阿卡波糖说明书
拜糖平说明书
拜糖平(阿卡波糖片)说明书【药品名称】通用名：阿卡波糖片商品名：拜糖平英文名：Acarbose Tablets 汉语拼音：Akɑbo TɑnɡPiɑn 本品主要成份是阿卡波糖，其主要成份为O-4，6-双脱氧-4[[（1S,4R,5S,6S）4，5，6-三羟基-3-（羟基甲基）-2-环己烯]氨基]-（-D-吡喃葡糖基（1→4）-O-（-D-吡喃葡糖基（1→4）-D-吡喃葡萄糖。
【性状】本品为类白色或淡黄色片。
【药理作用】本品为口服降血糖药。
其降糖作用的机制是抑制小肠壁细胞和寡糖竞争，而与a-葡萄糖苷酶可逆性地结合，抑制酶的活性，从而延缓碳水化合物的降解，造成肠道葡萄糖的吸收缓慢，降低餐后血糖的升高。
【药代动力学】本药口服后很少被吸收，避免了吸收所致的不良反应，其原形生物利用度仅为1%～2%，口服200mg 后，t1/2 为小时，消除t1/2 为小时，血浆蛋白结合率低，主要在肠道降解或以原形方式随粪便排泄，8 小时减少50%，长期服用未见积蓄。
【适应症】配合饮食控制治疗2 型糖尿病。
【用法用量】用餐前即刻整片吞服或与前几口食物一起咀嚼服用，剂量因人而异。
一般推荐剂量为：起始剂量为每次50mg，每日3 次。
以后逐渐增加至每次，每日3 次。
个别情况下，可增至每次，每日3 次。
或遵医嘱。
【不良反应】常有胃肠胀气和肠鸣音，偶有腹泻，极少见有腹痛。
如果不控制饮食，则胃肠道副作用可能加重。
如果控制饮食后仍有严重不适的症状，应咨询医生以便暂时或长期减小剂量。
个别病例可能出现诸如红斑、皮疹和荨麻疹等皮肤过敏反应。
【禁忌】（1）对阿卡波糖过敏者禁用。
（2）糖尿病昏迷及昏迷前期，酸中毒或酮症患者禁用。
（3）有明显消化和吸收障碍的慢性胃肠功能紊乱患者禁用。
（4）患有由于肠胀气而可能恶化的疾患（如Roemheld 综合症、严重的疝、肠梗阻、肠道术后和肠溃疡）的病人禁用。
（5）肝重肾功能损害的患者禁用。
【注意事项】（1）病人应遵医嘱调整剂量。
阿卡波糖 (Acarbose) 降糖药物
阿卡波糖 (Acarbose) 降糖药物阿卡波糖 (Acarbose) 降糖药物阿卡波糖是一种口服降糖药物，常用于治疗2型糖尿病患者。
它通过抑制肠内α-葡萄糖苷酶的作用，延缓肠道对复杂碳水化合物的消化和吸收，从而减少餐后高血糖的发生。
I. 机制阿卡波糖是一种碳水化合物酶抑制剂，通过抑制肠道内葡萄糖消化酶的活性，减缓淀粉和蔗糖的消化和吸收。
这种作用使得餐后血糖升高的速度减缓，降低了餐后血糖的峰值。
II. 用法和剂量一般情况下，阿卡波糖需要在餐前服用，并与第一口食物一同摄入。
初始用量为每日50毫克，每天三次分别在早、午、晚餐前服用；随着个体反应的不同，药物剂量可以逐渐增加至每次300毫克。
III. 不良反应1. 消化系统反应：阿卡波糖在肠道发挥作用，可能会导致腹胀、腹泻、腹痛、胃肠胀气等消化不良症状。
这些不良反应通常是由于阿卡波糖引起的肠道产气和延迟肠道排空所致，一般随用药时间延长而逐渐减轻。
2. 血糖过低：阿卡波糖的主要作用是减缓肠道对碳水化合物的消化和吸收，这可能会导致餐后血糖下降过快，引发低血糖反应。
因此，在使用阿卡波糖期间，应注意监测血糖水平，以防止低血糖的发生。
IV. 注意事项1. 阿卡波糖不适用于1型糖尿病患者和对该药物过敏的人士。
2. 在使用阿卡波糖期间，需要注意饮食的控制，减少饮食中快速消化和吸收的碳水化合物的摄入。
3. 阿卡波糖不会影响胰岛素的分泌，因此与胰岛素治疗联合使用可以显著改善血糖控制效果。
4. 对于可能发生低血糖反应的患者，应随身携带葡萄糖或其他能够迅速提高血糖的食物，以备急需。
V. 结论阿卡波糖是一种有效的口服降糖药物，通过抑制肠内碳水化合物的消化和吸收，有效控制了2型糖尿病患者的餐后高血糖。
然而，在使用过程中需要注意防止低血糖的发生，并遵循医生的用药指导，以确保疗效的最大化。
（本文参考了相关文献及专业信息，但文章仅供参考，具体用药和剂量请遵循医生的指导。
）。
阿卡波糖片拜糖平说明书
阿卡波糖片拜糖平说明书一、药品名称阿卡波糖片拜糖平二、成份每片含：阿卡波糖 25mg辅料：微晶纤维素、羟丙基纤维素、硬脂酸镁三、性状本品为片剂，白色或类白色，无臭。
四、适应症阿卡波糖片用于治疗非依赖胰岛素的2型糖尿病患者。
五、用法用量口服。
首次用药，建议每天1次，每次25mg，餐前服用。
根据病情可适量增加至每次50mg，每天最大剂量为100mg。
六、不良反应本品常见的不良反应包括：肝功能异常、胃肠道症状（如腹胀、腹痛、恶心）等。
重症反应如肝功能异常和过敏反应较为少见。
七、禁忌症1. 对本品过敏者禁用；2. 临床中对阿卡波糖不耐受者禁用；3. 患有酮症酸中毒或糖尿病酮症酸中毒的患者禁用；4. 孕妇、哺乳期妇女慎用。
八、注意事项1. 本品仅适合2型糖尿病患者使用，不适用于1型糖尿病患者；2. 在应用本品期间，应定期检测肝功能；3. 若患者出现严重的消化系统反应，应及时就医；4. 若患者需要进行胰岛素治疗或其他用药联合治疗，应在医生指导下进行；5. 对于即将进行外科手术的患者，应向医生告知目前正在使用的药物，以便他们决定是否暂停药物。
九、药物相互作用1. 本品可与其他降血糖药物（如胰岛素、磺酰脲类药物等）合用；2. 本品可增强格列美脲的血糖调节作用。
十、药理作用阿卡波糖是一种α-葡萄糖苷酶抑制剂，通过抑制肠道中α-葡萄糖苷酶的活性，减缓肠腔中糖类的降解和吸收，从而降低餐后血糖峰值。
此药不会引起胰岛素的释放，对胰岛素敏感性不明显。
十一、贮藏密闭保存，阴凉干燥处。
十二、包装规格每盒10片。
十三、执行标准中国药典2020年版二部。
以上为阿卡波糖片拜糖平说明书内容，使用前请仔细阅读并按照医生的嘱托使用。
如果在使用过程中有任何不适或疑问，请及时咨询医生。
拜糖平(阿卡波糖片)说明书
拜糖平(阿卡波糖片)说明书【药品名称】通用名：阿卡波糖片商品名：拜糖平英文名：Acarbose Tabl ets 汉语拼音：Akɑbo TɑnɡPiɑn 本品主要成份是阿卡波糖，其主要成份为O-4，6-双脱氧-4[[（1S,4R,5S,6S）4，5，6-三羟基-3-（羟基甲基）-2-环己烯]氨基]-（-D-吡喃葡糖基（1→4）-O-（-D-吡喃葡糖基（1→4）-D-吡喃葡萄糖。
【性状】本品为类白色或淡黄色片。
【药理作用】本品为口服降血糖药。
其降糖作用的机制是抑制小肠壁细胞和寡糖竞争，而与a-葡萄糖苷酶可逆性地结合，抑制酶的活性，从而延缓碳水化合物的降解，造成肠道葡萄糖的吸收缓慢，降低餐后血糖的升高。
【药代动力学】本药口服后很少被吸收，避免了吸收所致的不良反应，其原形生物利用度仅为1%～2%，口服200mg 后，t1/2 为3.7 小时，消除t1/2 为9.6 小时，血浆蛋白结合率低，主要在肠道降解或以原形方式随粪便排泄，8 小时减少50%，长期服用未见积蓄。
【适应症】配合饮食控制治疗2 型糖尿病。
【用法用量】用餐前即刻整片吞服或与前几口食物一起咀嚼服用，剂量因人而异。
一般推荐剂量为：起始剂量为每次50mg，每日3 次。
以后逐渐增加至每次0.1g，每日3 次。
个别情况下，可增至每次0.2g，每日3 次。
或遵医嘱。
【不良反应】常有胃肠胀气和肠鸣音，偶有腹泻，极少见有腹痛。
如果不控制饮食，则胃肠道副作用可能加重。
如果控制饮食后仍有严重不适的症状，应咨询医生以便暂时或长期减小剂量。
个别病例可能出现诸如红斑、皮疹和荨麻疹等皮肤过敏反应。
【禁忌】（1）对阿卡波糖过敏者禁用。
（2）糖尿病昏迷及昏迷前期，酸中毒或酮症患者禁用。
（3）有明显消化和吸收障碍的慢性胃肠功能紊乱患者禁用。
（4）患有由于肠胀气而可能恶化的疾患（如Roemheld 综合症、严重的疝、肠梗阻、肠道术后和肠溃疡）的病人禁用。
（5）肝重肾功能损害的患者禁用。
阿卡波糖说明书
【药物名称】中文通用名称：阿卡波糖英文通用名称：Acarbose其他名称：阿卡波什糖、阿卡糖、拜唐苹、宝易唐、卡博平、希糖停、抑葡萄糖苷酶、Acarbosum、Glucobay、Glucor、Glumida、Prandase、Precose。
【临床应用】1.治疗2型糖尿病，用于经饮食控制及体育锻炼2个月左右疗效不满意的2型糖尿病患者，可单独用药，也可与其他抗糖尿病药(如磺酰脲类、二甲双胍或胰岛素)合用。
2.与胰岛素合用，治疗血糖不稳定的1型糖尿病(单独应用本药对1型糖尿病患者无效)，可减少胰岛素用量，降低全天血糖波动。
3.用于糖耐量减低(IGT)患者，可降低IGT患者的餐后血糖。
【药理】1.药效学本药是新一代的口服抗糖尿病药，能明显降低餐后血糖。
食物中的碳水化合物(如分子量大的淀粉以及分子量较小的低聚糖)，必须先经过消化(即在唾液、胰液α淀粉酶作用下分解为寡糖)，然后在小肠黏膜细胞刷状缘处经α糖苷酶分解为单糖(葡萄糖、果糖)，最后被小肠上段上皮细胞吸收进入血循环。
本药结构类似寡糖(假寡糖)，且其活性中心结构上含有氮，与α糖苷酶结合能力远较寡糖强，能竞争性抑制寡糖的分解，从而延缓肠腔内双糖、低聚糖以及多糖释放为葡萄糖，最终降低餐后血糖，继而降低胰岛素水平。
另外，长期服用本药还可降低空腹血糖和糖化血红蛋白的浓度。
2.药动学本药口服后很少被吸收(其原形生物利用度仅为1%-2%)，血浆蛋白结合率低。
口服200mg后，代谢半衰期为3.7小时，消除半衰期为9.6小时。
主要在肠道降解或以原形随粪便排泄，8小时药量减少50%，长期服用未见蓄积。
严重肾功能不全的患者，血药浓度峰值及曲线下面积较健康志愿者分别高5倍、6倍。
尚不清楚能否随乳汁排泄。
【注意事项】1.禁忌症(1)对本药过敏者。
(2)有明显消化和吸收障碍的慢性胃肠功能紊乱者。
(3)Roemheld综合征、严重的疝、肠梗阻和肠溃疡等由于肠胀气而可能恶化的疾病患者。
卡博平(阿卡波糖片)解读
• 【专家指导用药】： • (1)病人应遵医嘱调整剂量。 • (2)如果病人在服药4～8周后疗效不明显，可以增加剂量。如果病人 坚持严格的糖尿病饮食仍有不适时，就不能再增加剂量，有时还需要 适当减少剂量，平均剂量为每次0.1g，每日3次。
• (3)个别病人，尤其是在使用大剂量时会发生无症状的肝酶升高，故 应考虑在用药的前6～12个月监测肝酶的变化。停药后肝酶值会恢复 正常。
• (4)如出现低血糖Leabharlann 应使用葡萄糖纠正，而不宜使用蔗糖。
卡 博 平 阿 卡 波 糖 片
北京金典糖尿病医院祝：糖友们圣诞快乐
( )
【通用名称】阿卡波糖片 【性状】本品为类白色或白色片。 【适应症】配合饮食控制治疗2型糖 尿病。 【用法用量】用餐前即刻整片吞服 或与前几口食物一起咀嚼服用，剂 量因人而异。一般推荐剂量为：起 始剂量为每次50mg，每日3次。以后 逐渐增加至每次0.1g，每日3次。个 别情况下，可增至每次0.2g，每日3 次。或遵医嘱。 【不良反应】常有胃肠胀气和肠鸣 音，偶有腹泻，极少见有腹痛。如 果不控制饮食，则胃肠道副作用可 能加重。如果控制饮食后仍有严重 不适的症状，应咨询医生以便暂时 或长期减小剂量。个别病例可能出 现诸如红斑、皮疹和荨麻疹等皮肤 过敏反应。
贝希(阿卡波糖胶囊)
贝希(阿卡波糖胶囊)【药品名称】商品名称：贝希通用名称：阿卡波糖胶囊英文名称：Acarbose【成份】阿卡波糖。
