Niaspan ER Uses

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What is Niaspan ER?

Niaspan ER, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niaspan ER is also present in many multiple vitamins and nutritional supplements.

Niaspan ER is used to treat and prevent a lack of natural Niaspan ER in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niaspan ER is sometimes used to treat coronary artery disease (also called atherosclerosis).

Niaspan ER may also be used for purposes not listed in this medication guide.

Niaspan ER indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niaspan ER, USP therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

1.
Niaspan ER Extended-Release Tablets USP are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
2.
In patients with a history of myocardial infarction and hyperlipidemia, Niaspan ER, USP is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
3.
In patients with a history of coronary artery disease (CAD) and hyperlipidemia, Niaspan ER, USP, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
4.
Niaspan ER Extended-Release Tablets USP in combination with a bile acid binding resin are indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
5.
Niaspan ER, USP is also 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.

Limitations of Use

Addition of Niaspan ER Extended-Release Tablets USP did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH).

How should I use Niaspan ER?

Use Niaspan ER as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Niaspan ER.

Uses of Niaspan ER in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Dietary supplement: Use as a dietary supplement.

Dyslipidemias: Treatment of dyslipidemias (Fredrickson types IIa and IIb or primary hypercholesterolemia) as mono- or adjunctive therapy; to lower the risk of recurrent MI in patients with a history of MI and hyperlipidemia; to slow progression or promote regression of coronary artery disease; adjunctive therapy for severe hypertriglyceridemia in adults at risk of pancreatitis

Note: Niaspan ER is no longer considered a primary or secondary agent for dyslipidemias. Although Niaspan ER consistently affects surrogate markers, especially LDL-C, it has not been shown to reduce cardiovascular disease outcomes beyond that achieved with statin use and may be associated with harm (ACC [Lloyd-Jones 2017]; Garg 2017; Wierzbicki 2014). In two large clinical trials, the addition of Niaspan ER to patients receiving simvastatin did not reduce cardiovascular morbidity or mortality (Boden 2011; Landray 2014). May consider use in patients with very high triglyceride levels (>500 mg/dL) or in dyslipidemia for patients who do not achieve the desired response or have intolerance to a statin or other alternative therapy (Boden 2014; Flink 2015).

Off Label Uses

Pellagra

Data from a limited number of patients studied (case reports) suggest that Niaspan ER may be beneficial for the treatment of pellagra.

Niaspan ER description

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A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has pellagra-curative, vasodilating, and antilipemic properties. [PubChem]

Niaspan ER dosage

Niaspan ER Extended-Release Tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with Niaspan ER Extended-Release Tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in Table 1 below.

Table 1. Recommended Dosing

Week(s)

Daily Dose

Niaspan ER Extended-Release Tablets Dosage

INITIAL

TITRATION

1 to 4

500 mg

1 Niaspan ER Extended-Release 500 mg Tablet at bedtime

SCHEDULE

5 to 8

1000 mg

1 Niaspan ER Extended-Release 1000 mg Tablet or

2 Niaspan ER Extended-Release 500 mg Tablets at bedtime

*

1500 mg

2 Niaspan ER Extended-Release 750 mg Tablets or

3 Niaspan ER Extended-Release 500 mg Tablets at bedtime

*

2000 mg

2 Niaspan ER Extended-Release 1000 mg Tablets or

4 Niaspan ER Extended-Release 500 mg Tablets at bedtime

* After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men.

Maintenance Dose

The daily dosage of Niaspan ER Extended-Release Tablets should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower Niaspan ER Extended-Release Tablet doses than men.

Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.

Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to Niaspan ER Extended-Release Tablet dose). Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of Niaspan ER and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of Niaspan ER Extended-Release Tablet ingestion.

Equivalent doses of Niaspan ER Extended-Release Tablets should not be substituted for sustained-release (modified-release, timed-release) Niaspan ER preparations or immediate-release (crystalline) Niaspan ER. Patients previously receiving other Niaspan ER products should be started with the recommended Niaspan ER Extended-Release Tablet titration schedule, and the dose should subsequently be individualized based on patient response.

