LOVASTATIN tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bryant Ranch Prepack

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin 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 is indicated to reduce the risk of: - Myocardial infarction - Unstable angina - Coronary revascularization procedures (See CLINICAL PHARMACOLOGY, Clinical Studies .) Lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to

Dettagli prodotto:

NDC: 63629-1464-1: 30 Tablets in a BOTTLE NDC: 63629-1464-2: 100 Tablets in a BOTTLE NDC: 63629-1464-3: 60 Tablets in a BOTTLE NDC: 63629-1464-4: 90 Tablets in a BOTTLE NDC: 63629-1464-5: 20 Tablets in a BOTTLE

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

LOVASTATIN- LOVASTATIN TABLET
BRYANT RANCH PREPACK
----------
LOVASTATIN TABLET USP
REVISION M
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 to the active ingredient lovastatin, each
tablet contains the
following inactive ingredients: lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, poloxamer, pregelatinized starch, sodium
starch glycolate,
butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is
added as a
preservative.
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 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