Drug Catalog - Product Detail
NIACIN ER TABS. TB 1000MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47335-0613-81 | SUN PHARMACEUTICALS | 90 | 1000MG | TABLET |
PACKAGE FILES
Generic Name
NIACIN
Substance Name
NIACIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA200484
Description
11 DESCRIPTION Niacin extended-release tablet, USP contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, sparingly soluble in water, with the following structural formula: Niacin extended-release tablets, USP are unscored, pink, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1,000 mg niacin USP. Niacin extended-release tablets, USP also contain the inactive ingredients hypromellose, hydrogenated vegetable oil Type I, glyceryl behenate, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol-partially hydrolyzed, titanium dioxide, polyethylene glycol, talc, iron oxide red and iron oxide yellow. Meet USP Dissolution Test 3 niacin-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Niacin extended-release tablets, USP are supplied as unscored, pink, film-coated, capsule-shaped tablets containing 500 mg, 750 mg or 1,000 mg of niacin USP in an extended-release formulation. Tablets are debossed ‘S’ on one side and the tablet strength (500, 750 or 1,000) on the other side. Tablets are supplied as follows: 500 mg tablets: Bottles of 30 with child resistant cap…....................NDC 47335-539-83 Bottles of 90 with child resistant cap…....................NDC 47335-539-81 Bottles of 100 with child resistant cap…..................NDC 47335-539-88 Bottles of 100……......NDC 47335-539-08 Bottles of 1,000………NDC 47335-539-18 750 mg tablets: Bottles of 30 with child resistant cap…....................NDC 47335-614-83 Bottles of 90 with child resistant cap…....................NDC 47335-614-81 Bottles of 100 with child resistant cap…..................NDC 47335-614-88 Bottles of 1,000……..NDC 47335-614-18 1,000 mg tablets Bottles of 30 with child resistant cap…....................NDC 47335-613-83 Bottles of 90 with child resistant cap…....................NDC 47335-613-81 Bottles of 100 with child resistant cap…..................NDC 47335-613-88 Bottles of 100……......NDC 47335-613-08 Bottles of 1,000……….NDC 47335-613-18 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container with child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE 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. 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. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. 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. Niacin extended-release in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia. 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 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 )] . Niacin extended-release tablets, USP contain extended-release niacin (nicotinic acid), and are indicated: To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.( 1 ) To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.( 1 ) In combination with a bile acid binding resin: Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. ( 1 ) As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. ( 1 ) To reduce TG in adult patients with severe hypertriglyceridemia. ( 1 ) Limitations of use: Addition of niacin extended-release did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (5.1).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Niacin extended-release tablets, USP should be taken at bedtime with a low-fat snack. ( 2 .1) Dose range: 500 mg to 2,000 mg once daily. ( 2 .1) 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 and should not be increased by more than 500 mg in any 4-week period. ( 2 .1) Maintenance dose: 1,000 mg to 2,000 mg once daily. ( 2 .2) Doses greater than 2,000 mg daily are not recommended. ( 2 .2) 2.1 Initial Dosing 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 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 * 2,000 mg 2 niacin extended-release 1,000 mg tablets or 4 niacin extended-release 500 mg tablets at bedtime * After Week 8, titrate to patient response and tolerance. If response to 1,000 mg daily is inadequate, increase dose to 1,500 mg daily; may subsequently increase dose to 2,000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2,000 mg daily are not recommended. Women may respond at lower doses than men. 2.2 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. 2.3 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 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)].