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niacin (Rx, OTC)Brand and Other Names:vitamin B3, Niacor, more...Niaspan, nicotinic acid

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

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

tablet, extended-release

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

capsule extended-release

  • 250mg
  • 500mg
more...

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Indication for use with statins withdrawn by FDA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

Dosage Forms & Strengths

tablet

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

tablet, extended-release

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

capsule extended-release

  • 250mg
  • 500mg
more...

Nutritional Supplementation

RDA

0-6 months: 2 mg/day

6-12 months: 3 mg/day

1-4 years: 6 mg/day

4-9 years: 8 mg/day

9-14 years: 12 mg/day

14-18 years: 16 mg/day (boys); 14 mg/day (girls)

Pellagra (Off-label)

50-100 mg PO q8hr

Monitor LFTs

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Interactions

Interaction Checker

niacin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Component of two coenzymes necessary for lipid metabolism, tissue respiration, glycogenolysis, inhibition of very low-density lipoprotein (VLDL) synthesis

            May increaase chylomicron triglyceride removal from plasma

            Absorption

            Rapidly absorbed (60-76%)

            Peak plasma time: Immediate release, 30-60 min; extended release, 4-5 hr

            Metabolism

            Metabolized in liver

            Pharmacokinetics

            Half-life: 20-45 min

            Excretion: Urine (60-88% as unchanged drug)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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