Niacin

DEA Class; Rx

Common Brand Names; vitamin B3, Niacor, Niaspan, nicotinic acid

  • B Vitamins; 
  • Lipid-Lowering Agents, Other; 
  • Vitamins, Water-Soluble

B-complex vitamin available in two chemical forms
Only nicotinic acid is used for hyperlipoproteinemia or peripheral vascular disease; both nicotinic acid and nicotinamide (niacinamide) are used for nutritional supplementation or pellagra
Contraindicated for use in patients with severe hepatic impairment

Indicated for the treatment of clinical manifestations of pellagra.

For nutritional supplementation to meet the recommended dietary allowance (RDA).
For the treatment of hypertriglyceridemia, primary hypercholesterolemia or mixed hyperlipoproteinemia to reduce total-C, LDL-C, Apo B, and triglycerides and to increase HDL-C, and primary hypercholesterolemia in combination with a bile acid binding resin to reduce total-C and LDL-C, as an adjunct to diet.
To slow progression or promote regression of atherosclerosis.
To reduce the risk of recurrent nonfatal myocardial infarction (myocardial infarction prophylaxis) in patients with a history of myocardial infarction and hyperlipidemia.

Hypersensitivity

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

Persistent, unexplained elevation of serum aminotransferase

  • 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
  • Burning sensation of skin, maculopapular rash, dry skin, sweating, skin discoloration, acanthosis nigricans
  • Depression
  • Dermatomyositis
  • Peripheral nerve palsy
  • Progression of cataracts

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

Discontinue therapy when pregnancy is recognized in patients receiving drug for treatment of hyperlipidemia

Drug is present in human milk and amount of drug increases with maternal supplementation

Maximum dosages listed are for the treatment of hyperlipidemia.

Adults

6 g/day PO for immediate-release products; 2 g/day PO for Niaspan.

Geriatric

6 g/day PO for immediate-release products; 2 g/day PO for Niaspan.

Adolescents

Up to 3 g/day PO for immediate release products; doses more than 1.5 g/day PO may not be tolerated. Safe and effective use of Niaspan has not been established.

Children

Up to 3 g/day PO for immediate release products; doses more than 1.5 g/day PO may not be tolerated. Safe and effective use of Niaspan has not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Niacin

tablet

  • 50mg
  • 100mg
  • 250mg
  • 500mg

tablet, extended-release

  • 250mg
  • 500mg
  • 750mg
  • 1000mg

capsule extended-release

  • 250mg
  • 500mg

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