部份中文瑞格列奈处方资料（仅供参考）
英文名：repaglinide
商品名：Prandin
中文名：瑞格列奈片
生产商：诺和诺德
药品介绍
批准日期：1997年12月22日 公司：
PRANDIN（瑞格列奈[repaglinide]）片剂，用于口服
最初的美国批准：1997年
最近的重大变化
•剂量和用量：2/2017
作用机制
瑞格列奈通过刺激胰腺释放胰岛素来降低血糖水平。这一作用取决于胰岛中β（β）细胞的功能。 胰岛素释放是葡萄糖依赖性的并且在低葡萄糖浓度下减少。
瑞格列奈通过在特征性位点结合来封闭β细胞膜中的ATP依赖性钾通道。 这种钾通道阻滞使β细胞去极化，导致钙通道开放。由此产生的钙流入增加诱导胰岛素分泌。离子通道机制是高度组织选择性的，对心脏和骨骼肌的亲和力低。
适应症和用法
PRANDIN是一种glinide，可作为饮食和运动的辅助手段，用于改善2型糖尿病患者的血糖控制。
使用限制：
不适用于治疗1型糖尿病或糖尿病酮症酸中毒。
剂量和给药
•如果HbA1c小于8％，则每餐前推荐的起始剂量为0.5 mg;如果HbA1c为8％或更大，则每餐前口服1或2mg。
•推荐剂量范围为饭前0.5毫克至4毫克，最大日剂量为16毫克。
•每餐的患者剂量应增加一倍至4毫克，直至达到令人满意的血糖控制。每次剂量调整后至少应过一周评估反应。
•如果跳过一餐，指导患者跳过PRANDIN的剂量。患有低血糖的住院患者，应减少PRANDIN的剂量。
•指导患者在饭前30分钟内服用PRANDIN。
•对于严重肾功能不全（CrCl=20-40 mL/min）的患者，每餐前推荐的起始剂量为0.5mg口服。
•与某些药物同时使用时，需要进行剂量调整。
剂量形式和强度
片剂：0.5mg，1mg，2mg
禁忌症
•与gemfibrozil同时使用
•已知对瑞格列奈或任何非活性成分过敏
警告和注意事项
•低血糖：PRANDIN可能导致低血糖。如果跳过一餐，则跳过预定的PRANDIN剂量以降低低血糖的风险。如果发生低血糖，减少PRANDIN的剂量。
•伴随NPH-胰岛素的严重心血管不良反应：PRANDIN不适用于与NPH-胰岛素联合使用。
•宏观血管结果：没有临床研究确定用PRANDIN确定大血管风险降低的确凿证据。
不良反应
在接受PRANDIN治疗的患者中，最常见的不良反应（发生率为5％或更高）为：低血糖，上呼吸道感染，头痛，鼻窦炎，关节痛，恶心，腹泻和背痛。
要报告疑似不良反应，请致电1-800-FDA-1088或www.fda.gov/medwatch联系Novo Nordiskat 1-800-727-6500或FDA。
药物相互作用
•氯吡格雷：避免同时使用;如果在每餐前同时使用0.5mg，则将每日总剂量限制在4mg
•环孢菌素：将PRANDIN的每日剂量限制在6 mg，并在共同给药时增加葡萄糖监测的频率
•可能增加低血糖风险的CYP2C8和CYP3A4抑制剂和药物：共同给药可能需要PRANDIN剂量减少和葡萄糖监测频率增加
•CYP2C8和CYP3A4诱导剂和药物可降低血糖降低PRANDIN的作用：共同给药可能需要PRANDIN剂量增加和葡萄糖监测频率增加
•可能导致低血糖症征和症状的药物：共同给药可能需要增加频率的葡萄糖监测
用于特定人群
哺乳母亲：停止PRANDIN或护理
包装如何提供/存储和处理
PRANDIN（瑞格列奈）片剂以双凸面片剂形式提供，有0.5毫克（白色），1毫克（黄色）和2毫克（桃子）强度，并用诺和诺德（Apis）公牛符号压花。
0.5mg片剂瓶100 NDC 0169-0081-81
  （白色）500 NDC 0169-0081-82瓶
1mg片剂100瓶NDC 0169-0082-81
  （黄色）500 NDC 0169-0082-82瓶
2mg片剂瓶100 NDC 0169-0084-81
  （桃子）500 NDC 0169-0084-82瓶
储存在20o至25o C（68o至77o F）[见USP Controlled Room Temperature]。
防潮。 保持瓶子紧闭。
在带有安全盖的紧密容器中进行分配。
完整说明资料附件：https://www.novo-pi.com/prandin.pdf 
Brand name in US: Prandin™ (in USA); NovoNorm™ (elsewhere).
