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  药店国别: 英国药房
产地国家: 英国
所属类别: 神经系统药物->神经肌肉松弛药物
处方药:处方药
包装规格: 300毫升/瓶
计价单位:
  点击放大  
生产厂家英文名:
Novartis (UK)
该药品相关信息网址1:
https://www.webmd.com/drugs/2/drug-12240/lioresal-oral/details
该药品相关信息网址2:
https://www.medbroadcast.com/drug/getdrug/lioresal
原产地英文商品名:
Lioresal liquid 5 mg/5ml (Min. Order 10)
原产地英文药品名:
Baclofen Solution
中文参考商品译名:
Lioresal液体5毫克/ 5毫升 (最小订单:10)
中文参考药品译名:
巴氯芬溶液
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
gastroesophageal reflux
临床试验期:
完成
中文适应病症参考翻译1:
胃食管反流症状
药品信息:

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 详细处方信息以本药内容附件PDF文件(201882123593735.pdf)的“原文Priscribing Information”为准
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部分中文Lioresal liquid处方资料(仅供参考)


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Lioresal liquid巴氯芬注射液

药理作用

本药是一个高效的作用在脊髓部位的肌肉松弛剂,其作用机制和药理学特性均与其他肌肉松弛剂不同。巴氯芬抑制单突触和多突触反射传递,它可能是通过刺激GABAB受体,而抑制兴奋性氨基酸如谷氨酸和天门冬氨酸的释放。神经肌肉传递不受巴氯芬的影响。巴氯芬具有抗感受伤害作用,对伴有骨骼肌痉挛的神经系统疾患,本药的临床作用为缓解反射性肌肉挛缩,对痛性阵挛、自动症和阵挛有明显缓解作用。本药能改善病人的活动能力,使病人生活较易自理,更有利于主动和被动的物理治疗。

药代动力学

本药的活性物质巴氯芬在胃肠道中吸收迅速而完全,单剂量口服10 mg、20 mg和30 mg巴氯芬,0.5-1.5小时后,其血浆峰浓度分别平均约为180、340和650 ng/mL,相应血药浓度曲线下面积(AUCs)与剂量大小成比例增加,其值分别为1140、2350和3350 ng x小时/mL。巴氯芬的分布面积为0.7 L/kg,脑脊液中活性物质浓度约比血浆中的低8.5倍。巴氯芬的血浆清除半衰期平均为3-4小时,其血清蛋白结合率约为30%。大部分巴氯芬以原型排出,在72小时内,摄入量中约75%经肾脏排出,其中代谢物约占5%,摄入量的其余部分,包括占5%的代谢物从粪便排出,主要代谢产物为β-(p-氨苯)-γ-羟丁酸,无药理活性。

适应症

多发性硬化症的骨骼肌痉挛状态。感染性、退行性、外伤性、肿胀或原因不明的脊髓疾病引起的痉挛状态,例如:痉挛性脊髓麻痹、肌萎缩性侧索硬化症、脊髓空洞症、横贯型脊髓炎、外伤性截瘫或麻痹、脊髓压迫、脑源性肌阵挛,特别是小儿脑性瘫痪,以及脑血管意外、肿瘤或退行性脑病引起的肌痉挛。

用法用量

应从小剂量开始,逐渐增加剂量,根据个体病情的不同,制定适当的每日剂量,既能使阵挛、屈肌和伸肌痉挛状态减轻,又能维持足够的肌张力,使病人能自主活动,并尽可能减少副反应。本药应在进餐时用少量液体送服,将每日用量分次服用,成人至少分3次,儿童分4次。 对成人患者,原则上初始剂量用每日3次,每次5 mg。应逐渐小心增加剂量,每隔3日增加剂量,每日3次,每次增加5 mg,直至所需剂量。 对该药敏感的患者,宜再降低其初始每日用量(15 mg或10 mg),并放慢增加剂量的速度。通常合适的剂量范围为每日30-75 mg,住院病人可能需要加至每日100-120 mg。

肾功能损害或长期血液透析病人,应使用特别小的剂量,即每日约5 mg。 由于老年或脑源性痉挛状态的患者更易发生副反应,对这些病例,建议极为小心地制订治疗计划,并于严密监护下用药。 儿童的用药剂量为0.75-2 mg/kg体重/日,对10岁以上儿童,每日最大剂量可达2.5 mg/kg体重。通常治疗开始时每次2.5 mg,每日4次,大约每隔3天小心增加剂量,直至达到儿童个体需要量。

