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瑞格列奈-二甲双胍复方片-治疗2型糖尿病

2009-05-17 12:05:11  作者:佚名  来源:新特药房药讯  浏览次数:261  文字大小:【】【】【
简介:美国FDA批准PrandiMet上市,治疗第二型糖尿病 Manufacturer: Novo Nordisk and Sciele Pharma Pharmacological Class: Antidiabetic agent (meglitinide analogue + biguanide) Active Ingredient(s): R ...

制造商:
诺和诺德制药和Sciele

药理分类:
降糖剂(meglitinide模拟+双胍类)

活性成分(补):
瑞格列奈,二甲双胍500毫克1毫克;标签。

另外:
PRANDIMET 2mg/500mg
瑞格列奈,二甲双胍500毫克2毫克;标签。
指示(补):
配合饮食与2型糖尿病的运动。

药理作用:
PrandiMet是一种口服降糖剂,结合了两种不同的作用机制与药物改善2型糖尿病患者的血糖控制。瑞格列奈降低,刺激胰腺释放胰岛素的血糖。这一行动是在运作中的胰岛β细胞依赖性。二甲双胍是一种降血糖剂,​​降低基础和餐后血糖水平。它减少肝脏葡萄糖的产生,减少肠道对葡萄糖的吸收,并通过提高外周葡萄糖的摄取和利用胰岛素的敏感性。


法律分类:
接收

成人:
食物前30分钟内采取;给予2-3分剂量;个性化。以前在二甲双胍单:最初一1mg/500mg标签,每日两次。以前在瑞格列奈单:最初添加成分二甲双胍500毫克,每日两次。以前在这两个组件:切换到PrandiMet然后类似剂量滴定。每顿最多4mg/1000mg,或每天10mg/2500mg。如果隐瞒毒品餐被跳过。

儿童:
不推荐。

禁忌(补):
肾功能损害。代谢性酸中毒。糖尿病酮症酸中毒。伴随同时并用gemfibrozil和itraconazole。

警告/注意事项:
不适用于治疗1型糖尿病。避免在肝脏疾病。瑞士法郎,肾或肝功能不全,败血症,脱水,过量饮酒:乳酸性酸中毒的风险增加。确认启动前肾功能正常和监测(尤其是患者≥八十年)。监测血糖,肝功能,血液病(特别是血清Vit.B12水平)。如果停止乳酸性酸中毒,休克,急性心肌梗塞,败血症或低氧血症发生。如果发生脱水暂停治疗和手术前。应力。无偿剧烈运动,营养不良或热量不足,肾上腺或垂体功能不全,或急性酒精中毒:低血糖的风险增加。老人。虚弱。怀孕(Cat.C),哺乳期妇女:不推荐。

互动(补):
见禁忌。不能与NPH胰岛素的使用。暂停期间及治疗后的48血管造影剂的使用碘化小时。瑞格列奈potentiated由吉非贝齐和itraconazole。二甲双胍可能会增强由肾小管分泌(如阿米洛利,地高辛,吗啡,普鲁卡因胺,奎尼丁,甲氧苄啶,雷尼替丁,万古霉素),速尿,硝苯地平消除阳离子药物。可能会增强瑞格列奈被CYP3A4抑制剂(如酮康唑,克拉霉素)。瑞格列奈可拮抗CYP3A4的诱导剂(如利福平)。避免过量饮酒。利尿剂,类固醇,吩噻嗪,苯妥英,就是一例,钙通道阻滞剂,异烟肼,烟酸,则可能导致高血糖。与酒精的风险增加,磺脲类,胰岛素低血糖。 β-阻断剂可能掩盖了低血糖。

不良反应(补):
低血糖,头痛,胃肠不适;乳酸性酸中毒(少见,一半的病例是致命的)。

如何提供:
制表- 20,100

最后更新:
2009年5月28日

Manufacturer:

Novo Nordisk and Sciele Pharma

Pharmacological Class:

Antidiabetic agent (meglitinide analogue + biguanide)

Active Ingredient(s):

Repaglinide 1mg, metformin 500mg; tabs.

Also:

PRANDIMET 2mg/500mg
Repaglinide 2mg, metformin 500mg; tabs.

Indication(s):

Adjunct to diet and exercise in type 2 diabetes.