【适应症】可用于胰岛素依赖型或非胰岛素依赖型的糖尿病，亦可与其他口服降血糖药或胰岛素联合应用。
【用法用量】口服剂量需个体化，一般50～200mg/次，3次/日，饭前服用。
【不良反应】可引起肠道多气、腹胀、腹痛、腹泻等，个别亦可出现低血糖反应。
【禁忌】对阿卡波糖过敏者、18岁以下患者、怀孕及哺乳期妇女、有明显消化或吸收障碍的慢性功能紊乱者、因肠胀气而可能恶化的情况（如Roemheid综合征、严重的疝气、肠梗阻和肠溃疡）禁用。
【注意事项】1.在使用高剂量时，个别病例可能会发生无症状的肝酶系升高，故在治疗开始的6～12月应考虑监测肝酶系的变化。
2.本品与磺脲类药物或二甲双胍或胰岛素合用时，血糖浓度降到低血糖范围，则应适当减少磺脲类药物、二甲双胍或胰岛素的剂量；如果发生急性低血糖，应考虑到本品抑制蔗糖的分解，为此蔗糖不适于迅速缓解低血糖症状，而应该使用葡萄糖。
3.应避免与抗酸药、消胆胺、肠道吸附剂和消化酶制品同时服用，因为它们有可能降低本品的作用。
4.运动员慎用。
【特殊人群用药】儿童注意事项：鉴于尚无本品对儿童和青春期少年的疗效和耐受性的足够资料，本品不应使用于18岁以下的患者。
妊娠与哺乳期注意事项：1.因为无法得到有关本药在妊娠妇女中使用的资料，妊娠期妇女禁用。
2.哺乳期大鼠服用放射性标记的阿卡波糖后，在其乳汁中发现了少量的放射活性物质，在人类尚无类似的发现。
即使如此，由于尚不能排除乳汁中阿卡波糖对婴儿的影响，故哺乳期妇女禁用。
老人注意事项：没有特殊注意事项。
【药物相互作用】1 在使用高剂量时，个别病例可能会发生无症状的肝酶系升高，故在治疗开始的6～12月应考虑监测肝酶系的变化。
2 本品与磺脲类药物或二甲双胍或胰岛素合用时，血糖浓度降到低血糖范围，则应适当减少磺脲类药物、二甲双胍或胰岛素的剂量；如果发生急性低血糖，应考虑到本品抑制蔗糖的分解，为此蔗糖不适于迅速缓解低血糖症状，而应该使用葡萄糖。
拜糖平说明书
拜糖平（阿卡波糖片）说明书【药品名称】通用名：阿卡波糖片商品名：拜糖平英文名：Acarbose Tablets汉语拼音：Ak cbo T en g Pi a本品主要成份是阿卡波糖，其主要成份为0-4, 6- 双脱氧-4[[ （1S,4R,5S,6S4, 5, 6-三羟基-3-（羟基甲基）-2-环己烯]氨基卜（-D- 吡喃葡糖基（1宀4）-O- （-D-吡喃葡糖基（1 T4）-D-吡喃葡萄糖。
【性状】本品为类白色或淡黄色片。
【药理作用】本品为口服降血糖药。
其降糖作用的机制是抑制小肠壁细胞和寡糖竞争，而与a-葡萄糖苷酶可逆性地结合，抑制酶的活性，从而延缓碳水化合物的降解，造成肠道葡萄糖的吸收缓慢，降低餐后血糖的升高。
【药代动力学】本药口服后很少被吸收，避免了吸收所致的不良反应，其原形生物利用度仅为1%〜2%，口服200mg后，t1/2为3.7小时，消除t1/2为9.6小时，血浆蛋白结合率低，主要在肠道降解或以原形方式随粪便排泄，8小时减少50%，长期服用未见积蓄。
【适应症】配合饮食控制治疗2型糖尿病。
【用法用量】用餐前即刻整片吞服或与前几口食物一起咀嚼服用，剂量因人而异。
一般推荐剂量为：起始剂量为每次50mg，每日3次。
以后逐渐增加至每次0.1g,每日3次。
个别情况下，可增至每次0.2g，每日3次。
或遵医嘱。
【不良反应】常有胃肠胀气和肠鸣音，偶有腹泻，极少见有腹痛。
如果不控制饮食，则胃肠道副作用可能加重。
如果控制饮食后仍有严重不适的症状，应咨询医生以便暂时或长期减小剂量。
个别病例可能出现诸如红斑、皮疹和荨麻疹等皮肤过敏反应。
【禁忌】（1）对阿卡波糖过敏者禁用。
（2 ）糖尿病昏迷及昏迷前期，酸中毒或酮症患者禁用。
（3）有明显消化和吸收障碍的慢性胃肠功能紊乱患者禁用。
（4）患有由于肠胀气而可能恶化的疾患（如Roemheld综合症、严重的疝、肠梗阻、肠道术后和肠溃疡）的病人禁用。
（5 ）肝重肾功能损害的患者禁用。
阿卡波糖的服用方法
阿卡波糖的服用方法阿卡波糖是一种口服降糖药，常用于治疗2型糖尿病。
下面是阿卡波糖的服用方法：1. 最好在餐前服用：阿卡波糖应在每次主要餐前（即早餐、午餐和晚餐）30分钟内口服。
这样能够最大程度地发挥其降低血糖的效果。
如果餐食被推迟或被错过，应暂时跳过服用阿卡波糖，直到下一次进餐。
2. 剂量选择：阿卡波糖的剂量应根据患者的具体情况和需求进行调整。
一般建议开始时的剂量为每次200毫克（0.2克），每天三次。
在开始治疗时，医生可能会根据患者的情况来调整剂量，以确保疗效最大化并减少副作用。
3. 逐渐增加剂量：开始治疗时，医生可能会建议患者每周逐渐增加剂量。
例如，第一周可以从每次50毫克开始，然后逐渐增加到每次200毫克。
这是因为阿卡波糖可能会引起肠胃不适等副作用，通过逐渐增加剂量，患者的身体可以适应药物并减少不适感。
4. 注意餐食中的碳水化合物含量：阿卡波糖通过抑制肠道中的酶来减缓食物中的碳水化合物消化和吸收，从而降低血糖水平。
因此，在服用阿卡波糖期间，患者需要特别注意膳食和碳水化合物摄入量。
建议选择含有较少碳水化合物的食物，并尽量避免食用高糖饮食。
此外，定时进餐和每餐食物数量的控制也是非常重要的。
5. 注意潜在的药物相互作用：阿卡波糖可能会与其他药物发生相互作用，因此患者在服用阿卡波糖期间需要特别注意其他药物的使用。
特别是一些可能增加低血糖风险的药物，如胰岛素或其他降糖药物。
在使用阿卡波糖之前，患者应告知医生其他正在使用的药物，以避免不良反应和不良事件发生。
6. 定期监测血糖水平：在开始使用阿卡波糖之前，医生可能会建议进行一些必要的检查，如空腹血糖测试、餐后血糖测试等。
随后，在使用阿卡波糖的过程中，患者还需要定期监测血糖水平，并与医生保持沟通以便调整剂量或其他治疗方案。
总的来说，阿卡波糖的服用方法需要患者遵循医生的指导，并且合理安排饮食和药物使用。
此外，患者还需要定期监测血糖水平，并与医生保持密切联系，以确保治疗效果和减少潜在的副作用。
阿卡波糖的说明书
阿卡波糖的说明书阿卡波糖的说明书阿卡波糖。
别名拜糖平。
化学名：O-4,6-双脱氧-4-[[（1S，4R，5S，6S）4，5，6-三羟基-3-（羟甲基）-2-环已烯基-1- 氨基]-α-D-吡喃葡萄糖基（1→4）-O-α-D-吡喃葡萄糖基-（1→4）-D-吡喃葡萄糖。
分子式：C25H4本品为胶囊剂，内容物为白色或类白色粉末。
阿卡波糖为一种α葡萄糖苷酶抑制剂，是复杂的低聚糖，其结构类似寡糖，这种非寡糖的“假寡糖”可在小肠上部细胞刷状缘处和寡糖竞争而与α葡萄糖苷酚可逆地结合，抑制各种α葡萄糖苷酚如麦芽糖酶、异麦芽糖酶、葡萄糖淀粉酚及蔗糖酶的活性，使淀粉分解成寡糖如麦芽糖（双糖）、麦芽三糖及糊精（低聚糖）进而分解成葡萄糖的速度减慢，使蔗糖分解成葡萄糖和果糖的’速度减慢，因此造成肠道葡萄糖的吸收减缓，从而缓解餐后高血糖，达到降低血糖的作用。
口服阿卡波糖0.3g后，血浆药物浓度达峰时间2h，峰浓度为0.097μg/ml，8h 后减少50%。
长期服用未见药物在体内积蓄。
在大肠、胃黏膜、小肠黏膜、膀胱、肝、肾分布浓度较高，单剂量0.2g顿服后体内血浆分布半衰期为3.7h，血浆消除半衰期为9.6h，血浆蛋白结合率很低。
主要在肠道降解或以原形方式随粪便中排出，肠道降解是由各种淀粉酶和肠道细菌作用分解的。
降解产物亦随粪便排泄，仅微量由尿液中排泄，尿液中的原形药物只有1.7%。
静脉注射阿卡波糖0.1g后，2h后尿液中以原形药物排泄为给药剂量的57%，24h 达90%，其他途径排泄约10%。
另有研究证明阿卡波糖口服的生物利用度仅为1%～2%。
由此可见，口服后很少被吸收。
阿卡波糖片可用于胰岛素依赖型或非胰岛素依赖型的糖尿病，亦可与其他口服降血糖药或胰岛素联合应用。
对阿卡波糖过敏者、18岁以下患者、怀孕及哺乳期妇女、有明显消化或吸收障碍的慢性功能紊乱者、因肠胀气而可能恶化的情况（如Roemheid综合征、严重的疝气、肠梗阻和肠溃疡）禁用。
阿卡波糖片说明书
阿卡波糖片说明书[ 药品名称]通用名：阿卡波糖片商品名：卡博平英文名：Acarbose 了ablets汉语拼音：Akabotang Pian 本品主要成份为阿卡波糖，匠性状]本品为白色或类白色片。
[ 药理毒理]本品是一种生物合成的假性四糖。
动物试验结果表明：本品对小肠壁细胞刷状缘的a葡萄糖苷酶的话性具有抑制作用，从而延缓了肠道内多糖、寡糖或双糖的降解，使来自碳水化合物的葡萄糖的降解和吸收入血速度变缓，降低了餐后血糖的升高，使平均血糖值下降。
[ 药代动力学]据文献报道，对健康志愿者13服放射性标记的阿卡波糖片0．2g 的药代动力学的研究表明：口服阿卡波糖后，有％的活性抑制剂经肠道吸收，加上被吸收的经消化酶和肠道细菌分解的产物，其占服药剂量的35％。
没有或未发现阿卡波糖在体内有可测定到的代谢现象，相反在肠腔内阿卡波糖被消化酶和肠道细菌分解，其降解产物可于小肠下段被吸收。
13服后阿卡波糖及其降解产物迅速完全地自尿中排出，服药剂量的5P%在96小时内经粪便排出.U适应症]配合饮食控制治疗糠尿病。
U用法用量｝用餐前即刻整片吞服或与前几口食物一起咀嚼服用，剂量需个体化。
一般推荐剂量为：起始剂量为一次50mg一次1片），一日3次；以后逐渐增加至一次0. Pg（一次2片），一日3次。
个别情况下。
可增加至一次0．2g（一次4片），一日3次．或遵医嘱。
[ 不良反应] 常有胃肠胀气和肠呜音，偶有腹泻和腹胀，极少见有腹痛。
如果不遵守规定的饮食控制，则胃肠道副作用可能加重。
如果控制饮食后仍有严重不适的症状。
应咨询医生以便暂时或长期减小剂量。
极个别病例可能出现诸如红斑、皮疹和荨麻疹等皮肤过敏反应。
极个别病例观察到水肿的发生。
极个别病例发生轻度肠梗阻或肠梗阻。
据报道在极个别情况可出现黄疸和／或肝炎合并肝损害。
在日本发现个别患者发生爆发性肝炎而死亡，但是否与阿卡波糖有关还不明确。
在接受阿卡波糖每曰、50~300m治疗的患者，观察到个别患者发生与临床有关的肝功能检查异常（3次超过正常高限，参考注意事项部分）。
阿卡波糖片
阿卡波糖片英文名称：Acarbose Tablets汉语拼音：A Ka Bo Tang Pian【成份】本品主要成分为阿卡波糖，其化学名为：0-4,6-双脱氧-4-[[(1S,4R,5S,6S)4,5,6-三羟基-3-(羟基甲基)-2-环已烯-1-基]氨基]-α-D吡喃葡糖基(1→4)-D-吡喃葡萄糖。
化学结构式：分子式:C25H43NO18分子量:645.6【性状】本品为类白色或淡黄色片。
【适应症】配合饮食控制，用于：(1)2型糖尿病。
(2)降低糖耐量低减者的餐后血糖。
【规格】50mg【用法用量】用餐前即刻整片吞服或与前几口食物一起咀嚼服用，剂量因人而异。
一般推荐剂量为：起始剂量为一次50mg(一次1片)，一日3次，以后逐渐增加至一次0.1g(一次2片)，一日3次。
个别情况下，可增加至一次0.2g(一次4片)，一日3次。
或遵医嘱。
如果病人在服药4～8周后疗效不明显，可以增加剂量。
如果病人坚持严格的糖尿病饮食仍有不适时，就不能再增加剂量，有时还需适当减少剂量，平均剂量为一次0.1g，一日3次。
【不良反应】血液和淋巴系统异常：极个别病例可能出现血小板减少。
免疫系统异常：极个别病例可能出现轻到中度的过敏反应，以及红斑、皮疹和荨麻疹等皮肤过敏反应。