Class: meglitinides (nonsulfonylurea oral hypoglycemic agents)
For: Type 2 Diabetes
Route of Administration: oral
Dose: 0.5 - 4.0 mg before each meal; maximum of 16 mg/day
Action: enhances insulin secretion; works differently than sulfonylurea; fast-acting, and short duration of action concentrates its effect around meal time
Manufacturer: Novo Nordisk; developed in cooperation with Boehringer Ingelheim GmBH.
Status: New Drug Application filed with the FDA June, 1997; Preliminary approval from the FDA Endocrine Advisory Committee November 20, 1997; approved by FDA December, 1997. In final stages of clinical trials in Europe. Available in the USA.
Other drugs in same class: nateglinide
(BW)(NOVO-NORDISK/PRANDIN)(NVO) US Food and Drug Administration Approves Prandin, New Oral Treatment for Type 2 Diabetes
BAGSVAERD, Denmark--(BUSINESS WIRE)--Dec. 23, 1997--Novo Nordisk A/S (NYSE:NVO) today announced that the United States Food and Drug Administration (FDA) has approved Prandin(TM) (repaglinide), a new anti-diabetic agent for treatment of Type 2 diabetes.
Lars Rebien Sorensen, Corporate Executive Vice President, head of Health Care at Novo Nordisk said, "We are extremely pleased to have received an approval from the FDA so quickly. We believe that Prandin™ strengthens the physicians' treatment armamentarium and offers people with Type 2 diabetes therapeutic advantages over other existing oral anti-diabetic drugs."
Bill Poole, President, Novo Nordisk Pharmaceuticals Inc., said, "Prandin™ helps people with Type 2 diabetes to manage their diabetes specifically when they need to-at mealtimes. Prandin™ is a highly potent, fast-working agent that is absorbed rapidly after dosing and cleared quickly from the bloodstream. We are very eager to introduce this exciting new product to the US marketplace so that physicians and patients with Type 2 diabetes may experience the benefits of Prandin™ for the treatment of this disease."
Prandin™ Basics
Prandin™ is the first approved product in a new chemical class (meglitinide class) of orally administered drugs for the treatment of Type 2 diabetes and was developed to manage meal related (prandial) glucose loads. It is different from other oral anti-diabetic agents in structure and clearance. Its quick onset and short duration of action concentrates its effect around meal time glucose load, which is important to the treatment of Type 2 diabetes.
The starting dose of Prandin™ in oral hypoglycemic agent (OHA) naive patient or patients with HbA1c_<8% is 0.5 mg before each meal. In OHA treated patients with HbA1c>8% the starting dose is 1 or 2 mg before each meal. The dose can be adjusted by physicians up to 4 mg before each meal. If a meal is skipped, so is the Prandin™ tablet; if a meal is added during the day, a tablet is added for that meal.
Prandin™ stimulates insulin secretion from the beta cells of the pancreas by binding to sites on the beta cell. Prandin™ is minimally excreted by the kidney, which may be an advantage for patients (often elderly) who often suffer from decreased kidney function.
Prandin™ was developed in cooperation with the German pharmaceutical company Boehringer Ingelheim GmBH. The agent is in-licensed by Novo Nordisk for worldwide development and marketing. The product trade name outside the US will be NovoNorm™.
Novo Nordisk filed for regulatory approval of Prandin™ with the FDA and the European authorities in June 1997. The product received priority review status from the FDA in August, and in November the FDA Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of Prandin™. Prandin™ will be available in the US in Spring 1998.
Novo Nordisk A/S is the world leader in insulin and diabetes care and also manufactures and markets a variety of other pharmaceutical products. Furthermore the company is the world's largest producer of industrial enzymes. Headquartered in Denmark, Novo Nordisk employs approximately 13,900 people n 61 countries and markets its products in 130 countries. Its B shares are listed on the stock exchanges in Copenhagen, London and Zurich. Its ADSs are listed on the New York Stock Exchange under the symbol "NVO."