不良反应

副作用主要见于治疗开始时,剂量增加过快、剂量过大或年老患者。这些副作用常为暂时性,减少剂量后可减弱或消失,其程度也较轻,一般不需停药。对有神经病史患者或伴有脑血管疾病(如中风)和年老患者,副作用可能较为严重。 中枢神经系统:治疗开始时常出现日间镇静、嗜睡和恶心等副作用,偶然出现口干、呼吸抑制、头晕、无力、虚脱、精神错乱、晕眩、恶心、呕吐、头痛和失眠。 神经病学和/或精神学的表现:偶然或罕见报导有:欣快、抑郁、感觉异常、肌痛、肌无力、共济失调、震颤、眼球震颤、调节紊乱、幻觉、恶梦,上述症状常难以与疾病本身的表现相区别。可能会降低惊厥阈,并引起惊厥发作,癫痫患者尤应注意。 胃肠道:偶有轻度的胃肠功能紊乱(便秘、腹泻)。 心血管系统:偶会发生低血压、心血管功能降低。 泌尿生殖系统:偶见或罕见排尿困难、尿频、遗尿,这些常难以与疾病本身的表现相区别。

其它副作用:罕见或个别病例有视力障碍,味觉障碍、多汗、皮疹、肝功能损害。某些病人对药物可显反常的反应而表现为痉挛状态加重。可能会出现肌张力过低,使病人更难于行走或照料自己,这种情况通常在调节剂量后可缓解(如减少日间剂量,可能的话增加夜间剂量)。

禁忌症

已知对巴氯芬过敏者禁用。

注意事项

痉挛状态合并精神障碍,精神分裂症或意识错乱状态的病人,因为病情可能恶化,应慎用,并对病人进行严密监护。对伴有癫痫的痉挛状态患者,除继续使用适量的抗惊厥药治疗外,可在适当的监护下使用本药。 对于消化性溃疡或有该病史的患者,以及患有脑血管病、呼吸、肝、肾功能衰竭者,也应慎用。因神经调节紊乱而影响膀胱排空的病人,使用本药治疗期间可有改善,因此,对已患有括约肌张力过高,而可能发生急性尿潴留的病人,应慎用本药。有报告显示,使用本药特别是长期使用者突然停药,可发生焦虑、意识错乱、幻觉、精神病、躁狂或偏执状态、惊厥(癫痫持续状态)、心动过速,并且可出现反跳现象,使痉挛状态一过性加重。除非发生严重的副作用,应通过逐渐减少剂量而终止治疗(大约需1-2周以上)。

由于有报告显示,在极个别病例中可引起血谷草转氨酶、碱性磷酸酶和血糖升高,对肝病或糖尿病患者应定期作有关实验室检查,以确证上述已有的疾病与药物的诱导无关。 本药之镇静作用可使患者的反应能力受影响,应激性降低,因此患者驾驶车辆或操纵机器时应小心。

孕妇及哺乳期妇女用药

在妊娠期间,尤其在最初三个月,只有在抢救生命时才能使用本药。应仔细权衡治疗对母亲和胎儿之间的利弊。巴氯芬可通过胎盘屏障,母亲服用治疗剂量的本药,活性物质可进入乳汁,但量甚少,对婴儿影响不大。

药物相互作用

与其它作用于中枢神经系统药物或酒精合用时,可增加镇静作用。当与三环类抗抑郁药合用时,可加强本药的作用,引起明显的肌张力过低。本药和降压药合用可使血压下降作用加强。帕金森氏病(震颤麻痹)患者,同时接受本药和左旋多巴加比多巴治疗,有报告引起精神错乱、幻想和激动不安。

药物过量

体征和症状

主要表现为中枢神经抑制如嗜睡、意识模糊、呼吸抑制、昏迷,容易发生的症状还有精神错乱、幻觉、激越、调节紊乱、瞳孔反射消失;全身性肌张力过低、肌阵挛、反射消失;惊厥;周围血管扩张、低血压、心动过缓、低体温;恶心、呕吐、腹泻、流涎;乳酸脱氢酶、谷草转氨酸和碱性磷酸酶升高。如同时服用各种作用在中枢神经系统的物质或药物(例如酒精、安定、三环类抗抑郁药),可使上述情况恶化。

