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Drug overview for NIACIN (niacin):
Generic name: niacin (NYE-a-sin)
Drug class: Niacin/Niacinamide (Vitamin B-3)
Therapeutic class: Electrolyte Balance-Nutritional Products
Niacin and niacinamide are water-soluble, B complex vitamins.
No enhanced Uses information available for this drug.
Generic name: niacin (NYE-a-sin)
Drug class: Niacin/Niacinamide (Vitamin B-3)
Therapeutic class: Electrolyte Balance-Nutritional Products
Niacin and niacinamide are water-soluble, B complex vitamins.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for NIACIN (niacin) have been approved by the FDA:
Indications:
High density lipoprotein deficiency
Hypercholesterolemia
Hyperlipidemia
Hypertriglyceridemia
Mixed hyperlipidemia
Myocardial reinfarction prevention
Treatment to slow progression of coronary artery disease
Professional Synonyms:
Abnormally increased triglycerides in the blood
Combined hypercholesterolemia and hypertriglyceridemia
Elevated blood cholesterol level
Elevated triglyceride level
HDL cholesterol deficiency
High density lipoid deficiency
High density lipoprotein (HDL) deficiency
Hyperlipoidemia
Hypoalphalipoproteinemia
Increased triglyceride levels
Lipemia
Lipidemia
Lipoidemia
Mixed dyslipidemia
Myocardial reinfarction prophylaxis
Treatment to slow progression of CAD
Indications:
High density lipoprotein deficiency
Hypercholesterolemia
Hyperlipidemia
Hypertriglyceridemia
Mixed hyperlipidemia
Myocardial reinfarction prevention
Treatment to slow progression of coronary artery disease
Professional Synonyms:
Abnormally increased triglycerides in the blood
Combined hypercholesterolemia and hypertriglyceridemia
Elevated blood cholesterol level
Elevated triglyceride level
HDL cholesterol deficiency
High density lipoid deficiency
High density lipoprotein (HDL) deficiency
Hyperlipoidemia
Hypoalphalipoproteinemia
Increased triglyceride levels
Lipemia
Lipidemia
Lipoidemia
Mixed dyslipidemia
Myocardial reinfarction prophylaxis
Treatment to slow progression of CAD
The following dosing information is available for NIACIN (niacin):
No enhanced Dosing information available for this drug.
Niacin and niacinamide are administered orally.
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
NIACIN ER 500 MG CAPLET | Maintenance | Adults take 1 tablet (500 mg) by oral route once daily |
NIACIN TR 250 MG CAPSULE | Maintenance | Adults take 1 capsule (250 mg) by oral route once daily |
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
NIACIN TR 500 MG TABLET | Maintenance | Adults take 1 tablet (500 mg) by oral route once daily |
NIACIN TR 250 MG CAPSULE | Maintenance | Adults take 1 capsule (250 mg) by oral route once daily |
NIACIN SA 250 MG CAPSULE | Maintenance | Adults take 1 capsule (250 mg) by oral route once daily |
NIACIN ER 500 MG TABLET | Maintenance | Adults take 1 tablet (500 mg) by oral route once daily |
NIACIN ER 500 MG CAPLET | Maintenance | Adults take 1 tablet (500 mg) by oral route once daily |
The following drug interaction information is available for NIACIN (niacin):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
Drug Interaction | Drug Names |
---|---|
HMG-CoA Reductase Inhibitors/Niacin (Greater Than or Equal To 250 mg) SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Unknown. CLINICAL EFFECTS: Myopathy and rhabdomyolysis (muscle aches, tenderness, and weakness) have been associated with concomitant administration of HMG-CoA reductase inhibitors and niacin. PREDISPOSING FACTORS: The risk for myopathy or rhabdomyolysis may be greater in patients 65 years and older, inadequately treated hypothyroidism, renal impairment, carnitine deficiency, malignant hyperthermia, or in patients with a history of myopathy or rhabdomyolysis. Patients with a SLCO1B1 polymorphism that leads to decreased function of the hepatic uptake transporter OATP1B1 may have increased statin concentrations and be predisposed to myopathy or rhabdomyolysis. Patients on rosuvastatin with ABCG2 polymorphisms leading to decreased or poor BCRP transporter function may have increased rosuvastatin concentrations and risk of myopathy. PATIENT MANAGEMENT: The benefit of further alterations in lipid levels with combined use of statins and lipid-lowering dosages of niacin (<= 1000 mg/day) should be carefully weighed against the potential risks.(1-10) The US manufacturer of simvastatin states that dosages of niacin should not exceed 1000 mg daily in patients of Chinese descent.(6) DISCUSSION: The risk of myopathy is increased during concurrent use of HMG-CoA reductase inhibitors and niacin.(1-10) Concomitant administration of niacin with the immediate release formulation of fluvastatin had no effect on fluvastatin pharmacokinetics. Myopathy was not observed in a trial of concurrent fluvastatin and niacin in 74 patients. Concurrent fluvastatin and niacin results in additive effects on total cholesterol and LDL cholesterol.