NIACIN tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)
Available from:
Golden State Medical Supply, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. 1. Niacin extended-release tablets is indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. 2. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. 3. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. 4. Niacin extended-release tablets in combination with a bile acid
Product summary:
Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows: Bottles of 90 NDC 51407-267-90 Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows: Bottles of 90 NDC 51407-268-90 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
51407-267-90, 51407-268-90

NIACIN- niacin tablet, extended release

Golden State Medical Supply, Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

niacin extended-release tablets

These highlights do not include all the information needed to use niacin extended-release tablets safely and

effectively. See full prescribing information for niacin extended-release tablets.

NIACIN extended-release tablets USP, film coated, for oral use.

Initial U.S. Approval: 1997

RECENT MAJOR CHANGES

Indications and Usage, Combination With a Statin - removal ( 1) 4/2015

Dosage and Administration, Combination With a Statin – removal ( 2) 4/2015

INDICATIONS AND USAGE

Niacin extended-release tablets contains extended-release niacin (nicotinic acid), and is indicated:

To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and

mixed dyslipidemia. ( 1)

To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and

hyperlipidemia. ( 1)

In combination with a bile acid binding resin:

Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery

disease (CAD) and hyperlipidemia. ( 1)

As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. ( 1)

To reduce TG in adult patients with severe hypertriglyceridemia. ( 1)

Limitations of use:

Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated

with simvastatin in a large, randomized controlled trail. ( 5.1)

DOSAGE AND ADMINISTRATION

Niacin extended-release tablets should be taken at bedtime with a low-fat snack. ( 2)

Dose range: 500 mg to 2000 mg once daily. ( 2)

Therapy with niacin extended-release tablets 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 and should not be increased by more than 500 mg in

any four week period. (2)

Maintenance dose: 1000 to 2000 mg once daily. ( 2)

Doses greater than 2000 mg daily are not recommended. ( 2)

DOSAGE FORMS AND STRENGTHS

Unscored film-coated tablets for oral administration: 500 and 1000 mg niacin extended-release. ( 3)

CONTRAINDICATIONS

Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. ( 4, 5.3)

Active peptic ulcer disease. ( 4)

Arterial bleeding. ( 4)

Known hypersensitivity to product components. ( 4, 6.1)

WARNINGS AND PRECAUTIONS

Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at

equivalent doses. ( 5.3)

Myopathy has been reported in patients taking niacin extended-release tablets. The risk for myopathy and

rhabdomyolysis are increased among elderly patients; patients with diabetes, renal failure, or uncontrolled

hypothyroidism; and patients being treated with a statin. ( 5.2)

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur. Monitor liver

enzymes before and during treatment. ( 5.3)

Use with caution in patients with unstable angina or in the acute phase of MI. ( 5)

Niacin extended-release tablets can increase serum glucose levels. Glucose levels should be closely monitored in

diabetic or potentially diabetic patients particularly during the first few months of use or dose adjustment. (

5.4)

ADVERSE REACTIONS

Most common adverse reactions (incidence >5% and greater than placebo) are flushing, diarrhea, nausea, vomiting,

increased cough, and pruritus. ( 6.1)

Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose

of 325 mg taken 30 minutes prior to niacin extended-release tablets dose). ( 2)

To report SUSPECTED ADVERSE REACTIONS, contact Lannet Company, Inc. at (1-844-834-0530) or FDA at

1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Statins: Caution should be used when prescribing niacin with statins as these agents can increase risk of

myopathy/rhabdomyolysis. ( 5.2, 7.1)

Bile Acid Sequestrants: Bile acid sequestrants have a high niacin-binding capacity and should be taken at least 4 to 6

hours before niacin extended-release tablets administration. ( 7.2)

USE IN SPECIFIC POPULATIONS

Renal impairment: Niacin extended-release tablets should be used with caution in patients with renal impairment. ( 5,

8.6)

