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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于代谢机制药物->戒酒药
处方药:处方药
包装规格: 333毫克/片 180片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
森林实验室
生产厂家英文名:
FOREST LABS
该药品相关信息网址1:
http://www.campral.com/
原产地英文商品名:
CAMPRAL DR TABLET 333mg/tab 180tabs/bottle
原产地英文药品名:
ACAMPROSATE CALCIUM
中文参考商品译名:
坎普劳缓释片 333毫克/片 180片/瓶
中文参考药品译名:
阿坎酸钙
原产地国家批准上市年份:
2004/07/29
英文适应病症1:
alcohol abuse
临床试验期:
完成
中文适应病症参考翻译1:
酒精滥用
药品信息:

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 详细处方信息以本药内容附件PDF文件(20098701433123.pdf)的“原文Priscribing Information”为准
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FDA批准治疗酒精中毒的新药.(通用名:阿坎酸[acamprosate])
    7月29日,FDA宣布批准新药Campral(商品名:坎普劳;通用名:阿坎酸[acamprosate])用于治疗已经停止饮酒后寻求继续戒酒的酒精依赖者(alcohol dependent individuals)。Campral对于在治疗开始时仍频繁饮酒,或滥用除酒精之外的其它物质的患者,可能不具疗效。
    Campral是十年来获准的第一个用于治疗酒精滥用(alcohol abuse)的新药。
    酒精中毒(alcoholism),又称酒精依赖(alcohol dependence),是一种疾病。酒精滥用(alcohol misuse)将造成严重后果,在很多情况下,甚至是威胁生命的。大量饮酒增加患某些癌症的风险,特别是肝脏、食管、咽和喉头等部位的癌症。大量饮酒也会引起肝硬化(liver cirrhosis)、免疫系统疾病、脑损害;如果在怀孕期,将对胎儿造成伤害。慢性酒精中毒(chronic alcoholism)一直以来都是一个普遍存在的消耗性疾病,在医疗保健费用(healthcare costs)、工资损失和个人身心痛苦等方面对社会造成巨大负担。
    Campral的作用机制尚未完全明了,目前认为它是通过作用于与酒精滥用有关的脑通路。通过包括已放弃酒精摄入的酒精依赖患者(即,已戒酒者[detoxified])的多重安慰剂对照临床试验,Campral被证明是安全和有效的。鉴于接受阿坎酸治疗的受试者中较大比例被评定为在整个治疗中达到持续性戒酒,证明Campral在维持戒酒(abstinence)(保持使患者不消费酒)中优于安慰剂。Campral没有成瘾性,并且在临床试验中普遍有良好的耐受性。所报告的患者最常见不良事件,包括头痛、腹泻、胃气胀和恶心。
    Campral治疗应作为包括心理社会支持在内的综合治疗项目的一部分。
    Campral的申报者是位于法国里昂的Lipha Pharmaceuticals, Inc.(利伐制药公司)。

Campral (acamprosate calcium) is the most recent medication approved for the treatment of alcohol dependence or alcoholism in the United States -- approved by the Food and Drug Administration in July 2004 -- but it has been used widely in Europe for many years. More than 1.5 million people have been treated worldwide with Campral.

How Does Campral Work?
It is not completely understood exactly how Campral works in the brain to help people maintain alcohol abstinence, but it is believed to restore a chemical balance in the brain that is disrupted by long-term or chronic alcohol abuse. In other words, it helps the brain begin working normally again
While Antabuse works by making someone sick if they drink alcohol and Naltrexone blocks the "high" people get when drinking, Campral reduces the physical distress and emotional discomfort people usually experience when they quit drinking. According to Forest Laboratories, the distributor the drug in the U.S., Campral reduces sweating, anxiety and sleep disturbances that many experience during the early stages of alcohol abstinence.

How Is Campral Taken?
Campral is prescribed in 333mg time-release tablets that are usually taken three times a day. For some patients, such as those with kidney disease, the standard dose may be adjusted by a physician. Because Campral tablets are time-release, they should be swallowed whole and never crushed, cut or chewed.
Because the side effects of Campral are few and mild and because Campral is not addictive, it is usually prescribed for up to 12 months after ceasing alcohol consumption.

What Are the Side Effects?
Campral was "generally well-tolerated in clinical trials" according to the FDA. The side effects that were reported are usually mild and temporary. They include:
?Diarrhea
?Dizziness
?Gas
?Dry mouth
?Headache
?Insomnia
?Itching
?Joint or muscle pain
?Loss of appetite
?Nausea
?Sweating
However, in rare cases Campral can cause more severe side effects. Anyone who experiences any of the following symptoms should stop taking Campral immediately and contact their healthcare provider:
?Anxiety or nervousness
?Burning, pricking or tingling in arms, legs, hands, or feet
?Depression
?Chest pains
?Passing urine less often
?Suicidal thoughts
What Campral Does Not Do
Campral does not help someone quit drinking; it helps those who have already withdrawn from alcohol to maintain abstinence. Campral does not help with withdrawal symptoms experienced while going through early detoxification from alcohol.
However, Campral has been shown to reduce sleep disturbances commonly experienced during early sobriety by recovering alcoholics.

How Effective Is Campral?
As with all other medications approved for the treatment of alcohol dependence, Campral is most effective as a part of an overall program of recovery including therapy, counseling and/or support group participation.
During the FDA clinical trials, Campral was three times more effective than a placebo in maintaining abstinence from alcohol as part of an overall support program. However, the more recent COMBINE (Combining Medications and Behavioral Interventions for Alcoholism) study, surprisingly found that Campral was no more effective than a placebo.
In other words, like all other treatments and approaches to maintaining alcohol abstinence, Campral does not work for everyone. It's not a magic bullet.

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 详细处方信息以本药内容附件PDF文件(20098701433123.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-10-09
附件:


20098701433123.pdf    

 
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