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  药店国别: 瑞士药房
产地国家: 瑞士
所属类别: 神经系统药物->镇静、催眠、抗焦虑及抗惊厥药
处方药:处方药
包装规格: 125毫升/ 支
计价单位:
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生产厂家英文名:
Interdelta (Switzerland)
该药品相关信息网址1:
https://www.drugs.com/international/nervifene.html
原产地英文商品名:
NERVIFENE solution 125 ml (Min.Order 20)
原产地英文药品名:
Chloral Hydrate
中文参考商品译名:
NERVIFENE溶液125毫升(最低訂購量:20)
中文参考药品译名:
水合氯醛
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
insomnia
临床试验期:
完成
中文适应病症参考翻译1:
失眠
药品信息:

组合物

适应症/机会 麻烦睡觉和入睡。紧张兴奋的状态。

剂量/说明 应使用最小有效剂量。

成年人

催眠:通常的剂量是睡前0.5至1克(1至2次5毫升扫描)(即0.5至1克水合氯醛)。 镇静剂:饭后每日3次,每次0.25克(½勺)。 最大单次或每日推荐剂量为2 g。

儿童

催眠:睡前常用剂量为30-50 mg / kg。 镇静剂:通常的每日剂量为25毫克/千克,白天分为三或四剂。 推荐的最大单剂量为1 g。

禁忌

水合氯醛禁用于对活性物质的过敏,以及严重的肝或肾功能不全,心脏疾病,呼吸衰竭,卟啉症,胃炎或抗凝治疗。 阻塞性睡眠呼吸暂停患儿也禁用Nervifen。 没有孕妇研究(动物研究:见“临床前数据”)。在这些条件下,不应在怀孕期间给药。 水合氯醛进入母乳,在哺乳期禁忌。

警告和注意事项 在连续使用2周后,耐受现像已经可以干预。 慢性使用可能会让人上瘾。像任何安眠药一样,Nervifen只会在短时间内服用。建议在抑郁症(自杀危险)和有依赖风险的患者中谨慎行事。如果长期使用,应注意避免药物突然停止,以避免突然停药的后果。 由于水合氯醛具有潜在的致癌风险(仅在动物中观察到),因此不鼓励在儿童和婴儿中经常使用Nervifen。

的相互作用 在使用香豆素衍生的抗凝血剂治疗的患者中,在给予水合氯醛之前应该小心,因为有改变抗凝血作用的风险(通常会增加这种效果)。 与呋塞米的关联可能在一些患者中诱发血管舒张,伴有红斑,心动过速,张力减退和出汗。 水合氯醛加速阿米替林的代谢。它还可以降低苯妥英的血液水平。 乙醇增强了水合氯醛的催眠作用并导致血管舒张。 在用氟西汀治疗或伴随其他CNS镇静剂的伴随治疗期间已经注意到水合氯醛作用的延长。 还提到了通过与MAOI的相互作用可能增加水合氯醛的作用。

怀孕/哺乳 没有孕妇研究(动物研究:见“临床前数据”)。在这些条件下,不应在怀孕期间给药。 对驾驶能力和机械使用的影响 Nervifen可导致道路交通和机器处理中的反应受损,特别是在伴随饮酒的情况下。

副作用 在推荐的治疗剂量下,在水合氯醛摄入后偶尔观察到一些可逆的副作用。 血液学:也观察到嗜酸性粒细胞增多和白细胞减少现象。 中枢神经系统:中枢神经系统抑郁,嗜睡,头痛,共济失调,反常觉醒,混乱状态,容忍发展,头晕,焦虑,噩梦,睡眠障碍。 眼部疾病:瞳孔缩小,眼睑下垂,过敏性结膜炎。 心血管系统:已报告室内心律失常的孤立病例,特别是在儿童中,当给予高治疗剂量的水合氯醛时。另见“过量”部分。 胃肠系统:胃刺激,恶心,胀气,腹泻。 过敏反应包括皮肤反应(红斑,荨麻疹)。 在慢性高剂量或过量服用时,经常报导“遗留”,心律失常,外周血管扩张,低血压,粘膜出血性腹泻和呼吸抑制。还观察到高胆红素血症的表现