Hepatic impairment: Niacin extended-release tablets is contraindicated in active liver disease or significant or

unexplained hepatic dysfunction or unexplained elevations of serum transaminases. ( 4, 5, 5.3, 8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Mortality and Coronary Heart Disease Morbidity

5.2 Skeletal Muscle

5.3 Liver Dysfunction

5.4 Laboratory Abnormalities

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Statins

7.2 Bile Acid Sequestrants

7.3 Aspirin

7.4 Antihypertensive Therapy

7.5 Other

7.6 Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Gender

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility

14 CLINICAL STUDIES

14.1 Niacin Clinical Studies

14.2 Niacin Extended-release Tablets Clinical Studies

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Patient Counseling

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in

individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia.

Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and

cholesterol and other nonpharmacologic measures alone has been inadequate.

1. Niacin extended-release tablets is indicated to reduce elevated TC, LDL-C, Apo B and TG levels,

and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.

2. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the

risk of recurrent nonfatal myocardial infarction.

3. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination

with a bile acid binding resin, is indicated to slow progression or promote regression of

atherosclerotic disease.

4. Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce

elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.

5. Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe

hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a

determined dietary effort to control them.

Limitations of Use

Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among

patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and

Precautions( 5.1)].

2 DOSAGE AND ADMINISTRATION

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

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.

Sections or subsections omitted from the full prescribing information are not listed.

Table 1. Recommended Dosing

Week(s )

Daily Dose

Niacin Extended-release Tablets

Dos age

INITIAL

TITRATION

SCHEDULE

1 to 4

500 mg

1 niacin extended-release tablet 500 mg

at bedtime

5 to 8

1000 mg

1 niacin extended-release tablet 1000 mg

2 niacin extended-release tablets 500 mg

at bedtime

1500 mg

3 niacin extended-release tablets 500 mg

at bedtime

2000 mg

2 niacin extended-release tablets 1000

mg or

4 niacin extended-release tablets 500 mg

at bedtime

* After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate,

increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should

not be increased more than 500 mg in a 4-week period and doses above 2000 mg daily are not

recommended. Women may respond at lower doses than men.

Maintenance Dose

The daily dosage of niacin extended-release tablets 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

doses than men [see Clinical Studies (14.2)].

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.

Flushing of the skin [see Adverse Reactions (6.1)] may be reduced in frequency or severity by

pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to niacin

extended-release tablets dose). Tolerance to this flushing 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 ingestion.

Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release

(modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see

Warnings and Precautions (5)]. Patients previously receiving other niacin products should be started

with the recommended niacin extended-release tablets titration schedule (see Table 1), and the dose

should subsequently be individualized based on patient response.

If niacin extended-release tablets therapy is discontinued for an extended period, reinstitution of therapy

should include a titration phase (see Table 1).

Niacin extended-release tablets should be taken whole and should not be broken, crushed or chewed

before swallowing.

Dosage in Patients with Renal or Hepatic Impairment

Use of niacin extended-release tablets in patients with renal or hepatic impairment has not been studied.

Niacin extended-release tablets is contraindicated in patients with significant or unexplained hepatic

dysfunction. Niacin extended-release tablets should be used with caution in patients with renal

impairment [see Warnings and Precautions (5)].

3 DOSAGE FORMS AND STRENGTHS

500 mg unscored, red, round, film-coated, convex tablet debossed with “KU” on one side, “320” on

the other side.

1000 mg unscored, red, oval, film-coated, convex tablet debossed with “KU” on one side, “322” on

the other side.

4 CONTRAINDICATIONS

Niacin extended-release tablets is contraindicated in the following conditions:

Active liver disease or unexplained persistent elevations in hepatic transaminases [see Warnings and

Precautions( 5.3)]

Patients with active peptic ulcer disease

Patients with arterial bleeding

Hypersensitivity to niacin or any component of this medication [see Adverse Reactions (6.1)]

5 WARNINGS AND PRECAUTIONS

Niacin extended-release tablets 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 [see Dosage and Administration (2)].

