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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->阿片受体拮抗剂
处方药:处方药
包装规格: 50毫克/片 30片/瓶
计价单位:
   
该药品相关信息网址1:
http://www.drugs.com/cdi/revia.html
该药品相关信息网址2:
http://www.rxlist.com/revia-drug.htm
原产地英文商品名:
NALTREXONE(REVIA GENERIC) 50MG/TAB 30TABS/BOTTLE
原产地英文药品名:
NALTREXONE HCL
中文参考商品译名:
纳曲酮(REVIA仿制药) 50毫克/片 30片/瓶
中文参考药品译名:
盐酸纳曲酮
中文参考化合物名称:
17环丙基甲基-4,与b-环氧-3,14-二羟基吗喃-6-酮
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Opioid receptor antagonist agents
英文适应病症2:
Release of opioid addiction has been the rehabilitation period adjuvant therapy
临床试验期:
完成
中文适应病症参考翻译1:
阿片受体桔抗剂
中文适应病症参考翻译2:
对已解除阿片类药物毒瘾者的康复期辅助治疗
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(2011102719182832.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文纳曲酮处方资料(仅供参考)

纳曲酮(Naltrexone)
【药品名称】
通用名:盐酸纳曲酮片曾用名:商品名:英文名:Naltrexone Hydrochloride Tablets汉语拼音:YɑnsuɑnNɑqutonɡPiɑn本品主要成份其化学名称:17环丙基甲基-4,与b-环氧-3,14-二羟基吗喃-6-酮。结构式:分子式:C20H23NO4分子量:341.14
 
【药理毒理】
药理学纳曲酮是阿片受体桔抗剂,药效学与纳洛酮的作用相似,能明显的减弱或完全阻断阿片受体,甚至反转由静脉注射阿片类药物所产生的作用。能解除其对阿片的身体依赖性,使已戒断阿片瘾者保持正常生活。本品口服有效,而且作用维持时间较长。本品不产生躯体或精神依赖性。毒理学本品对大鼠2年的致癌研究证明,在雄鼠间皮瘤和两性中血管源性肿瘤的数目稍有增加。但除雌性血管瘤稍有增加外,肿瘤的发生都在对照组的范围内。

【药代动力学】
纳曲酮口服后主要消除途径是大量被肝脏代谢,约占有吸收量的95%变为几种代谢产物,其中主要的活性代谢产物是6-b纳曲醇(6-b-naltrexol),其药理作用也是阻断阿片受体。一个次要的代谢物是2-羟基-3-甲氧基-6-b纳曲醇。纳曲酮及其代谢物主要经肾脏排出,原形由尿中排出的不到口服剂量的1%,由尿中排出的原形药物和结合的6-b纳曲醇约为口服剂量的38%。从药代动力学来看,本品及其代谢物能发生肝肠循环。给24名男性志愿者服用50mg纳曲酮后,纳曲酮及其主要代谢产物6-b纳曲醇的Cmax分别为8.6和99.3mg/ml。在50~200mg用量之间纳曲酮和6-b纳曲醇的Cmax和AUC呈比例的增加。Tmax约1小时。纳曲酮和6-b纳曲醇的消除T1/2分别为3.9和12.9小时。其平均消除T1/2和Tmax与用量无关。纳曲酮不在体内蓄积。由于T1/2长,6-b纳曲醇的血浓度在长期给药时可增加40%。体内纳曲酮的总清除率为1.5L/分(相当肝血流)。其肾清除率为127ml/分,完全由肾小球滤过。6-b纳曲醇的肾清除率为283ml/分,推测有肾小管分泌机制。纳曲酮静注后的分布容积为1350升。纳曲酮在治疗剂量范围内约有21%与血浆蛋白结合。

