文档介绍：瑞格列奈二甲双胍片说明书[1]
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 . Approval: 2008
警告: 乳酸性酸中毒
········································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, , , )
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。? PrandiMet is a meglitinide and bination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 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***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)
··································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