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 详细处方信息以本药内容附件PDF文件（20212721463413.pdf,20212721462616.pdf）的“原文Priscribing Information”为准
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部分中文Janumet处方资料（仅供参考）

糖尿病新药Janumet获准在欧盟国家上市
    美国默克公司的糖尿病复方新药Janumet(Sitagliptin/Metformin Tablets) 于7月22日获准在欧盟27个成员国上市。
　　这种药物含有西他列汀和盐酸二甲双胍两种成分，可以解决Ⅱ型糖尿病患者3个关键的病症，即胰岛素缺乏、胰岛素流失和葡萄糖过剩，从而有效降低患者的血糖水平。与单独服用盐酸二甲双胍药物相比，Janumet可以更有效降低Ⅱ型糖尿病患者体重增加和发生低血糖的风险。
　　去年4月，美国食品和药物管理局批准Janumet在美国上市。到目前为止，这种药物已在全球50多个国家和地区获得上市批准。
　　糖尿病分为Ⅰ型糖尿病、Ⅱ型糖尿病和妊娠期糖尿病。Ⅰ型糖尿病患者体内只能产生少量或不能产生胰岛素；Ⅱ型糖尿病又称成年发病型糖尿病，特点是胰岛素抵抗，即自体能够产生胰岛素，但细胞无法对它作出反应；妊娠期糖尿病是指妇女妊娠怀孕期间患上糖尿病。

FDA批准复方制剂Janumet缓释片用于治疗2型糖尿病
    2012年2月2日，默克公司宣布美国食品药品管理局(FDA)已经批准Janumet XR(西他列汀/二甲双胍缓释片)用于治疗2型糖尿病。Janumet XR适合作为饮食和运动疗法的辅助用药，用于同时适宜采用西他列汀和缓释型二甲双胍治疗的2型糖尿病患者，以改善其血糖控制。
    Janumet XR以糖尿病的3个重要缺陷为靶点：胰岛β细胞引起的胰岛素缺乏、胰岛素抵抗以及肝脏葡萄糖生成过量。
    FDA批准Janumet XR是基于一项临床生物等效性研究的结果，该研究显示应用Janumet XR与相应剂量的这两种药物——西他列汀和缓释二甲双胍联用的效果相当。缓释二甲双胍与速释二甲双胍等效。
    据默克公司称，西他列汀与二甲双胍联合用药所能使血红蛋白A1c(HbA1c)水平降低的程度大于西他列汀或二甲双胍单独用药。在一项对1,091例通过饮食和运动疗法未能充分控制血糖的2型糖尿病患者进行的随机、双盲、安慰剂对照的析因研究中，在24周时，速释型二甲双胍与西他列汀联合用药、每日2次治疗组的HbA1c水平相对于安慰剂对照组降低。西他列汀100 mg、每日1次+速释型二甲双胍2000 mg、每日1次治疗组(n=178)基线时的平均HbA1c水平为8.8%，安慰剂调整的平均降幅为2.1%(P<0.001)。该研究的其他小组安慰剂调整的平均HbA1c降幅分别为1.6%(西他列汀100 mg、每日1次+速释型二甲双胍1000 mg、每日1次治疗组，n=183)、1.3%(速释型二甲双胍2000 mg、每日1次治疗组，n=177)，1.0%(速释型二甲双胍1000 mg、每日1次治疗组，n=178)及0.8%(西他列汀治疗组，n=175)(所有治疗组vs. 安慰剂组：P<0.001)。在24周时，初始治疗方案为西他列汀100 mg、每日1次+速释型二甲双胍2000 mg、每日1次的患者中有66%达到美国糖尿病学会(ADA)设定的目标血红蛋白A1c水平<7%，而采用速释型二甲双胍2000 mg、每日1次单药治疗组中有38%的患者达到此目标。在该研究的其他小组中，西他列汀100 mg、每日1次+速释型二甲双胍1000 mg、每日1次联合治疗组有43%、速释型二甲双胍1000 mg、每日1次治疗组有23%、西他列汀治疗组有20%的患者达到了ADA设定的血红蛋白A1c<7%的目标水平。
    Janumet XR的说明书中包含一个有关乳酸酸中毒的黑框警告，该药禁用于有肾功能损害的患者。
    目前已收到有关服用西他列汀联合(或不联合)二甲双胍的患者发生肾功能恶化的上市后报告，其中包括急性肾衰竭，有时甚至需要透析治疗。在开始Janumet治疗前及此后至少每年应进行一次肾功能评估，以确认其正常。
    此外，上市后报告还涉及急性胰腺炎，其中包括服用西他列汀联合(或不联合)二甲双胍的患者发生致死性和非致死性出血性或坏死性胰腺炎。在开始Janumet XR治疗后，应该对患者密切监测胰腺炎的症状和体征。若疑似胰腺炎，则应立即停用Jamumet XR，并开始适当的处置。有胰腺炎病史的患者在接受Janumet XR治疗的过程中发生胰腺炎的风险是否会增加，尚不清楚。
    市售的Janumet XR有100 mg西他列汀/1000 mg二甲双胍缓释片、50 mg西他列汀/500 mg二甲双胍缓释片以及50 mg西他列汀/1000 mg二甲双胍缓释片。Janumet XR的用法为每日1次，最好在晚餐后服用。应告知患者Janumet XR片在吞服前不得切割、压碎或咀嚼。
    Janumet XR的剂量应根据患者当前的治疗方案、有效性和耐受性采取个体化原则，同时不要超过西他列汀和二甲双胍的每日最大推荐剂量(分别为100 mg和2000 mg)。初始联合治疗或联合治疗的维持用药也应采取个体化原则，并由医务人员判断决定。对于已经开始二甲双胍治疗的患者，Janumet XR的每日总推荐开始剂量为西他列汀100 mg，二甲双胍仍遵循之前的处方剂量。