过量

体征:昏迷,瞳孔散大,血压下降,心律不齐,呼吸抑制,胃肠道病变(出血,穿孔,胃坏死),肌肉松弛,肝脏疾病,肾脏疾病。 措施:根据阶段,洗胃,木炭给药,呼吸支持,血液透析或血液灌流。心血管疾病将得到适当治疗。

临床疗效 Nervifene用作催眠药,可促进睡眠,确保睡眠5至8小时。它也被用作成人和儿童的神经镇静剂。

药代动力学 水合氯醛在胃肠道中迅速再吸收。在半小时内达到有效的血浆水平。 水合氯醛通过肝脏的醇脱氢酶代谢成三氯乙醇。其血浆半衰期约为8小时。 三氯乙醇是具有催眠作用的活性代谢物;它在葡萄糖醛酸化后被泌尿道消除。 生物利用度约为60%,血浆蛋白结合率约为35%。 20-40%的三氯乙醇被氧化成三氯乙酸。 三氯乙醇存在于脑脊液,胎盘和胎儿中,并且在母乳中的浓度非常小。 临床前数据 对基因的潜在毒性 水合氯醛在一种(三种)鼠伤寒沙门氏菌菌株中诱导突变。 在体外,它诱导中国仓鼠卵巢细胞的姐妹染色单体交换和染色体畸变显著增加。 对果蝇(Drosophila melanogaster)的SLRL(性连锁隐性致死)试验结果尚无定论。 水合氯醛增加了小鼠骨髓中微核红细胞的频率。 潜在的致癌作用 动物实验(小鼠)表明怀疑肝细胞癌。 对诊断方法的影响 当测定尿糖水平或使用荧光测试影响儿茶酚胺测量时,水合氯醛可能导致假阳性结果。

存储注意事项 在原始密闭包装中远离光线和热量。

Composition

Indications / Opportunities Trouble sleeping and falling asleep. States of nervous excitement.

Dosage / Instructions The minimum effective dose should be used.

Adults

Hypnotic: the usual dose is 0.5 to 1 g (1 to 2 scans of 5 ml) at bedtime (ie 0.5 to 1 g of chloral hydrate). Sedative: 0.25 g (½ scoop) 3 times daily after meals. The maximum single or daily recommended dose is 2 g.

Children

Hypnotic: the usual dose is 30-50 mg / kg at bedtime. Sedative: the usual daily dose of 25 mg / kg divided into three or four doses during the day. The maximum recommended single dose is 1 g.

Contraindications

Chloral hydrate is contraindicated for hypersensitivity to the active substance as well as in severe hepatic or renal insufficiency, cardiac disorders, respiratory failure, porphyria, gastritis or anticoagulant therapy. The use of Nervifen is also contraindicated in children with obstructive sleep apnea. Studies in pregnant women are not available (studies in animals: see "Preclinical data"). Under these conditions, the drug should not be administered during pregnancy. Chloral hydrate passes into breast milk and is contraindicated during lactation.

Warnings and Precautions A phenomenon of tolerance can intervene already after 2 weeks of continuous use. Chronic use can be addictive. Like any sleeping pill, Nervifen will only be prescribed for a short time. Caution is recommended in depressives (danger of suicide) and in patients at risk of dependence. In case of prolonged use, care should be taken to avoid a sudden stop of the medication to avoid the consequences of abrupt withdrawal. Due to a potential carcinogenicity risk of chloral hydrate (observed only in animals), regular use of Nervifen in children and infants is discouraged.

