Jentadueto(利拉利汀/盐酸二甲双胍)复方制剂 制造商: 类药物: 活性成分(S): 指示(S): 药理作用: 临床试验: 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: 成人: 儿童: 禁忌症(S): 警告/注意事项: 互动(补): 不良反应(S): 如何提供: 最后更新: 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是一种口服片剂,每日服用2次。 Manufacturer:Boehringer Ingelheim and Lilly Pharmacological Class:Dipeptidyl peptidase-4 inhibitor (DPP-4) + biguanide. Active Ingredient(s):Linagliptin, metformin HCl; 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1000mg; tablets. 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 |
Jentadueto(利拉利汀/盐酸二甲双胍)简介:
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/85 ... 责任编辑:admin |
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