommended.
- Single-dose bioavailability studies have demonstrated that the 500 mg and 1000 mg tablet strengths are dosage form equivalent but the 500 mg and the 750 mg tablet strengths are not dosage form equivalent.

### Metabolism
- The pharmacokinetic profile of niacin is complicated due to extensive first-pass metabolism that is dose-rate specific and, at the doses used to treat dyslipidemia, saturable. In humans, one pathway is through a simple conjugation step with glycine to form nicotinuric acid (NUA). NUA is then excreted in the urine, although there may be a small amount of reversible metabolism back to niacin. The other pathway results in the formation of nicotinamide adenine dinucleotide (NAD). It is unclear whether nicotinamide is formed as a precursor to, or following the synthesis of, NAD. Nicotinamide is further metabolized to at least N-methylnicotinamide (MNA) and nicotinamide-N-oxide (NNO). MNA is further metabolized to two other compounds, N-methyl-2-pyridone-5-carboxamide (2PY) and N-methyl-4-pyridone-5-carboxamide (4PY). The formation of 2PY appears to predominate over 4PY in humans. At the doses used to treat hyperlipidemia, these metabolic pathways are saturable, which explains the nonlinear relationship between niacin dose and plasma concentrations following multiple-dose niacin extended-release tablets administration.
- Nicotinamide does not have hypolipidemic activity; the activity of the other metabolites is unknown.

### Elimination
- Following single and multiple doses, approximately 60 to 76% of the niacin dose administered as niacin extended-release tablet was recovered in urine as niacin and metabolites; up to 12% was recovered as unchanged niacin after multiple dosing. The ratio of metabolites recovered in the urine was dependent on the dose administered.

## Nonclinical Toxicology
There is limited information regarding Niacin (extended-release tablet) Nonclinical Toxicology in the drug label.

# Clinical Studies

## Niacin Clinical Studies
- The role of LDL-C in atherogenesis is supported by pathological observations, clinical studies, and many animal experiments. Observational epidemiological studies have clearly established that high total cholesterol or LDL-C and low HDL-C are risk factors for CHD. Additionally, elevated levels of Lp(a) have been shown to be independently associated with CHD risk.
- Niacin's ability to reduce mortality and the risk of definite, nonfatal myocardial infarction (MI) has been assessed in long-term studies. The Coronary Drug Project, completed in 1975, was designed to assess the safety and efficacy of niacin and other lipid-altering drugs in men 30 to 64 years old with a history of MI. Over an observation period of 5 years, niacin treatment was associated with a statistically significant reduction in nonfatal, recurrent MI. 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). Total mortality was similar in the two groups at 5 years (24.4% with nicotinic acid versus 25.4% with placebo; p =N.S.). At the time of a 15-year follow-up, there were 11% (69) fewer deaths in the niacin group compared to the placebo cohort (52.0% versus 58.2%; p =0.0004). However, mortality at 15 years was not an original endpoint of the Coronary Drug Project. In addition, patients had not received niacin for approximately 9 years, and confounding variables such as concomitant medication use and medical or surgical treatments were not controlled.
- The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a randomized, placebo-controlled, angiographic trial testing combined colestipol and niacin therapy in 162 non-smoking males with previous coronary bypass surgery. The primary, per-subject cardiac endpoint was global coronary artery change score. After 2 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); disease regression also occurred more frequently in the drug-treated group (16.2% versus 2.4%; p =0.002). In a follow-up to this trial in a subgroup of 103 patients treated for 4 years, again, significantly fewer patients in the drug-treated group demonstrated progression than in the placebo cohort (48% versus 85%, respectively; p <0.0001).
- The Familial Atherosclerosis Treatment Study (FATS) in 146 men ages 62 and younger with Apo 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 arteriography. Patients were given dietary counseling and randomized to treatment with either conventional therapy with double placebo (or placebo plus colestipol if the LDL-C was elevated); lovastatin plus colestipol; or niacin 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; regression was the only change in 11%. In contrast, progression (as the only change) was seen in only 25% in the niacin plus colestipol group, while regression was observed in 39%. Though not an original endpoint of the trial, clinical events (death, MI, or revascularization for worsening angina) occurred in 10 of 52 patients who received conventional therapy, compared with 2 of 48 who received niacin plus colestipol.
- The Harvard Atherosclerosis Reversibility Project (HARP) was a randomized placebo-controlled, 2.5-year study of the effect of a stepped-care antihyperlipidemic drug regimen on 91 patients (80 men and 11 women) with CHD and average baseline TC levels less than 250 mg/dL and ratios of TC to HDL-C greater than 4.0. Drug treatment consisted of an HMG-CoA reductase inhibitor administered alone as initial therapy followed by addition of varying dosages of either a slow-release nicotinic acid, cholestyramine, or gemfibrozil. Addition of nicotinic acid to the HMG-CoA reductase inhibitor resulted in further statistically significant mean reductions in TC, LDL-C, and TG, as well as a further increase in HDL-C in a majority of patients (40 of 44 patients). The ratios of TC to HDL-C and LDL-C to HDL-C were also significantly reduced by this combination drug regimen.

