Niacor, also called Niacor, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacor is also present in many multiple vitamins and nutritional supplements.
Niacor is used to treat and prevent a lack of natural Niacor in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacor is sometimes used to treat coronary artery disease (also called atherosclerosis).
Niacor may also be used for purposes not listed in this medication guide.
Niacor indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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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. Niacor, USP 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.
Niacor Extended-Release Tablets USP are 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, Niacor, USP is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
3.
In patients with a history of coronary artery disease (CAD) and hyperlipidemia, Niacor, USP, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
4.
Niacor Extended-Release Tablets USP in combination with a bile acid binding resin are indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
5.
Niacor, USP 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 Niacor Extended-Release Tablets USP did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH).
How should I use Niacor?
Use Niacor as directed by your doctor. Check the label on the medicine for exact dosing instructions.
To minimize flushing and upset stomach, take Niacor at bedtime after a low-fat snack (eg, low-fat yogurt, banana, crackers with a glass of milk) unless your doctor directs otherwise. Do not take Niacor with alcohol, a hot drink, or spicy foods.
Do not take bile acid sequestrants (eg, colestipol, cholestyramine) within 4 to 6 hours of taking Niacor.
If you miss a dose of Niacor, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Niacor.
Uses of Niacor in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Dietary supplement: Use as a dietary supplement.
Dyslipidemias: Treatment of dyslipidemias (Fredrickson types IIa and IIb or primary hypercholesterolemia) as mono- or adjunctive therapy; to lower the risk of recurrent MI in patients with a history of MI and hyperlipidemia; to slow progression or promote regression of coronary artery disease; adjunctive therapy for severe hypertriglyceridemia in adults at risk of pancreatitis
Note: Niacor is no longer considered a primary or secondary agent for dyslipidemias. Although Niacor consistently affects surrogate markers, especially LDL-C, it has not been shown to reduce cardiovascular disease outcomes beyond that achieved with statin use and may be associated with harm (ACC [Lloyd-Jones 2017]; Garg 2017; Wierzbicki 2014). In two large clinical trials, the addition of Niacor to patients receiving simvastatin did not reduce cardiovascular morbidity or mortality (Boden 2011; Landray 2014). May consider use in patients with very high triglyceride levels (>500 mg/dL) or in dyslipidemia for patients who do not achieve the desired response or have intolerance to a statin or other alternative therapy (Boden 2014; Flink 2015).
Off Label Uses
Pellagra
Data from a limited number of patients studied (case reports) suggest that Niacor may be beneficial for the treatment of pellagra.
Niacor description
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A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has pellagra-curative, vasodilating, and antilipemic properties. [PubChem]
Niacor dosage
Niacor Extended-Release Tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with Niacor 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.
Table 1. Recommended Dosing
Week(s)
Daily Dose
Niacor Extended-Release Tablets Dosage
INITIAL
TITRATION
1 to 4
500 mg
1 Niacor Extended-Release 500 mg Tablet at bedtime
SCHEDULE
5 to 8
1000 mg
1 Niacor Extended-Release 1000 mg Tablet or
2 Niacor Extended-Release 500 mg Tablets at bedtime
*
1500 mg
2 Niacor Extended-Release 750 mg Tablets or
3 Niacor Extended-Release 500 mg Tablets at bedtime
*
2000 mg
2 Niacor Extended-Release 1000 mg Tablets or
4 Niacor Extended-Release 500 mg Tablets 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 Niacor 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 Niacor Extended-Release Tablet 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.
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 Niacor Extended-Release Tablet 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 Niacor 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 Niacor Extended-Release Tablet ingestion.
Equivalent doses of Niacor Extended-Release Tablets should not be substituted for sustained-release (modified-release, timed-release) Niacor preparations or immediate-release (crystalline) Niacor. Patients previously receiving other Niacor products should be started with the recommended Niacor Extended-Release Tablet titration schedule, and the dose should subsequently be individualized based on patient response.
If Niacor Extended-Release Tablet therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.
Niacor 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 Niacor Extended-Release Tablets in patients with renal or hepatic impairment has not been studied. Niacor Extended-Release Tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Niacor Extended-Release Tablets should be used with caution in patients with renal impairment.
Caution should be used when prescribing Niacor ( ≥ 1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis.
Bile Acid Sequestrants
An in vitro study results suggest that the bile acid-binding resins have high Niacor 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 Niacor.
Aspirin
Concomitant aspirin may decrease the metabolic clearance of Niacor. The clinical relevance of this finding is unclear.
Antihypertensive Therapy
Niacor 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 Niacor or related compounds such as nicotinamide may potentiate the adverse effects of Niacor.
Laboratory Test Interactions
Niacor may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niacor may also give false-positive reactions with cupric sulfate solution (Benedict's reagent) in urine glucose tests.
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.
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 Niacor and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Niacor 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 Niacor 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 Niacor. 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 Niacor patients discontinued due to flushing. In comparisons of immediate-release (IR) Niacor and Niacor, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Niacor. 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 Niacor versus 1.9 following Niacor.
Other adverse reactions occurring in ≥ 5% of patients treated with Niacor 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
Niacor 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
13
7
10
10
14
Nausea
7
5
6
4
11
Vomiting
4
0
2
4
9
Respiratory
Cough, Increased
6
3
2
< 2
8
Skin and Subcutaneous Tissue Disorders
Pruritus
2
8
0
3
0
Rash
0
5
5
5
0
Vascular Disorders
Flushing*
19
68
69
63
55
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 Niacor, n = 245 and median treatment duration = 16 weeks. Number of Niacor patients (n) are not additive across doses.
‡ The 500 mg/day dose is outside the recommended daily maintenance dosing range.
& 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 Niacor 1500-2000 mg/day (n=1718) or matching placebo (IR Niacor, 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 Niacor group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus Niacor 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 Niacor:
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.
DailyMed. "NIACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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