LOVASTATIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Error! Hyperlink reference not valid. ). 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 strategy to lower

Product summary:

Lovastatin Tablets USP, 40 mg are light green colored, circular, beveled edged uncoated tablets, debossed with 'LU' on one side and 'G03' on the other side. They are supplied as follows: NDC 68788-8232-3                Bottles of 30 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Lovastatin tablets must be protected from light and stored in a well-closed, light-resistant container. 1     Kantola, T, et al., Clin Pharmacol Ther 1998; 63(4): 397-402 3    Manson, J.M., Freyssinges,C.Ducrocq, M.B., Stephenson, W.P., Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproductive Toxicology. 10(6):439-446, 1996. 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. Manufactured for Lupin Pharmaceuticals, Inc.  Baltimore, Maryland 21202 United States Manufactured by Lupin Limited  Goa 403 722 INDIA Revised: January 2021               .                                                                 ID#: 266228 Repackaged By: Preferred Pharmaceuticals, Inc. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOVASTATIN- LOVASTATIN TABLET
PREFERRED PHARMACEUTICALS, INC.
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LOVASTATIN TABLETS USP
10 MG, 20 MG AND 40 MG
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 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
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 USP 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: D&C Yellow No. 10 Aluminum Lake, FD&C
Blue No. 2
Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium
stearate,
microcrystalline cellulose and pregelatinized corn starch. Butylated
hydroxyanisole (BHA)
is added as a preservative.
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 cholest