Caution should also be used when niacin extended-release tablets 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

tablets is contraindicated in patients with significant or unexplained hepatic impairment [see

Contraindications (4) and Warnings and Precautions (5.3)] 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.

5.1 Mortality and Coronary Heart Disease Morbidity

Niacin extended-release tablets has not been shown to reduce cardiovascular morbidity or mortality

among patients already treated with a statin.

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 163-177

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 40-80 mg/dL, and were randomized to receive niacin extended-release

tablets 1500-2000 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 [95% CI, 0.87-1.21], 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, [95%CI = 0.95-3.36], 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 [see Adverse Reactions (6.1)].

5.2 Skeletal Muscle

Cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses

(≤ 1 g/day) of niacin and statins. Elderly patients and patients with diabetes, renal failure, or uncontrolled

hypothyroidism are particularly at risk. 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. 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.

5.3 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.

Liver-related 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.

5.4 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 tablets 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 tablets is administered concomitantly with

anticoagulants; platelet counts should be monitored closely in such patients.

Increase in Prothrombin Time (PT): Niacin extended-release tablets 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 tablets 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 tablets 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.

6 ADVERSE REACTIONS

Because clinical studies are conducted under widely varying conditions, adverse reaction rates

observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of

another drug and may not reflect the rates observed in practice.

6.1 Clinical Studies Experience

In the placebo-controlled clinical trials database of 402 patients (age range 21-75 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.

Table 2. Treatment-Emergent Adverse Reactions by Dose Level in ≥ 5% of Patients and at an

Incidence Greater than Placebo; Regardless of Causality Assessment in Placebo-Controlled

Clinical Trials

Placebo-Controlled Studies

Niacin Extended-release Tablets Treatment

Recommended Daily Maintenance Doses

Placebo

(n=157)

500 mg

(n=87)

1000 mg

(n=110)

1500 mg

(n=136)

2000 mg

(n=95)

Gastrointestinal Disorders

Diarrhea

Nausea

Vomiting

Respiratory

Cough, Increased

< 2

Skin and Subcutaneous

Tissue Disorders

Pruritus

Rash

Vascular Disorders

Flushing

Note: Percentages are calculated from the total number of patients in each column.

Adverse reactions are reported at the initial dose where they occur.

Pooled results from placebo-controlled studies; for niacin extended-release tablets, n = 245 and

median

treatment duration = 16 weeks. Number of niacin extended-release tablets patients (n) are not additive

across doses.

The 500 mg/day dose is outside the recommended daily maintenance dosing range [see Dosage and

Administration (2)].

10 patients discontinued before receiving 500 mg, therefore they were not included.

In general, the incidence of adverse events was higher in women compared to men.

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

40-80 mg/dL, and were randomized to receive niacin extended-release tablets 1500-2000 mg/day

(n=1718) or matching placebo (IR Niacin, 100-150 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 [see Warnings and Precautions( 5.1)].

6.2 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:

Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue

edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash;

maculopapular rash; dry skin; tachycardia; palpitations; atrial fibrillation; other cardiac 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; dyspnea; sweating; burning sensation/skin burning

sensation; skin discoloration, and migraine.

Clinical Laboratory Abnormalities

Chemistry: Elevations in serum transaminases [see Warnings and Precautions (5.3)], 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 [see Warnings and

Precautions (5.4)].

7 DRUG INTERACTIONS

7.1 Statins

Caution should be used when prescribing niacin (≥1 gm/day) with statins as these drugs can increase

risk of myopathy/rhabdomyolysis. [see Warnings and Precautions (5) and Clinical Pharmacology (12.3)].

7.2 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 [see Clinical Pharmacology

(12.3)].

7.3 Aspirin

Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of

this finding is unclear.

7.4 Antihypertensive Therapy

Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in

postural hypotension.

7.5 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.

7.6 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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category 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.

8.3 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.

8.4 Pediatric Use

Safety and effectiveness of niacin therapy in pediatric patients (≤ 16 years) have not been established.