【适应症】
盐酸纳曲酮主要用于对已解除阿片类药物毒瘾者的康复期辅助治疗,使戒除阿片瘾者能维正常生活,防止或减少复吸。

【用法和用量】
纳曲酮治疗必须在纳洛酮诱发呈阴性时才能实行。所以必须按下列原则用药:(1)本品需在阿片瘾者戒断后7~10天后使用。戒断需经检查患者尿样证实。再以纳洛酮诱发,进一步确定不存在阿片依赖性。(2)纳洛酮诱发试验:针筒内吸入盐酸纳洛酮0.8mg先静脉注射盐酸纳洛酮0.2mg,观察30秒钟看患者是否有阿片依赖性,若呈阴性反应,继续静注0.6mg,并观察20~30分钟,无症状者可给予治疗。(3)纳洛酮治疗可有以下几种方案:每个工作日口服50mg,周六给100mg;隔日给100mg或每3天给150mg,疗程可持续半年。

【不良反应】
(1)纳曲酮的每日用量达到300mg时可引起肝细胞损害。(2)除肝损害外,不良反应发生率在10%以上的反应有:睡眠困难、焦虑、易激动、腹痛/痉挛、恶心和/或呕吐、关节肌肉痛、头痛。(3)不良反应发生率在10%以下的反应有:食欲不振、腹泻、便秘、口渴、头晕。(4)在1%以下的不良反应有:呼吸系统:鼻充血、发痒、流鼻涕、咽痛、粘液过多、声音嘶哑、咳嗽、呼吸短促。心血管系统:鼻出血、静脉炎、浮肿、血压升高、非特异性心电改变、心悸、心动过速。胃肠道:产气过多、便血、腹泻、溃疡。肌肉骨路:肩、下肢和膝关节疼痛、震颤。皮肤:油皮肤、搔痒、痤疮、唇疱疹。泌尿生殖系:排尿不适增多、性欲降低。精神方面:抑郁、忘想狂、疲倦、不安、精神错乱、幻觉、恶梦。

【禁忌】
有下列情况者禁用纳曲酮:(1)应用阿片类镇痛药者。(2)有阿片瘾的病人未经戒除者。(3)突然停用阿片的病人。(4)纳曲酮诱发失败的病人。(5)尿检阿片类物质阳性者。(6)对纳洛酮有过敏史者,尚不清楚本品是否与纳洛酮或其他含有菲的阿片类物质是否有交叉过敏性。(7)急性肝炎或肝功衰竭的个体。

【注意事项】
(1)本品有肝脏毒性可引起转氨酶升高。引起肝毒性的剂量只有临床常用量的5倍,故对肝功轻度障碍者也应当慎用。(2)为避免发生戒断症状或戒断症状恶化,在应用纳曲酮之前病人至少应当有7~10天体内确无阿片类物质。(3)应用本品之前或应用后应定期检查肝功,最好每月查1次。

【孕妇及哺乳期妇女用药】
本品属于妊娠危险性C级的药物。实验证明,临床用量140倍的剂量(约为100mg/kg),对家兔和大鼠可能有杀灭胚胎的作用,而且在大鼠能明显增加假妊的比例,并降低雌鼠的受孕率。但在人尚无对生育影响的报告。关于本品是否能从人乳计中排出尚不得知。对产程是否有影响也是未知数。所以对孕妇和哺乳期妇女使用本品应当慎重。

【儿童用药】
对18岁以下的个体使用本品的安全性问题尚未确定。

【药物相互作用】
本品可能干扰含有阿片类药物的治疗作用,凡使用阿片类镇痛药应避免与这类药物同时使用。

【药物过量】
目前尚无人用过量的经验。只有1次研究说明,每日用纳曲酮800mg,连用1周而未发现毒性。在小鼠、大鼠和豚鼠口服本品的LD50分别为:1.100±96mg/kg,(1.450±265)mg/kg和1.490±102mg/kg。小鼠、大鼠和犬急性致死的原因是阵挛性强直性惊厥和呼吸衰竭。因为缺乏治疗纳曲酮过量的经验,故应做好对症治疗。

【规格】
50mg 

Revia
Pronunciation: nal-TREX-ohn
Generic Name: Naltrexone
Brand Name: Revia

Revia can cause liver problems when given in large doses. Stop using Revia and seek immediate medical help if symptoms of liver problems develop, such as abdominal or stomach pain for more than a few days, white bowel movements, yellowing of the eyes or skin, or dark urine. Revia must not be used in patients who already have liver problems (eg, hepatitis, liver failure).

