部分中文Jentadueto处方资料（仅供参考） FDA批准Jentadueto片应用于成人2型糖尿病治疗 勃林格殷格翰公司和礼来公司近日(NYSE: LLY)宣布Jentadueto(linagliptin/盐酸二甲双胍)片已经获得了美国食品和药品管理局 (FDA)的批准，该药是二肽基肽酶-4(DPP-4)抑制剂linagliptin和二甲双胍的新型复合片剂1。Linagliptin/盐酸二甲双胍的问世为需要改善血糖控制的2型糖尿病成年患者提供了全新的、每日服用两次的单一药片治疗选择1。 Linagliptin (5mg，每日给药一次)已经在美国以Tradjenta(linagliptin)片的形式上市，在欧洲和加拿大则以Trajenta为商品名上市，在日本和其他市场则以 Trazenta为商品名上市2,3，目前在中国尚未上市。 Linagliptin/盐酸二甲双胍治疗应基于饮食控制和体育锻炼之上，这一处方药物可应用于适合接受linagliptin和二甲双胍治疗的2型糖尿病成年患者，用以改善这些患者的血糖控制水平。在使用最大给药剂量的时候，linagliptin/盐酸二甲双胍可使得安慰剂校正的血红蛋白A1c（HbA1c或 A1C）出现高达1.7%的降幅 (安慰剂组为+0.1%，linagliptin/盐酸二甲双胍组为-1.6%)。A1C是糖尿病检测指标之一，可反映最近2个月到3个月的血糖控制水平。Linagliptin/盐酸二甲双胍不会导致任何具有临床意义的体重改变。Linagliptin/盐酸二甲双胍可单独使用，也可与2型糖尿病常用药物磺脲类药物联合使用。 Linagliptin/盐酸二甲双胍不应用于1型糖尿病或糖尿病酮症酸中毒(血液或尿液中的酮体含量增高)，目前尚未对该药与胰岛素的联合使用开展过研究。Linagliptin/盐酸二甲双胍的产品标签中包含有关乳酸酸中毒的加框警示，乳酸酸中毒是一种严重的代谢性并发症，由linagliptin/盐酸二甲双胍治疗过程中产生的二甲双胍蓄积所导致1。 “由于2型糖尿病具有复杂的发病机制，大多数2型糖尿病患者需要接受一种以上的药物治疗以降低其血糖水平，”来自德州肾脏和内分泌疾病研究所的 Lance Sloan博士如此说道。“Jentadueto获得批准是一个令人兴奋的消息，因为这种药物将两种降糖药复合成为单一片剂，从而为那些需要一种以上药物治疗、而且适合接受linagliptin和二甲双胍的患者提供了很好的治疗选择。” FDA批准两药复方片Jentadueto用于治疗2型糖尿病 2012年1月30日，礼来公司和勃林格殷格翰公司宣布美国食品药品管理局(FDA)已批准Jentadueto(利拉利汀/盐酸二甲双胍)用于改善成人2型糖尿病患者的血糖控制。该药适合作为饮食和运动疗法的辅助用药，用于同时适宜采用利拉利汀和二甲双胍治疗的患者。Jentadueto既可以单独用药，也可以与磺酰脲联合用药。 FDA批准利拉利汀/二甲双胍复方制剂是基于评价利拉利汀和二甲双胍作为单独片剂治疗糖尿病的临床试验结果。在最大剂量下，利拉利汀/二甲双胍组的血红蛋白A1c相对于安慰剂组的降幅达到1.7%(安慰剂组为+0.1%，利拉利汀/二甲双胍组为-1.6%)。健康受试者联合服用利拉利汀片和二甲双胍片显示与服用利拉利汀/二甲双胍复方制剂具有生物等效性。 Jentadueto治疗组中有≥5%的患者报告发生不良反应，该比例大于安慰剂对照组，不良反应包括鼻咽炎和腹泻。Jentadueto+磺酰脲联合治疗组与安慰剂+磺酰脲+二甲双胍联合治疗组相比，其报告发生低血糖的患者比例较高(分别为22.9%vs. 14.8%)。在这些研究中，服用利拉利汀/二甲双胍与任何明显的体重变化均无相关性。 Jentadueto的说明书中包含一个有关乳酸酸中毒的黑框警告。 Jentadueto是一种口服片剂，每日服用2次。 礼来公司2型糖尿病用药Jentadueto在美上市        勃林格殷格翰公司医药公司和礼来公司共同宣布Jentadueto（linagliptin/盐酸二甲双胍）片在美上市销售。 Jentadueto一天服用两次，能够帮助患者控制血糖，这是一种结合两种糖尿病药物linagliptin/盐酸二甲双胍的复方药。 美国食品药监局（FDA）于2012年1月30号批准Jentadueto上市销售，主要用于帮助2型糖尿病患者控制血液葡萄糖水平。 Jentadueto不能用于治疗1型糖尿病或者糖尿病酮症酸中毒症，而且其结合胰岛素治疗的也没有得到验证。 勃林格殷格翰公司公司心血管病副主席说：能够将两种有效的药物合成一种药，希望Jentadueto能够为2型糖尿病患者提供一种新的控制血糖的药物。在获得FDA批准后能够这么快将Jentadueto推向市场，主要是为了满足美国数以百万计的2型糖尿病患者的医疗需求. Twice-daily tablet to control blood sugar Product: Jentadueto Companies: Boehringer Ingelheim and Lilly Pharmacologic class: Dipeptidyl peptidase-4 inhibitor (DPP-4) + biguanide Active ingredients: Linagliptin, metformin HCl; 2.5 mg/500 mg, 2.5 mg/850 mg, 2.5 mg/1,000 mg; tablets. Indication: Adjunct to diet and exercise in type 2 diabetes when treatment with both linagliptin and metformin is appropriate. Pharmacology: Jentadueto is an antidiabetic product that combines linagliptin, a DPP-4 inhibitor, and extended-release metformin, a biguanide. Linagliptin slows the inactivation of incretin hormones, increasing their levels in the blood, leading to reduced fasting and postprandial glucose levels in a glucose-dependent manner. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Clinical trials: The coadministration of linagliptin and metformin was studied in type 2 diabetes patients inadequately controlled on diet and exercise and in combination with sulfonylurea. There have been no clinical efficacy studies conducted with Jentadueto; however, bioequivalence of Jentadueto to linagliptin and metformin coadministered as individual tablets was demonstrated in healthy subjects. Adults: Individualize. Take b.i.d. with meals. Previously not on metformin: initially 2.5 mg/500 mg b.i.d. Previously on metformin: Start with 2.5 mg linagliptin and current dose of metformin b.i.d. Previously on linagliptin and metformin: switch on mg/mg basis. Maximum 2.5 mg/1000mg b.i.d. Children: Not recommended. Contraindications: Renal impairment (serum creatinine ≥1.5 mg/dL [men], ≥1.4 mg/dL [women], or abnormal creatinine clearance). Metabolic acidosis, diabetic ketoacidosis. Warnings/Precautions: Not for treating type 1 diabetes. Confirm normal renal function before starting; monitor (especially in patients aged 80 years and older). Avoid in hepatic disease. Discontinue if lactic acidosis, shock, acute congestive heart failure or MI, sepsis, or hypoxemia occurs. Suspend therapy if dehydration occurs or before surgery. Monitor hepatic function, hematology (especially serum vitamin B12 in susceptible patients). Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Concomitant intravascular iodinated contrast agents (suspend during and for 48 hours after use). Pregnancy (Category B). Nursing mothers: not recommended. Interactions: Antagonized by strong P-gp or CYP3A4 inducers (e.g., rifampin); consider alternatives to linagliptin if used in combination. Concomitant sulfonylurea: may need lower dose of sulfonylurea to reduce risk of hypoglycemia. Cationic drugs eliminated by renal tubular secretion (e.g., amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin): may increase metformin levels. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide). Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, calcium channel blockers, isoniazid, nicotinic acid, others may cause hyperglycemia. Concomitant insulin: not studied Adverse reactions: Nasopharyngitis, diarrhea; hypoglycemia, hypersensitivity, cough, decreased appetite, nausea, vomiting, pruritus, pancreatitis. How supplied: Tabs—60, 180, 2,000 --------------------------------------------------------------- Jentadueto (linagliptin plus metformin hydrochloride) Company: Eli Lilly Approval Status: Approved February 2012 Treatment for: type II diabetes Areas: Diabetes / Endocrinology General Information Jentadueto is a fixed dose combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, plus metformin, which helps to control the amount of glucose in the blood. Jentadueto is specifically approved as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both linagliptin and metformin is appropriate. Jentadueto is supplied as a tablet for oral administration. Jentadueto