瑞格列奈二甲双胍片说明书[1].docx

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) Tablets
Initial . 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。()
•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 bination 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***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, )
•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, , , )
··