血管异常：极个别病例观察到水肿的发生。
胃肠道异常：多见胃肠胀气，常有腹泻和腹痛；偶有恶心、呕吐和消化不良；极个别病例出现不完全肠梗阻或肠梗阻。
肝胆异常：偶有一过性肝酶（包括转氨酶、碱性磷酸酶和γ-谷氨酰转肽酶）升高；极个别病例出现黄疸或肝炎；在日本发现个别患者发生爆发性肝炎而死亡，但是否与阿卡波糖有关还不明确。
如果不遵守规定的饮食，则胃肠道副作用可能加重。
如果控制饮食后仍有严重的不适症状，应咨询医生并且暂时或长期减小剂量。
在接受阿卡波糖每日150至300mg治疗的患者中，观察到个别患者发生与临床有关的肝功能检查异常，但这种异常在阿卡波糖治疗过程中是一过性的（超过正常高限3倍，参考注意事项部分）。
阿卡波糖的说明书.doc
阿卡波糖的说明书[药品名称]阿卡波糖。
另一个名字是白汤平。
[主要配料]化学名称:O-4，6-二脱氧-4-[[(1S，4R，5S，6S) 4，5，6-三羟基-3-(羟甲基)-2-环己烯基-1-氨基]-α-D-吡喃葡萄糖基(1→4)-O-α-D-吡喃葡萄糖基-(1→4)-D-吡喃葡萄糖基。
分子式:C25H4[·塞克斯]本品为胶囊，内容物为白色或类白色粉末。
[药理作用]阿卡波糖是一种α-葡萄糖苷酶抑制剂，是一种结构类似低聚糖的复合低聚糖。
这种非寡糖的“假寡糖”可与小肠上部细胞刷状边缘的寡糖竞争，与α-葡萄糖苷酶可逆结合，并抑制各种α-葡萄糖苷酶酚如麦芽糖酶、异麦芽糖酶、葡萄糖苷酶酚和转化酶的活性。
淀粉分解为寡糖如麦芽糖(二糖)、麦芽三糖和糊精(寡糖)以进一步分解为葡萄糖的速度减慢，蔗糖分解为葡萄糖和果糖的速度减慢，从而导致肠内葡萄糖吸收减慢，从而缓解餐后高血糖症并达到降低血糖的效果。
[药代动力学]口服阿卡波糖0.3g后，血药浓度峰值时间达到2h，峰值浓度为0.097μg/ml，8 h后下降50%。
长期给药后体内无药物蓄积。
大肠、胃粘膜、小肠粘膜、膀胱、肝、肾的分布浓度相对较高。
血浆在体内分布的半衰期为3.7h，血浆消除的半衰期为9.6h，单剂量0.2g后血浆蛋白结合率很低。
它主要在肠道中降解，或以原始形式随粪便排出。
肠道降解被各种淀粉酶和肠道细菌分解。
降解产物也随粪便排出，只有微量物质随尿液排出，尿液中的原药只有1.7%。
静脉注射阿卡波糖0.1g后，2小时后原药尿排泄量为剂量的57%，24小时达90%，其他途径排泄量约为10%。
其他研究证明阿卡波糖的口服生物利用度仅为1% ~ 2%。
这表明口服后很少被吸收。
[指示]阿卡波糖片可用于治疗胰岛素依赖型或非胰岛素依赖型糖尿病，也可与其他口服降糖药或胰岛素联合使用。
[禁忌症]禁止对阿卡波糖过敏、18岁以下患者、孕妇和哺乳期妇女、伴有明显消化或吸收障碍的慢性功能障碍、可能因肠胀气而恶化(如Roemheid综合征、严重疝、肠梗阻和溃疡)。
拜唐苹说明书
拜唐苹说明书【批准文号】国药准字H19990205【中文名称】阿卡波糖片【产品英文名称】Acarbose Tablet【生产企业】拜耳医药保健有限公司【功效主治】配合饮食控制治疗2型糖尿病。
【化学成分】阿卡波糖其化学名称:O-4，6-双脱氧-4[[（1S,4R,5S,6S）4，5，6-三羟基-3-（羟基甲基）-2-环己烯]氨基]-（-D-吡喃葡糖基（1→4）-O-（-D-吡喃葡糖基（1→4）-D-吡喃葡萄糖。
【药理作用】为一新型口服降血糖药，在肠道内竞争性抑制葡萄糖苷酶，可降低多糖及蔗糖分解生成葡萄糖，减少并延缓吸收，因此具有降低饭后高血糖和血浆胰岛素浓度的作用。
【药物相互作用】如正在使用其它药品，使用本品前应向医师或药师咨询。
【不良反应】常有胃肠胀气和肠鸣音，偶有腹泻，极少见有腹痛。
如果不控制饮食，则胃肠道副作用可能加重。
如果控制饮食后仍有严重不适的症状，应咨询医生以便暂时或长期减小剂量。
个别病例可能出现诸如红斑，皮疹和荨麻疹等皮肤过敏反应。
【禁忌症】1 对阿卡波糖过敏者禁用。
2 糖尿病昏迷及昏迷前期，酸中毒或酮症患者禁用。
3 有明显消化和吸收障碍的慢性胃肠功能紊乱患者禁用。
4 患有由于肠胀气而可能恶化的疾患（如Roemheld综合症、严重的疝、肠梗阻、肠道术后和肠溃疡）的病人禁用。
5 肝重肾功能损害的患者禁用。
【产品规格】50mg【用法用量】用餐前即刻整片吞服或与前几口食物一起咀嚼服用，剂量因人而异。
一般推荐剂量为：起始剂量为每次50mg，每日3次。
以后逐渐增加至每次0.1g，每日3次。
个别情况下，可增至每次0.2g，每日3次。
或遵医嘱。
【贮藏方法】遮光，密封，在阴凉处保存。
当温度高于25℃【注意事项】1 病人应遵医嘱调整剂量。
2 如果病人在服药4~8周后疗效不明显，可以增加剂量。
如果病人坚持严格的糖尿病饮食仍有不适时，就不能再增剂量，有时还需要适当减少剂量，平均剂量为每次0.1g，每日3次。
阿卡波糖FDA说明书
3/11PRECOSE ® (acarbose tablets)DESCRIPTIONPRECOSE ® (acarbose tablets) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is chemically known as O-4,6-dideoxy4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-α-D-glucopyranos yl-(1 → 4)-O-α-D-glucopyranosyl-(1 → 4)-D-glucose. It is a white to off-white powder with amolecular weight of 645.6. Acarbose is soluble in water and has a pKa of 5.1. Its empirical formula is C 25H 43NO 18and its chemical structure is as follows: PRECOSE is available as 25 mg, 50 mg and 100 mg tablets for oral use. The inactive ingredients are starch, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide.CLINICAL PHARMACOLOGYAcarbose is a complex oligosaccharide that delays the digestion of ingested carbohydrates,thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence ofplasma glucose reduction, PRECOSE reduces levels of glycosylated hemoglobin in patients with type 2diabetes mellitus. Systemic non-enzymatic protein glycosylation, as reflected by levels of glycosylatedhemoglobin, is a function of average blood glucose concentration over time.Mechanism of ActionIn contrast to sulfonylureas, PRECOSE does not enhance insulin secretion. The antihyperglycemicaction of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase andmembrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucoseand other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzymeinhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia. Because its mechanism of action is different, the effect of PRECOSE to enhance glycemic control isadditive to that of sulfonylureas, insulin or metformin when used in combination. In addition, PRECOSEdiminishes the insulinotropic and weight-increasing effects of sulfonylureas.Acarbose has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.Pharmacokinetics:AbsorptionIn a study of 6 healthy men, less than 2% of an oral dose of acarbose was absorbed as active drug, while approximately 35% of total radioactivity from a 14C-labeled oral dose was absorbed. An average of 51% of an oral dose was excreted in the feces as unabsorbed drug-related radioactivity within 96 hours of ingestion. Because acarbose acts locally within the gastrointestinal tract, this low systemic bioavailability of parent compound is therapeutically desired. Following oral dosing of healthy volunteers with 14C-labeled acarbose, peak plasma concentrations of radioactivity were attained 14–24 hours after dosing, while peak plasma concentrations of active drug were attained at approximately 1 hour. The delayed absorption of acarbose-related radioactivity reflects the absorption of metabolites that may be formed by either intestinal bacteria or intestinal enzymatic hydrolysis.MetabolismAcarbose