LOVASTATIN tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

LOVASTATIN (UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD)

Beschikbaar vanaf:

RPK Pharmaceuticals, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Therapy with Lovastatin Tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, Lovastatin Tablets are indicated to reduce the risk of: - Myocardial infarction - Unstable angina - Coronary revascularization procedures (See CLINICAL PHARMACOLOGY , Clinical Studies in Adults .) Lovastatin Tablets are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Therapy with lipid-altering agent

Product samenvatting:

Product: 53002-5701 NDC: 53002-5701-3 30 TABLET in a BOTTLE NDC: 53002-5701-6 60 TABLET in a BOTTLE NDC: 53002-5701-0 100 TABLET in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LOVASTATIN- LOVASTATIN TABLET
RPK PHARMACEUTICALS, INC.
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LOVASTATIN TABLETS, USP
RX ONLY
DESCRIPTION
Lovastatin, USP is a cholesterol lowering agent isolated from a strain
of _Aspergillus_
_terreus_. After oral ingestion, lovastatin, USP, 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, USP 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. Its structural formula is:
C
H
O M.W. 404.55
Lovastatin, USP is a white, nonhygroscopic crystalline powder that is
insoluble in water
and sparingly soluble in ethanol, methanol, and acetonitrile.
Lovastatin Tablets, USP are supplied as 10 mg, 20 mg and 40 mg tablets
for oral
administration. In addition to the active ingredient lovastatin, USP,
each tablet contains
the following inactive ingredients: lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, and pregelatinized corn starch. Butylated
hydroxyanisole
(BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also
contain FD&C
Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain
FD&C Blue #1
Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow
#10 Aluminum
Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake.
CLINICAL PHARMACOLOGY
24
36
5
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