Niacin
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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. Niacin, 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.
- Niacin 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, niacin, 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, niacin, USP, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
- 4.
- Niacin 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.
- Niacin, 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 Niacin Extended-Release Tablets USP did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].
History
There is currently no drug history available for this drug.
Other Information
Niacin Extended-Release Tablets USP, contain niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin, USP (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula:
Niacin Extended-Release Tablets USP are white to off-white, capsule-shaped, unscored, biconvex, debossed tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1000 mg niacin, USP. Niacin Extended-Release Tablets USP also contain the following inactive ingredients: hypromellose, povidone, and stearic acid.
Sources
Niacin Manufacturers
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Teva Pharmaceuticals Usa Inc
![Niacin Tablet, Extended Release [Teva Pharmaceuticals Usa Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Niacin | Teva Pharmaceuticals Usa Inc
Niacin Extended-Release Tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with Niacin 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 DosingWeek(s)
Daily Dose
Niacin Extended-Release Tablets Dosage
INITIAL
TITRATION1 to 4
500 mg
1 Niacin Extended-Release 500 mg Tablet at bedtimeSCHEDULE
5 to 8
1000 mg
1 Niacin Extended-Release 1000 mg Tablet or
2 Niacin Extended-Release 500 mg Tablets at bedtime*
1500 mg
2 Niacin Extended-Release 750 mg Tablets or
3 Niacin Extended-Release 500 mg Tablets at bedtime*
2000 mg
2 Niacin Extended-Release 1000 mg Tablets or
4 Niacin 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 Niacin 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 Niacin Extended-Release Tablet doses than men [see Clinical Studies (14.2)].
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 [see Adverse Reactions (6.1)] may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to Niacin 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 niacin 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 Niacin Extended-Release Tablet ingestion.
Equivalent doses of Niacin Extended-Release Tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see Warnings and Precautions (5)]. Patients previously receiving other niacin products should be started with the recommended Niacin Extended-Release Tablet titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.
If Niacin Extended-Release Tablet therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).
Niacin 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 Niacin Extended-Release Tablets in patients with renal or hepatic impairment has not been studied. Niacin Extended-Release Tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin Extended-Release Tablets should be used with caution in patients with renal impairment [see Warnings and Precautions (5)].
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Lupin Pharmaceuticals, Inc.
Niacin | Lupin Pharmaceuticals, Inc.
Niacin extended-release tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin 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
Niacin Dosage
* 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. INITIAL
1 to 4
500 mg
1 Niacin extended-release tablet, 500 mg at bedtime
TITRATION
SCHEDULE
5 to 8
1000 mg
1 Niacin extended-release tablet, 1000 mg or 2 Niacin extended-release tablets, 500 mg at bedtime
* 1500 mg
2 Niacin extended-release tablets, 750 mg or 3 Niacin extended-release tablets, 500 mg at bedtime
* 2000 mg
2 Niacin extended-release tablets, 1000 mg or 4 Niacin extended-release tablets, 500 mg at bedtime
Maintenance Dose
The daily dosage of niacin 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 niacin extended-release tablets doses than men [see CLINICAL STUDIES (14.2)].
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.
Tolerance to flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin 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 niacin extended-release tablets USP ingestion.
Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see WARNINGS AND PRECAUTIONS (5)]. Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.
If niacin extended-release tablets therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).
Niacin 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 niacin extended-release tablets in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablet is contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets should be used with caution in patients with renal impairment [see WARNINGS AND PRECAUTIONS (5)].
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Time Cap Labs Inc
Niacin | Time Cap Labs Inc
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Time Cap Labs Inc
Niacin | Time Cap Labs Inc
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Sun Pharma Global Fze
Niacin | Sun Pharma Global Fze
Niacin extended-release tablets, USP should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets, USP 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.
Week(s)
Daily dose
Niacin Extended-Release Dosage
INITIAL TITRATION
1 to 4
500 mg
1 niacin extended-release 500 mg tablet at bedtime
SCHEDULE
5 to 8
1,000 mg
1 niacin extended-release 1,000 mg tablet or 2 niacin extended-release 500 mg tablets at bedtime
1,500 mg
2 niacin extended-release 750 mg tablets or 3 niacin extended-release 500 mg tablets at bedtime
1,500 mg
2 niacin extended-release 750 mg tablets or 3 niacin extended-release 500 mg tablets at bedtime
Maintenance Dose
The daily dosage of niacin extended-release tablets, USP should not be increased by more than 500 mg in any 4–week period. The recommended maintenance dose is 1,000 mg (two 500 mg tablets or one 1,000 mg tablet) to 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2,000 mg daily are not recommended. Women may respond at lower niacin extended-release tablets, USP doses than men [see Clinical Studies (14.2)].
Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1,000 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 [see Adverse Reactions (6.1)] may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to niacin extended-release tablets, USP 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 niacin 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 niacin extended-release tablets, USP ingestion.
Equivalent doses of niacin extended-release tablets, USP should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see Warnings and Precautions (5)]. Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets, USP titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.
If niacin extended-release tablets, USP therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).
Niacin extended-release tablets, USP should be taken whole and should not be broken, crushed or chewed before swallowing.