is metabolized exclusively within the gastrointestinal tract, principally by intestinal bacteria, but also by digestive enzymes. A fraction of these metabolites (approximately 34% of the dose) was absorbed and subsequently excreted in the urine. At least 13 metabolites have been separated chromatographically from urine specimens. The major metabolites have been identified as4-methylpyrogallol derivatives (that is, sulfate, methyl, and glucuronide conjugates). One metabolite (formed by cleavage of a glucose molecule from acarbose) also has alpha-glucosidase inhibitory activity. This metabolite, together with the parent compound, recovered from the urine, accounts for less than 2% of the total administered dose.ExcretionThe fraction of acarbose that is absorbed as intact drug is almost completely excreted by the kidneys. When acarbose was given intravenously, 89% of the dose was recovered in the urine as active drug within 48 hours. In contrast, less than 2% of an oral dose was recovered in the urine as active (that is, parent compound and active metabolite) drug. This is consistent with the low bioavailability of the parent drug. The plasma elimination half-life of acarbose activity is approximately 2 hours in healthy volunteers. Consequently, drug accumulation does not occur with three times a day (t.i.d.) oral dosing.Special PopulationsThe mean steady-state area under the curve (AUC) and maximum concentrations of acarbose were approximately 1.5 times higher in elderly compared to young volunteers; however, these differences were not statistically significant. Patients with severe renal impairment (Clcr < 25 mL/min/1.73m2) attained about 5 times higher peak plasma concentrations of acarbose and 6 times larger AUCs than volunteers with normal renal function. No studies of acarbose pharmacokinetic parameters according to race have been performed. In U.S. controlled clinical studies of PRECOSE in patients with type 2 diabetes mellitus, reductions in glycosylated hemoglobin levels were similar in Caucasians (n=478) and African-Americans (n=167), with a trend toward a better response in Latinos (n=132).Drug-Drug InteractionsStudies in healthy volunteers have shown that PRECOSE has no effect on either the pharmacokinetics or pharmacodynamics of nifedipine, propranolol, or ranitidine. PRECOSE did not interfere with the absorption or disposition of the sulfonylurea glyburide in diabetic patients. PRECOSE may affect digoxin bioavailability and may require dose adjustment of digoxin by 16% (90% confidence interval: 8-23%), decrease mean C max of digoxin by 26% (90% confidence interval: 16–34%) and decreases mean trough concentrations of digoxin by 9% (90% confidence limit: 19% decrease to 2% increase). (See PRECAUTIONS, Drug Interactions.)The amount of metformin absorbed while taking PRECOSE was bioequivalent to the amount absorbed when taking placebo, as indicated by the plasma AUC values. However, the peak plasma level of metformin was reduced by approximately 20% when taking PRECOSE due to a slight delay in the absorption of metformin. There is little if any clinically significant interaction between PRECOSE and metformin. CLINICAL TRIALSClinical Experience from Dose Finding Studies in Type 2 Diabetes Mellitus Patients on Dietary Treatment Only: Results from six controlled, fixed-dose, monotherapy studies of PRECOSE in the treatment of type 2 diabetes mellitus, involving 769 PRECOSE-treated patients, were combined and a weighted average of the difference from placebo in the mean change from baseline in glycosylated hemoglobin (HbA1c) was calculated for each dose level as presented below:Table 1Mean Placebo-Subtracted Change in HbA1c in Fixed-Dose Monotherapy Studiesp-Value Dose of PRECOSE* N Change in HbA1c%25 mg t.i.d. 110 -0.44 0.030750 mg t.i.d. 131 -0.77 0.0001100 mg t.i.d. 244 -0.74 0.0001200 mg t.i.d.** 231 -0.86 0.0001300 mg t.i.d.** 53 -1.00 0.0001* PRECOSE was statistically significantly different from placebo at all doses. Although there were no statistically significant differences among the mean results for doses ranging from 50 to 300 mg t.i.d., some patients may derive benefit by increasing the dosage from 50 to 100 mg t.i.d.Although studies utilized a maximum dose of 200 or 300 mg t.i.d., the maximum recommended dose for patients < 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d. Results from these six fixed-dose, monotherapy studies were also combined to derive a weighted average of the difference from placebo in mean change from baseline for one-hour postprandial plasma glucose levels as shown in the following figure:Figure 1* PRECOSE was statistically significantly different from placebo at all doses with respect to effect on one-hour postprandial plasma glucose.