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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->重症肌无力
处方药:处方药
包装规格: 10毫克/毫升 5毫升/安醅 10安醅/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
MYLAN INSTITUTIONAL
生产厂家英文名:
MYLAN INSTITUTIONAL
该药品相关信息网址1:
www.drugs.com/pro/enlon-plus.html
该药品相关信息网址2:
www.rxlist.com/enlon-plus-drug.htm
原产地英文商品名:
ENLON PLUS 10mg/ml 5mls/ampul 10ampuls/box
原产地英文药品名:
ATROPINE SULFATE/EDROPHONIUM CHLORIDE
原产地英文化合物名称:
N-ethyl-3-hydroxy-N,N-dimethylanilinium chloride; ethyl(3-hydroxyphenyl)dimethylammonium chloride
中文参考商品译名:
ENLON PLUS 10毫克/毫升 5毫升/安醅 10安醅/盒
中文参考药品译名:
硫酸阿托品/依酚氯铵
中文参考化合物名称:
N-乙基-3-羟基-N,N-二甲基苯胺氯化物
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Myasthenia gravis
英文适应病症2:
Diagnosis of myasthenia gravis, or the amount of drug overdose less than
英文适应病症3:
Save the non-depolarizing muscle relaxant overdose Type
临床试验期:
完成
中文适应病症参考翻译1:
重症肌无力
中文适应病症参考翻译2:
诊断重症肌无力用药过量或用量不足
中文适应病症参考翻译3:
解救非去极化型肌肉松弛药过量
药品信息:

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 详细处方信息以本药内容附件PDF文件(201261422502719.PDF)的“原文Priscribing Information”为准
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部分中文ENLON PLUS处方资料(仅供参考)

中文名称:依酚氯铵

中文别名:氯化艾卓酚; N-乙基-3-羟基-N,N-二甲基苯胺氯化物
 
英文名称:
edrophonium chloride

英文别名:N-ethyl-3-hydroxy-N,N-dimethylanilinium chloride; ethyl(3-hydroxyphenyl)dimethylammonium chloride

分类名称:
一级分类:神经系统药物 二级分类:神经细胞活化剂及营养药物 三级分类:胆碱酯酶抑制剂  
  
药品别名:
腾喜龙、艾宙酚、Tensilon、Enlon、Enlon-Plus、Reversol、Camsilon
 
药物剂型:
注射剂
 
药理作用:
属季铵类易逆性抗胆碱酯酶药。作用同新斯的明。
 
药动学:对骨骼肌的兴奋作用强大,作用快速而短暂。注射后30~60秒即可出现作用,维持时间10分钟左右。Vd为1.1士0.2L/kg,t1/2为1.8土0.6小时。 
 
适应证:
(1)作为重症肌无力诊断剂:重症肌无力病人用药后,症状迅速改善,肌强度增加,作用维持5~15分钟后,恢复至原先的症状与体征。采用步骤为:静脉注射2mg,30~45秒内无不良反应,继续注射8mg。英国推荐儿童用药总量100μg/kg。开始采用剂量的1/5,若无不良反应,再给以余量。美国建议儿童用量:体重在34kg以下者,总量5mg,体重较重者为10mg。开始用剂量的1/5,每隔30~45秒增加1mg。静脉给药困难时可采用肌内注射,成人剂量10mg;儿童体重34kg以下用量2mg,体重较重者5mg。进行试验时,必须备有阿托品,以便及时处理严重的M胆碱受体兴奋症状。
(2)鉴别诊断重症肌无力用药过量或用量不足:用量不足者,用依酚氯铵后可使症状很快改善;若肌力下降,表踢抗胆碱酯酶药用药过量。
(3)解救非去极化型肌肉松弛药过量。
 
禁忌证:有肠或尿道梗阻者禁用,患支气管哮喘及心脏病者慎用。 
 
不良反应:流涎、恶心、呕吐、腹痛、腹泻、尿频、支气管痉挛、心动过缓、心律失常等。

Enlon-Plus
Generic Name: edrophonium chloride and atrophine sulfate
Dosage Form: injection, solution

Enlon-Plus Description
Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection, for intravenous use, is a sterile, nonpyrogenic, nondepolarizing neuromuscular relaxant antagonist. Enlon-Plus is a combination drug containing a rapid acting acetylcholinesterase inhibitor, edrophonium chloride, and an anticholinergic, atropine sulfate. Chemically, edrophonium chloride is ethyl (m-hydroxyphenyl) dimethylammonium chloride.

Enlon-Plus contains in each mL of sterile solution:
5 mL Ampul: 10 mg edrophonium chloride and 0.14 mg atropine sulfate compounded with 2.0 mg sodium sulfite as a preservative and buffered with sodium citrate and citric acid. The pH range is 4.0-5.0.

15 mL Multiple Dose Vial: 10 mg edrophonium chloride and 0.14 mg atropine sulfate compounded with 2.0 mg sodium sulfite and 4.5 mg phenol as a preservative and buffered with sodium citrate and citric acid. The pH range is 4.0-5.0.

Indications and Usage for Enlon-Plus
Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection is recommended as a reversal agent or antagonist of nondepolarizing neuromuscular blocking agents. It is not effective against depolarizing neuromuscular blocking agents. It is also useful if used adjunctively in the treatment of respiratory depression caused by curare overdosage.

