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当前位置:药品说明书与价格首页 >> 综合药讯 >> DEHYDRATED ALCOHOL(无水乙醇注射剂/无水酒精注射液)

DEHYDRATED ALCOHOL(无水乙醇注射剂/无水酒精注射液)

2015-09-02 10:02:50  作者:新特药房  来源:互联网  浏览次数:15  文字大小:【】【】【
简介: 部份中文无水乙醇资料(仅供参考)临床药理醇脱水和原生质沉淀产生损伤组织细胞。当醇在靠近喷射至神经组织,它产生神经炎和神经变性(神经松解)。故意伤害到选定脊柱神经,末梢神经,或神经节通过注射 ...

部份中文无水乙醇资料(仅供参考)
临床药理
醇脱水和原生质沉淀产生损伤组织细胞。当醇在靠近喷射至神经组织,它产生神经炎和神经变性(神经松解)。故意伤害到选定脊柱神经,末梢神经,或神经节通过注射醇导致感觉,运动和自主神经功能的更多或更少的持久块。
用于治疗神经松解醇的喷射涉及量太小,不能产生乙醇显著全身效应。
90至98%进入体内,乙醇的完全氧化。
适应症和用法
无水酒精注射液的适应症为神经治疗神经松解或神经节的顽固性慢性疼痛在这样的条件下无法操作肿瘤和三叉神经痛(ticdouloureux),患者对他们来说,神经外科手术禁忌的救济。三叉神经痛的救济通常只是暂时的。量注射醇的已报道的其它病症包括舌咽神经痛,心绞痛和严重跛行由于周围血管功能不全。40〜50%的酒精浓度(通过适当的稀释脱水醇)已用于硬膜外或个别运动神经注射控制脑瘫及痉挛性截瘫的某些表现形式。类似的浓度也已注射腹腔神经丛阻滞,以减轻对不能手术上腹部癌性疼痛,以及被注射区域内和皮下救济的顽固性肛门瘙痒。
禁忌
蛛网膜下腔注射无水乙醇是禁忌的接受,因为出血的危险抗凝剂的患者。
警告
酒精是易燃液体,应保持冷静,远离热源。酒精注射应谨慎,以避免不必要的组织坏死。患者的正确定位是必不可少的,以控制脱水酒精注射的本地化(即低压)进入蛛网膜下腔。
注意事项
不要管理,除非解决方案是明确的,容器是否完好。丢弃未使用的部分。
它有时是可取的为醇注射进行试注射普鲁卡因或其他局部麻醉剂的先有作为确认针的精确放置的一种手段,并减轻疼痛的过程期间所经历。用于精确定位的X射线可视化也可能是可取的。
当蛛网膜下腔内用于选择性感觉块,它是必不可少的,以避免醇与前(马达)接触,如果运动麻痹不希望要治疗的脊神经根。当周围神经注射,应注意该残余的醇不沿针轨道或在组织破坏是不想要的任何其他位置沉积。实例已经报道了,其中从后喷射神经炎所得的疼痛明显低于现有的注射前更严重。
DEHYDRATED ALCOHOL-alcohol injection, solution 
American Regent, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here
DEHYDRATED ALCOHOL INJECTION, USP
Rx Only
For Therapeutic Neurolysis
DESCRIPTION
Dehydrated Alcohol Injection, USP consists of not less than 98% by volume of ethanol (ethyl alcohol). Dehydrated alcohol is hypobaric in relation to the cerebrospinal fluid. It is injected proximate to nerve tissues and into spinal subarachnoid spaces to produce degeneration of nerve function (neurolysis) for control of chronic pain.
The product contains no bacteriostat or antimicrobial agent (other than ethanol) and no added buffer.
Dehydrated alcohol is a clear, colorless liquid miscible with water and has the following structural formula:


CLINICAL PHARMACOLOGY
Alcohol produces injury to tissue cells by dehydration and precipitation of protoplasm. When alcohol is injected in close proximity to nerve tissues, it produces neuritis and nerve degeneration (neurolysis). Deliberate injury to selected spinal nerves, peripheral nerves, or ganglia by injection of alcohol results in more or less enduring block of sensory, motor and autonomic function.
The injection of alcohol used for therapeutic neurolysis involves amounts too small to produce significant systemic effects of ethanol.
Ninety to 98% of ethyl alcohol that enters the body is completely oxidized.
INDICATIONS AND USAGE
Dehydrated Alcohol Injection is indicated for therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (ticdouloureux), in patients for whom neurosurgical procedures are contraindicated. Relief of trigeminal neuralgia usually is only temporary. Other conditions for which injection of alcohol has been reported include glossopharyngeal neuralgia, angina pectoris and severe claudication due to peripheral vascular insufficiency.
Alcohol concentrations of 40 to 50% (prepared by appropriate dilution of dehydrated alcohol) have been used for epidural or individual motor nerve injections to control certain manifestations of cerebral palsy and spastic paraplegia. Similar concentrations also have been injected for celiac plexus block to relieve pain of inoperable upper abdominal cancer, and have been injected intra-and subcutaneously for relief of intractable pruritus ani.
CONTRAINDICATIONS
Subarachnoid injection of dehydrated alcohol is contraindicated in patients receiving anticoagulants because of the danger of bleeding.
WARNINGS
Alcohol is a flammable liquid and should be kept cool and away from any heat source. Alcohol injections should be made with care to avoid unwanted tissue necrosis. Proper positioning of the patient is essential to control localization of injections of dehydrated alcohol (which is hypobaric) into the subarachnoid space.
PRECAUTIONS
Do not administer unless solution is clear and container is intact. Discard unused portion.
It is sometimes advisable to make a trial injection of procaine or other local anesthetic prior to alcohol injection as a means of confirming accurate placement of the needle, and to decrease pain experienced during the procedure.  X-ray visualization for precise placement also may be advisable.
When used for selective sensory block within the subarachnoid space, it is essential to avoid contact of the alcohol with the anterior (motor) roots of the spinal nerve to be treated if motor paralysis is not desired. When peripheral nerves are injected, care should be taken that residual alcohol is not deposited along the needle track or in any other locations where tissue destruction is not wanted. Instances have been reported in which the pain resulting from post-injection neuritis was more severe than that existing before the injection.
Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with dehydrated alcohol. It is also not known whether dehydrated alcohol can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Dehydrated alcohol should be given to a pregnant woman only if clearly needed.
ADVERSE REACTIONS
The most commonly encountered side effects are post-injection neuritis with persistent pain, hyperesthesia and paresthesia. Subarachnoid neurolysis and lumbar sympathetic block may be followed by motor paralysis, bladder or rectal incontinence and impotence. Severe hypotension may follow celiac ganglion injection. Corneal anesthesia, meningitis or cranial nerve palsy may follow injection of the gasserian ganglion.
DRUG ABUSE AND DEPENDENCE
None known with this size and manner of presentation.
OVERDOSAGE
Excessive or faulty localization of injections may result in unwanted post-injection neuritis and/or tissue necrosis.
In such cases, efforts should be directed toward dilution of deposited alcohol when feasible, relief of pain with analgesics and surgical intervention if indicated.
Hypotension following celiac ganglion injection may be controlled with appropriate vasopressor agents. See PRECAUTIONS and ADVERSE REACTIONS.
DOSAGE AND ADMINISTRATION
The dosage of Dehydrated Alcohol Injection for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites.  Since Dehydrated Alcohol Injection is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.
When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.
The LD50 oral dose in rats is 13.7 g/kg.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
HOW SUPPLIED
Dehydrated Alcohol Injection, USP
NDC 0517-8571-10     1 mL Ampule     Packages of 10
NDC 0517-8575-10     5 mL Ampule     Packages of 10
http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=470b8865-6c71-4bf0-bb5d-ea88e5ea7bd4
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
DEHYDRATED ALCOHOL 1mL/AMPULES  10AMPULES/BOX
原产地英文药品名:
alcohol
中文参考商品译名:
DEHYDRATED ALCOHOL注射剂 1毫升/安瓿 10安瓿/盒
中文参考药品译名:
无水酒精
生产厂家英文名:
American Regent, Inc.
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
DEHYDRATED ALCOHOL 5mL/AMPULES  10AMPULES/BOX
原产地英文药品名:
alcohol
中文参考商品译名:
DEHYDRATED ALCOHOL注射剂 5毫升/安瓿 10安瓿/盒
中文参考药品译名:
无水酒精
生产厂家英文名:
American Regent, Inc.

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