Drug Catalog - Product Detail
NIACIN TAB ER 1000 MG (ANTIHYPERLIPIDEMIC) 100 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0223-01 | LUPIN PHARMACEUTICALS | 100 | 1000MG | TABLET |
PACKAGE FILES
Generic Name
NIACIN
Substance Name
NIACIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090892
Description
11 DESCRIPTION Niacin extended-release tablets USP (film-coated), contain 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 USP are unscored, orange, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg and 1000 mg niacin. Niacin extended-release tablets USP also contain the inactive ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, povidone, polyethylene glycol, stearic acid, and the following coloring agents: iron oxide red, iron oxide yellow, FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol and titanium dioxide. Niacin extended-release tablets USP meets USP Dissolution Test 2. Footer
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below. 500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03 Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below. 750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02 Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below. 1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Niacin extended-release tablet USP contains extended-release niacin (nicotinic acid), and is 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 tablets USP did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial ( 5.1 ). 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 tablet USP 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. 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 tablet USP 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 tablets USP did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warning and Precautions ( 5.1 )] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Niacin extended-release tablets should be taken at bedtime with a low-fat snack. ( 2.1 ) Dose range: 500 mg to 2000 mg once daily. ( 2.1 ) 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 and should not be increased by more than 500 mg in any 4 week period. ( 2.1 ) Maintenance dose: 1000 to 2000 mg once daily. ( 2.2 ) Doses greater than 2000 mg daily are not recommended. ( 2.2 ) 2.1 Initial Dosing 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 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 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. 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 2.2 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. 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 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 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. 2.3 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 Warning and Precautions ( 5 )].