Atozet 易降脂

Atozet 易降脂

Name Ezetimibe / Atorvastatin
Chinese Name 易降脂
Brand Name Atozet
Dosing 10/10mg , 10/20mg
Administration 1. ATOZET 的劑量範圍為10/10 mg-ezetimibe/atorvastatin 10/20 mg，每日一次。ATOZET的起始建議劑量為10/10 mg或ezetimibe/atorvastatin 10/20 mg，每日一次。ATOZET可於一天當中的任何時間隨食物或不隨食物投予單一劑量。在開始使用ATOZET之後及/或調整劑量時，應於2週(含)以上的時間內進行血脂檢測，並據以調整劑量。
2. 患者應將ATOZET錠劑整粒吞服。不可將錠劑研碎、溶解或咀嚼使用。		 1. The dose range of ATOZET is 10/10 mg/day through 10/20 mg/day.
2. ATOZET is for oral administration. ATOZET can be administered as a single dose at any time of the day, with or without food.
Use: Labeled indication 高膽固醇血症，家族性高膽固醇血症
作為輔助療法，
 適用於對於單獨使用 atorvastatin 或 ezetimibe 治療仍無法控制的病人或
 已經正在使用 atorvastatin 或 ezetimibe		 ATOZET is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not.
Adverse Reactions ALT升高、AST升高、以及肌肉骨骼疼痛。 ALT and/or AST increased, myalgia
Contraindication 1. 活動性肝病或不明原因的肝臟轉胺酶持續升高。
2. 對ATOZET的任何成分過敏。		 Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Therapy with ATOZET is contraindicated during pregnancy and breast-feeding, and in women of child-bearing potential not using appropriate contraceptive measures (see section 4.6).
ATOZET is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases exceeding 3 times the upper limit of normal (ULN).
Warnings/Precautions 肌病變/橫紋肌溶解症,肝臟酵素,內分泌功能 Myopathy/Rhabdomyolysis, Liver Enzymeselevation
Drugs/Food Interactions 1. ATOZET 於使用statin類藥物治療期間發生肌病的風險會因同時投予fibric acid衍生物、降血脂劑量的niacin、cyclosporine、或強效的CYP3A4抑制劑(如clarithromycin、HIV蛋白酶抑制劑、itraconazole)而升高。
2. 本品若同時併用降脂膠囊、紅麴併用，可能會造成肝功能指數上升及血中肌酸激酶上升。
3. 葡萄柚汁含有一種(含)以上會抑制CYP3A4的成分，因此會使atorvastatin的血中濃度升高，尤其是在過量攝取葡萄柚汁(>每天1.2升)的情況下。		 Atorvastatin, a component of ATOZET, is metabolized by cytochrome P450 3A4 (CYP3A4) and is a substrate to transport proteins e.g., the hepatic uptake transporter OATP1B1. Concomitant administration of medicinal products that are inhibitors of CYP3A4 or transport proteins may lead to increased plasma concentrations of atorvastatin and an increased risk of myopathy. The risk might also be increased at concomitant administration of ATOZET with other medicinal products that have a potential to induce myopathy, such as fibric acid derivatives and ezetimibe
Mechanism of Action Ezetimibe
可抑制小腸的膽固醇吸收作用，從而降低血中膽固醇。
Atorvastatin
動物模型研究顯示，atorvastatin可抑制HMG-CoA還原酶與肝臟的膽固醇合成作用，並可增加細胞表面之肝臟LDL接受體的數量，促進LDL的吸收與代謝，從而降低血中膽固醇與脂蛋白的濃度；atorvastatin亦可降低LDL生成作用及LDL粒子的數量。		 Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. ATOZET contains ezetimibe and atorvastatin, two lipid-lowering compounds with complementary mechanisms of action. ATOZET reduces elevated total cholesterol (total-C), LDL-C, apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and increases high-density lipoprotein cholesterol (HDL-C) through dual inhibition of cholesterol absorption and synthesis.
Product Details - Product Description
Product Detials - Characteristic 複合藥物提高病人依從性, 兩種有效成份分別抑制小腸的膽固醇吸收作用及降低LDL生成作用,更有效降低血中膽固醇 Improve patient compliance as Atozet is a fixeddose combination. Dual action to reduce LDL-c level.
Origin Puerto Rico