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部分中文瑞格列奈处方资料（仅供参考）

中文名称：瑞格列奈

中文别名：(S)-2-乙氧基-4-[2-[3-甲基-1-[2-(1-哌啶基)苯基]-丁烷基]-氨基]-2-羰乙基苯甲酸; 瑞哌格列尼 

英文名称：Repaglinide

英文别名：4-Ethoxycarbonyl-3-ethoxy phenyl acetic acid; (S)-(+)-2-Ethoxy-4-[N-[1-(2-piperidinophenyl)-3-methyl-1-butyl]aminocarbonylmethyl]benzoic acid; 2-ethoxy-4-[2-({3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl}amino)-2-oxoethyl]benzoic acid; 2-ethoxy-4-[2-({(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl}amino)-2-oxoethyl]benzoic acid

药品类别：胰岛素及其他影响血糖药

药理毒理：非磺酰脲类促胰岛素分泌剂，本品与胰岛β细胞膜外依赖ATP的钾离子通道上的36KDA蛋白特异性结合，使钾通道关闭，β细胞去极化，钙通道开放，钙离子内流，促进胰岛素分泌，其作用快于磺酰脲类，故餐后降血糖作用较快。
 
药代动力学：据国外文献报导：瑞格列奈片经胃肠道快速吸收、导致血浆药物浓度迅速升高。服药后1小时内血浆药物浓度达峰值。然后血浆浓度迅速下降，4~6小时内被清除。血浆半衰期约为1小时。瑞格列奈片与人血浆蛋白的结合大于98％。瑞格列奈片几乎全部被代谢，代谢物未见有任何临床意义的降血糖作用。瑞格列奈片及其代谢产物主要自胆汁排泄，很小部分（小于8％）代谢产物自尿排出。粪便中的原形药物少于1％。

适应症：用于饮食控制及运动锻炼不能有效控制高血糖的2型糖尿病（非胰岛素依赖性）患者。瑞格列奈片可与二甲双胍合同。与各自单独使用相比，二者合用对控制血糖有协同作用。

用法用量：瑞格列奈片应在主餐前服用（即餐前服用）。在口服瑞格列奈片30分钟内即出现促胰岛素分泌反应。通常在餐前15分钟内服用本药。服药时间也可掌握在餐前0~30分钟内。请遵医嘱服用瑞格列奈片。剂量因人而异，以个人血糖而定。推荐起始剂量为0.5毫克，以后如需要可每周或每两周作调整。接受其它口服降血糖药治疗的病人可直接转用瑞格列奈片治疗。其推荐起始剂量为0.5毫克。最大的推荐单次剂量为4mg，进餐时服用。但最大日剂量不应超过16mg。对于衰弱和营养不良的患者，应谨慎调整剂量。如果与二甲双胍合用，应减少瑞格列奈片的剂量。尽管瑞格列奈主要由胆汁排泄，但肾功能不全的患者仍应慎用。 

不良反应
1．低血糖 这些反应通常较轻微，通过给予碳水化合物较易纠正。若较严重，可输入葡萄糖。
2．视觉异常 已知血糖水平的改变可导致暂时性视觉异常，尤其是在治疗开始时。只有极少数病例报告瑞格列奈片治疗开始时发生上述的视觉异常，但在临床试验中没有因此而停用瑞格列奈片的病例。
3．胃肠道 临床试验中有报告发生胃肠道反应，如腹痛、腹泻、恶心、呕吐和便秘。同其它口服降血糖药物相比，这些症状出现的频率以及严重程度均无差别。
4．肝酶系统 个别病例报告用瑞格列奈片治疗期间肝功酶指标升高。多数病例为轻度和暂时性，因酶指标升高而停止治疗的病人极少。
5．过敏反应 可发生皮肤过敏反应，如瘙痒、发红、荨麻疹。由于化学结构不同，没有理由怀疑可能发生与磺脲类药物之间的交叉过敏反应。

禁忌症
1．已知对瑞格列奈或本品中的任何赋型剂过敏的患者
2．1型糖尿病患者（胰岛素依赖型，IDDM）。
3．伴随或不伴昏迷的糖尿病酮症酸中毒患者。
4．妊娠或哺乳妇女。
5．8岁以下儿童。
6．严重肾功能或肝功能不全的患者。
7．与CYP3A4抑制剂或诱导剂合并治疗时。
 
注意事项
1．肾功能不良患者慎用，营养不良患者应调整剂量。
2．同其它大多数口服促胰岛素分泌降血糖药物一样，瑞格列奈片也可致低血糖。
3．与二甲双胍合用会增加发生低血糖的危险性。如果合并用药后仍发生持续高血糖，则不宜继续用口服降糖药控制血糖，而需改用胰岛素治疗。
4．在发生应激反应时，如发热、外伤、感染或手术，可能会出现显著高血糖。
5．瑞格列奈片尚未在肝功能不全的患者中进行过研究。也未在18岁以下或75岁以上的患者中进行过研究。故肝功能不全的患者审用。
6．患者必须慎用，不进餐不服药，同时避免开车时发生低血糖。
 
孕妇及哺乳期妇女用药
尚未在怀孕期或哺乳期妇女中进行研究。因此怀孕期和哺乳期妇女禁用。

儿童用药
瑞格列奈片尚未在18岁以下患者中进行过研究。故12岁以下儿童禁用。

老年患者用药
瑞格列奈片未在75岁以上的患者中进行过研究。故75岁以上的患者不宜使用。

药物相互作用
1．下列药物可增强瑞格列奈片的降血糖作用：单胺氧化酶抑制剂（MAOI），非选择性β受体阻滞剂，ACE抑制剂，非甾体抗炎药，水杨酸盐，奥曲肽，酒精以及促合成代谢的激素。β受体阻滞剂可能会掩盖低血糖症状。酒精可能会加重或延长由瑞格列奈片所致的低血糖症状。
2．下列药物可减弱瑞格列奈片的降血糖作用：口服避孕药，噻嗪类药，皮质激素，达那唑，甲状腺激素和拟交感神经药。
3．瑞格列奈片不影响地高辛、茶碱和法华令的药代动力学特性，西米替西丁也不影响瑞格列奈片的药代动力学特性。
4． 体外研究结果显示瑞格列奈片主要由P450（CYP3A4）诱导剂代谢。所以，CYP3A4抑制剂如酮康唑，伊曲康唑、红霉素、氟康唑、米比法地尔可能升高瑞格列奈片血浆水平。而能诱导CYP3A4的化合物如利福平或苯妥英可能降低瑞格列奈片血浆水平。因不了解其诱导或抑止的程度，应禁忌上述药物与瑞格列奈片合并使用。 
 
贮藏
避光，室温下密闭保存。

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."

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