8.5 Geriatric 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.

8.6 Renal Impairment

No studies have been performed in this population. Niacin extended-release tablets should be used with

caution in patients with renal impairment [see Warnings and Precautions (5)].

8.7 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

[seeContraindications (4) and Warnings and Precautions (5.3)] .

8.8 Gender

Data from the clinical trials suggest that women have a greater hypolipidemic response than men at

equivalent doses of niacin extended-release tablets.

10 OVERDOSAGE

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

11 DESCRIPTION

Niacin Extended-release Tablets, USP (niacin tablet, film-coated extended-release), contains 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:

Niacin extended-release tablets is an unscored, red, film-coated tablet for oral administration and are

available in two tablet strengths containing 500 and 1000 mg niacin. Niacin extended-release tablets

also contain the inactive ingredients black iron oxide, colloidal silicon dioxide, hydroxypropyl

cellulose, lecithin, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium stearyl fumarate,

talc, titanium dioxide, and yellow iron oxide.

USP Dissolution Test 5.

12 CLINICAL PHARMACOLOGY

12.1 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.

12.3 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 750 mg tablets 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 tablets 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.

Pediatric Use

No pharmacokinetic studies have been performed in this population (≤ 16 years) [see Use in Specific

Populations (8.4)].

Geriatric Use

No pharmacokinetic studies have been performed in this population (> 65 years) [see Use in Specific

Populations (8.5)].

Renal Impairment

No pharmacokinetic studies have been performed in this population. Niacin extended-release tablets

should be used with caution in patients with renal disease [see Warnings and Precautions (5)].

Hepatic Impairment

No pharmacokinetic studies have been performed in this population. Active liver disease, unexplained

transaminase elevations and significant or unexplained hepatic dysfunction are contraindications to the

use of niacin extended-release tablets [see Contraindications (4) and Warnings and Precautions (5.3)].

Gender

Steady-state plasma concentrations of niacin and metabolites after administration of niacin extended-

release tablets are generally higher in women than in men, with the magnitude of the difference varying

with dose and metabolite. This gender differences observed in plasma levels of niacin and its

metabolites may be due to gender-specific differences in metabolic rate or volume of distribution.

Recovery of niacin and metabolites in urine, however, is generally similar for men and women,

indicating that absorption is similar for both genders [see Gender (8.8)].

Drug interactions

Fluvastatin

Niacin did not affect fluvastatin pharmacokinetics [see Drug Interactions (7.1)].

Lovastatin

When niacin extended-release tablets 2000 mg and lovastatin 40 mg were co-administered, niacin

extended-release tablets increased lovastatin C

and AUC by 2% and 14%, respectively, and

decreased lovastatin acid C

and AUC by 22% and 2%, respectively. Lovastatin reduced niacin

extended-release tablets bioavailability by 2-3% [see Drug Interactions (7.1)].

Simvastatin

When niacin extended-release tablets 2000 mg and simvastatin 40 mg were co-administered, niacin

extended-release tablets increased simvastatin C

and AUC by 1% and 9%, respectively, and

simvastatin acid C

and AUC by 2% and 18%, respectively. Simvastatin reduced niacin extended-

release tablets bioavailability by 2% [see Drug Interactions (7.1)].

Bile Acid Sequestrants

An in vitro study was carried out investigating the niacin-binding capacity of colestipol and

cholestyramine. About 98% of available niacin was bound to colestipol, with 10 to 30% binding to

cholestyramine [see Drug Interactions (7.2)].

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility

Niacin administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The

mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined on

an mg/m

basis. Niacin was negative for mutagenicity in the Ames test. No studies on impairment of

fertility have been performed. No studies have been conducted with niacin extended-release tablets

regarding carcinogenesis, mutagenesis, or impairment of fertility.

14 CLINICAL STUDIES

14.1 Niacin Clinical Studies

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.

14.2 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

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 tablets dose level (see

Gender Effect, below).

