Product Description.:
Logo and 40
tablet , peach , round round
Convex
ALTOPREV
(lovastatin) Extended-Release Tablets
DRUG DESCRIPTION
ALTOPREV lovastatin extended-release tablets contain 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 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.
ALTOPREV? extended-release tablets are designed for once-a-day oral administration and deliver 20 mg, 40 mg, or 60 mg of lovastatin. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: acetyltributyl citrate butylated hydroxyanisole candellila wax cellulose acetate confectioner's sugar (contains corn starch) F D & C yellow # 6 glyceryl monostearate hypromellose hypromellose phthalate lactose methacrylic acid copolymer, type B polyethylene glycols (PEG 400, PEG 8000) polyethylene oxides polysorbate 80 propylene glycol silicon dioxide sodium chloride sodium lau-ryl sulfate synthetic black iron oxide red iron oxide talc titanium dioxide and triacetin.
NDICATIONS
Therapy with ALTOPREV? lovastatin extended-release tablets should be a component of multiple risk factor intervention in those individuals with dyslipi-demia who are at risk for atherosclerotic vascular disease. ALTOPREV? 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.
ALTOPREV?
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, ALTOPREV? is indicated to reduce the risk of:
* Myocardial infarction
* Unstable angina
* Coronary revascularization procedures (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Coronary Heart Disease
ALTOPREV? 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.
Hyperlipidemia
Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
ALTOPREV? is indicated as an adjunct to diet for the reduction of elevated Total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dys-lipidemia (Fredrickson types IIa and IIb, see Table VI) when the response to diet restricted in saturated fat and cholesterol and to other non-pharmacological measures alone has been inadequate.
