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SYNJARDY tablets（恩格列净/盐酸二甲双胍复方片）

2016-01-11 01:40:07 作者：新特药房来源：互联网浏览次数：0 文字大小：【大】【中】【小】

简介： 新型降糖单片复方制剂Synjardy已获美国及欧盟批准上市，Synjardy（恩格列净/盐酸二甲双胍 empagliflozin and metformin hydrochloride）用于辅助运动和饮食以改善成人2型糖尿病患者的血糖控制。Synjard ...

关键字：恩格列净/盐酸二甲双胍复方片 empagliflozin and metformin hydrochloride 商品名Synjardy 用于成人2型糖尿病

新型降糖单片复方制剂Synjardy已获美国及欧盟批准上市，Synjardy（恩格列净/盐酸二甲双胍 empagliflozin and metformin hydrochloride）用于辅助运动和饮食以改善成人2型糖尿病患者的血糖控制。Synjardy是由SGLT-2抑制剂empagliflozin与盐酸二甲双胍组成的复方制剂，适用于单用empagliflozin或二甲双胍后血糖控制不佳的患者。
批准日期：2015年8月28日（美国）2015年6月5日（欧盟） 公司：勃林格殷格翰-礼来糖尿病联盟
SYNJARDY®（恩格列净/盐酸二甲双胍 empagliflozin and metformin hydrochloride）片，供口服使用
美国首次批准：2015年
警告：
风险乳酸ACIDOSISSee完整处方信息了解完整的黑框警告。
乳酸性酸中毒可能是由于二甲双胍积累。的风险增加了与诸如肾损伤，败血症，脱水，过量饮酒，肝功能不全，急性和充血性心脏衰竭的条件。
症状包括全身不适，肌肉疼痛，呼吸困难，增加嗜睡和非特异性腹痛困扰。实验室检查异常包括低pH值，增加阴离子间隙，以及升高血乳酸。
如果酸中毒被怀疑，停止SYNJARDY并立即就医患者.
目前的主要变化
警告和注意事项 12/2015
ActionSYNJARDY机制
SYNJARDY结合2抗高血糖药物的行动的互补机制，改善血糖控制的患者的2型糖尿病：empagliflozin，钠 - 葡萄糖协同转运2（SGLT2）抑制剂和二甲双胍，双胍类的一个成员。
Empagliflozin
钠-葡萄糖协同转运2（SGLT2）负责从肾小球滤液回循环再吸收葡萄糖的主要转运蛋白。Empagliflozin是SGLT2的抑制剂。通过抑制SGLT2，empagliflozin减少过滤的葡萄糖重吸收的肾和降低肾阈葡萄糖，并由此增加尿葡萄糖排泄。
盐酸二甲双胍
二甲双胍是一种降血糖剂，其改善葡萄糖耐受患者的2型糖尿病，降低基础和餐后血糖。它不是化学或药理学上相关的任何其它类的口服抗高血糖剂。二甲双胍降低肝葡萄糖生产，降低葡萄糖的肠吸收，并通过增加外周葡萄糖摄取和利用提高胰岛素的敏感性。不同的SU，二甲双胍不会产生低血糖在任何例2型糖尿病或正常人（特殊情况除外）[见警告和注意事项]，并不会导致高胰岛素血症。与二甲双胍治疗，胰岛素的分泌保持不变，而空腹胰岛素水平和一天的血浆胰岛素反应实际上可能会降低。
适应症和用法
SYNJARDY是empagliflozin的组合，钠-葡萄糖协同转运2（SGLT2）抑制剂和二甲双胍，双胍类，表示作为辅助饮食和锻炼，以改善血糖控制成人2型糖尿病谁不充分控制上含empagliflozin或二甲双胍的方案，或在患者已经接受治疗既empagliflozin和二甲双胍。
限制使用：
不适用于1型糖尿病或糖尿病酮症酸中毒的治疗.
用法用量
个性SYNJARDY的基于患者的当前治疗方案的起始剂量.
最大推荐剂量为12.5毫克empagliflozin/1000毫克二甲双胍每日两次.
每日两次随餐服用，并逐渐增加剂量，以减少胃肠道副作用，由于二甲双胍
启动SYNJARDY前评估肾功能。不开始或继续SYNJARDY如果肌酸酐水平大于或等于1.5毫克/分升的男性或1.4毫克/分升的女性，或如果eGFR的是低于45毫升/分钟/1.73平方米.
剂型和规格
片剂：
5毫克 empagliflozin/500毫克的盐酸二甲双胍
5毫克 empagliflozin/1000毫克的盐酸二甲双胍
