Dosage Forms & Strengths

Nutritional Supplementation

Recommended daily allowance (RDA)

Males: ≥19 years: 16 mg/day

Females: ≥19 years: 14 mg/day

Pregnant women: 18 mg/day

Breastfeeding: 17 mg/day

Dietary supplement (OTC)

50 mg PO q12hr or 100 mg PO qDay; many formulations exist

Hyperlipidemia

Immediate-release: 250 mg PO once daily; dose or frequency adjusted every 4-7 days on basis of effect and tolerance to first-level therapeutic dose of 1.5-2 g PO divided q6-8hr, then adjusted every 2-4 weeks; not to exceed 6 g/day

Extended-release: 500 mg/day PO at bedtime initially; dose adjusted every 4 weeks on basis of effect and tolerance to therapeutic dose of 1-2 g once daily; not to exceed 1-2 g/day

Indications

  • Reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia
  • Indicated to reduce the risk of recurrent nonfatal myocardial infarction in patients with history of MI and hyperlipidemia
  • Indicated in combination with a bile acid binding resin to slow progression or promote regression of atherosclerotic disease in patients with history of CAD and hyperlipidemia, and also to reduce elevated TC and LDL-C levels in adults with primary hyperlipidemia
  • 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
  • Extended release niacin did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large rantomized trial

Dosing Considerations

Limitations of use: Extended-release niacin did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large rantomized trial

Nonsteroidal anti-inflammatory drug (NSAID) will decrease flushing when administered 30-60 minutes before dosing

Monitor liver function tests (LFTs)

Indication for use with statins withdrawn by FDA

  • April 15, 2016: Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events"
  • Consistent with this conclusion, the FDA has determined that the benefits of niacin ER tablets for coadministration with statins no longer outweigh the risks, and the approval for this indication should be withdrawn

Overdose management

  • Symptoms of acute overdose include flushing, GI distress, and pruritus
  • Chronic overdose has been associated with hepatitis
  • Treatment is symptomatic

Pellagra (Off-label)

50-100 mg PO q6-8hr; not to exceed 500 mg/day

Contraindicated (0)

Serious - Use Alternative (8)

  • atorvastatin
  • fluvastatin
  • ivacaftor
  • lovastatin
  • pitavastatin
  • pravastatin
  • rosuvastatin
  • simvastatin

Significant - Monitor Closely (10)

  • cholestyramine
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • insulin degludec
  • insulin degludec/insulin aspart
  • insulin inhaled
  • mipomersen
  • roxithromycin

Minor (20)

  • carbamazepine
  • cefamandole
  • cefpirome
  • colestipol
  • demeclocycline
  • doxycycline
  • flucloxacillin
  • isoniazid
  • lymecycline
  • mecamylamine
  • minocycline
  • netilmicin
  • nicotine inhaled
  • nicotine intranasal
  • oxytetracycline
  • pivmecillinam
  • sulfisoxazole
  • teicoplanin
  • temocillin
  • tetracycline

Adverse Effects

Frequency Not Defined

Reversible increase in serum aminotransferase

Flushing (lower incidence with extended-release products)

Pruritus, rash

Diarrhea

Headache

Arrhythmias

Hepatic necrosis, hepatotoxicity (higher incidence with extended-release products)

Postural hypotension

Rhabdomyolysis

Abdominal pain

Dyspepsia

Nausea

Vomiting

Postmarketing Reports

Burning sensation of skin

Depression

Dermatomyositis

Peripheral nerve palsy

Progression of cataracts

Warnings

Contraindications

Hypersensitivity

Hepatic disease, active peptic ulcer, severe hypotension, arterial bleeding

Persistent, unexplained elevation of serum aminotransferase

Cautions

Flushing or pruritus may occur

Hepatotoxicity reported

Use with caution in patients with history of liver disease, gout or gouty diathesis, diabetes mellitus, gallbladder disease, cardiovascular disease, or renal or hepatic impairment

Use with caution if patients are taking anticoagulants or HMG-CoA reductase inhibitors or if symptoms of myopathy occur (monitor creatine phosphokinase)

Immediate release and extended release dosage forms are not interchangeable

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Pregnancy & Lactation

Pregnancy category: A; C (for doses exceeding RDA)

Lactation: Unknown if excreted in milk (consider risk vs benefit)

Pregnancy Categories