文档介绍：药品说明书此说明书说不包括安全并有效使用PrandiMet的所有信息。请参阅PrandiMet完整的处方信息。PrandiMet(瑞格列奈盐酸二甲双胍片):2008警告:乳酸性酸中毒请参阅黑框警告完整处方信息•由于二甲双胍蓄积可造成乳酸酸中毒,增加脓毒病、脱水、过量摄入酒精、肝损伤、肾损伤和充血性心力衰竭的危险。•症状表现为不适。肌痛、呼吸抑制、嗜睡增加和非特异性腹部不适。实验室检查出现pH值降低和血中乳酸盐增加。()•若疑有酸中毒,应停用Prandimet,并立即住院治疗。·······································适应症和使用·········································•ontrolonameglitinidealoneormetforminHClalone.(1)重要限制使用:•不要用来治疗1型糖尿病或糖尿病***酸症。(1)··································用法与用量·································•PrandiMet的用量应根据个人调整剂量(2)•从每日两次1mg/500mg剂量开始服用,除非患者已经高剂量服用瑞格列奈和二甲双胍联合使用。(2)•不超过10mg盐酸二甲双胍/瑞格列奈/2500mg每天或4mg瑞格列奈/1000mg盐酸二甲双胍每顿饭。(2)•分剂量在饭前15分钟内给予。(2)•跳过一顿饭的病人应跳过那顿饭对应的Prandmet的剂量。(2)······························剂型和强度·································片剂:•1mgrepaglinide/500mgmetforminHCl(3)•2mgrepaglinide/500mgmetforminHCl(3)········································禁忌症··············································不适用于以下患者:•肾损伤.(4,)•代谢性酸中毒,包括糖尿病***症酸中毒.(4,)•同时接受二甲苯氧庚酸和伊曲康唑.(4,,,)··································警告和预防措施··································•盐酸二甲双胍禁止适用于肾损伤患者。在使用Prandimet之前和以后每年一次肾功能检查应正常。(4,)•在接受放射性碘造影的患者暂时停止使用Prandimet()•乳酸性酸中毒与肝损害有关。建议肝损害患者不要使用()•酒精能增强二甲双胍对乳酸的代谢。警告患者不要过量饮酒()•PrandiMet不应与NPH胰岛素结合使用.()•吉非贝奇可以大大增加瑞格列奈在体内的暴露时间。不建议Prandimet和吉非贝奇何用(4,,,)•瑞格列奈成分可以导致低血糖。()•二甲双胍可导致维生素B12缺乏症。应当每年对血液指标进行测量.()•如果血糖控制能力或者在减少摄入的流体和食物(如感染、手术)期间恶化,可能需要停止使用Prandimet并暂时使用胰岛素。()•没有临床研究证明Prandimet或其他口服抗糖尿病药物能够减少大血管病变的风险。()······································不良反应·············································.•低血糖和头痛是最常见的不良反应(≥10%),据报道瑞格列奈和盐酸二甲双胍联合使用发生的不良反应事件比患者单独使用瑞格列奈或盐酸二甲双胍的多()•盐酸二甲双胍治疗的最常见的不良反应是胃肠道反应(如腹泻、恶心和呕吐),在较高剂量盐酸二甲双胍时发生更频繁。(,)可疑不良反应报告,联系诺和诺德公司1-888-NOVO-444orFDAat1-800-FDA-1088orwatch.········································药物相互作用·············································•阳离子药物通过肾小管代谢可能会干扰二甲双胍消除:谨慎使用。()•。()患者信息咨询请参阅17修订:6/20081全处方信息:内容*警告-乳酸酸性中毒1 