If Niaspan ER Extended-Release Tablet therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.

Niaspan ER Extended-Release Tablets should be taken whole and should not be broken, crushed or chewed before swallowing.

Dosage in Patients with Renal or Hepatic Impairment

Use of Niaspan ER Extended-Release Tablets in patients with renal or hepatic impairment has not been studied. Niaspan ER Extended-Release Tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Niaspan ER Extended-Release Tablets should be used with caution in patients with renal impairment.

Niaspan ER interactions

See also:
What other drugs will affect Niaspan ER?

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Statins

Caution should be used when prescribing Niaspan ER ( ≥ 1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis.

Bile Acid Sequestrants

An in vitro study results suggest that the bile acid-binding resins have high Niaspan ER binding capacity. Therefore, 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of Niaspan ER.

Aspirin

Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear.

Antihypertensive Therapy

Niaspan ER may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

Other

Vitamins or other nutritional supplements containing large doses of Niaspan ER or related compounds such as nicotinamide may potentiate the adverse effects of Niaspan ER.

Laboratory Test Interactions

Niaspan ER may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niaspan ER may also give false-positive reactions with cupric sulfate solution (Benedict's reagent) in urine glucose tests.

Niaspan ER side effects

See also:
What are the possible side effects of Niaspan ER?

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

In the placebo-controlled clinical trials database of 402 patients (age range 21-75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% of patients on Niaspan ER and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Niaspan ER that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs. 0%), rash (2% vs. 0%), diarrhea (2% vs. 0%), nausea (1% vs. 0%), and vomiting (1% vs. 0%). The most commonly reported adverse reactions (incidence > 5% and greater than placebo) in the Niaspan ER controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus.

In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for Niaspan ER. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, 6% (14/245) of Niaspan ER patients discontinued due to flushing. In comparisons of immediate-release (IR) Niaspan ER and Niaspan ER, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Niaspan ER. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4-week period averaged 8.6 events per patient for IR Niaspan ER versus 1.9 following Niaspan ER.

Other adverse reactions occurring in ≥ 5% of patients treated with Niaspan ER and at an incidence greater than placebo are shown in Table 2 below.

Table 2: Treatment-Emergent Adverse Reactions by Dose Level in ≥ 5% of Patients and at an Incidence Greater than Placebo; Regardless of Causality Assessment in Placebo- Controlled Clinical Trials

Placebo-Controlled Studies

Niaspan ER Treatment@

Recommended Daily Maintenance Doses †
Placebo

(n = 157) %

500 mg‡

(n = 87) %

1000 mg

(n = 110) %

1500 mg

(n = 136) %

2000 mg

(n = 95) %

Gastrointestinal Disorders
Diarrhea 13 7 10 10 14
Nausea 7 5 6 4 11
Vomiting 4 0 2 4 9
Respiratory
Cough, Increased 6 3 2 < 2 8
Skin and Subcutaneous Tissue Disorders
Pruritus 2 8 0 3 0
Rash 0 5 5 5 0
Vascular Disorders
Flushing* 19 68 69 63 55
Note: Percentages are calculated from the total number of patients in each column.

† Adverse reactions are reported at the initial dose where they occur.

@ Pooled results from placebo-controlled studies; for Niaspan ER, n = 245 and median treatment duration = 16 weeks. Number of Niaspan ER patients (n) are not additive across doses.

‡ The 500 mg/day dose is outside the recommended daily maintenance dosing range.

& 10 patients discontinued before receiving 500 mg, therefore they were not included.

In general, the incidence of adverse events was higher in women compared to men.

Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH)

In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40-80 mg/dL, and were randomized to receive Niaspan ER 1500-2000 mg/day (n=1718) or matching placebo (IR Niaspan ER, 100-150 mg, n=1696). The incidence of the adverse reactions of “blood glucose increased” (6.4% vs. 4.5%) and “diabetes mellitus” (3.6% vs. 2.2%) was significantly higher in the simvastatin plus Niaspan ER group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus Niaspan ER group and one ( < 0.1%) in the simvastatin plus placebo group.

