NIACOR- niacin tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Avondale Pharmaceuticals, LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

NIACOR® (Niacin Tablets, USP) 500 mg. Each tablet is a white, capsule-shaped, scored, uncoated tablet, debossed "A2" to the left and "01" to the right of the score, with "A" on the unscored side. NIACOR® is available in bottles of 100 tablets (NDC 71740-001-10). 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].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

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 surger