Jentadueto(利拉利汀/盐酸二甲双胍)复方制剂

制造商：
勃林格殷格翰和礼来公司

类药物：
二肽基肽酶4抑制剂（DPP-4）+双胍类。

活性成分（S）：
的linagliptin，盐酸二甲双胍; 2.5mg/500mg的，2.5mg/850mg的，2.5mg/1000mg;片。

指示（S）：
在2型糖尿病linagliptin和二甲双胍治疗是适当的饮食和锻炼的辅助。

药理作用：
jentadueto是结合linagliptin，DPP-4抑制剂，缓释二甲双胍，1双胍类降糖产品。 linagliptin减慢肠促胰岛素激素的灭活，提高他们的水平，导致血液中葡萄糖依赖性降低空腹和餐后血糖水平。二甲双胍降低肝葡萄糖生产，减少肠道对葡萄糖的吸收，增加周边葡萄糖的摄取和利用，提高胰岛素的敏感性。

临床试验：
linagliptin和二甲双胍合用在2型糖尿病患者不足与磺酰脲类控制饮食和锻炼，并结合研究。

有没有研究与Jentadueto进行临床疗效;然而，生物等效性Jentadueto linagliptin和二甲双胍作为独立片并用正常人证明。

法律分类：
RX

成人：
个性化。采取每天两次餐。以前没有二甲双胍：最初2.5mg/500mg，每日两次。先前二甲双胍：每公升2.5毫克的linagliptin及二甲双胍的剂量，每日两次开始。 linagliptin和二甲双胍以前：毫克/毫克的基础上的开关。最大2.5mg/1000mg每日两次。

儿童：
不推荐使用。

禁忌症（S）：
肾功能不全（血清肌酐≥1.5mg/dL [男性]，≥1.4mg/dL [妇女]，或异常肌酐清除率）。代谢性酸中毒，糖尿病酮症酸中毒。

警告/注意事项：
不用于治疗1型糖尿病。确认开始前肾功能正常;显示器（尤其是在患者≥80岁）。避免在肝脏疾病。停止，如果发生乳酸性酸中毒，休克，急性心衰或心肌梗死，脓毒症，或低氧血症。暂停治疗，如果发生脱水或手术前。监测肝功能，血液（尤其是易感患者血清中维生素B12的）。老人，体弱，无偿剧烈运动，营养不良或缺乏热量的摄入，肾上腺或垂体功能不全，或酒精中毒：低血糖的风险增加。伴随血管造影剂（期间暂停使用后48小时）。怀孕（部件）。哺乳母亲：不推荐。

互动（补）：
对抗强大的P-糖蛋白或CYP3A4诱导剂（如利福平）;结合使用linagliptin如果考虑替代品。伴随磺酰脲类：可能需要低剂量的磺脲类药物，以减少低血糖的风险。淘汰的阳离子药物通过肾小管分泌（例如，阿米洛利，西咪替丁，地高辛，吗啡，普鲁卡因胺，奎尼丁，奎宁，雷尼替丁，氨苯喋啶，甲氧苄啶，万古霉素）：可能会增加二甲双胍水平。避免过量饮酒（potentiates影响二甲双胍对乳酸）。托吡酯，其他碳酸酐酶抑制剂（如唑尼沙胺，乙酰唑胺，dichlorphenamide）乳酸性酸中毒的危险性增加。利尿剂，类固醇，酚噻嗪，甲状腺产品，雌激素，口服避孕药，苯妥英钠，拟交感神经药，钙通道阻滞剂，异烟肼，烟酸，别人可能会导致高血糖。 concom itant胰岛素：没有研究。

不良反应（S）：
鼻咽炎，腹泻，低血糖，过敏，咳嗽，食欲不振，恶心，呕吐，皮肤瘙痒，胰腺炎下降。

如何提供：
标签-60，180，2000

最后更新：
2012年3月12日

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。

Indication(s):

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.

Legal Classification:

Rx

Adults:

Individualize. Take twice daily with meals. Previously not on metformin: initially 2.5mg/500mg twice daily. Previously on metfor­min: Start with 2.5mg linagliptin and current dose of metformin twice daily. Previously on linagliptin and metformin: switch on mg/mg basis. Maximum 2.5mg/1000mg twice daily.

Children:

Not recommended.

Contraindication(s):

Renal impairment (serum creatinine ≥1.5mg/dL [men], ≥1.4mg/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 ≥80 years). Avoid in hepatic disease. Discontinue if lactic acidosis, shock, acute CHF 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 (Cat. B). Nursing mothers: not recommended.

Interaction(s):

Antagonized by strong P-gp or CYP3A4 inducers (eg, 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 (eg, 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 (eg, 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 Reaction(s):

Nasopharyngitis, diarrhea; hypoglycemia, hypersensitivity, cough, decreased appetite, nausea, vomiting, pruritus, pancreatitis.

How Supplied:

Tabs—60, 180, 2000