治疗

目前尚缺乏特异性解毒药。从胃肠清除药物(催吐、洗胃、昏迷病人在洗胃前应行气管插管);给予活性碳,如需要,给予轻泻剂;有呼吸抑制者,给予人工呼吸,并给予心血管功能支持疗法。由于本药主要经肾脏排泄,应大量输液,如有可能,加用利尿剂。如有惊厥,应小心静脉注射安定。

Lioresal (Baclofen) liquid

Pharmacological action

This drug is an effective muscle relaxant that acts on the spinal cord. Its mechanism of action and pharmacological properties are different from other muscle relaxants. Baclofen inhibits the transmission of monosynaptic and multi-synaptic reflexes, which may inhibit the release of excitatory amino acids such as glutamate and aspartate by stimulating the GABAB receptor. Neuromuscular transmission is not affected by baclofen. Baclofen has anti-nociceptive effects. For neurological diseases with skeletal muscle spasm, the clinical effect of this drug is to relieve reflex muscle contracture, and it has obvious relief effect on painful clonic sputum, autonomic disease and clonic mites. The drug can improve the patient's ability to move, make the patient's life easier to take care of, and is more conducive to active and passive physical therapy.

Pharmacokinetics

The active substance of this drug, baclofen, is rapidly and completely absorbed in the gastrointestinal tract. Single doses of 10 mg, 20 mg and 30 mg of baclofen are administered orally. After 0.5-1.5 hours, the peak plasma concentrations are about 180, respectively. At 340 and 650 ng/mL, the area under the corresponding plasma concentration curve (AUCs) increased in proportion to the dose size, with values of 1140, 2350, and 3350 ng x hr/mL, respectively. The distribution area of baclofen was 0.7 L/kg, and the concentration of active substances in cerebrospinal fluid was about 8.5 times lower than that in plasma. Baclofen has an average plasma elimination half-life of 3-4 hours and a serum protein binding rate of about 30%. Most of the baclofen is excreted as a prototype, and within 72 hours, about 75% of the intake is excreted by the kidneys, with metabolites accounting for about 5%, and the rest of the intake, including 5% of the metabolites excreted from the feces. The main metabolite is β-(p-aminophenyl)-γ-hydroxybutyric acid, which has no pharmacological activity.

Indications

Skeletal tendon status in multiple sclerosis. Infectious, degenerative, traumatic, swollen or unexplained spinal cord disease caused by spasticity, such as spastic spinal cord paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paralysis Spinal cord compression, brain-derived myoclonus, especially cerebral palsy in children, as well as tendons caused by cerebrovascular accidents, tumors or degenerative brain diseases.

 

Usage and Usage

Starting at a small dose, gradually increasing the dose, according to the individual's condition, the appropriate daily dose, can not only reduce the state of clonic, flexor and extensor tendon, but also maintain sufficient muscle tone, so that patients can Autonomous activities and minimize side effects. This medicine should be taken with a small amount of liquid at the time of eating. The daily dose should be taken in divided doses. The adult is divided into at least 3 times and the child is divided into 4 times. For adult patients, the initial dose is, in principle, 3 mg three times a day. Gradually increase the dose gradually, increase the dose every 3 days, 3 times a day, each time increase 5 mg until the required dose. Patients who are sensitive to the drug should reduce their initial daily dose (15 mg or 10 mg) and slow down the rate of increase. A typical dose range is 30-75 mg per day, and inpatients may need to be added to 100-120 mg daily.

In patients with impaired renal function or long-term hemodialysis, a particularly small dose of approximately 5 mg per day should be used. Because elderly or brain-derived patients are more prone to side effects, it is recommended that these cases be treated with extreme care and under close supervision. The dosage for children is 0.75-2 mg/kg body weight/day, and for children over 10 years old, the maximum daily dose is 2.5 mg/kg body weight. Usually 2.5 mg each time at the start of treatment, 4 times a day, approximately every 3 days, until the child's individual needs are reached.