(9) In uncontrolled studies, most subjects who developed myopathy while on lovastatin were also taking cyclosporine, gemfibrozil, or niacin.(1) However, a systematic review showed comparable rates of adverse event reports (AERs) including serious adverse events, hepatotoxicity, or rhabdomyolysis for the combination of lovastatin with niacin-extended release (ER) pill relative to either agent alone or to other statins. Therefore, these results did not support a clinically significant adverse drug interaction between niacin-ER and statins.(14) In clinical trials involving small numbers of patients, no myopathy was reported with concurrent pravastatin and niacin.(10) There are case reports of myopathy during concurrent lovastatin and niacin.(2,11,12) Interim HPS2 results showed a higher rate of myopathy in patients of Chinese descent (0.43%) when compared to patients of non-Chinese descent (0.03%) in patients taking simvastatin (40 mg) with cholesterol-lowering doses of niacin.(7) Kosoglou suggests that there is a small pharmacokinetic drug interaction between ER niacin and ezetimibe/simvastatin but is not clinically significant.(15) However, the HPS2-THRIVE showed a significant four-fold excess risk of myopathy with the addition of ER niacin 2g plus laropiprant 40mg daily (ERN/LRPT) to simvastatin 40mg daily (with or without ezetimibe 10mg daily). This additional risk is particularly prevalent among Chinese descent versus European descent.(16) The AIM-HIGH trial randomized 3414 patients to receive niacin extended-release 1500-2000 mg per day or placebo in addition to current therapy of simvastatin 40-80 mg per day and ezetimibe 10 mg per day if needed to achieve a goal LDL of 40-80 mg/dL. Patients were followed for a mean of 3 years. The primary efficacy endpoint of composite of the first event of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization (greater than 23 hours) for an acute coronary syndrome, or symptom-driven coronary or cerebral vascularization, occurred in 16.4% of patients in the niacin group and 16.2% of patients in the placebo group (p=0.80).(17) The HPS2-THRIVE trial randomized 25,673 patients to receive extended-release niacin 2000 mg with laropiprant 40 mg per day or placebo in addition to current therapy of simvastatin 40 mg per day. Patients were followed for a median of 3.9 years. The primary efficacy endpoint of first major vascular event, defined as a major coronary event (nonfatal myocardial infarction or death from coronary causes), stroke of any type, or coronary or noncoronary vascularization, occurred in 13.2% of patients in the niacin-laropiprant group and 13.7% of patients in the placebo group (p=0.29).(18) A post-hoc analysis of the AIM-HIGH trial showed significant lowering of triglycerides (59 mg/dL) in the extended-release niacin (ERN) group compared to the placebo group (20mg/dL). High density lipoprotein levels showed improvement in the ERN group compared to the placebo (11.3mg/dL vs. 4.7 mg/dL, respectively). The incidence of cardiovascular disease events was similar in both groups. However, all-cause mortality was significantly higher in the ERN group (15.4%) versus the control group (9.2%).(19) A meta-analysis investigating the effects of niacin for primary and secondary prevention of cardiovascular events suggests that niacin does not reduce mortality or rates of myocardial infarctions or strokes. Increased side effects are reported with niacin. Benefits from niacin therapy in the prevention of cardiovascular disease events are unlikely.(20) The AIM HIGH trial investigated the effects of ERN added to simvastatin/ezetimibe on glucose and insulin values. ERN increased fasting glucose from baseline to 1 year in patients with normal (7.9 vs 4.3 mg/dL, respectively) and impaired fasting glucose (4.1 vs 1.4 mg/dL, respectively). There was an increased risk of progressing from normal to impaired fasting glucose in the ERN (58.6% cases) versus placebo (41.5% cases).(21) One or more of the drug pairs linked to this monograph have been included in a list of interactions that could be considered for classification as "non-interruptive" in EHR systems. This DDI subset was vetted by an expert panel commissioned by the U.S. Office of the National Coordinator (ONC) for Health Information Technology. |
ALTOPREV, AMLODIPINE-ATORVASTATIN, ATORVALIQ, ATORVASTATIN CALCIUM, CADUET, CRESTOR, EZALLOR SPRINKLE, EZETIMIBE-SIMVASTATIN, FLOLIPID, FLUVASTATIN ER, FLUVASTATIN SODIUM, LESCOL XL, LIPITOR, LIVALO, LOVASTATIN, PITAVASTATIN CALCIUM, PRAVASTATIN SODIUM, ROSUVASTATIN CALCIUM, ROSUVASTATIN-EZETIMIBE, ROSZET, SIMVASTATIN, VYTORIN, ZOCOR, ZYPITAMAG |
There are 0 moderate interactions.