12.5毫克 empagliflozin/500毫克的盐酸二甲双胍
12.5毫克 empagliflozin/1000毫克二甲双胍盐酸盐
禁忌
肾功能不全，终末期肾病，或透析.
代谢性酸中毒，包括糖尿病酮症酸中毒.
严重过敏反应的历史，以empagliflozin或二甲双胍.
警告和注意事项
乳酸性酸中毒：警告不要过度饮酒。 SYNJARDY不建议在肝功能不全或缺氧状态，并禁用于肾功能损害。发起此后每年至少前确保正常的肾功能。
低血压：在利尿剂启动SYNJARDY评估和正确的卷状态的肾损害患者，老年人，患者低收缩压和患者。监测治疗期间的症状和体征。
酮症酸中毒：评估病人谁与标志和代谢性酸中毒的酮症酸中毒的症状出现，无论血糖水平。如果怀疑，停止SYNJARDY，评估和治疗及时。在启动SYNJARDY，考虑风险因素酮症酸中毒。在SYNJARDY患者可能需要监测和治疗暂时中止在已知诱发酮症酸中毒临床情况。
肾功能损害：在治疗期间监测肾功能。
放射学研究和手术方法：暂时停止SYNJARDY的经历与对比剂的材料或任何外科手术迫使食物和液体摄入限制的血管内给药放射学检查的患者。
尿脓毒症和肾盂肾炎：评估患者症状和泌尿道感染症状和治疗及时，在指定
低血糖：考虑降低胰岛素分泌或胰岛素的剂量开始SYNJARDY时减少低血糖的风险
生殖器真菌感染：监测和治疗适当.
维生素B12缺乏：二甲双胍可降低维生素B12水平。每年监测血液学参数。
增加LDL-C：监测和治疗适当.
大血管的结果：有建立大血管还原SYNJARDY风险的结论性证据没有临床研究。
不良反应
与empagliflozin（5％或更高的发病率）有关的最常见的不良反应是尿路感染，女性外阴真菌感染。
与二甲双胍相关的最常见不良反应（> 5％）为腹泻，恶心/呕吐，胀气，上腹不适，消化不良，乏力，头痛。
药物相互作用
由肾小管分泌消除阳离子药物：可减少二甲双胍消除。请谨慎使用。
特殊人群中使用
妊娠：孕妇没有足够和良好对照的研究。在怀孕期间使用只有在潜在的好处辩解潜在的风险对胎儿。
哺乳母亲：请停止SYNJARDY或停止哺乳.
老年患者：与血容量不足和肾功能降低不良反应的发生率较高.
肾功能不全患者：与减少肾功能不良反应的发生率较高.
包装规格/储存与处理
SYNJARDY（恩格列净/盐酸二甲双胍）片剂有以下优势和封装：
SYNJARDY tablets 5mg/500mg empagliflozin and metformin hydrochloride Bottles of 60   0597-0159-60
SYNJARDY tablets 5mg/500mg empagliflozin and metformin hydrochloride Bottles of 180   0597-0159-18
SYNJARDY tablets 5mg/1000mg empagliflozin and metformin hydrochloride Bottles of 60   0597-0175-60
SYNJARDY tablets 5mg/1000mg empagliflozin and metformin hydrochloride Bottles of 180   0597-0175-18
SYNJARDY tablets 12.5mg/500mg empagliflozin and metformin hydrochloride Bottles of 60   0597-0180-60
SYNJARDY tablets 12.5mg/500mg empagliflozin and metformin hydrochloride Bottles of 180   0597-0180-18
SYNJARDY tablets 12.5mg/1000mg empagliflozin and metformin hydrochloride Bottles of 60   0597-0168-60
SYNJARDY tablets 12.5mg/1000mg empagliflozin and metformin hydrochloride Bottles of 180   0597-0168-18
存储
储存于25°C（77°F）;游览允许15°-30°C（59°-86°F）[见USP控制室温。在一个安全的地方存放在儿童接触不到的地方。

