美国FDA批准诺和诺德公司(Novo Nordisk)的瑞格列奈+盐酸二甲双胍复方片(replaglinide+metformin HCl,PrandiMet)上市,用于治疗2型糖尿病。本品剂量规格:瑞格列奈/盐酸二甲双胍 1 mg/500 mg,2 mg/500 mg。 本品是首个和唯一速效促分泌药瑞格列奈与胰岛素敏感药盐酸二甲双胍的固定剂量制剂。本品已被证明可降低不能采用美格列奈(meglitinide)和(或)二甲双胍很好地控制高血糖2型糖尿病成人患者的血糖。美国FDA批准本品是基于瑞格列奈/盐酸二甲双胍 1mg/500 mg,2mg/500 mg与相应剂量的瑞格列奈和盐酸二甲双胍单一药物制剂联用呈相近的生物等效性数据。 临床证明,本品可安全有效地降低血红蛋白A1c浓度。本品提供了两药在1片中方便服药的制剂。瑞格列奈刺激餐后胰腺分泌胰岛素,从而降低餐后2小时血糖(PPG),二甲双胍减少由肝产生的血糖量从而降低空腹血糖(FPG),改善人体对胰岛素的自然反应。本品不可用于治疗1型糖尿病或糖尿病酮酸中毒。 PRANDIMET 2mg/500mg Generic Name for PRANDIMET 2mg/500mgRepaglinide 2mg, metformin 500mg; tabs. Legal Classification:Rx Pharmacological Class for PRANDIMET 2mg/500mgMeglitinide analogue + biguanide. Manufacturer of PRANDIMET 2mg/500mgNovo Nordisk Indications for PRANDIMET 2mg/500mgAdjunct to diet and exercise in type 2 diabetes patients already treated with a meglitinide and metformin or who have inadequate glycemic control on a meglitinide alone or metformin alone. Adult dose for PRANDIMET 2mg/500mgTake 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's dosing for PRANDIMET 2mg/500mgNot recommended. Also:PRANDIMET 1mg/500mg
Contraindications for PRANDIMET 2mg/500mgRenal impairment. Metabolic acidosis. Diabetic ketoacidosis. Concomitant gemfibrozil. Warnings/Precautions for PRANDIMET 2mg/500mgNot 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. Interactions for PRANDIMET 2mg/500mgSee 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 concomitant 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 CYP2C8/3A4 inhibitors (eg, trimethoprim, ketoconazole, clarithromycin), OATP1B1 inhibitors (eg, cyclosporine). Repaglinide may be antagonized by CYP2C8/3A4 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. β-blockers may mask hypoglycemia. Adverse Reactions for PRANDIMET 2mg/500mgHypoglycemia, headache, GI upset; lactic acidosis (rare, half the cases are fatal). How is PRANDIMET 2mg/500mg supplied?Tabs—20, 100 部分中文瑞格列奈处方资料(仅供参考) Indication: Novo Nordisk and Sciele Pharmaceuticals announced the availability of PrandiMet (repaglinide and metformin HCl) tablets. PrandiMet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are already treated with a meglitinide and metformin HCl or who have insufficient glycemic control on a meglitinide alone or metformin HCl alone. It is the first and only fixed-dose combination of Prandin and insulin sensitizer metformin HCl for the treatment of type 2 diabetes in the United States. 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。 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。 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。 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。 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。 【原产地英文商品名】PRANDIMET (REPAGLINIDE 2MG/METFORMIN HCL 500MG)/100 tabs
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PRANDIMET(瑞格列奈/盐酸二甲双胍复方)简介:
美国FDA批准诺和诺德公司(Novo Nordisk)的瑞格列奈+盐酸二甲双胍复方片(replaglinide+metformin HCl,PrandiMet)上市,用于治疗2型糖尿病。本品剂量规格:瑞格列奈/盐酸二甲双胍 1 mg/500 mg,2 ... 责任编辑:admin |
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