Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
LOVASTATIN (UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD)
RPK Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Therapy with Lovastatin Tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets 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 Tablets are indicated to reduce the risk of: - Myocardial infarction - Unstable angina - Coronary revascularization procedures (See CLINICAL PHARMACOLOGY , Clinical Studies in Adults .) 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 target levels. Therapy with lipid-altering agent
Product: 53002-5701 NDC: 53002-5701-3 30 TABLET in a BOTTLE NDC: 53002-5701-6 60 TABLET in a BOTTLE NDC: 53002-5701-0 100 TABLET in a BOTTLE
Abbreviated New Drug Application
LOVASTATIN- LOVASTATIN TABLET RPK PHARMACEUTICALS, INC. ---------- LOVASTATIN TABLETS, USP RX ONLY DESCRIPTION Lovastatin, USP is a cholesterol lowering agent isolated from a strain of _Aspergillus_ _terreus_. After oral ingestion, lovastatin, USP, 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, USP 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. Its structural formula is: C H O M.W. 404.55 Lovastatin, USP is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets, USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also contain FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain FD&C Blue #1 Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake. 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 Soma hati kamili