Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
Lovastatin (UNII: 9LHU78OQFD) (Lovastatin - UNII:9LHU78OQFD)
AvPAK
Lovastatin
Lovastatin 10 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
LOVASTATIN - LOVASTATIN TABLET AVPAK ---------- LOVASTATIN TABLET USP 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, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyaniso and talc. 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. 24 36 5 Lovastatin has been shown to reduce both n Прочитайте повний документ