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AdvicorŽ
(niacin extended-release/lovastatin)
Tablets
Lovastatin blocks the production of cholesterol
(a type of fat) in the body. Niacin, also known as nicotinic acid, is vitamin
B3. It occurs naturally in plants and animals and is also added to many foods as
a vitamin supplement. Niacin also blocks the production of cholesterol in the
body.
Together, lovastatin and niacin are used to reduce levels of LDL (or "bad")
cholesterol, total cholesterol, and triglycerides and to raise levels of "good"
(HDL) cholesterol. These actions are important in the prevention of heart disease
and hardening of the arteries, which can lead to heart attacks, stroke, and
peripheral vascular disease. Lovastatin and niacin may also be used for
purposes.
ADVICORŽ (niacin extended-release and lovastatin) is intended to facilitate the
daily administration of its individual components, NiaspanŽ and lovastatin, when
used together for the intended patient population (see INDICATIONS AND USAGE and
DOSAGE AND ADMINISTRATION).
ADVICOR contains niacin extended-release and lovastatin in combination.
Lovastatin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase, and niacin are both lipid-altering agents.
Niacin is nicotinic acid, or 3-pyridinecarboxylic acid. Niacin is a white,
nonhygroscopic crystalline powder that is very soluble in water, boiling ethanol
and propylene glycol. It is insoluble in ethyl ether. The empirical formula of
niacin is C6H5NO2 and its molecular weight is 123.11.
Lovastatin is [1S -[1(alpha)(R *), 3(alpha), 7(beta), 8(beta)(2S *, 4S *),
8a(beta)]]-1,2,3,
7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)
ethyl]-1-naphthalenyl 2-methylbutanoate. Lovastatin is a white, nonhygroscopic
crystalline powder that is insoluble in water and sparingly soluble in ethanol,
methanol, and acetonitrile. The empirical formula of lovastatin is C24H36O5 and
its molecular weight is 404.55.
ADVICOR tablets contain the labeled amount of niacin and lovastatin and have the
following inactive ingredients: hypromellose, povidone, stearic acid,
polyethylene glycol, titanium dioxide, polysorbate 80.
The individual tablet strengths (expressed in terms of mg niacin/mg lovastatin)
contain the following coloring agents:
ADVICOR 500 mg/20 mg - synthetic red and yellow iron oxides.
ADVICOR 750 mg/20 mg - FD&C yellow #6 Aluminum Lake.
ADVICOR 1000 mg/20 mg - synthetic red, yellow, and black iron oxides.
ADVICOR 1000 mg/40 mg - red iron oxide.
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