ADVICOR niacin and lovastatin tablet extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)

זמין מ:

AbbVie Inc.

INN (שם בינלאומי):

NIACIN

הרכב:

NIACIN 500 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

ADVICOR- NIACIN AND LOVASTATIN TABLET, EXTENDED RELEASE
ABBVIE INC.
----------
ADVICOR
(NIACIN EXTENDED-RELEASE/LOVASTATIN TABLETS)
DESCRIPTION
ADVICOR (niacin extended-release and lovastatin) is intended to
facilitate the daily administration of
its individual components, Niaspan 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 C H NO and its molecular weight is
123.11. Niacin has the
following structural formula:
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
C
H O and its molecular weight is 404.55. Lovastatin has the following
structural formula:
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 - Iron Oxide Yellow, Iron Oxide Red.
ADVICOR 750 mg/20 mg - FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake.
®
®
®
6
5
2
24
36
5
ADVICOR 1000 mg/20 mg - Iron Oxide Red, Iron Oxide Yellow, Iron Oxide
Black.
ADVICOR 1000 mg/40 mg - Iron Oxide Red.
CLINICAL PHARMAC