Revia is used for:
Treating alcoholism and narcotic (opioid) addiction in adults, as part of a complete treatment program. It may also be used to treat other conditions as determined by your doctor.

Revia is a narcotic antagonist. It is thought to work by blocking the effects of injectable opioids (eg, heroin, narcotic pain relievers). It has also been shown to decrease alcohol consumption.

Do NOT use Revia if:
•you are allergic to any ingredient in Revia
•you are taking narcotic medications for pain, are dependent on narcotics, are experiencing withdrawal symptoms from narcotics, have failed the challenge test with Revia, or have tested positive for narcotics
•you have hepatitis, liver failure, or liver disease
Contact your doctor or health care provider right away if any of these apply to you.

Before using Revia:
Some medical conditions may interact with Revia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
•if you are pregnant, planning to become pregnant, or are breast-feeding
•if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
•if you have allergies to medicines, foods, or other substances
•if you have kidney or liver problems, or a history of suicidal thoughts or behavior with or without depression

Some MEDICINES MAY INTERACT with Revia. Tell your health care provider if you are taking any other medicines, especially any of the following:
•Narcotic analgesics (eg, codeine), narcotic cough/cold medicines, or medicines used for diarrhea because effectiveness may be decreased by Revia. Withdrawal symptoms may occur if you are physically dependent on opioid medicines.
•Thioridazine because side effects such as sleepiness and sluggishness may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Revia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Revia:
Use Revia as directed by your doctor. Check the label on the medicine for exact dosing instructions.
•Revia may be taken with or without food.
•Revia should not be taken until the naltrexone challenge test is negative.
•Before taking Revia, you must be willing to take Revia to help with alcohol dependence, you must be free of substance abuse for 7 to 10 days, you must not have any severe or active liver or kidney problems, and you must not have any other medical problems or conditions that make taking Revia inadvisable.
•If you miss a dose of Revia and you are taking 1 dose daily, do no try to make up the missed dose by doubling the dose the next day. Take the next scheduled dose and consult your doctor.

Ask your health care provider any questions you may have about how to use Revia.

Important safety information:
•Revia may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Revia. Using Revia alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
•Carry identification to alert health care providers that you are taking Revia. You can get a medication card from your doctor to use for this purpose.
•Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Revia.
•Contact your health care provider at once if any of the following signs or symptoms of hepatitis occur while taking Revia: stomach pain lasting more than a few days; white bowel movements; dark urine; yellowing of the skin or eyes.
•Do not use narcotics while taking Revia, including opioid-containing medicines (eg, cough and cold products, pain relievers, heroin). Revia may increase your sensitivity to narcotics. Therefore, even very low doses may cause coma or be life-threatening.
•Before you have any medical or dental surgery or emergency treatments, tell the doctor or dentist that you are taking Revia.
•LAB TESTS, including liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
•Use Revia with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
•PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Revia during pregnancy. It is unknown if Revia is excreted in breast milk. If you are or will be breast-feeding while you are using Revia, check with your doctor or pharmacist to discuss the risks to your baby.

If you are addicted to narcotics and are given Revia, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Revia:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Anxiety; appetite loss; chills; constipation; delayed ejaculation; diarrhea; dizziness; drowsiness; feeling down; headache; increased energy; increased thirst; irritability; joint and muscle pain; low energy; nausea; nervousness; sleeplessness; stomach pain/cramps; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal or stomach pain; cramping; dark urine; depression; suicidal thoughts or behaviors; unusual tiredness or weakness; vomiting; white bowel movements; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Revia:
Store Revia at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Revia out of the reach of children and away from pets.

General information:
•If you have any questions about Revia, please talk with your doctor, pharmacist, or other health care provider.
•Revia is to be used only by the patient for whom it is prescribed. Do not share it with other people.
•If your symptoms do not improve or if they become worse, check with your doctor.
•Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Revia. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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 详细处方信息以本药内容附件PDF文件(2011102719182832.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2011-10-28
附件:


2011102719182832.PDF    

 
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