---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（201161521374521.pdf）的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文匹伐他汀处方资料（仅供参考）

匹伐他汀—最新高胆固醇治疗药在美上市
2009年8月3日，美国食品药品监督管理局批准使用最大剂量为4mg的Livalo(pitavastatin，匹伐他汀)上市，用于伴有升高或异常血胆固醇水平的患者以改善症状。
FDA药物评估和研究中心的代谢和内分泌产品部门副主任EricC.Colman医学博士表示，“升高或异常的胆固醇水平与心脏病和中风的发生风险增加相关，这次的批准为患者及其医疗卫生专业人士提供了另一种治疗高胆固醇的方案。”
同其他他汀类药物一样，匹伐他汀适用于通过饮食控制和运动均无法降低其胆固醇水平的患者。匹伐他汀主要通过对一种叫作HMGCo-A还原酶的肝脏酶的抑制来降低肝脏制造胆固醇的能力，以此改善升高后的血胆固醇水平。
Livalo的批准是基于5项临床试验，这些试验将该药的安全性和有效性与3种已上市的他汀类药物进行了比较。服用Livalo时最常见的不良反应为肌痛、背痛、关节痛和便秘。Livalo由位于美国阿拉巴马州首府蒙哥马利市的科瓦制药（美国）公司（KowaPharmaceuticalsAmericaInc.）生产。

【匹伐他汀钙】最初的名字为依伐他汀（Itavastatin），又名Livalo、NIK-104、NK-104、NKS-104等，中文通用名目前药典委员会尚无统一，药监局现称为匹伐他汀钙。

【中文别名】伊伐他汀 CAS 147526-32-7

【英文名】Pitavastatin Calcium

【化学名】 (3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy -6-heptenoic acid，calcium salt(2:1)

【分子式】C50H46 Ca F2N2O8

【分子量】881.00

【类别】化学药品3.1类。

【适应症】临床用于高血脂症和家族性高胆固醇血症的治疗。

【产品简介】匹伐他汀是由日本Nissan Chem成功开发的第3代羟甲戊二酰辅酶A还原酶抑制剂(HMG-CoA)。HMG-CoA是治疗高胆固醇血症的首选药，也被药理学界赞誉为“现代医药史上的奇迹”。 HMG-CoA对羟甲戊二酰辅酶A还原酶有高度而专一的竞争性抑制，抑制肝脏合成胆固醇(CH)，使LDL-ch 受体合成增加，促使LDL-ch降解而降低脂血浓度；另外大剂量尚可降低血清TG水平。匹伐他汀（Pitavastatin）是能最有效地降低低密度脂蛋白胆固醇(LDL-C)水平，并升高高密度脂蛋白胆固醇(HDL-C)水平的药物之一。日本和欧洲的临床试验数据提示，pitavastatin对LDL-C、甘油三酯和HDL-C水平的调节作用比同类药物中的其他化合物都好。

What is LIVALO?
LIVALO is a prescription medicine that, along with diet, has been approved for the treatment of high cholesterol.
Important Safety Information for LIVALO

Who should NOT take LIVALO?
LIVALO is not right for everyone, including:
•Those who have had an allergic reaction to LIVALO
•Anyone with liver disease
•Patients with severe kidney disease not on hemodialysis
•Women who are nursing, pregnant, or who may become pregnant
•Anyone currently taking cyclosporine

What should I talk to my doctor about?
•If you take LIVALO, tell your doctor right away if you experience any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by fever or a general feeling of discomfort. This could be a sign of a rare but serious side effect.
•Your doctor should do blood tests to monitor your liver function before starting LIVALO, and then at 12 weeks following the start of LIVALO, after any increase in dose, and periodically (e.g., every 6 months) thereafter.
•Please talk to your doctor about your alcohol use.
•Tell your doctor about all the medications you take including nonprescription medicines, vitamins, or herbal supplements.

What are the most common side effects of LIVALO?
The most common side effects of LIVALO in clinical studies were:
•Back pain
•Constipation
•Diarrhea
•Muscle pain
•Pain in the legs or arms
This is not a complete list of side effects.

Other Important Information about LIVALO
•LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（201161521374521.pdf）的“原文Priscribing Information”为准
---------------------------------------------------------------