瑞格列奈二甲双胍片说明书.docxVIP

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) Tablets Initial U.S. Approval: 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。 (5.1) ? 若疑有酸中毒，应停用Prandimet，并立即住院治疗。 ·······································适应症和使用········································· ? PrandiMet is a meglitinide and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl or who have inadequate glycemic control on a meglitinide alone or metformin HCl alone. (1) 重要限制使用: ? 不要用来治疗1型糖尿病或糖尿病酮酸症。 (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: ? 1 mg repaglinide/500 mg metformin HCl (3) ? 2 mg repaglinide/500 mg metformin HCl (3)  ········································禁忌症·············································· 不适用于以下患者: ? 肾损伤. (4, 5.2) ? 代谢性酸中毒，包括糖尿病酮症酸中毒. (4, 5.1) ? 同时接受二甲苯氧庚酸和伊曲康唑. (4, 5.7, 7.2, 12.3) ····??·····························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, 5.2) ? 在接受放射性碘造影的患者暂时停止使用Prandimet (5.3) ? 乳酸性酸中毒与肝损害有关。建议肝损害患者不要使用 (5.4) ? 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(5.5 ) ? PrandiMet 不应与NPH胰岛素结合使用. (5.6) ? 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, 5.7, 7.2, 12.3) ? 瑞格列奈成分可以导致低血糖。 (5.8) ? 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. (5.9) ? 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。(5.10) ? 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。(5.15) ······································不良反应·············································. ? 低血糖和头痛是最常见的不良反应（