Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
LOVASTATIN (UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD)
Blenheim Pharmacal, Inc.
LOVASTATIN
LOVASTATIN 20 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 tablets are indicated to reduce the risk of: - Myocardial infarction - Unstable angina - Coronary revascularization procedures (See CLINICAL PHARMACOLOGY, Clinical Studies.) Coronary Heart Disease: Lovastatin tablets are 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
Lovastatin Tablets, USP are available as follows: 10 mg — Each white, round, flat faced beveled edge tablet imprinted with on one side and 633 on the other side contains 10 mg of lovastatin. Tablets are supplied in bottles of 60 (NDC 0228-2633-06), with a child-resistant closure and 500 (NDC 0228-2633-50), without a child-resistant closure. 20 mg — Each pink, round, flat faced beveled edge tablet imprinted with on one side and 634 on the other side contains 20 mg of lovastatin. Tablets are supplied in bottles of 60 (NDC 0228-2634-06), with a child-resistant closure and 500 (NDC 0228-2634-50), without a child-resistant closure. 40 mg — Each yellow, round, flat faced beveled edge tablet imprinted with on one side and 635 on the other side contains 40 mg of lovastatin. Tablets are supplied in bottles of 60 (NDC 0228-2635-06), with a child-resistant closure and 500 (NDC 0228-2635-50), without a child-resistant closure. Dispense in a tight, light-resistant container as defined in the USP. Store between 5°-25°C (41°-77°F). Protect from light and store in a well-closed, light-resistant container. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 07207 USA 40-8843 Revised — January 2008
Abbreviated New Drug Application
LOVASTATIN- LOVASTATIN TABLET BLENHEIM PHARMACAL, INC. ---------- LOVASTATIN TABLETS, USP 40-8843 REVISED – JANUARY 2008 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 molecular formula of lovastatin is C H O and its molecular weight is 404.54. Its structural formula is: Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Each tablet for oral administration, contains 10 mg, 20 mg, or 40 mg of lovastatin. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Butylated hydroxyanisole is added as a preservative. The 20 mg tablet also contains D&C Red #30 aluminum lake. The 40 mg tablet also contains D&C Yellow #10 HT aluminum lake. 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 24 36 5 (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 ( Lees het volledige document