药名：阿坎酸钙缓释片(レグテクト錠３３３ｍｇ)
商標名
Regtect Tablets 333mg
一般名
アカンプロサートカルシウム（Acamprosate calcium）（JAN）
化学名
Monocalcium bis(3-acetamidopropane-1-sulfonate)
分子式
C10H20CaN2O8S2
分子量
400.48
化学構造式

性状
本品是一种白色粉末。这是很容易溶于水，几乎不溶于乙醇或二氯甲烷中。
分配系数
0（1 - 辛醇/水）
组成
1片，这种药物含有钙333mg。
成份
含有交联聚维酮，微晶纤维素，硅酸镁，羟基乙酸淀粉钠，二氧化硅，硬脂酸镁，甲基丙烯酸共聚物LD，滑石，丙二醇。
效果或疗效
剂量效应和/或使用的疗效
辅助酒精依赖患者保持禁欲
相关使用说明的效果或疗效
诊断1。酒精中毒，进行仔细的基础上，适当的诊断标准国际分类疾病等，只有当他们要使用符合标准的。
可用于结合。心理治疗。
只用于患者的意愿三种。戒断。
患者中发现有。戒断症状，​​并可以用来完成的戒断症状的治疗。 [此药不是治疗戒断症状]
用法与用量
通常口服，每日三次。
药理
1，药理作用
表明对使用乙醇的依赖心理模型动物的抑制作用。
其结果是重复剂量口服和腹腔的影响自愿摄入乙醇模型中，12抑制自发摄入乙醇。
进行调节乙醇在使用条件性位置偏爱的测试方法。单次口服剂量的钙。
2。作用机理
进一步增加乳酸脱氢酶泄漏到细胞外谷氨酸刺激引起的，持续的曝光乙醇原代培养大鼠皮层神经元，抑制了反应问责亲断言钙）。中的相关模型大鼠吸入乙醇蒸气钙16用乙醇退出抑制谷氨酸灌流海马和伏隔核的量的增加）。
据认为，谷氨酸能神经的活动是中枢神经系统中主要的兴奋性神经增强，不平衡之间产生酒精依赖的抑制神经传递和兴奋性神经传导。据推测钙的作用机制尚不清楚，但恢复平衡神经递质，抑制谷氨酸能神经元的活动增加乙醇依赖性，它会导致效应的抑制和吸收自发抑制乙醇18）至20）
包装
レグテクト錠333mg：PTP 100錠、500錠
レグテクト錠333mg：バラ 500錠

製造販売元
日本新薬株式会社
完整资料附件：http://www.info.pmda.go.jp/go/pack/1190022H1020_1_01/
Campral is prescribed to treat alcohol dependence.
Acamprosate is thought to stabilize the chemical balance in the brain that would otherwise be disrupted by alcoholism, possibly by blocking glutamatergic N-methyl-D-aspartate receptors, while gamma-aminobutyric acid (GABA) type A receptors are activated. Reports indicate that acamprosate only works with a combination of attending support groups and abstinence from alcohol. Certain serious side effects include allergic reactions, irregular heartbeats, and low or high blood pressure, while less serious side effects include headaches, insomnia, and impotence. Acamprosate should not be taken by people with kidney problems or allergies to the drug.
Campral: Medications and PrescriptionsGeneric name: acamprosate
Product Brand Name: Campral
Product Manufacturer: Merck, France
Campral descriptionWhy is Campral prescribed?
Campral is prescribed to treat alcohol dependence. It helps people who have already stopped drinking alcohol keep from starting again. You must be alcohol-free before taking Campral for it to work. You must also be prepared to follow a complete alcohol treatment plan that includes mental and behavioral health counseling. Campral is thought to work by restoring and regulating brain chemicals that have been disrupted by long-term exposure to alcohol. Campral is not used for any type of substance dependence other than alcohol.
