LOVASTATIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

LOVASTATIN

Composition:

LOVASTATIN 10 mg

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 CLINICAL PHARMACOLOGY, Clinical Studies.) 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 t

Product summary:

Lovastatin Tablets USP, 10 mg are light green colored, oval shaped, uncoated tablets, debossed with ‘LU’ on one side and ‘G01’ on the other side. They are supplied as follows: Bottles of 30  -  NDC 16590-311-30 Bottles of 60  -  NDC 16590-311-60 Bottles of 90  -  NDC 16590-311-90 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. **    Kantola, T, et al., Clin Pharmacol Ther 1998; 63(4): 397-402 †  Manson, J.M., Freyssinges,C.Ducroq, M.B., Stephenson, W.P., Postmarketing Surveillance of Lovastating and Simvastatin Exposure During Pregnancy. Reproductive Toxicology. 10(6):439-446, 1996. ††  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 403722 INDIA August 2012 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOVASTATIN - LOVASTATIN TABLET
STAT RX USA LLC
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LOVASTATIN TABLETS USP
10 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-methylglutarylcoenzyme 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 [_1S_-[1α(_R ),_3α,7β,8β(_2S ,4S ),_8aβ]]-1,2,3,7,
8,8a-hexahydro-3,7-dimethyl-8-[2(tetrahydro-
4-hydroxy-6-oxo-_2H_-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, FD&C Blue No. 2, lactose anhydrous, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose and pregelatinized 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 cholesterol (total-C) and LDL-C in the
lower end of this range.
Lovastatin h