Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
LOVASTATIN (UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
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. 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 .) Lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to
NDC: 63629-1464-1: 30 Tablets in a BOTTLE NDC: 63629-1464-2: 100 Tablets in a BOTTLE NDC: 63629-1464-3: 60 Tablets in a BOTTLE NDC: 63629-1464-4: 90 Tablets in a BOTTLE NDC: 63629-1464-5: 20 Tablets in a BOTTLE
Abbreviated New Drug Application
LOVASTATIN- LOVASTATIN TABLET BRYANT RANCH PREPACK ---------- LOVASTATIN TABLET USP REVISION M 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 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. CLINICAL PHARMACOLOGY 24 36 5 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 Baca dokumen lengkap