Postmarketing Experience

Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval use of Niaspan ER:

Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash; maculopapular rash; dry skin; tachycardia; palpitations; atrial fibrillation; other cardiac arrhythmias; syncope; hypotension; postural hypotension; blurred vision; macular edema; peptic ulcers; eructation; flatulence; hepatitis; jaundice; decreased glucose tolerance; gout; myalgia; myopathy; dizziness; insomnia; asthenia; nervousness; paresthesia; dyspnea; sweating; burning sensation/skin burning sensation; skin discoloration, and migraine.

Clinical Laboratory Abnormalities

Chemistry: Elevations in serum transaminases, LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus.

Hematology: Slight reductions in platelet counts and prolongation in prothrombin time.

Niaspan ER contraindications

See also:
What is the most important information I should know about Niaspan ER?

Niaspan ER extended-release tablets are contraindicated in the following conditions:
Active liver disease or unexplained persistent elevations in hepatic transaminases
Patients with active peptic ulcer disease
Patients with arterial bleeding
Hypersensitivity to Niaspan ER or any component of this medication

Active ingredient matches for Niaspan ER:

Niacin )

Niacin


Unit description / dosage (Manufacturer)Price, USD
Niaspan ER tablet, film coated, extended release 500 mg/1 (Lake Erie Medical DBA Quality Care Products LLC (US))

List of Niaspan ER substitutes (brand and generic names):

Niaspan 750 mg x 2 x 14's (Abbott)
Niaspan 750 mg x 9 x 14's (Abbott)
Niaspan 750 mg x 4 x 14's (Abbott)
Niaspan 1000 mg x 2 x 14's (Abbott)
Niaspan 1000 mg x 4 x 14's (Abbott)
Niaspan 1000 mg x 9 x 14's (Abbott)
100 tablet in 1 bottle (Abbott)
90 tablet in 1 bottle (Abbott)
Niaspan ER tab 500 mg 30's (Abbott)
Niaspan tablet / extended-release 500 mg (Abbott)
Niaspan tablet, film coated, extended release 500 mg/1 (Abbott)
Niaspan tablet, film coated, extended release 1000 mg/1 (Abbott)
Niaspan tablet / extended-release 1000 mg (Abbott)
Niaspan tablet, film coated, extended release 750 mg/1 (Abbott)
Niaspan tablet / extended-release 750 mg (Abbott)
NICOGLOW 250 MG TABLET 1 strip / 10 tablets each (Glowderma Labs Pvt Ltd)$ 0.95
Nicoglow 250mg Tablet (Glowderma Labs Pvt Ltd)$ 0.10
Tablet; Oral; Vitamin B3 / Niacin 500 mg (Rhone-poulenc rorer)
Tablet; Oral; Vitamin B3 / Nicotinic Acid 100 mg (Densa Pharmaceuticals Pvt.Ltd.)
Tablet; Oral; Vitamin B3 / Nicotinic Acid 50 mg (Densa Pharmaceuticals Pvt.Ltd.)
Injectable; Injection; Vitamin B3 / Nicotinic Acid 10 mg / ml (Densa Pharmaceuticals Pvt.Ltd.)
Tablet; Oral; Vitamin B3 / Nicotinic Acid 250 mg (Densa Pharmaceuticals Pvt.Ltd.)
Nicotinic acid 1%/1ml - 10 Vial (Densa Pharmaceuticals Pvt.Ltd.)$ 8.00
Nicotinic acid 50mg - 50 Tablets (Densa Pharmaceuticals Pvt.Ltd.)$ 7.00
Nicotinic Acid 50 mg Tablet (Densa Pharmaceuticals Pvt.Ltd.)$ 0.00
Plusssz Junior 50 tube 20 Tablet

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