The following contraindication information is available for NIACIN (niacin):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 2 contraindications.
Absolute contraindication.
Contraindication List |
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Arterial hemorrhage |
Disease of liver |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
Severe List |
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Alcohol use disorder |
Peptic ulcer |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
Moderate List |
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30 day risk period post-myocardial infarction |
Diabetes mellitus |
Gout |
Hypophosphatemia |
Hypotension |
Increased risk of bleeding due to coagulation disorder |
The following adverse reaction information is available for NIACIN (niacin):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 16 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
None. | None. |
Rare/Very Rare |
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Abnormal hepatic function tests Anaphylaxis Angioedema Atrial fibrillation Drug-induced hepatitis Dyspnea Edema Jaundice Laryngeal edema Laryngismus Macular retinal edema Myopathy Paresthesia Peptic ulcer Urticaria Vesicular rash |
There are 39 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Cough Diarrhea Dyspepsia Flushing Nausea Pruritus of skin Vomiting |
Cardiac arrhythmia Dizziness Dry skin Exacerbation of peptic ulcer Hyperglycemia Hyperuricemia Hypophosphatemia Myalgia Syncope |
Rare/Very Rare |
---|
Acquired acanthosis nigricans Blurred vision Chills Dyschromia Eructation Facial edema Flatulence General weakness Hyperhidrosis Hypoprothrombinemia Hypotension Insomnia Maculopapular rash Migraine Muscle weakness Nervousness Orthostatic hypotension Palpitations Peripheral edema Skin rash Stinging of skin Tachycardia Thrombocytopenic disorder |
The following precautions are available for NIACIN (niacin):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
None |
Severe Precaution
None |
Management or Monitoring Precaution
Niacin Extended Release | 1 Day – 16 Years | No established safety and efficacy age < 16 years. |
Administration of supplementary doses of niacin during pregnancy has not been associated with any adverse effects to the mother or fetus. However, toxicologic studies have not been performed with large doses of niacin, and large doses of the drug should not be used in women who are or may become pregnant unless the possible benefits outweigh the potential risks to the fetus.
Drug/Drug Class | Severity | Precaution Description | Pregnancy Category Description |
---|---|---|---|
Niacin (> 50 Mg) | 2 | Not rec for lipid lowering tx; assess risk benefit for triglyceride lowering tx | No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information. |
Administration of supplementary doses of niacin during lactation has not been associated with any adverse effects to the mother or fetus.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Drug Name | Excretion Potential | Effect on Infant | Notes |
---|---|---|---|
Niacin | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Potential adv effect on infant with lipid altering dose, mfg does not rec |
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for NIACIN (niacin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NIACIN (niacin)'s list of indications:
High density lipoprotein deficiency | |
E78.6 | Lipoprotein deficiency |
Hypercholesterolemia | |
E78.0 | Pure hypercholesterolemia |
E78.00 | Pure hypercholesterolemia, unspecified |
E78.01 | Familial hypercholesterolemia |
Hyperlipidemia | |
E78.2 | Mixed hyperlipidemia |
E78.4 | Other hyperlipidemia |
E78.49 | Other hyperlipidemia |
E78.5 | Hyperlipidemia, unspecified |
Hypertriglyceridemia | |
E78.1 | Pure hyperglyceridemia |
E78.2 | Mixed hyperlipidemia |
Mixed hyperlipidemia | |
E78.2 | Mixed hyperlipidemia |
Myocardial reinfarction prevention | |
I21 | Acute myocardial infarction |
I21.0 | ST elevation (STEMi) myocardial infarction of anterior wall |
I21.01 | ST elevation (STEMi) myocardial infarction involving left main coronary artery |
I21.02 | ST elevation (STEMi) myocardial infarction involving left anterior descending coronary artery |
I21.09 | ST elevation (STEMi) myocardial infarction involving other coronary artery of anterior wall |
I21.1 | ST elevation (STEMi) myocardial infarction of inferior wall |
I21.11 | ST elevation (STEMi) myocardial infarction involving right coronary artery |
I21.19 | ST elevation (STEMi) myocardial infarction involving other coronary artery of inferior wall |
I21.2 | ST elevation (STEMi) myocardial infarction of other sites |
I21.21 | ST elevation (STEMi) myocardial infarction involving left circumflex coronary artery |
I21.29 | ST elevation (STEMi) myocardial infarction involving other sites |
I21.3 | ST elevation (STEMi) myocardial infarction of unspecified site |
I21.4 | Non-ST elevation (NSTEMi) myocardial infarction |
I21.9 | Acute myocardial infarction, unspecified |
I21.A | Other type of myocardial infarction |
I21.A1 | Myocardial infarction type 2 |
I21.A9 | Other myocardial infarction type |
I21.B | Myocardial infarction with coronary microvascular dysfunction |
I22 | Subsequent ST elevation (STEMi) and non-ST elevation (NSTEMi) myocardial infarction |
