Classes
DEA Class; Rx
Common Brand Names; vitamin B3, Niacor, Niaspan, nicotinic acid
- B Vitamins;
- Lipid-Lowering Agents, Other;
- Vitamins, Water-Soluble
Description
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
Indications
Indicated for the treatment of clinical manifestations of pellagra.
Contraindications
Hypersensitivity
Hepatic disease, active peptic ulcer, severe hypotension, arterial bleeding
Persistent, unexplained elevation of serum aminotransferase
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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 Dosage
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
Maximum dosages listed are for the treatment of hyperlipidemia.
6 g/day PO for immediate-release products; 2 g/day PO for Niaspan.
6 g/day PO for immediate-release products; 2 g/day PO for Niaspan.
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Niacin