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Niacin

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Overview

What is Niacin?

Niacin Extended-release Tablets, USP (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula:

Niacin extended-release tablets is an unscored, red, film-coated tablet for oral administration and are available in two tablet strengths containing 500 and 1000 mg niacin. Niacin extended-release tablets also contain the inactive ingredients black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, lecithin, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium stearyl fumarate, talc, titanium dioxide, and yellow iron oxide.

USP Dissolution Test 5.



What does Niacin look like?



What are the available doses of Niacin?

Unscored film-coated tablets for oral administration: 500 and 1000 mg niacin extended-release. ()

What should I talk to my health care provider before I take Niacin?

How should I use Niacin?

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 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 is 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 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, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.

4. Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.

5. Niacin 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 did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) .

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 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

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

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 niacin extended-release tablets 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 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 . 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 tablets is contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets should be used with caution in patients with renal impairment .


What interacts with Niacin?

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What are the warnings of Niacin?

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What are the precautions of Niacin?

Sorry No Records found


What are the side effects of Niacin?

Sorry No records found


What should I look out for while using Niacin?

Niacin extended-release tablets is 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 niacin or any component of this medication


What might happen if I take too much Niacin?

Supportive measures should be undertaken in the event of an overdose.


How should I store and handle Niacin?

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Keep out of the reach of children.Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-320-46Bottles of 1000           NDC 62175-320-43Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-322-46Bottles of 1000           NDC 62175-322-43Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-320-46Bottles of 1000           NDC 62175-320-43Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-322-46Bottles of 1000           NDC 62175-322-43Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-320-46Bottles of 1000           NDC 62175-320-43Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-322-46Bottles of 1000           NDC 62175-322-43Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-320-46Bottles of 1000           NDC 62175-320-43Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-322-46Bottles of 1000           NDC 62175-322-43Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-320-46Bottles of 1000           NDC 62175-320-43Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-322-46Bottles of 1000           NDC 62175-322-43Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-320-46Bottles of 1000           NDC 62175-320-43Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-322-46Bottles of 1000           NDC 62175-322-43Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-320-46Bottles of 1000           NDC 62175-320-43Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows:Bottles of 90               NDC 62175-322-46Bottles of 1000           NDC 62175-322-43Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism by which niacin alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Niacin decreases the rate of hepatic synthesis of VLDL and LDL, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

Non-Clinical Toxicology
Niacin extended-release tablets is 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 niacin or any component of this medication

Drug Interactions:

Niacin extended-release tablets preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to niacin

extended-release tablets, therapy with niacin extended-release tablets should be initiated with low doses (i.e., 500 mg at bedtime) and the niacin extended-release tablets dose should then be titrated to the desired therapeutic response

.

Caution should also be used when niacin extended-release tablets is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.

Niacin is rapidly metabolized by the liver, and excreted through the kidneys. Niacin extended-release tablets is contraindicated in patients with significant or unexplained hepatic impairment and should be used with caution in patients with renal impairment. Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during niacin extended-release tablets therapy.

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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