Interactions In patients treated with a coumarin-derived anticoagulant, caution should be exercised before administering chloral hydrate, because of the risk of altering the anticoagulant effect (usually an increase in this effect). The association with furosemide may induce in some patients vasodilation with erythema, tachycardia, hypotonia and sweating. Chloral hydrate accelerates the metabolism of amitriptyline. It can also decrease blood levels of phenytoin. Ethanol potentiates the hypnotic effect of chloral hydrate and causes vasodilatation. An extension of the effects of chloral hydrate has been noted during treatment with fluoxetine or concomitant treatment with other CNS sedatives. A possible increase in the effects of chloral hydrate by interaction with MAOIs was also mentioned.

Pregnancy / Breastfeeding Studies in pregnant women are not available (studies in animals: see "Preclinical data"). Under these conditions, the drug should not be administered during pregnancy. Effect on driving ability and use of machinery Nervifen can cause impaired reflexes in road traffic and the handling of machines, especially during concomitant consumption of alcohol.

Side effects At the recommended therapeutic doses, some reversible side effects have been observed occasionally following chloral hydrate intake. Hematology: eosinophilia and leukopenia phenomena have also been observed. Central Nervous System: CNS depression, drowsiness, headache, ataxia, paradoxical arousal, confusional state, development of tolerance, dizziness, anxiety, nightmares, sleep disturbances. Eye disorders: miosis, ptosis, allergic conjunctivitis. Cardiovascular System: Isolated cases of ventricular arrhythmia have been reported, particularly in children, when a high therapeutic dose of chloral hydrate is administered. See also section "Overdose". Gastrointestinal system: gastric irritation, nausea, flatulence, diarrhea. Hypersensitivity reactions include skin reactions (erythema, urticaria). In chronic high doses or overdose, "hang-over", arrhythmias, peripheral vasodilatation, hypotension, muco-haemorrhagic diarrhea and respiratory depression have been frequently reported. Manifestations of hyperbiliruminemia have also been observed.

Overdose

Signs: coma, pupillary dilatation, hypotension, cardiac arrhythmia, respiratory depression, gastrointestinal lesions (haemorrhages, perforations, gastric necrosis), muscular relaxation, hepatic disorders, renal disorders. Measures: gastric lavage, charcoal administration, respiratory support, hemodialysis or hemoperfusion depending on the phase. Cardiovascular disorders will be treated appropriately.

Clinical Efficacy

Used as a hypnotic, Nervifene facilitates sleep and ensures sleep for 5 to 8 hours. It is also used as a nervous sedative in adults and children.

Pharmacokinetics

Chloral hydrate is rapidly resorbed in the gastrointestinal tract. An effective plasma level is reached in ½ hour. Chloral hydrate is metabolized to trichloroethanol by the alcohol dehydrogenase of the liver. Its plasma half-life is about 8 hours. Trichlorethanol is the active metabolite with a hypnotic effect; it is eliminated by the urinary tract after glucuronidation. The bioavailability is about 60% and the plasma protein binding is about 35%. 20-40% of the trichloroethanol is oxidized to trichloroacetic acid. Trichlorethanol is found in the cerebrospinal fluid, placenta and fetus and in very small concentrations in breast milk. Preclinical data Potential toxicity to genes Chloral hydrate induces mutations in one (out of three) Salmonella typhimurium strain. In vitro, it induces significantly increased sister chromatid exchange and chromosomal aberrations of Chinese hamster ovary cells. The results of SLRL (sex-linked recessive lethal) tests on Drosophila melanogaster are inconclusive. Chloral hydrate increases the frequency of micro-nuclei erythrocytes in the bone marrow of mice. Potential carcinogenic effect Animal experiments (mice) indicate suspicion of hepatocellular carcinomas. Influence on diagnostic methods Chloral hydrate may cause false positive results when determining urinary glucose levels or influence catecholamine measurements using fluorimetric tests.

Storage considerations

Keep away from light and heat in the original closed packaging.
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