国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
Ezetimibe; Simvastatin
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
C10BA02
TABLET
Ezetimibe 10mg; Simvastatin 20 mg
ORAL
Prescription Only
Watson Pharma Private Limited
ACTIVE
2020-04-17
151352_S1 - P: Ezetimibe / Simvastatin (Valcore), SG, Tablet, All strengths SMPC , Teva 01 29.01.2024 GP 190x500 mm Actavis Ltd., Zejtun ZTN 3000, MALTA 7.3 pt Black VALCORE TABLET I. THERAPEUTIC CLASS VALCORE TABLET is a lipid-lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous synthesis of cholesterol. II. ACTIVE INGREDIENTS VALCORE TABLET is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VALCORE TABLET 10 MG/10 MG) or 20 mg of simvastatin (VALCORE TABLET 10 MG/20 MG). III. INDICATIONS _PRIMARY HYPERCHOLESTEROLEMIA_ VALCORE TABLET is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non- HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non- familial) hypercholesterolemia or mixed hyperlipidemia. _HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)_ VALCORE TABLET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. IV. CLINICAL PHARMACOLOGY _IV A. MECHANISM OF ACTION_ EZETIMIBE-SIMVASTATIN TABLET Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. Ezetimibe-Simvastatin Tablet contains ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. Ezetimibe-Simvastatin Tablet reduces elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and increases HDL-C through dual inhibition of cholesterol absorption and synthesis. _EZETIMIBE_ Ezetimibe inhibits the intestinal absorption of cholesterol. Ezetimibe is orally active and has a mechanism of action that differs from other classes of cholesterol-reducing compounds (e.g., statins, b 阅读完整的文件