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

nutritional specialties, inc. - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), arnica montana whole (unii: o80ty208zw) (arnica montana - unii:o80ty208zw), camphor (natural) (unii: n20hl7q941) (camphor (natural) - unii:n20hl7q941), strychnos nux-vomica seed (unii: 269xh13919) (strychnos nux-vomica seed - unii:269xh13919), veratrum album root (unii: qns6w5us1z) (veratrum album root - unii:qns6w5us1z), epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh), - assists in correction of circulatory disorders.† †claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. assists in correction of circulatory disorders.† †claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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)

redmont pharmaceuticals, llc - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - i. therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and ldl cholesterol levels in patients with primary hypercholesterolemia (types iia and iib)† , when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also the ncep treatment guidelines6 ). prior to initiating therapy with nicotinic acid, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total cholesterol, hdl cholesterol, and triglycerides. ii. nicotinic acid is also indicated as adjunctive therapy for the treatment of adult patients with very high serum triglyceride levels (types iv and v hyperlipidemia)† who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. such patients typically have serum triglyceride levels over 2,000 mg/dl and have elevations of vldl cholesterol as well as fasting chylomicrons (type v hyperlipidemia)† . subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dl are unlikely to develop pancreatitis. therapy with nicotinic acid may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. some type iv patients with triglycerides under 1,000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of nicotinic acid therapy on the risk of pancreatitis in such situations has not been adequately studied. drug therapy is not indicated for patients with type i hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of vldl. inspection of plasma refrigerated for 14 hours is helpful in distinguishing types i, iv, and v hyperlipoproteinemia7 . nicotinic acid is contraindicated in patients with a known hypersensitivity to any component of this medication; significant or unexplained hepatic dysfunction; active peptic ulcer disease; or arterial bleeding.

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

emerald therapeutics, llc - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - i. therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and ldl cholesterol levels in patients with primary hypercholesterolemia (types iia and iib)† , when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also the ncep treatment guidelines6 ). prior to initiating therapy with nicotinic acid, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total cholesterol, hdl cholesterol, and triglycerides. ii. nicotinic acid is

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

redmont pharmaceuticals, llc - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - i. therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and ldl cholesterol levels in patients with primary hypercholesterolemia (types iia and iib)†, when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also the ncep treatment guidelines6 ). prior to initiating therapy with nicotinic acid, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total cholesterol, hdl cholesterol, and triglycerides. ii. nicotinic acid is

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)

amneal pharmaceuticals llc - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 750 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)

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)

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