I22.0 | Subsequent ST elevation (STEMi) myocardial infarction of anterior wall |
I22.1 | Subsequent ST elevation (STEMi) myocardial infarction of inferior wall |
I22.2 | Subsequent non-ST elevation (NSTEMi) myocardial infarction |
I22.8 | Subsequent ST elevation (STEMi) myocardial infarction of other sites |
I22.9 | Subsequent ST elevation (STEMi) myocardial infarction of unspecified site |
I25.2 | Old myocardial infarction |
I25.85 | Chronic coronary microvascular dysfunction |
Treatment to slow progression of coronary artery disease | |
I25 | Chronic ischemic heart disease |
I25.1 | Atherosclerotic heart disease of native coronary artery |
I25.10 | Atherosclerotic heart disease of native coronary artery without angina pectoris |
I25.11 | Atherosclerotic heart disease of native coronary artery with angina pectoris |
I25.110 | Atherosclerotic heart disease of native coronary artery with unstable angina pectoris |
I25.111 | Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm |
I25.112 | Atherosclerotic heart disease of native coronary artery with refractory angina pectoris |
I25.118 | Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris |
I25.119 | Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris |
I25.7 | Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris |
I25.70 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris |
I25.700 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris |
I25.701 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm |
I25.702 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with refractory angina pectoris |
I25.708 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris |
I25.709 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris |
I25.71 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris |
I25.710 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina pectoris |
I25.711 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm |
I25.712 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with refractory angina pectoris |
I25.718 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris |
I25.719 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris |
I25.72 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris |
I25.720 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with unstable angina pectoris |
I25.721 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm |
I25.722 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with refractory angina pectoris |
I25.728 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris |
I25.729 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina pectoris |
I25.73 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris |
I25.730 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unstable angina pectoris |
I25.731 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm |
I25.732 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with refractory angina pectoris |
I25.738 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris |
I25.739 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris |
I25.75 | Atherosclerosis of native coronary artery of transplanted heart with angina pectoris |
I25.750 | Atherosclerosis of native coronary artery of transplanted heart with unstable angina |
I25.751 | Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm |
I25.752 | Atherosclerosis of native coronary artery of transplanted heart with refractory angina pectoris |
I25.758 | Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris |
I25.759 | Atherosclerosis of native coronary artery of transplanted heart with unspecified angina pectoris |
I25.76 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris |
I25.760 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with unstable angina |
I25.761 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm |
I25.762 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with refractory angina pectoris |
I25.768 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina pectoris |
I25.769 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina pectoris |
I25.79 | Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris |
I25.790 | Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris |
I25.791 | Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with documented spasm |
I25.792 | Atherosclerosis of other coronary artery bypass graft(s) with refractory angina pectoris |
I25.798 | Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina pectoris |
I25.799 | Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris |
I25.8 | Other forms of chronic ischemic heart disease |
I25.81 | Atherosclerosis of other coronary vessels without angina pectoris |
I25.810 | Atherosclerosis of coronary artery bypass graft(s) without angina pectoris |
I25.811 | Atherosclerosis of native coronary artery of transplanted heart without angina pectoris |
I25.812 | Atherosclerosis of bypass graft of coronary artery of transplanted heart without angina pectoris |
I25.82 | Chronic total occlusion of coronary artery |
I25.83 | Coronary atherosclerosis due to lipid rich plaque |
I25.84 | Coronary atherosclerosis due to calcified coronary lesion |
I25.85 | Chronic coronary microvascular dysfunction |
I25.89 | Other forms of chronic ischemic heart disease |
I25.9 | Chronic ischemic heart disease, unspecified |
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