Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
Lovastatin (UNII: 9LHU78OQFD) (Lovastatin - UNII:9LHU78OQFD)
Aphena Pharma Solutions - Tennessee, LLC
Lovastatin
Lovastatin 40 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: - 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 levels. Therapy wit
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Lovastatin Tablets USP (white to off white round, unscored tablets) containing 10mg of lovastatin and engraved with “CTI; 141" Bottle of 90 (NDC 42291-375-90) Lovastatin Tablets USP (white to off white round, unscored tablets) containing 20mg of lovastatin and engraved with "CTI; 142" Bottle of 90 (NDC 42291-376-90) Lovastatin Tablets USP (white to off white round, unscored tablets) containing 40mg of lovastatin and engraved with "CTI; 143" Bottle of 90 (NDC 42291-377-90) Bottle of 1000 (NDC 42291-377-10)
Abbreviated New Drug Application
LOVASTATIN - LOVASTATIN TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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 Կարդացեք ամբողջական փաստաթուղթը