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Niacin ER

Class
Dietary supplements
Subclass
Vitamins
Substance name
Niacin, nicotinic acid ER
Common formulations
Tablet
See also
Niacin (Niacor®)
Dosage and administration
Adults patients
Treatment
Mixed hyperlipidemia
•
Start at: 500 mg PO qHS for 4 weeks, followed by 1,000 mg PO qHS for another 4 weeks
•
Maintenance: 1,000-2,000 mg PO qHS
•
Maximum: 2,000 mg per day
Taken after a low-fat snack. Titrate by 500 mg at 4-week intervals based on response and tolerance.
Primary hyperlipidemia
•
Start at: 500 mg PO qHS for 4 weeks, followed by 1,000 mg PO qHS for another 4 weeks
•
Maintenance: 1,000-2,000 mg PO qHS
•
Maximum: 2,000 mg per day
Taken after a low-fat snack. Titrate by 500 mg at 4-week intervals based on response and tolerance.
Adjunctive treatment
Adjunctive treatment for coronary artery disease in patients with hyperlipidemia
•
Start at: 500 mg PO qHS for 4 weeks, followed by 1,000 mg PO qHS for another 4 weeks
•
Maintenance: 1,000-2,000 mg PO qHS
•
Maximum: 2,000 mg per day
Taken after a low-fat snack. Titrate by 500 mg at 4-week intervals based on response and tolerance.
Secondary prevention
Secondary prevention of myocardial infarction in patients with hyperlipidemia
•
Start at: 500 mg PO qHS for 4 weeks, followed by 1,000 mg PO qHS for another 4 weeks
•
Maintenance: 1,000-2,000 mg PO qHS
•
Maximum: 2,000 mg per day
Taken after a low-fat snack. Titrate by 500 mg at 4-week intervals based on response and tolerance.
Indications for use
Labeled indications
Adults
•
Treatment of familial hypertriglyceridemia
•
Treatment of mixed hyperlipidemia
•
Treatment of primary hyperlipidemia
•
Adjunctive treatment for coronary artery disease in patients with hyperlipidemia
•
Secondary prevention of myocardial infarction in patients with hyperlipidemia
Safety risks
Contraindications
Hypersensitivity to niacin or its components
Active peptic ulcer disease
Arterial bleeding
Warnings and precautions
Cardiovascular mortality
•
Maintain a high level of suspicion, as the effect of niacin on cardiovascular morbidity and mortalit has not been established.
Decreased platelet count, prolonged PT
•
Maintain a high level of suspicion, as niacin may cause dose-related increase in PT, particularly with concomitant anticoagulant use, and reduction in platelet count.
Decreased serum phosphate
•
Maintain a high level of suspicion, as niacin may cause a reduction in serum phosphorus levels. Monitor phosphorus levels in patients at risk for hypophosphatemia.
Exacerbation of increased blood glucose
•
Maintain a high level of suspicion, as niacin can increase fasting blood glucose levels. Monitor blood glucose levels.
Exacerbation of skin flushing
•
Maintain a high level of suspicion, as niacin can cause skin flushing. Consider administering pretreatment with aspirin (up to 325 mg taken 30 minutes before the niacin dose). Increase the niacin dose slowly and avoid taking it on an empty stomach or with alcohol, hot drinks, or spicy foods to reduce flushing.
Hepatotoxicity
•
Maintain a high level of suspicion, as niacin has been associated with an increased risk of liver dysfunction, including cases of severe hepatotoxicity and fulminant hepatic necrosis. Monitor LFTs before treatment, every 6-12 weeks during the first year, and approximately every 6 months thereafter. Discontinue use if hepatic transaminase levels persist at ≥3× ULN or are accompanied by symptoms such as nausea, fever, or malaise.
Increased urine uric acid
•
Use caution in patients with a predisposition to gout.
Rhabdomyolysis
•
Maintain a high level of suspicion, as cases of rhabdomyolysis has been reported with the concomitant use of statins, especially in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use with caution.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
Do not use.
Substantial chronic alcohol consumption
•
Use with caution.
Unexplained abnormality in LFTs
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B2
•
Use only if benefits outweigh potential risks. Discontinue niacin ER for hyperlipidemia when the patient becomes pregnant. Assess the benefits and risks of continued drug therapy for hypertriglyceridemia when the patient becomes pregnant.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Diarrhea, skin flushing
Common 1-10%
•
Cough, itching, nausea, skin rash, vomiting
Unknown frequency
•
Abnormal oral glucose tolerance test, tachycardia, palpitations, macular edema, blurred vision, belching, flatulence, jaundice, angioedema, urticaria, dyspnea, tongue swelling, laryngeal edema, facial edema, peripheral edema, vesiculobullous rash, myalgia, dizziness, insomnia, asthenia, nervousness, paresthesia, migraine, skin dryness, maculopapular rash, sweating, skin discoloration, burning sensation, syncope, hypotension, orthostatic hypotension, ↑ serum transaminases, ↑ serum LDH, ↑ blood glucose, ↑ serum uric acid, ↑ serum TBIL, ↑ serum amylase, ↑ serum CK, ↓ serum phosphate, ↓ platelet count, ↑PT, diabetes mellitus, atrial fibrillation, cardiac arrhythmias, peptic ulcer disease, hepatitis, anaphylaxis, gout, myopathy, acanthosis nigricans
Interactions
Drug(s)
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