## Niacin Extended-release Tablets Clinical Studies
Placebo-Controlled Clinical Studies in Patients with Primary Hyperlipidemia and Mixed Dyslipidemia
- In two randomized, double-blind, parallel, multi-center, placebo-controlled trials, niacin extended-release tablets dosed at 1000, 1500 or 2000 mg daily at bedtime with a low-fat snack for 16 weeks (including 4 weeks of dose escalation) favorably altered lipid profiles compared to placebo (Table 3). Women appeared to have a greater response than men at each niacin extended-release tablet dose level (see Gender Effect, below).
- In a double-blind, multi-center, forced dose-escalation study, monthly 500 mg increases in niacin extended-release tablet dose resulted in incremental reductions of approximately 5% in LDL-C and Apo B levels in the daily dose range of 500 mg through 2000 mg (TABLE 4). Women again tended to have a greater response to niacin extended-release tablets than men.
Pooled results for major lipids from these three placebo-controlled studies are shown below (Table 5).222

### Gender Effect
- Combined data from the three placebo-controlled niacin extended-release tablets studies in patients with primary hyperlipidemia and mixed dyslipidemia suggest that, at each niacin extended-release tablets dose level studied, changes in lipid concentrations are greater for women than for men.

### Other Patient Populations
- In a double-blind, multi-center, 19-week study the lipid-altering effects of niacin extended-release tablet (forced titration to 2000 mg at bedtime) were compared to baseline in patients whose primary lipid abnormality was a low level of HDL-C (HDL-C 40 mg/dL, TG 400 mg/dL, and LDL-C 160, or <130 mg/dL in the presence of CHD). Results are shown below
- At niacin extended-release tablets 2000 mg/day, median changes from baseline (25th, 75th percentiles) for LDL-C, HDL-C, and TG were -3% (-14, +12%), +27% (+13, +38%), and -33% (-50, -19%), respectively.

## Niacin Extended-release Tablets and Lovastatin Clinical Studies
- In a multi-center, randomized, double-blind, parallel, 28-week study, a combination tablet of niacin extended-release tablets and lovastatin was compared to each individual component in patients with Type IIa and IIb hyperlipidemia. Using a forced dose-escalation study design, patients received each dose for at least 4 weeks. Patients randomized to treatment with the combination tablet of niacin extended-release tablets and lovastatin initially received 500 mg/20 mg (expressed as mg of niacin/mg of lovastatin) once daily before bedtime. The dose was increased by 500 mg at 4-week intervals (based on the niacin extended-release tablets component) to a maximum dose of 1000 mg/20 mg in one-half of the patients and 2000 mg/40 mg in the other half. The niacin extended-release tablets monotherapy group underwent a similar titration from 500 mg to 2000 mg. The patients randomized to lovastatin monotherapy received 20 mg for 12 weeks titrated to 40 mg for up to 16 weeks. Up to a third of the patients randomized to the combination tablet of niacin extended-release tablets and lovastatin or niacin extended-release tablets monotherapy discontinued prior to Week 28. Results from this study showed that combination therapy decreased LDL-C, TG and Lp(a), and increased HDL-C in a dose-dependent fashion (Tables 8, 9, 10, and 11). Results from this study for LDL-C mean percent change from baseline (the primary efficacy variable) showed that:
- LDL-lowering with the combination tablet of niacin extended-release tablets and lovastatin was significantly greater than that achieved with lovastatin 40 mg only after 28 weeks of titration to a dose of 2000 mg/40 mg (p <0.
- The combination tablet of niacin extended-release tablets and lovastatin at doses of 1000 mg/20 mg or higher achieved greater LDL-lowering than niacin extended-release tablets (p<0.0001).
- Combination therapy achieved significantly greater HDL-raising compared to lovastatin and niacin extended-release tablets monotherapy at all doses.
- In addition, combination therapy achieved significantly greater TG-lowering at doses of 1000 mg/ 20 mg or greater compared to lovastatin and niacin extended-release tablets monotherapy
- The Lp(a)-lowering effects of combination therapy and niacin extended-release tablets monotherapy were similar, and both were superior to lovastatin. The independent effect of lowering Lp(a) with niacin extended-release tablets or combination therapy on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

