Niacin
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From MedlinePlus, U.S. National Library of Medicine
Nicotinic Acid
Dosing in kidney impairment
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 are 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] .
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 are 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] .
Dosing in liver 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 [see Contraindications and Warnings and Precautions] .
Drug interactions
Check niacin against a medication listLabel text (7 paragraphs)
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 administration. ( 7.2 )
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.
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.
Supplement interactions
Dietary supplement interactions
1 noted- Some people take vitamin E supplements with other antioxidants, such as vitamin C, selenium, and beta-carotene. This collection of antioxidant ingredients blunted the rise in high-density lipoprotein (HDL) cholesterol levels among people who were treated with a combination of simvastatin (brand name Zocor) and niacin.
Contraindications
Niacin extended-release tablets are 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 )] 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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
A[HD]Likelihood score A[HD]: Well known cause of clinically apparent liver injury when given in high doses.
Niacin, also known as nicotinic acid and vitamin B3, is a water soluble, essential B vitamin that, when given in high doses, is effective in lowering low density lipoprotein (LDL) cholesterol and raising high density lipoprotein (HDL) cholesterol, which makes this agent of unique value in the therapy of dyslipidemia. Niacin can cause mild-to-moderate serum aminotransferase elevations and high doses and certain formulations of niacin have been linked to clinically apparent, acute liver injury which can be severe as well as fatal.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Discontinue niacin extended-release tablets when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Assess the individual risks and benefits of continuing niacin extended-release tablets during pregnancy in patients receiving the drug for the treatment of hypertriglyceridemia. Advise patients to inform their healthcare provider of a known or suspected pregnancy. The potential for embryofetal toxicity with the doses of niacin in niacin extended-release tablets is unknown.
The available data on niacin extended-release tablets use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with niacin or with niacin extended-release tablets. Treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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