NIACOR- niacin tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

niacin (UNII: 2679MF687A) (niacin - UNII:2679MF687A)

Prieinama:

Avondale Pharmaceuticals, LLC

INN (Tarptautinis Pavadinimas):

niacin

Sudėtis:

niacin 500 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 2000 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 1000 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.

Produkto santrauka:

NIACOR® (Niacin Tablets, USP) 500 mg. Each tablet is a white, capsule-shaped, scored, uncoated tablet, debossed "US" to the left and "67" to the right of the score, with "500" strength on the unscored side. NIACOR® is available in bottles of 100 tablets (NDC 71740-201-10). Dispense in a tight container as defined in the USP, with a child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

NIACOR- NIACIN TABLET
AVONDALE PHARMACEUTICALS, LLC
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NIACOR
(NIACIN TABLETS, USP)
500 MG
DESCRIPTION
Niacin or nicotinic acid, a water-soluble B-complex vitamin and
antihyperlipidemic agent,
is 3-pyridinecarboxylic acid. It is a white, crystalline powder,
sparingly soluble in water. It
has the following structural formula:
MW=123.11
C H NO
Each NIACOR Tablet, for oral administration, contains 500 mg of
nicotinic acid. In
addition, each tablet contains the following inactive ingredients:
croscarmellose sodium,
hydrogenated vegetable oil, magnesium stearate and microcrystalline
cellulose.
CLINICAL PHARMACOLOGY
The role of low-density lipoprotein (LDL) cholesterol in atherogenesis
is supported by
pathological observations, clinical studies, and many animal
experiments. Observational
epidemiological studies have clearly established that high total or
LDL cholesterol and low
high-density lipoprotein (HDL) cholesterol are risk factors for
coronary heart disease.
The Coronary Drug Project , completed in 1975, was designed to assess
the safety and
efficacy of nicotinic acid and other lipid-altering drugs in men 30 to
64 years old with a
history of myocardial infarction (MI). Over an observation period of
five years, nicotinic
acid showed a statistically significant benefit in decreasing
nonfatal, recurrent myocardial
infarctions. The incidence of definite, nonfatal MI was 8.9% for the
1,119 patients
randomized to nicotinic acid versus 12.2% for the 2,789 patients who
received placebo
(p< 0.004). Though total mortality was similar in the two groups at
five years (24.4%
with nicotinic acid versus 25.4% with placebo; p =N.S.), in a fifteen
year cumulative
follow-up there were 11% (69) fewer deaths in the nicotinic acid group
compared to the
placebo cohort (52.0% versus 58.2%; p=0.0004) .
The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a
randomized, placebo-
controlled, angiographic trial testing combined colestipol and
nicotinic acid therapy in
162 non-smoking males with previous coronary bypass surgery