**The 300 mg t.i.d. PRECOSE regimen was superior to lower doses, but there were no statistically significant differences from 50 to 200 mg t.i.d.Clinical Experience in Type 2 Diabetes Mellitus Patients on Monotherapy, or in Combination with Sulfonylureas, Metformin or Insulin: PRECOSE was studied as monotherapy and as combination therapy to sulfonylurea, metformin, or insulin treatment. The treatment effects on HbA1c levels and one-hour postprandial glucose levels are summarized for four placebo-controlled,double-blind, randomized studies conducted in the United States in Tables 2 and 3, respectively. The placebo-subtracted treatment differences, which are summarized below, were statistically significant for both variables in all of these studies.Study 1 (n=109) involved patients on background treatment with diet only. The mean effect of the addition of PRECOSE to diet therapy was a change in HbA1c of -0.78%, and an improvement ofone-hour postprandial glucose of -74.4 mg/dL.In Study 2 (n=137), the mean effect of the addition of PRECOSE to maximum sulfonylurea therapy was a change in HbA1c of -0.54%, and an improvement of one-hour postprandial glucose of -33.5 mg/dL.In Study 3 (n=147), the mean effect of the addition of PRECOSE to maximum metformin therapy was a change in HbA1c of -0.65%, and an improvement of one-hour postprandial glucose of -34.3 mg/dL. Study 4 (n=145) demonstrated that PRECOSE added to patients on background treatment with insulin resulted in a mean change in HbA1c of -0.69%, and an improvement of one-hour postprandial glucose of -36.0 mg/dL.A one year study of PRECOSE as monotherapy or in combination with sulfonylurea, metformin or insulin treatment was conducted in Canada in which 316 patients were included in the primary efficacy analysis (Figure 2). In the diet, sulfonylurea and metformin groups, the mean decrease in HbA1c produced by the addition of PRECOSE was statistically significant at six months, and this effect was persistent at one year. In the PRECOSE-treated patients on insulin, there was a statistically significant reduction in HbA1c at six months, and a trend for a reduction at one year.Table 2: Effect of Precose on HbA1cStudy Treatment HbA1c (%)a p-Value Mean Baseline Mean change from baseline b Treatment Difference1 Placebo Plus Diet 8.67 +0.33 — — PRECOSE 100 mg t.i.d. Plus Diet 8.69 -0.45 -0.78 0.00012Placebo Plus SFU c 9.56 +0.24 — —PRECOSE 50–300d mg t.i.d. Plus SFU c 9.64 -0.30 -0.54 0.00963 Placebo Plus Metformin e 8.17+0.08 g — — PRECOSE 50–100 mg t.i.d. Plus Metformin e 8.46 -0.57 g-0.65 0.00014 Placebo Plus Insulin f 8.69 +0.11 — — PRECOSE 50–100 mg t.i.d. Plus Insulin f 8.77 -0.58 -0.69 0.0001a HbA1c Normal Range: 4–6%b After four months treatment in Study 1, and six months in Studies 2, 3, and 4cSFU, sulfonylurea, maximum dose d Although studies utilized a maximum dose of up to 300 mg t.i.d., the maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d. e Metformin dosed at 2000 mg/day or 2500 mg/day fMean dose of insulin 61 U/day g Results are adjusted to a common baseline of 8.33%Table 3: Effect of Precose on Postprandial GlucoseStudy Treatment One-Hour Postprandial Glucose (mg/dL)p-Value MeanBaselineMean changefrom baseline aTreatmentDifference1 Placebo Plus Diet 297.1 +31.8 — —PRECOSE100mg t.i.d.PlusDiet299.1 -42.6 -74.4 0.00012 Placebo Plus SFU b 308.6 +6.2 — —PRECOSE 50–300c mg t.i.d.PlusSFU b311.1 -27.3 -33.5 0.00173 Placebo Plus Metformin d 263.9 +3.3f — —PRECOSE 50–100 mg t.i.d.PlusMetformin d283.0 -31.0f -34.3 0.00014 Placebo Plus Insulin e 279.2 +8.0 — —PRECOSE 50–100 mg t.i.d.PlusInsulin e277.8 -28.0 -36.0 0.0178a After four months treatment in Study 1, and six months in Studies 2, 3, and 4b SFU, sulfonylurea, maximum dosec Although studies utilized a maximum dose of up to 300 mg t.i.d., the maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d.d Metformin dosed at 2000 mg/day or 2500 mg/daye Mean dose of insulin 61 U/dayf Results are adjusted to a common baseline of 273 mg/dLFigure 2Figure 2: Effects of PRECOSE ( ш ) and Placebo ( ш ) on mean change in HbA1c levels from baseline throughout a one-year study in patients with type 2 diabetes mellitus when used in combination with: (A) diet alone; (B) sulfonylurea; (C) metformin; or (D) insulin. Treatment differences at 6 and 12 months were tested: * p < 0.01; # p = 0.077.INDICATIONS AND USAGEPRECOSE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.CONTRAINDICATIONSPRECOSE is contraindicated in patients with known hypersensitivity to the drug. Precose is contraindicated in patients with diabetic ketoacidosis or cirrhosis. PRECOSE is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, PRECOSE is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine. PRECAUTIONSGeneralMacrovascular OutcomesThere have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with PRECOSE or any other anti-diabetic drug.HypoglycemiaBecause of its mechanism of action, PRECOSE when administered alone should not cause hypoglycemia in the fasted or postprandial state. Sulfonylurea agents or insulin may cause hypoglycemia. Because PRECOSE given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the potential for hypoglycemia. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when PRECOSE was added to metformin therapy.Oral glucose (dextrose), whose absorption is not inhibited by PRECOSE, should be used instead of sucrose (cane sugar) in the treatment of mild to moderate hypoglycemia. Sucrose, whose hydrolysis to glucose and fructose is inhibited by PRECOSE, is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection. Elevated Serum Transaminase LevelsIn long-term studies (up to 12 months, and including PRECOSE doses up to 300 mg t.i.d.) conducted in the United States, treatment-emergent elevations of serum transaminases (AST and/or ALT) above the upper limit of normal (ULN), greater than 1.8 times the ULN, and greater than 3 times the ULN occurred in 14%, 6%, and 3%, respectively, of PRECOSE-treated patients as compared to 7%, 2%, and 1%, respectively, of placebo-treated patients. Although these differences between treatments were statistically significant, these elevations were asymptomatic, reversible, more common in females, and, in general, were not associated with other evidence of liver dysfunction. In addition, these serum transaminase elevations appeared to be dose related. In US studies including PRECOSE doses up to the maximum approved dose of 100 mg t.i.d., treatment-emergent elevations of AST and/or ALT at any level of severity were similar between PRECOSE-treated patients and placebo-treated patients (p ≥0.496).In approximately 3 million patient-years of international postmarketing experience with PRECOSE, 62 cases of serum transaminase elevations > 500 IU/L (29 of which were associated with jaundice) have been reported. Forty-one of these 62 patients received treatment with 100 mg t.i.d. or greater and 33 of 45 patients for whom weight was reported weighed < 60 kg. In the 59 cases where follow-up was recorded, hepatic abnormalities improved or resolved upon discontinuation of PRECOSE in 55 and were unchanged in two. Cases of fulminant hepatitis with fatal outcome have been reported; the relationship to acarbose is unclear.Loss of Control of Blood GlucoseWhen diabetic patients are exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary. Information for PatientsPatients should be told to take PRECOSE orally three times a day at the start (with the first bite) of each main meal. It is important that patients continue to adhere to dietary instructions, a regular exercise program, and regular testing of urine and/or blood glucose.PRECOSE itself does not cause hypoglycemia even when administered to patients in the fasted state. Sulfonylurea drugs and insulin, however, can lower blood sugar levels enough to cause symptoms or sometimes life-threatening hypoglycemia. Because PRECOSE given in combination with a sulfonylurea or insulin will cause a further lowering of blood sugar, it may increase the hypoglycemic potential of these agents. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when PRECOSE was added to metformin therapy. The risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be well understood by patients and responsible family members. Because PRECOSE prevents the breakdown of table sugar, patients should have a readily available source of glucose (dextrose, D-glucose) to treat symptoms of low blood sugar when taking PRECOSE in combination with a sulfonylurea or insulin.If side effects occur with PRECOSE, they usually develop during the first few weeks of therapy. They are most commonly mild-to-moderate gastrointestinal effects, such as flatulence, diarrhea, or abdominal discomfort, and generally diminish in frequency and intensity with time.Laboratory TestsTherapeutic response to PRECOSE should be monitored by periodic blood glucose tests. Measurement of glycosylated hemoglobin levels is recommended for the monitoring of long-term glycemic control. PRECOSE, particularly at doses in excess of 50 mg t.i.d., may give rise to elevations of serum transaminases and, in rare instances, hyperbilirubinemia. It is recommended that serum transaminase levels be checked every 3 months during the first year of treatment with PRECOSE and periodically thereafter. If elevated transaminases are observed, a reduction in dosage or withdrawal of therapy may be indicated, particularly if the elevations persist.Renal ImpairmentPlasma concentrations of PRECOSE in renally impaired volunteers were