Table 3. Lipid Response to Niacin Extended-release Tablets Therapy

Mean Percent Change from Baseline to Week

16

Treatment

n

TC

LDL-C

HDL-C

TG

Apo B

Niacin extended-release tablets 1000 mg at

bedtime

Niacin extended-release tablets 2000 mg at

bedtime

41 -10

Placebo

Niacin extended-release tablets 1500 mg at

bedtime

Placebo

n = number of patients at baseline;

* Mean percent change from baseline for all niacin extended-release tablets doses were significantly

different ( p < 0.05) from placebo.

In a double-blind, multi-center, forced dose-escalation study, monthly 500 mg increases in niacin

extended-release tablets 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 (see Gender Effect, below).

Table 4. Lipid Response in Dose-Escalation Study

Mean Percent Change from Baseline

Treatment

n

TC

LDL-C

HDL-C

TG

Apo B

Placebo

Niacin extended-release tablets

500 mg at bedtime

1000 mg at bedtime

1500 mg at bedtime

2000 mg at bedtime

n = number of patients enrolled;

‡ Placebo data shown are after 24 weeks of placebo treatment.

* For all niacin extended-release tablets doses except 500 mg, mean percent change from baseline was

significantly different ( p < 0.05) from placebo for all lipid parameters shown.

Pooled results for major lipids from these three placebo-controlled studies are shown below (Table 5).

Table 5. Selected Lipid Response to Niacin Extended-release Tablets in Placebo-Controlled

Clinical Studies*

Mean Baseline and Median Percent Change from Baseline

(25

, 75

Percentiles)

Niacin Extended-release Tablets Dose

n

LDL-C

HDL-C

TG

1000 mg at bedtime

Baseline (mg/dL)

*

*

th

th

Percent Change

-7 (-15, 0)

+14 (+7, +23)

-16 (-34, +3)

1500 mg at bedtime

Baseline (mg/dL)

Percent Change

-13 (-21, -4)

+19 (+9, +31)

-25 (-45, -2)

2000 mg at bedtime

Baseline (mg/dL)

Percent Change

-16 (-26, -7)

+22 (+15, +34)

-38 (-52, -14)

* Represents pooled analyses of results; minimum duration on therapy at each dose was 4 weeks.

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

(Table 6).

Table 6. Effect of Gender on Niacin Extended-release Tablets Dose Response

Mean Percent Change from Baseline

Niacin Extended-release Tablets

n

LDL-C

HDL-C

TG

Apo B

Dose

(M/F)

500 mg at bedtime

50/37

1000 mg at bedtime

76/52 -6

+14 +20 -10 -20 -5

1500 mg at bedtime

104/59 -12

+19 +24 -17 -28 -13

2000 mg at bedtime

75/53

+23 +26 -30 -36 -16

n = number of male/female patients enrolled.

* Percent change significantly different between genders ( p < 0.05).

Other Patient Populations: In a double-blind, multi-center, 19-week study the lipid-altering effects of

niacin extended-release tablets (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 (Table 7).

Table 7. Lipid Response to Niacin Extended-release Tablets in Patients with Low HDL-C

Mean Baseline and Mean Percent Change from Baseline

n

TC

LDL-C

HDL-C

TG

Apo B

Baseline (mg/dL)

Week 19 (% Change)

n = number of patients

* Mean percent change from baseline was significantly different ( p < 0.05) for all lipid parameters

shown except LDL-C.

n = 72 at baseline and 69 at week 19.

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets

debossed with “KU” on one side, “320” on the other side. They are supplied as follows:

*

Bottles of 90 NDC 51407-267-90

Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets

debossed with “KU” on one side, “322” on the other side. They are supplied as follows:

Bottles of 90 NDC 51407-268-90

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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 tablets.

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.

Flus hing

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 tablets 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.

Use of Aspirin Medication

Taking aspirin (up to the recommended dose of 325 mg) approximately 30 minutes before dosing can

minimize flushing.