Mechanism of action:
Glutamate, as amino acid, is one of the most important messenger substances used by the nervous system. The cell membrane of the receiving neuron has NMDA receptors that bund the incoming glutamate. Binding leads to a flood of sodium and calcium ions inside the neuron, setting off an action potential that arouses the cell. Alcohol blocks the binding of glutamate to NMDA receptors – slowing or stopping the forwarding of messages. To compensate – and raise the chance of capturing glutamate – the number of receptors and their sensitivity are increased in the brain of people who chronically consume alcohol.
Yet if the alcohol supply is interrupted – duting a period of abstinence or even duting a single night’s sleep for the most dependent alcoholics – the receptors continue to be more sensitive, because the brain cann not adjust quicly enough to the new chemical situation. As a result, neurons overreact to glutamate. This hyperexcitatory condition is a major factor leading to withdrawal symptoms such as craving, unstable blood circulation and anxiety. The excessive activity can also kill off large numbers of neurons – essentially by poisoning them with too many chemicals – causing dementia or lasting damage of the nervous system.
Mechanism: Acamprosate suppress NMDA receptors and seems especially helpful for persons suffering conditioned withdrawal. Clinical studies shows patients remain dry for the first year after detoxification while taking acamprosate. The drug is particularly effective during the first few hard month os abstinence, when relapce rates are the highest.
Most important fact about Campral:
Individuals being treated with Campral and their caregivers should be aware that alcohol dependence and mental health problems frequently occur together. Pay special attention to any worsening of depression or any new symptoms that occur while taking Campral--especially agitation, anxiety, hostility, and suicidal thoughts or behavior--and report them to the doctor immediately.
How should you take Campral?
Campral may be taken with food or on an empty stomach. However, taking it with meals may make it easier to keep on a regular schedule. Continue taking Campral regularly even if you experience a relapse.
--If you miss a dose...
Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once.
--Storage instructions...
Store at room temperature.
Campral side effects
Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Campral.
Side effects may include:
Anxiety, body pain or weakness, chest pain, depression, diarrhea, dizziness, headache, heart failure, insomnia, irregular heartbeat, kidney failure, nausea, seizure, sudden death, and suicidal thinking or suicide attempt
Why should Campral not be prescribed?
You cannot use Campral if you have severe kidney disease. You must also avoid the drug if it causes an allergic reaction.
Special warnings about Campral
You must completely avoid alcohol while taking Campral. If you begin drinking again, keep taking Campral and call your doctor right away to discuss your relapse. Campral does not relieve the symptoms of alcohol withdrawal. Use Campral with caution if you have kidney problems. Because mental health problems and alcoholism frequently occur together, tell your doctor about any change in mood or behavior while using Campral (see "Most important fact about Campral"). Campral could affect your judgment, thinking, or motor skills. Do not drive, operate dangerous machinery, or participate in hazardous activities until you know how Campral affects you.
Possible food and drug interactions when taking Campral
At this time, there are no documented drug interactions with Campral. However, you should always tell the doctor about any medicines you take, including over-the-counter drugs, vitamins, and herbal supplements.
Special information if you are pregnant or breastfeeding
Campral has not been studied in pregnant women and should be used only if the benefits outweigh the potential risks. Be sure to tell your doctor if you're pregnant or plan to become pregnant. In lab studies Campral showed up in the milk of breastfeeding animals. It is not known whether Campral appears in human breast milk. Your doctor may advise you not to breastfeed while taking this drug.
Recommended dosage for Campral:
ADULTS
The usual starting dose is two tablets (each tablet contains 333 milligrams) taken three times a day, for a total of six tablets a day. Your doctor may lower the dose as needed. People with moderate kidney disease take half the regular dose—one tablet three times a day.
CHILDREN
The safety and effectiveness of Campral have not been studied in children.
Overdosage
Any medication taken in excess can have serious consequences. If you suspect an overdose, seek emergency treatment immediately.
Symptoms of overdose may include: Diarrhea
Campral notes:
Manufactured by a French company named Merck, Campral is the product brand name of acamprosate. Campral is an alcoholism medicine that is beneficiary for people who have stopped drinking. It cannot be prescribed to patients who are not hundred percent alcohol free or are not ready to undergo a total alcohol treatment, including the health counseling related to the mental and behavioral conditions. In addition, patients with addictions other than alcoholism cannot be prescribed to have the campral drug.
