LOVASTATIN- 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.

INN (International Name):

LOVASTATIN

Composition:

LOVASTATIN 10 mg

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 leve

Product summary:

Lovastatin Tablets, USP are available as follows: 10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of; Bottle of 30 - 68788-0926-3 Bottle of 60 - 68788-0926-6 Bottle of 90 - 68788-0926-9 Bottle of 100 - 68788-0926-1 20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of; Bottle of 30 - 68788-2634-3 Bottle of 60 - 68788-2634-6 Bottle of 90 - 68788-2634-9 Bottle of 100 - 68788-2634-1 40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of; Bottle of 30 - 68788-0074-3 Bottle of 60 - 68788-0074-6 Bottle of 90 - 68788-0074-9 Bottle of 100 - 68788-0074-1 Dispense in a tight, light-resistant container as defined in the USP. Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9186 Revised – March  2017 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOVASTATIN- LOVASTATIN TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
LOVASTATIN TABLETS, USP
40-9186
Revised – March 2017
RX ONLY
DESCRIPTION
Lovastatin, USP 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, USP is [1S-[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 molecular
formula of lovastatin is C
H O and its molecular weight is 404.55. Its structural formula is:
Lovastatin, USP is a white, nonhygroscopic crystalline powder that is
insoluble in water and sparingly
soluble in ethanol, methanol, and acetonitrile.
Each tablet for oral administration, contains 10 mg, 20 mg, or 40 mg
of lovastatin, USP. In addition, each
tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, and pregelatinized starch (corn).
Butylated hydroxyanisole is added as a
preservative. The 20 mg tablet also contains D&C Red #30 aluminum
lake. The 40 mg tablet also
contains D&C Yellow #10 HT 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. However, the
risk of developing coronary
heart disease is continuous and graded over the range of cholesterol
levels and many coronary events
*
*
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36
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do occur