Coartem(通用名：artermether/lumefantrine，复方蒿甲醚-苯芴醇)

适应症： 疟疾(Malaria)

生产公司： 诺华(Novartis)

http://www.oneyao.net/article/2010/0513/19828.html

药品简介

美国FDA于2009年4月7日批准诺华公司的复方口服蒿甲醚-苯芴醇片（Artemether-Lumefantrine Tablets，商品名：Coartem ）用于治疗体重5kg以上（含5kg）、恶性疟原虫引起的单纯性疟疾感染患者.

复方蒿甲醚Coartem (蒿甲醚, Artemether和本芴醇, lumefantrine)片

批准日期：美国FDA：2009年4月7日；

公司：Novartis

适应症：
适用于治疗体重5公斤以上患者疟原虫Plasmodium falciparum所致急性，无合并症感染。已证实Coartem®片对氯喹耐药地理区域有疗效。本品不用于治疗严重疟疾或预防疟疾。

用法用量：
与食物服用，服前压碎与1～2茶匙水混合。3天期间6次，初始剂量，8小时后，后2天早晨和傍晚各1次。

禁忌：青蒿素和本芴醇或其赋形剂过敏患者。

不良反应：
成人最常见不良反应(30%)是头痛、食欲不振、眩晕、虚弱、关节和肌肉痛。儿童(12%)为发热、咳嗽、呕吐、食欲减退和头痛。

Drug: Coartem (artermether/lumefantrine)
Indication: Malaria
Company: Novartis
Approval Date: April 7
 FDA advisory panel unanimously endorsed the efficacy of Coartem for malaria in December 2008, and the agency approved it the following April. Coartem was already in use in some 80 countries to treat malaria infections caused by the parasite P falciparam.
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The Gambia’s health officials have disclosed the availability of the new anti-malaria drug [coartem] in the country.

Coartem is combination of artemether and lumegentrin and has 100% efficacy of eliminating malaria parasite from the victim’s system.

The introduction of coartem followed the ineffectiveness of chloroquine, the amendment of the malaria policy treatment and consultations of health experts.

Malaria has been declared a major killer disease among children and pregnant women in The Gambia. It kills at least 2,000 children every year and represents over 50% of clinical cases.

The killer disease is seasonal in the country with highest risk from May to September.

National Malaria Control Programme (NMCP) officials briefed journalists at a day’s forum about the urgent need for the introduction of the new drug. They said many African countries have started using coartem to combat malaria.

The Deputy Programme Manager, Adam Jagne-Sonko, attributed chloroquine resistance among many Gambians to their failure to abide by the strict treatment procedure.

“The new drug is very effective for malaria treatment, but it is not meant for pregnant women and children under five years,” Jagne-Sonko said. It is available at all public health facilities at a minimal price.

Gambian health experts said the change of attitude towards malaria treatment will help combat malaria drug resistance.

FDA批准抗疟药Coartem上市

2009年04月08日，美国药品管理局( FDA)批准复方蒿甲醚+苯芴醇（artemether+lumefantrine，Coartem）用于治疗成人及儿童急性非重症疟疾感染。疟疾感染表现为发热、寒战及与感冒类似的症状。如果不进行治疗，可导致严重的并发症，甚至死亡。约90%的死亡病例发生在撒哈拉以南的非洲地区，该病症也流行于亚洲和拉丁美洲的部分地区。
据估计，每年有3.5~5亿的新感染人群，约100万患者死亡，其中大多数为儿童。本品在临床研究中最常见的成人不良反应为头痛、食欲不振、头晕、虚弱、关节痛及肌肉疼痛。儿童常见的不良反应包括发烧（发热）、咳嗽、呕吐、食欲不振和头痛。作为Coartem的有效成分之一的蒿甲醚是在美国批准上市的第一个青蒿素类药物，从青蒿植物中分离获取。