## Niacin Extended-release Tablets and Simvastatin Clinical Studies
- In a double-blind, randomized, multicenter, multi-national, active-controlled, 24-week study, the lipid effects of a combination tablet of niacin extended-release tablets and simvastatin were compared to simvastatin 20 mg and 80 mg in 641 patients with type II hyperlipidemia or mixed dyslipidemia. Following a lipid qualification phase, patients were eligible to enter one of two treatment groups. In Group A, patients on simvastatin 20 mg monotherapy, with elevated non-HDL levels and LDL-C levels at goal per the NCEP guidelines, were randomized to one of three treatment arms: combination tablet of niacin extended-release tablets and simvastatin 1000/20 mg, combination tablet of niacin extended-release tablets and simvastatin 2000/20 mg, or simvastatin 20 mg. In Group B, patients on simvastatin 40 mg monotherapy, with elevated non-HDL levels per the NCEP guidelines regardless of attainment of LDL-C goals, were randomized to one of three treatment arms: combination tablet of niacin extended-release tablets and simvastatin 1000/40 mg, combination tablet of niacin extended-release tablets and simvastatin 2000/40 mg, or simvastatin 80 mg. Therapy was initiated at the 500 mg dose of combination tablet of niacin extended-release tablets and simvastatin and increased by 500 mg every four weeks. Thus patients were titrated to the 1000 mg dose of combination tablet of niacin extended-release tablets and simvastatin after four weeks and to the 2000 mg dose of combination tablet of niacin extended-release tablets and simvastatin after 12 weeks. All patients randomized to simvastatin monotherapy received 50 mg immediate-release niacin daily in an attempt to keep the study from becoming unblinded due to flushing in the combination tablet of niacin extended-release tablets and simvastatin groups. Patients were instructed to take one 325 mg aspirin or 200 mg ibuprofen 30 minutes prior to taking the double-blind medication to help minimize flushing effects.
- In Group A, the primary efficacy analysis was a comparison of the mean percent change in non-HDL levels between the combination tablet of niacin extended-release tablets and simvastatin 2000/20 mg and simvastatin 20 mg groups, and if statistically significant then a comparison was conducted between the combination tablet of niacin extended-release tablets and simvastatin 1000/20 mg and simvastatin 20 mg groups. In Group B, the primary efficacy analysis was a determination of whether the mean percent change in non-HDL in the combination tablet of niacin extended-release tablets and simvastatin 2000/40 mg group was non-inferior to the mean percent change in the simvastatin 80 mg group, and if so, whether the mean percent change in non-HDL in the combination tablet of niacin extended-release tablets and simvastatin 1000/40 mg group was non-inferior to the mean percent change in the simvastatin 80 mg group.
- In Group A, the non-HDL-C lowering with combination tablet of niacin extended-release tablets and simvastatin 2000/20 and combination tablet of niacin extended-release tablets and simvastatin 1000/20 was statistically significantly greater than that achieved with simvastatin 20 mg after 24 weeks (p<0.05; Table 12). The completion rate after 24 weeks was 72% for the combination tablet of niacin extended-release tablets and simvastatin arms and 88% for the simvastatin 20 mg arm. In Group B, the non-HDL-C lowering with combination tablet of niacin extended-release tablets and simvastatin 2000/40 and combination tablet of niacin extended-release tablets and simvastatin 1000/40 was non-inferior to that achieved with simvastatin 80 mg after 24 weeks (Table 13). The completion rate after 24 weeks was 78% for the combination tablet of niacin extended-release tablets and simvastatin arms and 80% for the simvastatin 80 mg arm.
- The combination tablet of niacin extended-release tablets and simvastatin was not superior to simvastatin in lowering LDL-C in either Group A or Group B. However, the combination tablet of niacin extended-release tablets and simvastatin was superior to simvastatin in both groups in lowering TG and raising HDL.

