LOVASTATIN tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Lovastatin (UNII: 9LHU78OQFD) (Lovastatin - UNII:9LHU78OQFD)

제공처:

AvPAK

INN (International Name):

Lovastatin

구성:

Lovastatin 10 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LOVASTATIN - LOVASTATIN TABLET
AVPAK
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LOVASTATIN TABLET USP
RX ONLY
DESCRIPTION
Lovastatin is a cholesterol lowering agent isolated from a strain of
_Aspergillus terreus._ After oral
ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to
the corresponding β-hydroxyacid
form. This is a principal metabolite and an inhibitor of
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-
CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to
mevalonate, which is an early
and rate limiting step in the biosynthesis of cholesterol.
Lovastatin is [1_S_-[1α(_R_*), 3α, 7β,
8β(2_S_*,4_S_*),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-
(tetrahydro-4-hydroxy-6-oxo-2 _H_ -pyran-2-yl)ethyl]-1-naphthalenyl
2-methylbutanoate. The empirical
formula of lovastatin is C
H O and its molecular weight is 404.55. Its structural formula is:
Lovastatin is a white, nonhygroscopic crystalline powder that is
insoluble in water and sparingly
soluble in ethanol, methanol, and acetonitrile.
Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for
oral administration. In addition,
each tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, poloxamer, pregelatinized starch, sodium
starch glycolate, butylated
hydroxyaniso and talc. Butylated hydroxyanisole (BHA) is added as a
preservative.
CLINICAL PHARMACOLOGY
The involvement of low-density lipoprotein cholesterol (LDL-C) in
atherogenesis has been well
documented in clinical and pathological studies, as well as in many
animal experiments. Epidemiological
and clinical studies have established that high LDL-C and low
high-density lipoprotein cholesterol
(HDL-C) are both associated with coronary heart disease. However, the
risk of developing coronary
heart disease is continuous and graded over the range of cholesterol
levels and many coronary events
do occur in patients with total cholesterol (total-C) and LDL-C in the
lower end of this range.
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Lovastatin has been shown to reduce both n