Synjardy (empagliflozin and metformin hydrochloride)
• Synjardy® combines two products with different mechanisms of action to improve glycaemic control in patients with T2D
• Side effects identified with Synjardy® are consistent with known safety profiles of the individual compounds
General Information
Synjardy is a combination of empagliflozin and metformin, two medicines with complementary mechanisms of action. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin lowers glucose production by the liver and its absorption in the intestine.
Synjardy is specifically indicated an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin.
Synjardy is supplied as a tablet for oral administration. Synjardy comes in the following dose strengths:
5mg empagliflozin/500mg metformin hydrochlorideth
5mg empagliflozin/1000mg metformin hydrochloride
12.5mg empagliflozin/500mg metformin hydrochloride
12.5mg empagliflozin/1000mg metformin hydrochloride
Individualize the starting dose of Synjardy based on the patient’s current regimen:
In patients on metformin, switch to Synjardy containing empagliflozin 5 mg with a similar total daily dose of metformin;
In patients on empagliflozin, switch to Synjardy containing metformin 500 mg with a similar total daily dose of empagliflozin;
In patients already treated with empagliflozin and metformin, switch to Synjardy containing the same total daily doses of each component.
Take Synjardy twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.
In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating Synjardy.
Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin 2000 mg and empagliflozin 25mg
SYNJARDY Rx
Generic Name and Formulations:
Empagliflozin, metformin HCl; 5mg/500mg, 12.5mg/500mg, 5mg/1000mg, 12.5mg/1000mg; tabs.

Company:
Boehringer Ingelheim and Lilly
Indications for SYNJARDY:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on metformin or empagliflozin regimen, or who are already being treated with both.

Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:
See full labeling. Individualize. Take twice daily with meals; increase dose gradually. Max daily dose: 25mg/2000mg.

Children:
<18yrs: not established.

Contraindications:
Renal impairment (SCr ≥1.5mg/dL [men], ≥1.4mg/dL [women], or eGFR <45mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.

Warnings/Precautions:
Confirm normal renal function before starting and monitor thereafter (esp. in elderly). Discontinue if lactic acidosis, renal impairment, shock, acute MI or CHF, hypoxemia, dehydration, or sepsis occur. Avoid in hepatic disease. Discontinue prior to any intravascular radiocontrast study or surgery; withhold for 48hrs after procedure. Correct volume depletion before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment, low systolic BP, on diuretics). Elderly, debilitated, uncompensated strenuous exercise, malnourished, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor for genital mycotic infections, UTIs, Vit. B12 deficiency, increases in LDL-C; treat if occur. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin); may increase metformin levels; monitor. Increased risk of lactic acidosis with topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide). Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Avoid excessive alcohol. Concomitant drugs that may affect renal function or metformin disposition; monitor. Concomitant insulin or insulin secretagogue: consider a lower dose of insulin/insulin secretagogue to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.

Pharmacological Class:
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + biguanide.

Adverse Reactions:
UTI, female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache; lactic acidosis (rare), hypotension, hepatic or renal impairment.

Generic Availability:
NO

How Supplied:
Tabs—60, 180
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fdd0255-0055-65f3-b2c0-db8fbb87beae