Campral medication helps to revive the brain chemicals and bring them back to normal functioning, after the same is hindered by the continuous exposure to alcohol for a long time. It is vital to understand that the brain cells of an alcoholic are overtly sensitive and drug acamprosate mechanism of action, reduces this hyper sensitivity of the brain cells. During the time a patient, who has undergone a detoxification, takes Campral, it helps him/her to stay away from the urge to start drinking alcohol again.
Campral reviews have shown that a few of the patients, who have been prescribed to take the drug, might develop symptoms of agitation, anxiety, hostility, and suicidal thoughts or behavior. Any such symptoms should immediately be reported to the doctor. Moreover, people taking care of alcohol dependent patients need to remember that alcohol dependence can be a major cause of mental health problems, and to treat the patient, alcoholism medicine needs to be combined with much love and care.
Although, Campral costs are quite high, it is still a preferred medicine for alcoholics. An 84 tablet packing of Campral 333 mg costs USD 98.00. Campral can be taken either empty stomach or with meals. Even if a patient forgets to take a dose, it should be given to him/her as soon as one remembers about it, unless it is time for the next dose.
Campral update:
Campral known in the medical terminology as acamprosate is a drug used worldwide for curing alcohol addiction. The repercussions of this drug are to counteract the production of glutamatergic N-methyl-D-aspartate receptors and stimulate the creation of gamma-aminobutyric acid (GABA) type A receptors which have been affected adversely when alcohol intake is curtailed. For people facing alcohol problems, this drug can be used for recovery during a period of their self-restraint from alcohol and when they are attending alcohol support groups.
Apart from making patients leave alcohol, it also reduces the potent side-effects caused by leaving alcohol immediately like brain injuries and death. Brain damage results subsequently after alcohol withdrawal when neurons die due to insufficient blood flow schemia).
People suffering from severe kidney ailments should not ingest this drug. Certain adverse effects of its consumption can include irregular heartbeats, erratic blood pressure, impotency and insomnia. The consumption of this drug can’t result in any kind of an addiction. It has been legalized in the European markets in 1989.
More information about Campral:
Campral, containing the active ingredient acamprosate calcium is an FDA approved prescription only medication that is used to keep former alcoholics away from their drinking habits. In other words, it is a treatment for alcoholism. It is manufactured and marketed in the US by Forest Laboratories; outside the US its marketing is handled by Merck KGaA.
Campral comes in the form of white tablets, each containing 300mg of the active substance acamprosate calcium. This active substance works in the brain to dull the effects of alcohol; it provides neuro-protection to people suffering from alcoholism and helps them get rid of the addiction. As a long-standing and widely prescribed medication, Campral has been successfully used by more than 1.5 million people worldwide.
Campral’s mode of action is to restore the chemical balance of substances in the brain that have been affected by alcoholism. However, Campral only works if the patient has stopped drinking completely. Prior to starting treatment with this drug, the patient must have gone through complete detoxification. Campral can help such a patient stay away from alcohol; however, it is not effective if the person is an active alcoholic.
The drug is an easy to use one that just requires the patient to stick to a regular dosage schedule. It can be taken with or without food, but preferably around the meal times. Most adult patients who are started on Campral are prescribed a dosage of six tablets a day to be taken in batches of two tablets, thrice daily. It is usually advised only to adult patients as its effects in children have not been studied.
Similarly, this drug has also not been studied sufficiently for pregnant or breast-feeding women and so should be taken with care by both groups. Always talk to your doctor before starting on its treatment if you are pregnant or have recently delivered a baby.
As a drug for the treatment of alcoholism, Campral is bound to have certain side effects on account of its action in the brain. Among the major known side effects of this drug, anxiety, chest pain, body pain, depression, diarrhea, dizziness, headache, and insomnia are more common. On rare occasions, there have also been reports of more serious side effects like heart failure, kidney failure, seizure, sudden death, and suicidal thoughts. Patients on Campral must be closely monitored during treatment to ensure avoidance of any such side effects.
