LOVASTATIN tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Dispensing Solutions, Inc.

DCI (Denominação Comum Internacional):

Lovastatin

Composição:

Lovastatin 10 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. Primary Prevention of Coronary Heart Disease 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.) Coronary Heart Disease Lovastatin is 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 wit

Resumo do produto:

Lovastatin Tablets USP (white to off white round, unscored tablets) containing 10mg of lovastatin and engraved with “CTI” 141 ----Bottle of 60 (NDC 61442-141-60), Bottle of 100 (NDC 61442-141-01), Bottle of 500 (NDC 61442-141-05), Bottle of 1,000 (NDC 61442-141-10) Lovastatin Tablets USP (white to off white round, unscored tablets) containing 20mg of lovastatin and engraved with “CTI” 142 ---- Bottle of 60 (NDC 61442-142-60), Bottle of 100 (NDC 61442-142-01), Bottle of 500 (NDC 61442-142-05), Bottle of 1,000 (NDC 61442-142-10) Lovastatin Tablets USP (white to off white round, unscored tablets) containing 40mg of lovastatin and engraved with “CTI” 143 ---- Bottle of 60 (NDC 61442-143-60), Bottle of 100 (NDC 61442-143-01), Bottle of 500 (NDC 61442-143-05), Bottle of 1,000 (NDC 61442-143-10)

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LOVASTATIN - LOVASTATIN TABLET
DISPENSING SOLUTIONS, INC.
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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