should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended dose of 2.5 mg linagliptin/1000 mg metformin twice daily. The recommended starting dose is as follows: Subjects not currently treated with metformin: initiate treatment with 2.5 mg linagliptin/500 mg metformin hydrochloride twice dailySubjects already treated with metformin: start with 2.5mg linagliptin and the current dose of metformin taken at each of the two daily meals Subjects already treated with linagliptin and metformin: individual components may be switched to Jentadueto containing the same doses of each component. Clinical Results FDA Approval The FDA approval of Jentadueto was based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of Jentadueto was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects. A 24-week, randomized, double-blind, placebo-controlled factorial study enrolled 791 adults with type 2 diabetes and inadequate glycemic control with diet and exercise who received linagliptin plus metformin concurrently. At the maximum dose (2.5 mg linagliptin/1,000 mg metformin twice-daily) Jentadueto demonstrated placebo-corrected reductions in hemoglobin A(1c) (HbA(1c) levels of up to 1.7%(+0.1% for placebo and -1.6% for Jentadueto). Side Effects Adverse events associated with the use of Jentadueto may include, but are not limited to, the following: nasopharyngitis diarrhea hypoglycemia pancreatitis Mechanism of Action Jentadueto is a fixed dose combination of linagliptin plus metformin. Linagliptin is a dipeptidyl peptidase-4 (DPP-4)inhibito. DDP-4 is an enzyme that degrades the incretin hormones glucagon-like-peptide-1 (GLP-1) and glucose-dependent insulinotrophic polypeptide. Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the increase of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Metformin is an antihyperglycemic agent which improves glucose tolerance, lowering both basal and postprandial plasma glucose. 附件: 20096721474825.pdf -------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买时请以咨询为准！ -------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: JENTADUETO (2.5/1000)MG/TAB 60TABS/BOTTLE 原产地英文药品名: LINAGLIPTIN/METFORMIN HCL 中文参考商品译名: JENTADUETO (2.5/1000)毫克/片 60片/瓶 中文参考药品译名: 利拉利汀/盐酸二甲双胍 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM -------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: JENTADUETO (2.5/850)MG/TAB 60TABS/BOTTLE 原产地英文药品名: LINAGLIPTIN/METFORMIN HCL 中文参考商品译名: JENTADUETO (2.5/850)毫克/片 60片/瓶 中文参考药品译名: 利拉利汀/盐酸二甲双胍 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM -------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: JENTADUETO (2.5/500)MG/TAB 60TABS/BOTTLE 原产地英文药品名: LINAGLIPTIN/METFORMIN HCL 中文参考商品译名: JENTADUETO (2.5/500)毫克/片 60片/瓶 中文参考药品译名: 利拉利汀/盐酸二甲双胍 生产厂家中文参考译名: 勃林格殷格翰 生产厂家英文名: BOEHRINGER INGELHEIM 该药品相关信息网址1: https://www.jentadueto.com/ 该药品相关信息网址2: https://www.jentadueto.com/ 该药品相关信息网址3: http://www.medilexicon.com/drugs/jentadueto.php