País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
lovastatin (UNII: 9LHU78OQFD) (lovastatin - UNII:9LHU78OQFD)
Mutual Pharmaceutical Company, Inc.
lovastatin
lovastatin 10 mg
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. 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: (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 levels. Hypercholesterolemia Therapy with lipid-altering agents should be a component of multiple ris
Lovastatin tablets USP are available as follows: Lovastatin tablets USP 10 mg are round, light-orange, debossed MP 532 Lovastatin tablets USP 20 mg are round, light-blue, debossed MP 533 Lovastatin tablets USP 40 mg are round, light-green, debossed MP 534 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
LOVASTATIN- LOVASTATIN TABLET MUTUAL PHARMACEUTICAL COMPANY, INC. ---------- LOVASTATIN TABLETS 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 principle 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-2yl)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: butylated hydroxyanisole (BHA), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Additionally, lovastatin 10 mg contains pigment blend light orange, lovastatin 20 mg contains FD&C Blue #2 Aluminum Lake, and lovastatin 40 mg contains Lake blend green. 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 oc Leia o documento completo