繁体中文
设为首页
加入收藏
当前位置:药品说明书与价格首页 >> 抗肿瘤药 >> 新药动态 >> FDA批准阿片类镇痛药羟考酮的新剂型

FDA批准阿片类镇痛药羟考酮的新剂型

2010-10-31 15:06:11  作者:新特药房  来源:互联网  浏览次数:237  文字大小:【】【】【
简介: 2010年4月5日,美国食品药品监督管理局(FDA)批准了控释药物OxyContin(奥施康定,通用名为羟考酮,Oxycodone)的一种新的剂型,以避免该药被误用或滥用。   OxyContin可缓慢释放强效阿片类药物羟 ...

 2010年4月5日,美国食品药品监督管理局(FDA)批准了控释药物OxyContin(奥施康定,通用名为羟考酮,Oxycodone)的一种新的剂型,以避免该药被误用或滥用。

  OxyContin可缓慢释放强效阿片类药物羟考酮,用于治疗需要一种持续性、24小时起效的阿片类镇痛药以缓解长期中重度疼痛的患者。由于该药的控释特性,每片OxyContin中都含有大量羟考酮,以便患者减少服药频率。不过,一些人习惯滥用原有剂型的OxyContin,这种剂型会突然释放大量羟考酮,从而会引起致命性过量和高频率滥用该药。

  改变剂型后的OxyContin目的在于防止该药被切割、掰开、咀嚼、挤压或溶解而达到释放更多药物的效果。这种新剂型或许是一种改进,它可能会降低因擅自改变药片而引起的过量风险,并可能会减少通过吸食或注射途径的药物滥用,不过,该药仍可通过直接吞服大于推荐用法的剂量而被滥用或误用。

  FDA药物评估和研究中心的麻醉和镇痛药品部门主任Bob Rappaport博士表示,“尽管这种新的OxyContin剂型对于该药的现有剂型而言可能只是一种量的改进,但这毕竟是正确的一步。同所有的阿片类药物一样,对于OxyContin而言,安全性是一个重要的考虑因素。医生和患者应认识到这种新剂型的抗擅自改变的能力是有限的,并应仔细权衡使用这种药物治疗疼痛的益处和风险。”

  根据美国药物滥用和精神健康服务管理局(U.S. Substance Abuse and Mental Health Services Administration)所进行的有关用药和健康的全国性调查的统计,在2008年,约有50万人首次非治疗性使用过OxyContin。

  OxyContin的生产商Purdue PHarma公司将被要求进行一项上市后研究,以收集有关这种新剂型对降低该药滥用和误用的程度的数据。FDA还要求建立一项风险评估和最小化计划(Risk Evaluation and Mitigation Strategy,REMS),其中将包括发布一份患者用药指南和一份用于医生教育的有关在疼痛治疗中正确使用阿片类镇痛药的规定。

Oxycontin Addiction

The introduction of OxyContin in 1995resulted in increasing patterns of abuse.

Prescription drug abuse- Oxycont

Unlike Percocet, whose potential for abuse is limited by the presence of acetaminophen, OxyContin contains only oxycodone and inert filler. Abusers crush the tablets to defeat the time-release mechanism, then either ingest the resulting powder orally, intranasally, via intravenous/intramuscular/subcutis injection, or rectally to achieve rapid absorption into the bloodstream.

The vast majority of OxyContin-related deaths are attributed to ingesting substantial quantities of OxyContin or ingesting OxyContin along with another depressant of the central nervous system such as alcohol or benzodiazepines. While high doses of oxycodone can be fatal to an opiate-naïve individual in and of itself, this is (comparatively) rarely the case.

It was once felt that “combination” opioids (those that contain one or more additional, non-narcotic ingredients) would be less subject to abuse, since, for example, the amount of acetaminophen present in large overdoses of Percocet would cause stomach upset and liver damage. However, it has been demonstrated that abusers seeking the euphoric “high” are not deterred by these potential side effects or toxicities. Abusers soon discovered that extremely simple methods to separate the ingredients exist, particularly due to the widely disparate solubility of the alkaloids and analgesics in water (”cold water extraction”).

Similar thinking also once motivated Canadian authorities to package oral methadone for use only in combination with Tang, an orange-flavored beverage powder, in hopes that it would only be taken correctly; however, it was still abused.

Oxycodone has similar effects to morphine and heroin, and appeals to the same abuse community. Armed robberies of pharmacies where the robber demanded only OxyContin, not cash, have occurred. In some areas, particularly the eastern U.S., OxyContin has been the drug of greatest concern to enforcement authorities. Oxycodone abuse has been notably problematic in Appalachia; because of this, the drug has earned the nickname hillbilly heroin.

Because oxycodone is highly regulated, when acquired illegally it is quite expensive. Street prices in Washington, DC, for example, have been reported to be anywhere from fifty cents to one dollar per milligram, making it anywhere from 30 to 60 times more costly than gold, gram for gram. Like other opioids, oxycodone can be fatal at high doses or when combined with depressants such as alcohol.

Several documented fatalities from OxyContin abuse have been made public.

责任编辑:admin


相关文章
 

最新文章

更多

· Sensipar被FDA批准用于治...
· Perjeta(pertuzumab,帕...
· ImMucin新型癌症疫苗-可...
· 2011年获FDA批准上市的抗...
· Supect(拉多替尼胶囊,R...
· FDA批准前列腺癌药物(l...
· 磷雌酚钠(Fostestrol S...
· 易普利姆玛(Ipilimumab)...
· Revlimid(Lenalidomide,...
· FDA批准Erivedge(vismod...

推荐文章

更多

· Sensipar被FDA批准用于治...
· Perjeta(pertuzumab,帕...
· ImMucin新型癌症疫苗-可...
· 2011年获FDA批准上市的抗...
· Supect(拉多替尼胶囊,R...
· FDA批准前列腺癌药物(l...
· 磷雌酚钠(Fostestrol S...
· 易普利姆玛(Ipilimumab)...
· Revlimid(Lenalidomide,...
· FDA批准Erivedge(vismod...

热点文章

更多