LOVASTATIN- lovastatin tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

American Health Packaging

INN (Kansainvälinen yleisnimi):

LOVASTATIN

Koostumus:

LOVASTATIN 10 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. Hy

Tuoteyhteenveto:

Lovastatin Tablets, USP are available as follows: 20 mg – Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in unit dose packages of 100 (10 x 10) NDC 68084-559-01 Store between 5° to 25°C (41° to 77°F). Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Actavis Pharma, Inc. as follows: (20 mg / 100 UD) NDC 68084-559-01 packaged from NDC 45963-634 Distributed by: American Health Packaging Columbus, OH 43217 8255901/1217

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

LOVASTATIN- LOVASTATIN TABLET
AMERICAN HEALTH PACKAGING
----------
LOVASTATIN TABLETS, USP
8255901/1217
R 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, USP 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
heart disease is continuous and graded over the range of cholesterol
levels and many coronary events
do occur in patients with total cholesterol (