# How Supplied
Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below:
- 500 mg tablets: bottles of 100 - NDC# 68180-221-01
- 500 mg tablets: bottles of 1000 - NDC# 68180-221-03
Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below:
- 750 mg tablets: bottles of 100 - NDC# 68180-222-01
- 750 mg tablets: bottles of 500 - NDC# 68180-222-02
Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below:
- 1000 mg tablets: bottles of 100 - NDC# 68180-223-01
- 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03

## Storage
- Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
Read this information carefully before you start taking niacin extended-release tablets 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 is niacin extended-release tablet?
- Niacin extended-release tablet 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.
- Niacin extended-release tablets can be used by itself or with other cholesterol-lowering medicines.
- Niacin extended-release tablet 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 tablets, 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 tablets with another cholesterol-lowering medicine (simvastatin) has not been shown to reduce heart attacks or strokes more than taking simvastatin alone.
It is not known if niacin extended-release tablet is safe and effective in children 16 years of age and under.
Who should not take niacin extended-release tablets?
Do not take niacin extended-release tablets if you have:
- liver problems
- a stomach ulcer
- bleeding problems
- an allergy to niacin or any of the ingredients in niacin extended-release tablets. See the end of this leaflet for a complete list of ingredients in niacin extended-release tablets.
What should I tell my doctor before taking niacin extended-release tablets?
Before you take niacin extended-release tablets, tell your doctor, if you:
- have diabetes. Tell your doctor if your blood sugar levels change after you take niacin extended-release :*tablets.
- have gout
- have kidney problems
- are pregnant or plan to become pregnant. It is not known if niacin extended-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant while taking niacin extended-release tablets.
- are breastfeeding or plan to breastfeed. Niacin can pass into your breast milk. You and your doctor should decide if you will take niacin extended-release tablets 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 tablets.
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 tablets and other medicines may affect each other causing side effects. Niacin extended-release tablets may affect the way other medicines work, and other medicines may affect how niacin extended-release tablets 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 tablets?
- Take niacin extended-release tablets exactly as your doctor tells you to take it.
- Take niacin extended-release tablets whole. Do not break, crush or chew niacin extended-release tablets before swallowing.
- Take niacin extended-release tablets 1 time a day at bedtime after a low-fat snack. Niacin extended-release tablets should not be taken on an empty stomach.
- All forms of niacin are not the same as niacin extended-release tablets. 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 tablets unless your doctor tells you to.
- If you need to stop taking niacin extended-release tablets, call your doctor before you start taking niacin extended-release tablets again. Your doctor may need to lower your dose of niacin extended-release tablets.
- If you forget to take a dose of niacin extended-release tablets, take it as soon as you remember.
- If you take too much niacin extended-release tablets, 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 tablets. You should take niacin extended-release tablets 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 tablets 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 tablets?
Niacin extended-release tablets 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 tablets include:
- flushing
- diarrhea
- nausea
- vomiting
- increased cough
- rash
Flushing is the most common side effect of niacin extended-release tablets. 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 tablets. Flushing may last for a few hours. Flushing is more likely to happen when you first start taking niacin extended-release tablets or when your dose of niacin extended-release tablets 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 tablets.
- Take niacin extended-release tablets 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 tablets. 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 tablets. 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 tablets?
Store niacin extended-release tablets at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) .
Keep niacin extended-release tablets and all medicines out of the reach of children.
General information about the safe and effective use of niacin extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use niacin extended-release tablets for a condition for which it was not prescribed. Do not give niacin extended-release tablets 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 tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about niacin extended-release tablets that is written for health professionals.
For more information, call our toll-free number, 1-800-399-2561, visit our website at www.lupinpharmaceuticals.com.
What are the ingredients in niacin extended-release tablets?
Active ingredient:
niacin
Inactive Ingredients:
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, povidone, polyethylene glycol, stearic acid, and the following coloring agents: iron oxide red, iron oxide yellow, FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol and titanium dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.

# Precautions with Alcohol
- Alcohol-Niacin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- NIACIN
- Niaspan
- Slo-Niacin
- Niacor
- Niacinol
- Nicotinex

# Look-Alike Drug Names
There is limited information regarding Niacin (extended-release tablet) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price