JANUMET (JAN-you-met) tablets contain 2 prescription medicines: sitagliptin (JANUVIA®) and metformin. JANUMET can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Your doctor will determine whether JANUMET is right for you.

JANUMET should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUMET.

Selected Risk Information About JANUMET
Metformin, one of the ingredients in JANUMET, can cause a rare but serious side effect called lactic acidosis (a buildup of lactic acid in the blood), which can cause death. Lactic acidosis is a medical emergency that must be treated in a hospital. Stop taking JANUMET and call your doctor right away if you get any of the following symptoms of lactic acidosis: you feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual sleepiness or sleep longer than usual; have sudden stomach or intestinal problems with nausea and vomiting or diarrhea; feel cold, especially in your arms and legs; feel dizzy or lightheaded; or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis if you have kidney problems, liver problems, or congestive heart failure that requires treatment with medicine; if you drink alcohol very often, drink a lot of alcohol in a short period of time, or get dehydrated (lose large amounts of body fluids); if you have certain x-ray tests with dyes or contrast agents that are injected into your body; if you have surgery, a heart attack, severe infection, or stroke; or if you are 80 years or older and have not had your kidneys tested.

Pancreatitis is another serious side effect that can happen in people taking JANUMET. Pancreatitis may be severe and lead to death. Before you start taking JANUMET, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUMET and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Do not take JANUMET if you are allergic to any of the ingredients in JANUMET. Allergic reactions, which may be serious, including rash; hives; and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have an allergic reaction, stop taking JANUMET and call your doctor right away.

Do not take JANUMET if you are going to receive an injection of dye or contrast agent for an x-ray procedure or if your kidneys are not working properly. Your doctor will do blood tests before and during your treatment with JANUMET to see how well your kidneys are working.

If you take JANUMET with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, and feeling jittery.

Kidney problems, sometimes requiring dialysis, have been reported.

Common side effects when taking JANUMET include stuffy or runny nose and sore throat, upper respiratory tract infection, diarrhea, nausea and vomiting, gas, upset stomach, indigestion, weakness, and headache.

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 详细处方信息以本药内容附件PDF文件（20212721463413.pdf,20212721462616.pdf）的“原文Priscribing Information”为准
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