Adverse reactions

The side effects are mainly seen at the beginning of treatment, when the dose is increased too fast, the dose is too large or the elderly patient. These side effects are often temporary, and can be attenuated or disappeared after the dose is reduced, to a lesser extent, and generally do not need to be discontinued. For patients with a history of neuropathy or with cerebrovascular disease (such as stroke) and elderly patients, side effects may be more serious. Central nervous system: side effects such as daytime sedation, lethargy, and nausea often occur at the beginning of treatment, and occasionally dry mouth, respiratory depression, dizziness, weakness, collapse, confusion, dizziness, nausea, vomiting, headache, and insomnia. Neurological and/or psychiatric manifestations: incidental or rare reports include: euphoria, depression, paresthesia, myalgia, muscle weakness, ataxia, tremors, nystagmus, dysregulation, hallucinations, nightmares, often It is difficult to distinguish it from the performance of the disease itself. It may reduce the threshold of convulsions and cause seizures, especially for patients with epilepsy. Gastrointestinal tract: occasionally mild gastrointestinal disorders (constipation, diarrhea). Cardiovascular system: Occasionally, hypotension and cardiovascular function decrease. Genitourinary system: Occasionally or rarely dysuria, frequent urination, enuresis, these are often difficult to distinguish from the performance of the disease itself.

Other side effects: rare or individual cases of visual impairment, dysgeusia, sweating, rash, liver damage. Some patients have an abnormal reaction to the drug and appear to be aggravated. Muscle tone may be too low, making it more difficult for patients to walk or care for themselves, which is usually relieved after adjusting the dose (eg reducing the daytime dose and, if possible, increasing the nocturnal dose).

Contraindications

It is known to be banned from allergic to baclofen.

Notes

Patient state patients with mental disorders, schizophrenia or dysfunctional conditions, because the condition may worsen, should be used with caution, and the patient should be closely monitored. In patients with spasticity with epilepsy, in addition to continued use of appropriate anticonvulsant medication, the drug can be used under appropriate supervision. For peptic ulcers or patients with a history of this disease, as well as those with cerebrovascular disease, respiratory, liver and kidney failure, should also be used with caution. Patients with bladder imbalance due to neuromodulation disorders may be improved during treatment with this drug. Therefore, patients with sphincter hypertonia who may have acute urinary retention should be used with caution. Reports have shown that the use of this drug, especially long-term users suddenly stop, can occur anxiety, confusion, hallucinations, mental illness, mania or paranoid state, convulsions (epileptic state), tachycardia, and can occur rebound phenomenon To make the state of paralysis aggravated. Unless serious side effects occur, treatment should be discontinued by gradually reducing the dose (approximately 1-2 weeks or more).

Because of reports, blood cell grass transaminase, alkaline phosphatase and blood sugar are elevated in very few cases, and laboratory tests should be performed regularly for patients with liver disease or diabetes to confirm the above-mentioned existing diseases and drugs. The induction is irrelevant. The sedative effect of the drug can affect the patient's ability to respond and the stress is reduced, so patients should be careful when driving the vehicle or operating the machine.

Pregnant women and lactating women

This medicine can only be used during pregnancy, especially during the first three months, only when you are saving your life. The pros and cons of treating the mother and the fetus should be carefully weighed. Baclofen can pass through the placental barrier, and the mother takes a therapeutic dose of the drug. The active substance can enter the milk, but the amount is very small, which has little effect on the baby.

Drug interaction

In combination with other drugs or alcohols that act on the central nervous system, it can increase sedation. When combined with a tricyclic antidepressant, it can enhance the effect of the drug, causing significant hypotonia. The combination of the drug and the antihypertensive drug can enhance the blood pressure lowering effect. Patients with Parkinson's disease (tremor palsy) who received both this drug and levodopa plusibedopa were reported to cause confusion, fantasies, and anxiety.

Overdose

Signs and symptoms

Mainly manifested as central nervous system depression such as lethargy, confusion, respiratory depression, coma, prone to symptoms, mental confusion, hallucinations, agitation, regulatory disorders, pupillary reflexes; systemic hypotonia, myoclonus Reflex disappeared; convulsions; peripheral vasodilatation, hypotension, bradycardia, hypothermia; nausea, vomiting, diarrhea, salivation; lactate dehydrogenase, aspartate transaminase and alkaline phosphatase increased. This can be exacerbated by taking a variety of substances or drugs that act on the central nervous system (such as alcohol, diazepam, and tricyclic antidepressants).

Treatment

There is currently no specific antidote. Gastrointestinal clearance drugs (emetic vomiting, gastric lavage, coma patients should be tracheal intubation before gastric lavage); administration of activated carbon, if necessary, administration of laxatives; respiratory depression, artificial respiration, and cardiovascular function Supportive therapy. Since the drug is mainly excreted by the kidney, a large amount of infusion should be given, and if possible, a diuretic is added. If you have convulsions, you should be careful about intravenous infusion.

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 详细处方信息以本药内容附件PDF文件(201882123593735.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-07-30
附件:
 
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