Synjardy XR(Empagliflozin and Metformin Hydrochloride Extended-release)Tablets-每日口服一次，适用于结合饮食和运动改善2型糖尿病（T2D）成人患者的血糖控制。
 2016年12月14日，美国FDA批准新型缓释片empagliflozin/metformin（商标名 SYNJARDY XR 勃林格殷格翰-礼来共同开发产品）用于治疗2型糖尿病成人。当配合饮食和运动，SYNJARDY XR可有效改善成年2型糖尿病成人患者的血糖水平。
  全世界范围约有4.15亿人患有糖尿病，它是一种由于身体不适当产生胰岛素或对胰岛素抵抗而发生的慢性病症。以美国数据为例，那些20岁及以上的成人大约有12％患有糖尿病。2型糖尿病是最常见的类型，占美国所有确诊成人糖尿病病例的90％到95％。
  SYNJARDY XR是empagliflozin和二甲双胍两种药物的组合，具有互补作用机制，有助于改善成人2型糖尿病的血糖。Empagliflozin是一种钠-葡萄糖共转运蛋白2的抑制剂，可通过阻断肾脏中的葡萄糖再吸收而去除过量的葡萄糖。
  SYNJARDY XR是第四个FDA批准的含有empagliflozin成分的治疗方案。二甲双胍是2型糖尿病的常规初始治疗手段，主要降低肝脏中葡萄糖的产生及其在肠道中的吸收。
  SYNJARDY XR获得FDA的批准是基于多个临床试验的结果，在成人2型糖尿病患者中评估了      empagliflozin和二甲双胍联合用药、或各自单独使用，以及与磺酰脲联合治疗的功效。目前，SYNJARDY XR不适用于治疗1型糖尿病或糖尿病酮症酸中毒。
  Boehringer Ingelheim的总裁兼首席执行官Paul Fonteyne先生说道：“患有2型糖尿病的成年人通常服用多种药物，有时每天需要服用多次药物。SYNJARDY XR是经FDA批准的与礼来合作的产品。无论对初治或经治2型糖尿病成人来说，他们现在又多有了一个方便的日常选择，以帮助他们达到控制血糖的目标。

SYNJARDY XR (Empagliflozin,Metformin HCl)
SYNJARDY XR Rx
Generic Name and Formulations:
Empagliflozin, metformin HCl ext-rel; 5mg/1000mg, 10mg/1000mg, 12.5mg/1000mg, 25mg/1000mg; tabs.
Company:
Boehringer Ingelheim and Lilly
Indications for SYNJARDY XR:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both empagliflozin and metformin is appropriate.
Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis.
Adult:
See full labeling. Swallow whole. Individualize. Take once daily with morning meal; increase dose gradually. Max daily dose: 25mg/2000mg.
Children:
<18yrs: not established.
Contraindications:
Moderate to severe renal impairment (eGFR <45mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.
Warnings/Precautions:
Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR 45–60mL/min/1.73m2, history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Correct volume depletion before initiating. Monitor for symptomatic hypotension in renal impairment, elderly, low systolic BP, or those on diuretics. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Assess renal function prior to starting and monitor periodically thereafter; more frequently in elderly or if eGFR <60mL/min/1.73m2. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Increased risk of genital mycotic infections, UTIs, or elevated LDL-C; monitor and treat as appropriate. Discontinue if hypersensitivity reaction occurs; treat promptly and monitor until resolve. Measure hematologic parameters annually (esp. serum Vit. B12 in susceptible patients). Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.
Interactions:
Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels; monitor. Avoid excessive alcohol. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Greater potential for volume depletion with concomitant diuretics. Consider a lower dose of concomitant insulin or 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:
UTIs, female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache; lactic acidosis (rare), hypotension, ketoacidosis, renal impairment, urosepsis, pyelonephritis, angioedema.
Generic Availability:
NO
How Supplied:
Tabs—60, 180; XR tabs 5mg/1000mg, 12.5mg/1000mg—60, 180; 10mg/1000mg, 25mg/1000mg—30, 90