Pharmacology:

PrandiMet is an oral antidiabetic agent that combines two drugs with different mechanisms of action to improve glycemic control in patients with type 2 diabetes. Repaglinide lowers blood glucose by stimulating the release of insulin from the pancreas. This action is dependent upon functioning beta cells in the pancreatic islets. Metformin is an antihyperglycemic agent that lowers basal and postprandial blood glucose levels. It decreases hepatic glucose production, decreases the intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Legal Classification:

Rx

Adults:

Take within 30mins before food; give in 2–3 divided doses; individualize. Previously on metformin alone: initially one 1mg/500mg tab twice daily. Previously on repaglinide alone: initially add metformin component 500mg twice daily. Previously on both components: switch to similar doses of PrandiMet then titrate. Max 4mg/1000mg per meal, or 10mg/2500mg per day. Withhold drug if meal is skipped.

Children:

Not recommended.

Contraindication(s):

Renal impairment. Metabolic acidosis. Diabetic ketoacidosis. Concomitant both gemfibrozil and itraconazole.

Warnings/Precautions:

Not for treating type 1 diabetes. Avoid in hepatic disease. CHF, renal or hepatic dysfunction, sepsis, dehydration, excessive alcohol intake: increased risk of lactic acidosis. Confirm normal renal function before starting and monitor (esp. in patients ≥80years). Monitor blood glucose, hepatic function, hematology (esp. serum Vit.B12 levels). Discontinue if lactic acidosis, shock, acute MI, sepsis, or hypoxemia occurs. Suspend therapy if dehydration occurs and before surgery. Stress. Uncompensated strenuous exercise, malnourished or caloric deficiency, adrenal or pituitary insufficiency, or acute alcohol intoxication: increased risk of hypoglycemia. Elderly. Debilitated. Pregnancy (Cat.C), nursing mothers: not recommended.

Interaction(s):

See Contraindications. Not for use with NPH insulin. Suspend therapy during and for 48 hours after the use of intravascular iodinated radiocontrast agents. Repaglinide potentiated by gemfibrozil and itraconazole. Metformin may be potentiated by cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinidine, trimethoprim, ranitidine, vancomycin), furosemide, nifedipine. Repaglinide may be potentiated by CYP3A4 inhibitors (eg, ketoconazole, clarithromycin). Repaglinide may be antagonized by CYP3A4 inducers (eg, rifampin). Avoid excessive alcohol. Diuretics, steroids, phenothiazines, phenytoin, sympathomimetics, calcium channel blockers, isoniazid, niacin, others may cause hyperglycemia. Increased risk of hypoglycemia with alcohol, sulfonylureas, insulin. Beta-blockers may mask hypoglycemia.

Adverse Reaction(s):

Hypoglycemia, headache, GI upset; lactic acidosis (rare, half the cases are fatal).

How Supplied:

Tabs—20, 100

临床疗效:

一项为期18周的随机、双盲、安慰剂对照试验(包括6周的剂量调节期和随后12周的维持剂量期)的结果显示:在12周的维持剂量期间,瑞格列奈组患者的平均糖基化血红蛋白(HbA1c)值从8.5%下降至7.8%,而安慰剂组患者的平均HbA1c值从8.1%上升至9.3%(P<0.01)。与安慰剂组比较,瑞格列奈组平均空腹和餐后血糖浓度均明显下降(P<0.01),空腹和餐后胰岛素和C肽浓度则有明显上升(P<0.05)。

与格列本脲的临床对比试验表明在餐前每日2~3次口服瑞格列奈0.5~4mg与每日服用格列本脲2.5-15mg的疗效相当。

与二甲双胍对照试验的结果显示,瑞格列奈或二甲双胍单药治疗的效果没有明显差别,HbA1c值分别下降了0.4%和0.3%。两药联合应用,HbA1c值下降了(1.40.2)%,从8.3%下降至6.9%(P=0.0016),空腹血糖下降了2.2mmol/L(P=0.0003)。瑞格列奈单用和(或)与二甲双胍合用,空腹胰岛素水平分别提高了4.04mU/L和4.23mU/L(P<0.02)。

糖尿病是一种常见的内分泌代谢疾病,随着生活方式的改变和老龄化进程的加速,我国糖尿病的患病率正在呈快速上升趋势,成为继心脑血管疾病、肿瘤之后的另一个严重危害人民健康的重要慢性非传染性疾病。它的急、慢性并发症,尤其是慢性病并发症累及多个器官,致残、致死率高,严重影响患者的身心健康,并给个人、家庭和社会带来沉重的负担。

2型糖尿病是糖尿病人群的主体,占糖尿病患者的90%左右,2型糖尿病起病时症状比较隐蔽,很难在初发时即获确诊,但其患病率较高。一般用患病率对2型糖尿病的流行病学特点进行研究。近年来,世界各国2型糖尿病的患病率均有急剧增加的趋势,2型糖尿病患者激增是造成全世界糖尿病患者总数剧增的主要原因。

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