LOVASTATIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hyperch

Product summary:

Lovastatin Tablets USP (white to off white round, unscored tablets) containing 10mg of lovastatin and engraved with “CTI 141" Bottle of 60.................................................................................................................................. Bottle of 90.................................................................................................................................. Bottle of 100................................................................................................................................ Bottle of 500............................................................................................................................... Bottle of 1,000............................................................................................................................. Lovastatin Tablets USP (white to off white round, unscored tablets) containing 20mg of lovastatin and engraved with “CTI 142” Bottle of 60............................................................................................................................... Bottle of 90................................................................................................................................ Bottle of 100................................................................................................................................ Bottle of 500................................................................................................................................ Bottle of 1,000............................................................................................................................. Lovastatin Tablets USP (white to off white round, unscored tablets) containing 40mg of lovastatin and engraved with “CTI 143” Bottle of 60.................................................................................................................................. Bottle of 90................................................................................................................................. Bottle of 100............................................................................................................................. Bottle of 500................................................................................................................................ Bottle of 1,000............................................................................................................................. ____________________________________ 4 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics . 89(3):495-501, 1992. Storage Store at 20º to 25º C (68º to 77º F). [See USP Controlled Room Temperature.] Lovastatin Tablets must be protected from light and stored in a well-closed, light-resistant container. Manufactured and Distributed By: Carlsbad Tech 5928 Farnsworth Court Carlsbad, CA 92008 Revised: March 2017 CTI-13 Rev. J

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOVASTATIN- LOVASTATIN TABLET
DIRECT_RX
----------
LOVASTATIN
Rx only
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 24 H 36 O 5
and its molecular
weight is 404.55. Its structural formula is:
[Structural Formula ]
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: lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, poloxamer, pregelatinized starch, sodium
starch glycolate,
butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is
added as a
preservative.
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.
Lovastatin has been shown t