proportionally increased relative to the degree of renal dysfunction. Long-term clinical trials in diabetic patients with significant renal dysfunction (serum creatinine > 2.0 mg/dL) have not been conducted. Therefore, treatment of these patients with PRECOSE is not recommended.Drug InteractionsCertain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. When such drugs are administered to a patient receiving PRECOSE, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from patients receiving PRECOSE in combination with sulfonylureas or insulin, patients should be observed closely for any evidence of hypoglycemia.Patients Receiving Sulfonylureas or Insulin: Sulfonylurea agents or insulin may cause hypoglycemia. PRECOSE given in combination with a sulfonylurea or insulin may cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made. Very rarely, individual cases of hypoglycemic shock have been reported in patients receiving PRECOSE therapy in combination with sulfonylureas and/or insulin.Intestinal adsorbents (for example, charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (for example, amylase, pancreatin) may reduce the effect of PRECOSE and should not be taken concomitantly.PRECOSE has been shown to change the bioavailability of digoxin when they are coadministered, which may require digoxin dose adjustment. (See CLINICAL PHARMACOLOGY, Drug-Drug Interactions.)Carcinogenesis, Mutagenesis, and Impairment of FertilityEight carcinogenicity studies were conducted with acarbose. Six studies were performed in rats (two strains, Sprague-Dawley and Wistar) and two studies were performed in hamsters.In the first rat study, Sprague-Dawley rats received acarbose in feed at high doses (up to approximately 500 mg/kg body weight) for 104 weeks. Acarbose treatment resulted in a significant increase in the incidence of renal tumors (adenomas and adenocarcinomas) and benign Leydig cell tumors. This study was repeated with a similar outcome. Further studies were performed to separate direct carcinogenic effects of acarbose from indirect effects resulting from the carbohydrate malnutrition induced by the large doses of acarbose employed in the studies.In one study using Sprague-Dawley rats, acarbose was mixed with feed but carbohydrate deprivation was prevented by the addition of glucose to the diet. In a 26-month study of Sprague-Dawley rats, acarbose was administered by daily postprandial gavage so as to avoid the pharmacologic effects of the drug. In both of these studies, the increased incidence of renal tumors found in the original studies did not occur. Acarbose was also given in food and by postprandial gavage in two separate studies in Wistar rats. No increased incidence of renal tumors was found in either of these Wistar rat studies. In two feeding studies of hamsters, with and without glucose supplementation, there was also no evidence of carcinogenicity.Acarbose did not induce any DNA damage in vitro in the CHO chromosomal aberration assay, bacterial mutagenesis (Ames) assay, or a DNA binding assay. In vivo, no DNA damage was detected in the dominant lethal test in male mice, or the mouse micronucleus test.Fertility studies conducted in rats after oral administration produced no untoward effect on fertility or on the overall capability to reproduce.PregnancyTeratogenic Effects: Pregnancy Category B.The safety of PRECOSE in pregnant women has not been established. Reproduction studies have been performed in rats at doses up to 480 mg/kg (corresponding to 9 times the exposure in humans, based on drug blood levels) and have revealed no evidence of impaired fertility or harm to the fetus due to acarbose. In rabbits, reduced maternal body weight gain, probably the result of the pharmacodynamic activity of high doses of acarbose in the intestines, may have been responsible for a slight increase in the number of embryonic losses. However, rabbits given 160 mg/kg acarbose (corresponding to 10 times the dose in man, based on body surface area) showed no evidence of embryotoxicity and there was no evidence of teratogenicity at a dose 32 times the dose in man (based on body surface area). There are, however, no adequate and well-controlled studies of PRECOSE in pregnant women. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.Nursing MothersA small amount of radioactivity has been found in the milk of lactating rats after administration of radiolabeled acarbose. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, PRECOSE should not be administered to a nursing woman.Pediatric UseSafety and effectiveness of PRECOSE in pediatric patients have not been established.Geriatric UseOf the total number of subjects in clinical studies of PRECOSE in the United States, 27% were 65 and over, while 4% were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. The mean steady-state area under the curve (AUC) and maximum concentrations of acarbose were approximately 1.5 times higher in elderly compared to young volunteers; however, these differences were not statistically significant.ADVERSE REACTIONSDigestive Tract: Gastrointestinal symptoms are the most common reactions to PRECOSE. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 19%, 31%, and 74% respectively in 1255 patients treated with PRECOSE 50–300 mg t.i.d., whereas the corresponding incidences were 9%, 12%, and 29% in 999 placebo-treated patients.In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with PRECOSE are a manifestation of the mechanism of action of PRECOSE and are related to the presence of undigested carbohydrate in the lower GI tract.If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.Elevated Serum Transaminase Levels: See PRECAUTIONS.Other Abnormal Laboratory Findings: Small reductions in hematocrit occurred more often in PRECOSE-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 levels were associated with PRECOSE therapy but are thought to be either spurious or of no clinical significance.Postmarketing Adverse Event Reports:Additional adverse events reported from worldwide postmarketing experience include fulminant hepatitis with fatal outcome, hypersensitive skin reactions (for example rash, erythema, exanthema and uticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosis cystoides intestinalis (see PRECAUTIONS). OVERDOSAGEUnlike sulfonylureas or insulin, an overdose of PRECOSE will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside. In cases of overdosage the patient should not be given drinks or meals containing carbohydrates (polysaccharides, oligosaccharides and disaccharides) for the next 4–6 hours. DOSAGE AND ADMINISTRATIONThere is no fixed dosage regimen for the management of diabetes mellitus with PRECOSE or any other pharmacologic agent. Dosage of PRECOSE must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dose of 100 mg t.i.d. PRECOSE should be taken three times daily at the start (with the first bite) of each main meal. PRECOSE should be started at a low dose, with gradual dose escalation as described below, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.During treatment initiation and dose titration (see below), one-hour postprandial plasma glucose may be used to determine the therapeutic response to PRECOSE and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months.。
拜糖平阿卡波糖片说明书-拜糖平性状
拜糖平阿卡波糖片说明书-拜糖平性状拜糖平阿卡波糖片说明书拜糖平性状一、药品名称通用名称：阿卡波糖片商品名称：拜糖平二、成分本品主要成份为阿卡波糖。
三、性状拜糖平阿卡波糖片为类白色或淡黄色片。
四、药理作用阿卡波糖是一种生物合成的假性四糖。
动物试验结果表明，阿卡波糖对小肠壁细胞刷状缘的α葡萄糖苷酶的活性具有抑制作用，从而延缓了肠道内多糖、寡糖或双糖的降解，使来自碳水化合物的葡萄糖的降解和吸收入血速度变缓，降低了餐后血糖的升高，使平均血糖值下降。
五、药代动力学据文献报道，对健康志愿者口服放射性标记的阿卡波糖片 02g 后，有 1% 2% 的活性抑制剂经肠道吸收，加上被吸收的经消化酶和肠道细菌分解的产物，共占服药剂量的 35%。
没有或很少量的阿卡波糖以原形从尿中排出。
六、适应症配合饮食控制，用于治疗 2 型糖尿病，以及降低糖耐量低减者的餐后血糖。
七、用法用量用餐前即刻整片吞服或与前几口食物一起咀嚼服用，剂量因人而异。
一般推荐剂量为：起始剂量为每次 50mg，每日 3 次。
以后逐渐增加至每次 01g，每日 3 次。
个别情况下，可增至每次 02g，每日 3 次。
或遵医嘱。
八、不良反应常有胃肠胀气和肠鸣音，偶有腹泻和腹胀，极少见有腹痛。
如果不遵守规定的饮食控制，则胃肠道副作用可能加重。
如果控制饮食后仍有严重不适的症状，应咨询医生以便暂时或长期减小剂量。
个别病例可能出现红斑、皮疹和荨麻疹等皮肤过敏反应。
九、禁忌1、对阿卡波糖和/或非活性成分过敏者禁用。
2、有明显消化和吸收障碍的慢性胃肠功能紊乱患者禁用。
3、患有由于肠胀气而可能恶化的疾患（如 Roemheld 综合征、严重的疝气、肠梗阻和肠溃疡）的病人禁用。
4、严重肾功能损害（肌酐清除率＜ 25ml/分）的患者禁用。
十、注意事项1、病人应遵医嘱调整剂量。
2、如果病人在服药 4 8 周后疗效不明显，可以增加剂量。
但如果病人坚持严格的糖尿病饮食仍有不适时，就不能再增加剂量，有时还需适当减少剂量，平均剂量为每次 01g，每日 3 次。
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拜唐苹(阿卡波糖片)
拜唐苹配合饮食控制用于
. 型糖尿病
. 降低糖耐量低减者的餐后血糖
您认为此药的治疗效果如何？
【主要成分】
拜唐苹主要成分为阿卡波糖
化学名称--双脱氧--[[(S R S S)-三羟基--(羟基甲基)--环已烯--基]氨基]-α-D吡喃葡糖基(→)-D-吡喃葡萄糖
【包装规格】
铝塑水泡眼包装.g片/板板/盒
【用法用量】
用餐前即刻整片吞服或与前几口食物一起咀嚼服用剂量因人而异一般推荐剂量为起始剂量为一次mg(一次片)一日次以后逐渐增加至一次.g(一次片)一日次个别情况下可增加至一次. g(一次片)一日次或遵医嘱
如果病人在服药～周后疗效不明显可以增加剂量如果病人坚持严格的糖尿病饮食仍有不适时就不能再增加剂量有时还需适当减少剂量平均剂量为一次.g一日次
【不良反应】
常有胃肠胀气和肠鸣音偶有腹泻和腹胀极少见有腹痛
如果不遵守规定的饮食控制则胃肠道副作用可能加重如果控制饮食后仍有严重不适的症状应咨询医生以便暂时或长期减小剂量
极个别病例可能出现诸如红斑皮疹和荨麻疹等皮肤过敏反应
极个别病例观察到水肿的发生极个别病例发生轻度肠梗阻或肠梗阻据报道在极个别情况可出现黄疸和/或肝炎合并肝损害在日本发现个别患者发生爆发性肝炎而死亡但是否与阿卡波糖有关还不明确在接受阿卡波糖每日至 mg治疗的患者观察到个别患者发生与临床有关的肝功能检查异常（次超过正常高限参考注意事项部分）
【注意事项】
. 病人应遵医嘱调整剂量
. 个别病人尤其是在使用大剂量时会发生无症状的肝酶升高因此应考虑在用药的前～个月监测肝酶的变化但停药后肝酶值会恢复正常
. 拜唐苹可使蔗糖分解为果糖和葡萄糖的速度更加缓慢因此如果发生急性的低血糖不宜使用蔗糖而应该使用葡萄糖纠正低血糖反应
【禁忌】
. 对阿卡波糖和/或非活性成分过敏者
. 有明显消化和吸收障碍的慢性胃肠功能紊乱患者禁用
. 患有由于肠胀气而可能恶化的疾患（如Roemheld综合症严重的疝气肠梗阻和肠溃疡）的病人禁用
. 严重肾功能损害（肌酐清除率<ml/分钟）的患者禁用
【孕妇用药】
. 因为缺乏有关本药在妊娠妇女中使用的资料妊娠妇女不得使用拜唐苹
. 哺乳期大鼠服用放射性标记的阿卡波糖片后在其乳汁中发现了少量的放射性物质在人类尚无类似的发现即使如此由于尚不能排除乳汁中阿卡波糖片对婴儿的影响原则上建议在哺乳期妇女不使用拜唐苹
【儿童用药】
鉴于尚无拜唐苹对儿童和青春期少年的疗效和耐受性的足够资料拜唐苹不应使用于岁以下的患者
【老年用药】
对于岁以上老年患者无须改变服药的剂量和次数
【药物相互作用】
. 服用阿卡波糖治疗期间由于结肠内碳水化合物酵解增加蔗糖或含有蔗糖的食物常会引起腹部不适甚至导致腹泻用
. 拜唐苹具有抗高血糖的作用但它本身不会引起低血糖如果拜唐苹与磺酰脲类药物二甲双胍或胰岛素一起使用时血糖会下降至低血糖的水平故合用时需减少磺酰脲类药物二甲双胍或胰岛素的剂量
. 个别情况下阿卡波糖可影响地高辛的生物利用度因此需调整地高辛的剂量
. 服用拜唐苹期间避免同时服用考来酰胺肠道吸附剂和消化酶类制剂以免影响拜唐苹的疗效
未发现与二甲基硅油有相互作用。