BIAXIN Filmtab（克拉霉素 clarithromycin）片剂  用于口服
BIAXIN XL Filmtab（克拉霉素 clarithromycin）缓释片  用于口服
BIAXIN Granules（克拉霉素 clarithromycin）颗粒  用于口服悬浮液
初始美国批准：1991
近期主要变化
警告和注意事项，与其他药物同时使用的严重不良反应：10/2015
作用机制
克拉霉素是大环内酯抗微生物药物[参见Microbiology]。
适应症和用法
BIAXIN是一种大环内酯抗微生物剂，用于指定的易感细菌引起的轻度至中度感染，如下：
慢性支气管炎的急性细菌性恶化
急性上颌窦炎
社区获得性肺炎
咽炎/扁桃体炎
不复杂的皮肤和皮肤结构感染
急性中耳炎在儿科患者
分散分枝杆菌感染的治疗和预防
幽门螺杆菌感染和十二指肠溃疡病在成人
使用限制
BIAXIN XL Filmtab仅适用于慢性支气管炎，急性上颌窦炎和成人社区获得性肺炎的急性细菌性恶化。
为了减少耐药细菌的发展并保持BIAXIN和其他抗菌药物的有效性，BIAXIN应仅用于治疗或预防被证明或强烈怀疑由细菌引起的感染。
剂量和给药
成人：
BIAXIN 250mg或500mg每12小时7-14天; BIAXIN XL 1克每24小时7-14天
幽门螺杆菌根除（与兰索拉唑/阿莫西林，奥美拉唑/阿莫西林或奥美拉唑组合）：BIAXIN 500mg，每8或12小时，持续10-14天。有关其他信息，请参阅完整处方信息（FPI）。
儿科患者：BIAXIN 15mg/kg /天，每12小时分为10天
分枝杆菌感染：BIAXIN 500 mg每12小时; BIAXIN 7.5mg/kg，每12小时在儿科患者中至多500mg
减少中度肾功能损害伴随阿扎那韦或含利托那韦的方案中的剂量和重度肾损伤
剂量形式和强度
片剂：250mg和500mg
缓释片剂：500 mg
口服悬浮液的颗粒：125mg/5mL，250mg/5mL
禁忌症
对克拉霉素或任何大环内酯药物的超敏反应
西沙必利，匹莫齐特，洛伐他汀/辛伐他汀，麦角胺/双氢麦角胺
使用克拉霉素的胆汁淤积性黄疸/肝功能障碍的病史
秋水仙碱肾或肝损害
警告和注意事项
严重急性超敏反应：如果发生，停止BIAXIN
QT延长：在已知QT延长或已知延长QT间期，室性心律失常（尖端扭转型室性心动过速），低钾血症/低镁血症，显着心动过缓或采用IA或III类抗心律失常药的患者中避免BIAXIN
肝毒性：如果发生肝炎的体征和症状，则停止
严重的不良反应可能由于BIAXIN与秋水仙碱，一些HMG CoA还原酶抑制剂，一些钙通道阻滞剂和其他药物的药物相互作用而发生
艰难梭菌相关性腹泻（CDAD）：评估是否发生腹泻
胚胎毒性：BIAXIN不应该用于孕妇，除非在临床情况下，没有替代治疗是适当的
重症肌无力的恶化
不良反应
在临床试验中成人和儿科人群最常见的不良反应：腹痛，腹泻，恶心，呕吐，dysgeusia
药物相互作用
BIAXIN的共同给药可以改变其他药物的浓度。在治疗之前和期间必须考虑药物 - 药物相互作用的可能性。
在特定人群中使用
老年：增加尖端扭转型室速的风险
完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa44552c-3cfe-4111-8aa5-4251aeed9be9
Clarithromycin, also known as erythromycin, is erythromycin derivatives, the early 90s of last century by the Japanese Dazheng company successfully developed and registered under the trade name Clarith. In 1991, it was listed in Ireland and Italy. In October 1991, the FDA approved the listing of IB-like drugs, trade name Biaxin, and in 1993, Klacid was listed in Hong Kong, China. In 1991, In Europe and Asia, the trade name of Clara cents, has been listed in more than 50 countries around the world, the steady growth in market usage, and played an important role in clinical practice. Clarithromycin and its tablets, capsules have been incorporated into the Chinese Pharmacopoeia 2000 edition (Note: 2005 Pharmacopoeia included in the second page 232), the current production of formulations are granules, dispersible tablets, sustained-release tablets, injections and Dry suspensions. The following are the same as the "
Clarithromycin is highly effective, easy to absorb oral, acidic stability of the characteristics of the drug on the Gram-positive bacteria activity, the enzyme stability, high concentrations in serum and lung tissue. Clinical proof of in vivo activity is erythromycin 6 to 10 times, is 12 to 35 times the amount of josamycin. And to improve the bioavailability is characterized by excellent organization and intracellular distribution, long half-life, the incidence of adverse reactions was only 3%, is used for the treatment of upper respiratory tract and lower respiratory tract and skin, soft tissue infection, has become a substitute for erythropoies The macrolide antibiotic varieties.
In addition, the US FDA has approved the use of clarithromycin and Losecom, Helicobacter pylori as a result of gastric and duodenal ulcer treatment program; the drug is also the first choice for the treatment of AIDS patients infected.