Diet

Avoid ingestion of alcohol, hot beverages and spicy foods around the time of taking niacin extended-

release tablets to minimize flushing.

Supplements

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

nicotinamide.

Dizzines s

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

tablets if they are trying to conceive. Patients should be advised that if they become pregnant, they

should stop taking niacin extended-release tablets and call their healthcare professional.

Breas tfeeding

Women who are breastfeeding should be advised to not use niacin extended-release tablets. Patients,

who have a lipid disorder and are breastfeeding, should be advised to discuss the options with their

healthcare professional.

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

CIA78142C

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

Rev.10/2019

PATIENT INFORMATION

Niacin (ny-a-sin) Extended-release Tablets, USP

CIA78143C Rev.

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 tablets?

Niacin extended-release tablets 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 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) does not reduce heart attacks or

strokes more than taking simvastatin alone.

It is not known if niacin extended-release tablets 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 extended-release tablets can pass into your breast

milk. You and your doctor should decide if you will take niacin extended-release tablets or

breastfeed. 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

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:

Ask your doctor if you can take aspirin to help lower the flushing side effect from niacin extended-

release tablets. You can take aspirin (up to the recommended dose of 325 mg) about 30 minutes

before you take niacin extended-release tablets to help lower the flushing side effect.

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 at 20° to 25° C (68º to 77ºF) [see USP Controlled Room Temperature].

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 Lannett Company, Inc. at 1-844-834-0530.

What are the ingredients in niacin extended-release tablets?

Active Ingredient: niacin

Inactive Ingredients: black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, lecithin,

polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium stearyl fumarate, talc, titanium dioxide,

and yellow iron oxide

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

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

CIA78143C

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

Rev. 10/2019

500 mg Bottle Label

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

NDC 51407-267-90

Niacin

Extended-release

Tablets, USP

500 mg

PHARMACIST: Dispense accompanying

Patient Information Leaflet to each patient.

Rx Only

90 Tablets

1000 mg Bottle Label

PRINCIPAL DISPLAY PANEL - 1,000 mg Tablet Bottle Label

NDC 51407-268-90

Niacin

Extended-release

Tablets, USP

1,000 mg

PHARMACIST: Dispense accompanying

Patient Information Leaflet to each patient.

Rx Only

90 Tablets

NIACIN

niacin tablet, extended release

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:5140 7-26 7(NDC:6 2175-320 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NIACIN (UNII: 26 79 MF6 8 7A) (NIACIN - UNII:26 79 MF6 8 7A)

NIACIN

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYDRO XYPRO PYL CELLULO SE ( 7 0 0 0 0 WAMW) (UNII: 6 6 O7AQV0 RT)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

PO LYETHYLENE GLYCO L 10 0 0 (UNII: U0 76 Q6 Q6 21)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

re d

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

KU;320

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5140 7-26 7-9 0

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 5/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 38 9 9

0 6 /16 /20 17

NIACIN

niacin tablet, extended release

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:5140 7-26 8 (NDC:6 2175-322)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NIACIN (UNII: 26 79 MF6 8 7A) (NIACIN - UNII:26 79 MF6 8 7A)

NIACIN

10 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYDRO XYPRO PYL CELLULO SE ( 7 0 0 0 0 WAMW) (UNII: 6 6 O7AQV0 RT)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

PO LYETHYLENE GLYCO L 10 0 0 (UNII: U0 76 Q6 Q6 21)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Golden State Medical Supply, Inc.

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

re d

S core

no sco re

S hap e

SEMI-CIRCLE

S iz e

19 mm

Flavor

Imprint Code

KU;322

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5140 7-26 8 -9 0

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 5/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 38 9 9

0 6 /16 /20 17

Labeler -

Golden State Medical Supply, Inc. (603184490)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Go lden State Medical Supply, Inc.

6 0 318 449 0

relabel(5140 7-26 7, 5140 7-26 8 ) , repack(5140 7-26 7, 5140 7-26 8 )

Revised: 12/2019

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