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Campral EC 333mg Tablets(阿坎酸钙缓释片)
药店国别  
产地国家 英国 
处 方 药: 是 
所属类别 333mg/片 84片/盒 
包装规格 333mg/片 84片/盒 
计价单位: 盒 
生产厂家中文参考译名:
默克
生产厂家英文名:
Merck
该药品相关信息网址1:
http://www.campral.com/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
CAMPRAL EC TABLET 333mg/tab 84tabs/bottle
原产地英文药品名:
Acamprosate
中文参考商品译名:
坎普劳缓释片 333毫克/片 84片/盒
中文参考药品译名:
阿坎酸钙
曾用名:
简介:

 

部份中文阿坎酸钙 处方资料(仅供参考)
【中文通用名】阿坎酸钙缓释片
【别 名】坎普拉尔,乙酰高牛磺酸钙,Campral.
【英文名】Acamprosate Calcium
药理毒理
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。
药代动力学
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。
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。
用法用量
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。
任何疑问,请遵医嘱!
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。
禁 忌
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。 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。
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。
Campral®
contains the active ingredient acamprosate calcium
CONSUMER MEDICINE INFORMATION
General Information
Campral (acamprosate) is a structural analogue of the amino acid homotaurine and the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). While it's specific mechanism of action is not entirely understood, neurotransmossion systems involving GABA and it's excitatory counterpart glutamate are observed to be thrown out of equilibrium when chronically exposed to alcohol; Campral, by mimicing GABA's actions and interacting with these systems directly, is thought to help restore this equilibrium.
It is specifically indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It has not been established as effective for initiating abstinence in patients who have not done so on their own prior to taking the drug, and it was designed to be a portion of a full behavioral and pharmacological treatment program. Campral has also not been shown to be effective in patients with multiple subtance dependencies including alcohol.
Campral is administered as an oral tablet, with a recommended dosage of two tablets (each containing 333 mg of Campral) thrice daily.
Clinical Results
FDA approval of Campral was based on three double-blind, placebo-controlled clinical studies enrolling a combined total of 998 subjects. The trials ranged from 90 to 360 days, with all subjects receiving at least one dose of Campral or placebo. All subjects had a history of alcohol abuse and dependence, and all had undergone inpatient detoxification and were abstinent from alcohol on the day of randomization. All subjects received their treatment in combination with standard psychosocial couselling. In all three studies, treatment with Campral yielded a greater portion of subjects maintaining abstinence than with placebo.
A fourth clinical study invesigated the efficacy of Campral in subjects with multiple substance dependencies, and in patients who had not established abstinence prior to dosing. In these studies, Campral was not shown to be superior to placebo.
Side Effects
Adverse events associated with the use of Campral may include, but are not limited to, the following:
•Diarrhea
•Nausea
•Flatulence
•Pruritus
In addition to these events, acute kidney failure was observed in 3 subjects during the trials. A causal role of Campral has not been found, and it has not been determined if these events were relevant to clinical treatment.
Mechanism of Action
Campral (acamprosate) is a structural analogue of the amino acid homotaurine, the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and the neuromodulatory amino acid taurine. The drug's specific mechanism of action is not entirely understood, but it is thought to help restore GABA-glutamate equilibrium by acting specifically on sites of alcohol dependence. It has been shown to have little to no additional CNS activity, and did not demonstrate significant behavioral effects (depression, anxiety, dizziness, etc.) significantly more often than placebo. 

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