The appropriateness of the specific fixed ratio of edrophonium and atropine contained in Enlon-Plus has not been evaluated in myasthenia gravis. Therefore, Enlon-Plus is not recommended for use in the differential diagnosis of this condition.

Contraindications
Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection is not to be used in patients with known hypersensitivity to either of the components, or in patients with intestinal or urinary obstruction of mechanical type. Atropine sulfate is contraindicated in the presence of acute glaucoma, adhesions (synechiae) between the iris and lens of the eye, and pyloric stenosis.

Warnings
Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection should be used with caution in patients with bronchial asthma or cardiac arrhythmias. Cardiac arrest has been reported to occur in digitalized patients as well as in jaundiced subjects receiving cholinesterase inhibitors. In patients with cardiovascular disease, given anesthesia with narcotic and nitrous oxide without a potent inhalational agent, there is increased risk for clinically significant bradycardia. In patients receiving beta-adrenergic blocking agents there is increased risk for excessive bradycardia from unopposed parasympathetic vagal tone. Such patients should receive atropine sulfate alone prior to Enlon-Plus. Isolated instances of respiratory arrest have also been reported following the administration of edrophonium chloride. Additional atropine sulfate (1 mg) should be available for immediate use to counteract severe cholinergic reaction which may occur in hypersensitive individuals when Enlon-Plus is used.

Enlon-Plus contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

There is a potential for tissue irritation by extravascular injection.

Precautions
General
As with any antagonist of nondepolarizing muscle relaxants, adequate recovery of voluntary respiration and neuromuscular transmission must be obtained prior to the discontinuation of respiratory assistance. Should a patient develop "anticholinesterase insensitivity" for brief or prolonged periods, the patient should be carefully monitored and the dosage of anticholinesterase drugs reduced or withheld until the patient again becomes sensitive to them. Use with caution in patients with prostatic hypertrophy and in debilitated patients with chronic lung disease.

When used in therapeutic doses, atropine can cause dryness of the mouth. This effect is additive when the product is administered with other drugs that can cause dryness of the mouth.

Since atropine sulfate slows gastric emptying and gastrointestinal motility, it may interfere with the absorption of other medications. The effect of atropine on dryness of the mouth may be increased if it is given with other drugs that have anticholinergic action (tricyclic antidepressants, antipsychotics, some antihistamines, and antiparkinsonism drugs).

Drug Interactions
Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection should not be administered prior to the administration of any nondepolarizing muscle relaxants. It should be administered with caution to patients with symptoms of myasthenic weakness who are also on anticholinesterase drugs. Anticholinesterase overdosage (cholinergic crisis) symptoms may mimic underdosage (myasthenic weakness), so the use of this drug may worsen the condition of these patients (see OVERDOSAGE section for treatment).

Narcotic analgesics, except when combined with potent inhaled anesthetics, appear to potentiate the effect of edrophonium on the sinus node and conduction system, increasing both the frequency and duration of bradycardia. In patients with cardiovascular disease, given anesthesia with narcotic and nitrous oxide without a potent inhalational agent, there is increased risk for clinically significant bradycardia. In patients receiving beta-adrenergic blocking agents there is increased risk for excessive bradycardia from unopposed parasympathetic vagal tone. Such patients should receive atropine sulfate alone prior to Enlon-Plus.

Compared to muscle relaxants with some vagolytic activity, muscle relaxants with no vagolytic effects, i.e. vecuronium, may be associated with a slightly higher incidence of vagotonic effects such as bradycardia and first-degree heart block when reversed with Enlon-Plus.

Overdosage
Muscarinic symptoms (nausea, vomiting, diarrhea, sweating, increased bronchial and salivary secretions and bradycardia) may appear with overdosage (cholinergic crisis) of Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection, but may be managed by the use of additional atropine sulfate. Obstruction of the airway by bronchial secretions can arise and may be managed with suction (especially if tracheostomy has been performed).

Should edrophonium chloride overdosage occur:
1.Maintain respiratory exchange.
2.Monitor cardiac function.

Appropriate measures should be taken if convulsions occur or shock is present.

Principal manifestations of overdosage (poisoning) with atropine sulfate are delirium, tachycardia and fever. In the treatment of atropine poisoning, respiratory assistance and symptomatic support are indicated. Death is usually due to paralysis of the medullary centers.

In the clinical studies performed with Enlon-Plus, there were no reported overdoses and therefore no clinical information is available regarding overdosing with Enlon-Plus.

Enlon-Plus Dosage and Administration
Dosages of Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection range from 0.05-0.1 mL/kg given slowly over 45 seconds to 1 minute at a point of at least 5% recovery of twitch response to neuromuscular stimulation (95% block). The dosage delivered is 0.5-1.0 mg/kg of edrophonium chloride and 0.007-0.014 mg/kg of atropine sulfate. A total dosage of 1.0 mg/kg of edrophonium chloride should rarely be exceeded. Response should be monitored carefully and assisted or controlled ventilation secured. Satisfactory reversal permits adequate voluntary respiration and neuromuscular transmission (as tested with a peripheral nerve stimulator). Recurarization has not been reported after satisfactory reversal has been attained.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

How is Enlon-Plus Supplied
Enlon-Plus (edrophonium chloride, USP and atropine sulfate, USP) Injection should be stored between 15°-26°C (59°-78°F).

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 详细处方信息以本药内容附件PDF文件(201261422502719.PDF)的“原文Priscribing Information”为准
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更新日期: 2012-6-15
附件:






201261422502719.PDF    

 
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