United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 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 tablets in combination with a bile acid bi

United States - English - NLM (National Library of Medicine)

avpak - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 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 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. - 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) [see warnings and precautions (5.1)] . niacin extended-release tablets are contraindicated in the following conditions: - active liver disease or unexplained persistent elevations in hepatic transaminases [see warnings and precautions (5.3)] - patients with active peptic ulcer disease - patients with arterial bleeding - hypersensitivity to niacin or any component of this medication [see adverse reactions (6.1)] pregnancy category c. animal reproduction studies have not been conducted with niacin or with niacin extended-release. it is also not known whether niacin at doses typically used for lipid disorders can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. if a woman receiving niacin for primary hyperlipidemia becomes pregnant, the drug should be discontinued. if a woman being treated with niacin for hypertriglyceridemia conceives, the benefits and risks of continued therapy should be assessed on an individual basis. niacin is excreted into human milk but the actual infant dose or infant dose as a percent of the maternal dose is not known. because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of nicotinic acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. no studies have been conducted with niacin extended-release in nursing mothers. safety and effectiveness of niacin therapy in pediatric patients (≤16 years) have not been established. of 979 patients in clinical studies of niacin extended-release, 21% of the patients were age 65 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no studies have been performed in this population. niacin extended-release should be used with caution in patients with renal impairment [see warnings and precautions (5)] . no studies have been performed in this population. niacin extended-release should be used with caution in patients with a past history of liver disease and/or who consume substantial quantities of alcohol. active liver disease, unexplained transaminase elevations and significant or unexplained hepatic dysfunction are contraindications to the use of niacin extended-release [see  contraindications (4.0) and warnings and precautions (5.3)] . data from the clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of niacin extended-release.

United States - English - NLM (National Library of Medicine)

american health packaging - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 ac

United States - English - NLM (National Library of Medicine)

lupin limited - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 ac

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 ac

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 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 tablets in combination with a bile acid bi

United States - English - NLM (National Library of Medicine)

marlex pharmaceuticals inc - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 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 tablets in combination with a bile acid

United States - English - NLM (National Library of Medicine)

lannett company, inc. - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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 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 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 aci

United States - English - NLM (National Library of Medicine)

carilion materials management - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - 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. 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 )] . teratogenic effects pregnancy category c animal reproduction studies have not been conducted with niacin or with niacin extended-release tablets. it is also not known whether niacin at doses typically used for lipid disorders can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. if a woman receiving niacin for primary hyp

United States - English - NLM (National Library of Medicine)

macleods pharmaceuticals limited - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - 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 tablet 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 tablet 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) [see warnings and precautions (5.1)]. niacin extended-release tablet is contraindicated in the following conditions: • active liver disease or unexplained persistent elevations in hepatic transaminases [see warnings and precautions (5.3)] • patients with active peptic ulcer disease • patients with arterial bleeding • hypersensitivity to niacin or any component of this medication [see adverse reactions (6.1)] risk summary discontinue niacin extended-release tablets when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. assess the individual risks and benefits of continuing niacin extended-release tablets during pregnancy in patients receiving the drug for the treatment of hypertriglyceridemia. advise patients to inform their healthcare provider of a known or suspected pregnancy. the potential for embryofetal toxicity with the doses of niacin in niacin extended-release tablets is unknown. the available data on niacin extended-release tablets use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with niacin or with niacin extended-release tablets. treatment of hypercholesterolemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary niacin is present in human milk and the amount of niacin increases with maternal supplementation. there is no information on the effects of the doses of niacin in niacin extended-release tablets on the breastfed infant or the effects on milk production. because of the potential for serious adverse reactions in breastfeeding infants, including hepatotoxicity, advise patients not to breastfeed during treatment with niacin extended-release tablets. safety and effectiveness of niacin therapy in pediatric patients (≤16 years) have not been established. of 979 patients in clinical studies of niacin extended-release tablets, 21% of the patients were age 65 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no studies have been performed in this population. niacin extended-release tablets should be used with caution in patients with renal impairment [see warnings and precautions (5)]. no studies have been performed in this population. niacin extended-release tablets should be used with caution in patients with a past history of liver disease and/or who consume substantial quantities of alcohol. active liver disease, unexplained transaminase elevations and significant or unexplained hepatic dysfunction are contraindications to the use of niacin extended-release tablets [see contraindications (4) and warnings and precautions (5.3)]. data from the clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of niacin extended-release tablets.