LOVASTATIN- lovastatin tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

International Laboratories, LLC

INN:

LOVASTATIN

composition:

LOVASTATIN 10 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

Lovastatin Tablets USP, 10 mg are available as light peach, unscored, round, flat beveled tablets debossed “926” on one side and “TEVA” on the other side. Packaged in adherence packages of 30 (NDC 54458-916-10). Lovastatin Tablets USP, 20 mg are available as light blue, unscored, round, flat beveled tablets, debossed “576” on one side and “TEVA” on the other side. Packaged in adherence packages of 30 (NDC 54458-915-10). Lovastatin Tablets USP, 40 mg are available as light green, unscored, round, flat beveled tablets, debossed “928” on one side and “TEVA” on the other side. Packaged in adherence packages of 30 (NDC 54458-914-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lovastatin Tablets USP must be protected from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Packaged by: International Laboratories, LLC St. Petersburg, FL 33710 Distributed by: Walmart Bentonville, AR 72716 Rev.  04/17                                                                                                                                                          LI0044

authorization_status:

Abbreviated New Drug Application

SPC

LOVASTATIN- LOVASTATIN TABLET
INTERNATIONAL LABORATORIES, LLC
----------
LOVASTATIN TABLETS USP
DESCRIPTION
Lovastatin, USP is a cholesterol lowering agent isolated from a strain
of _Aspergillus terreus_. After oral
ingestion, lovastatin, USP, 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
[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. Its structural
formula is:
STRUCTURE FORMULA C
H O M.W. 404.55 C
H O M.W. 404.55
Lovastatin, USP is a white, nonhygroscopic crystalline powder that is
insoluble in water and sparingly
soluble in ethanol, methanol, and acetonitrile.
Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets
for oral administration. In
24
36
5
24
36
5
addition to the active ingredient lovastatin, USP, each tablet
contains the following inactive ingredients:
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
and pregelatinized corn starch.
Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin
Tablets USP, 10 mg also contain
FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also
contain FD&C Blue #1
Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow
#10 Aluminum Lake, FD&C
Blue #1 Aluminum Lake, and FD&C Yellow #6 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. H