Campral is an effective medication and treatment if it is taken regularly and for the period prescribed by your doctor. You must continue taking Campral for the entire period advised even if you suffer a relapse and start drinking again during treatment; just make sure you talk to your doctor immediately. This is most important because while Campral can help you stay away from alcohol, it does not provide any relief against the symptoms of alcohol withdrawal

阿坎酸钙缓释片详细的说明书
[附件:/uploadfile/article/uploadfile/201010/20101003033924977.pdf]
坎普拉尔(CAMPRAL(R))戒酒药中文临床资料
[附件:/uploadfile/article/uploadfile/201010/20101003055953753.pdf]

阿坎酸钙缓释片,商品名坎普拉尔(CAMPRAL(R))戒酒药
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）。
阿坎酸钙（Ａｃａｍｐｒｏｓａｔｅ Ｃａｌｃｉｕｍ），即乙酰高牛磺酸钙，是一种用于治疗酒精依赖性的新药，不过，在欧洲本药已有多年的用药历史。阿坎酸钙一般不会产生滥用，长期用药通常不会出现耐受性或依赖性。
【适应症】
阿坎酸钙（结合社会心理治疗）有助于酒精依赖性患者在酒精解毒之后继续维持戒酒状态。本药在临床上常常与阿片受体部分拮抗剂纳曲酮合用。
【药理及药代动力学】
阿坎酸钙的分子结构与神经递质高牛磺酸（ｈｏｍｏｔａｕｒｉｎｅ）相似，是γ－氨基丁酸（ＧＡＢＡ）和牛磺酸的类似物，属于中枢神经系统的神经调节剂。虽然本药作用机制仍不清楚，但临床试验提示本药可能是通过直接抑制ＧＡＢＡ和大脑伏核（Ｎａｃｃ）中的谷氨酸能受体来发挥其药理作用。阿坎酸钙口服生物利用度为１１％。当患者口服本药６６６ｍｇ，每天３次时，可在５天内达到稳态血药浓度。虽然进食可降低阿坎酸钙口服生物利用度，但这种影响没有临床意义。本药不在体内代谢，直接随尿液经肾脏排泄。
【禁忌症】
严重肾功能损害患者（肌酸酐清除率≤３０ｍｌ／ｍｉｎ）禁用本药。
【注意事项】
本药不能减轻急性酒精戒断症候群。事实上，所有参与临床试验的受试者在试验过程中都没有继续饮酒，因此，现实生活中那些持续饮酒的酗酒者在应用本药时有可能达不到所预期的治疗效果。中度肾功能损害患者（肌酸酐清除率为３０～５０ｍｌ／ｍｉｎ）应慎用本药。
【药物相互作用】
欧洲一项研究发现，虽然建议患者在服用本药过程中完全戒酒，但饮酒并不会影响本药的药代动力学。本药不会与苯二氮类卓药物、抗焦虑药、镇静药、安眠药或者非阿片类镇痛药产生相互作用。
【不良反应】
在临床试验中，受试者对本药耐受良好；不良反应情况在大多数情况下与安慰剂相似。本药最常见的不良反应为消化道反应（包括腹泻），发生率为１０％～１７％（安慰剂组为０．７％）。发生率超过１％的不良反应还包括头痛、腹痛、背痛和寒战。其他类型的不良反应还有心悸、晕厥、外周性水肿和体重增加。此外，在参与临床试验的总数为４４６１名受试者中，还发现了３例原因未明的急性肾功能衰竭病例。
【剂量及用药】本药为缓释片剂，规格为３３３ｍｇ。临床有效剂量为６６６ｍｇ，每天３次，进食时服用。建议患者在出现急性酒精戒断症状后立即服用本药，以防病情复发和达到最佳疗效。中度肾功能损害患者应减量至３３３ｍｇ，每天３次。
【患者咨询】应告知患者从家庭、朋友和精神辅导人员处得到社会心理支持的重要性。在服用本药过程中，患者应避免操作重型机械、驾驶或其他任何需要技巧和协调性的行为，因为本药可能暂时性影响这些功能。