LOVASTATIN- lovastatin tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NuCare Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

LOVASTATIN

Samenstelling:

LOVASTATIN 40 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. Hyp

Product samenvatting:

Lovastatin Tablets, USP are available as follows: 40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 30 NDC 68071-3108-3 bottles of 60 NDC 68071-3108-6 bottles of 90 NDC 68071-3108-9 Dispense in a tight, light-resistant container as defined in the USP. Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9186 Revised – May 2016

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LOVASTATIN- LOVASTATIN TABLET
NUCARE PHARMACEUTICALS, INC.
----------
LOVASTATIN TABLETS, USP
40-9186
Revised – May 2016
RX ONLY
DESCRIPTION
Lovastatin, USP 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, USP is [1S-[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 molecular
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.
Each tablet for oral administration, contains 10 mg, 20 mg, or 40 mg
of lovastatin, USP. In addition, each
tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, and pregelatinized starch (corn).
Butylated hydroxyanisole is added as a
preservative. The 20 mg tablet also contains D&C Red #30 aluminum
lake. The 40 mg tablet also
contains D&C Yellow #10 HT aluminum lake.
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
*
*
*
24
36
5
heart disease is continuous and graded over the range of cholesterol
levels and many coronary events
do occur in pa