Dosage in Patients with Renal or Hepatic ImpairmentUse of niacin extended-release tablets, USP in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablets, USP are contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets, USP should be used with caution in patients with renal impairment [see Warnings and Precautions (5)].
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Zydus Pharmaceuticals Usa Inc
Niacin | Zydus Pharmaceuticals Usa Inc
Niacin extended-release tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin 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 Niacin Extended-Release Tablets Dosage INITIAL
TITRATION 1 to 4 500 mg
1 Niacin extended-release 500 mg tablet at bedtime
SCHEDULE 5 to 8 1000 mg
1 Niacin extended-release 1000 mg tablet or
2 Niacin extended-release 500 mg tablets at bedtime
* 1500 mg
2 Niacin extended-release 750 mg tablets or
3 Niacin extended-release 500 mg tablets at bedtime
* 2000 mg
2 Niacin extended-release 1000 mg tablets or
4 Niacin 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 niacin 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 niacin extended-release tablet doses than men [see Clinical Studies (14.2)].
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 [see Adverse Reactions (6.1)] may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to niacin 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 niacin 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 niacin extended-release tablet ingestion.
Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see Warnings and Precautions (5)]. Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablet titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.
If niacin extended-release tablet therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).
Niacin 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 niacin extended-release tablets in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets should be used with caution in patients with renal impairment [see Warnings and Precautions (5)].
-
American Health Packaging
Niacin | American Health Packaging
Niacin extended-release tablets USP should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets USP 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
Niacin Dosage
* 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.INITIAL
TITRATION
SCHEDULE1 to 4
500 mg
1 Niacin Extended-release Tablet USP, 500 mg at
bedtime5 to 8
1000 mg
1 Niacin Extended-release Tablet USP, 1000 mg or
2 Niacin Extended-release Tablets USP, 500 mg at bedtime*
1500 mg
2 Niacin Extended-release Tablets USP, 750 mg or
3 Niacin Extended-release Tablets USP, 500 mg at bedtime*
2000 mg
2 Niacin Extended-release Tablets USP, 1000 mg or
4 Niacin Extended-release Tablets USP, 500 mg at bedtimeMaintenance Dose
The daily dosage of niacin extended-release tablets USP 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 niacin extended-release tablets USP doses than men [see CLINICAL STUDIES (14.2)].
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.
If lipid response to niacin extended-release tablets USP alone is insufficient or if higher doses of niacin extended-release tablets USP are not well tolerated, some patients may benefit from combination therapy with a bile acid binding resin or statin [see DRUG INTERACTIONS (7.3), Concomitant Therapy below and CLINICAL STUDIES (14.3, 14.4)].
Tolerance to flushing of skin develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin 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 niacin extended-release tablets USP ingestion.
Equivalent doses of niacin extended-release tablets USP should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see WARNINGS AND PRECAUTIONS (5)]. Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets USP titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.
If niacin extended-release tablets USP therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).
Niacin extended-release tablets USP should be taken whole and should not be broken, crushed or chewed before swallowing.
Concomitant TherapyConcomitant Therapy with Lovastatin or Simvastatin
Patients already receiving a stable dose of lovastatin or simvastatin who require further TG-lowering or HDL-raising (e.g., to achieve NCEP non-HDL-C goals), may receive concomitant dosage titration with niacin extended-release tablets USP per niacin extended-release tablets USP recommended initial titration schedule [see DOSAGE AND ADMINISTRATION (2)]. For patients already receiving a stable dose of niacin extended-release tablets USP who require further LDL-lowering (e.g., to achieve NCEP LDL-C goals), the usual recommended starting dose of lovastatin and simvastatin is 20 mg once a day. Dose adjustments should be made at intervals of 4 weeks or more. Combination therapy with niacin extended-release tablets USP and lovastatin or niacin extended-release tablets USP and simvastatin should not exceed doses of 2000 mg niacin extended-release tablets USP and 40 mg lovastatin or simvastatin daily.
Dosage in Patients with Renal or Hepatic Impairment
Use of niacin extended-release tablets USP in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablet USP is contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets USP should be used with caution in patients with renal impairment [see WARNINGS AND PRECAUTIONS (5)].
![Niacin Tablet, Extended Release [Lupin Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9&name=7e2899e1-99ef-4a21-8f6b-8590cb0674c9-02.jpg)
![Niacin Capsule, Extended Release [Time Cap Labs Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1bafcb0b-3564-4f3b-8ffb-d916d112fae9&name=053TLABEL100.jpg)
![Niacin Capsule, Extended Release [Time Cap Labs Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=15fc2066-525b-4ebf-ae51-0eddd90489b5&name=069TLABEL100.jpg)
![Niacin Tablet, Film Coated, Extended Release [Sun Pharma Global Fze]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e290f96-e8c6-47fd-863f-1c9480f28d9b&name=niacin-label-1000mg.jpg)
![Niacin Tablet, Film Coated, Extended Release [Zydus Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=62efc71c-9746-d603-3e9d-a8786f7d4de8&name=label-niacin-er-1000mg-90ct.jpg)
![Niacin Tablet, Extended Release [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=09bccfc6-71eb-420f-92d3-cd21789a0dbc&name=Niacin1000mgLabel.jpg)
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