LOVASTATIN tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

lovastatin (UNII: 9LHU78OQFD) (lovastatin - UNII:9LHU78OQFD)

Dostopno od:

Mutual Pharmaceutical Company, Inc.

INN (mednarodno ime):

lovastatin

Sestava:

lovastatin 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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: (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. Hypercholesterolemia Therapy with lipid-altering agents should be a component of multiple ris

Povzetek izdelek:

Lovastatin tablets USP are available as follows: Lovastatin tablets USP 10 mg are round, light-orange, debossed MP 532 Lovastatin tablets USP 20 mg are round, light-blue, debossed MP 533 Lovastatin tablets USP 40 mg are round, light-green, debossed MP 534 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

LOVASTATIN- LOVASTATIN TABLET
MUTUAL PHARMACEUTICAL COMPANY, INC.
----------
LOVASTATIN TABLETS 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 principle 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-2yl)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: butylated
hydroxyanisole (BHA), lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and
pregelatinized starch. Additionally, lovastatin 10 mg contains pigment
blend light orange, lovastatin 20
mg contains FD&C Blue #2 Aluminum Lake, and lovastatin 40 mg contains
Lake blend green.
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 oc