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AEMCOLO(rifamycin delayed-release Tablets)

2018-11-21 04:11:20  作者:新特药房  来源:互联网  浏览次数:26  文字大小:【】【】【
简介:近日:美国FDA批准Aemcolo(利福霉素[rifamycin])缓释片,Aemcolo是一种抗细菌药适用为被大肠杆菌(E. coli)的非侵袭性株所致的旅行者的腹泻,不合并发热或粪中血成年患者的治疗。FDA的药品评价和研究中心 ...

近日:美国FDA批准Aemcolo(利福霉素[rifamycin])缓释片,Aemcolo是一种抗细菌药适用为被大肠杆菌(E. coli)的非侵袭性株所致的旅行者的腹泻,不合并发热或粪中血成年患者的治疗。
FDA的药品评价和研究中心中抗微生物产品办公室主任Edward Cox,M.D.,M.P.H.说:"旅行者的腹泻每年影响数百万人和有治疗选择对这个条件可帮助减轻这个条件的症状," 。
批准日期:
2018年11月16日 公司:Cosmo Technologies, Ltd.
AEMCOLO(利福霉素[rifamycin])缓释片,供口服使用
美国初步批准:2018年
作用机制
利福霉素是一种抗菌药物。
适应症和用法
AEMCOLO是一种利福霉素抗菌药物,用于治疗成人无创大肠杆菌菌株引起的旅行者腹泻。
使用限制:
AEMCOLO不推荐用于因发烧和/或血便引起的腹泻患者,也不推荐用于非侵入性大肠杆菌菌株以外的病原体引起的腹泻患者。为了减少耐药细菌的产生,并保持AEMCOLO和其他抗菌药物的有效性,aemcolo2只能用于治疗或预防被证实或强烈怀疑是由细菌引起的感染。
剂量和管理
•AEMCOLO的推荐剂量为388 mg(两片),每天口服两次,连续三天。
每次服用一剂都要喝一杯液体。不要与酒精同时服用。
AEMCOLO可以在带或不带食物的情况下服用。
•整片吞下AEMCOLO药片。不要压碎、打碎或咀嚼药片。
剂型及强度
缓释片:利福霉素194mg。
禁忌症
对于已知对利福霉素过敏的患者(如利福霉素类抗菌药物(如利福霉素类抗菌药物)或AEMCOLO中的任何一种成分过敏的患者,AEMCOLO禁用。
警告和预防措施
•持续或恶化的腹泻风险并发发热/或血便:AEMCOLO对因发热和/或由非侵入性大肠杆菌菌株以外的病原体引起的腹泻和/或血便或腹泻的住院患者无效。这类患者不推荐使用大肠杆菌。如果腹泻加重或持续超过48小时,停止使用,并考虑替代抗菌疗法。艰难梭状芽胞杆菌相关腹泻:评估是否在治疗后发生腹泻,或在治疗期间没有改善或恶化。
不良反应
最常见的不良反应(发生率为2%)是头痛和便秘。
包装提供/存储和处理
AEMCOLO缓释片含有194毫克利福霉素(相当于200毫克利福霉素钠),呈黄褐色、椭球形和涂膜。这些是用12片装在纸板箱里的吸塑卡包装的。它们的供应情况如下:
NDC(71068-001-10): 12片儿童耐药盒。
NDC(71068-001-11): 36片一盒
商店在20°到25°C(68到77°F)旅行允许15到30°C (59°- 86°F)。


完整资料附件:https://www.ariespharma.com/wp-content/uploads/2018/11/1-AEM18176-NDA-210910-Approved-PI-11-16-18.pdf
AEMCOLO(rifamycin)delayed-release tablets, for oral use.
Generic name:
rifamycin
Company: Cosmo Technologies, Ltd.
Treatment for: Traveler's Diarrhea
Aemcolo(rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli.
Limitations of Use: Aemcolo is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aemcolo and other antibacterial drugs, Aemcolo should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Aemcolo should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Aemcolo or other antibacterial drugs in the future.
DOSAGE AND ADMINISTRATION
The recommended dosage of Aemcolo is 388 mg (two tablets) orally twice daily for three days.
Take each dose with a a full glass of liquid (6-8 ounces). Do NOT take Aemcolo concomitantly with alcohol.
Aemcolo may be taken with or without food.
Swallow Aemcolo tablets whole. Do NOT crush, break or chew the tablets.
CONTRAINDICATIONS
Aemcolo is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the other ingredients in Aemcolo.
WARNINGS AND PRECAUTIONS
Risk of Persistent or Worsening Diarrhea Complicated by Fever and/or Bloody Stool: Aemcolo was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea due to pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients. Discontinue use if diarrhea gets worse or persists more than 48 hours, and consider alternative antibacterial therapy.
Clostridium difficile-associated Diarrhea: Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery or bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of Aemcolo. If diarrhea occurs after therapy, or does not improve or worsens during therapy, patients should contact their physician as soon as possible.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 2%) are headache and constipation.

责任编辑:p53


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