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  药店国别: 日本药房
产地国家: 日本
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: 50毫克/片 100片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
卫材
生产厂家英文名:
Eisai
该药品相关信息网址1:
http://www.eisai.com/
原产地英文商品名:
MYONAL(ミオナール)50mg/tab 100tabs/box
原产地英文药品名:
EPERISONE HCL
中文参考商品译名:
妙纳(ミオナール)50毫克/片 100片/盒
中文参考药品译名:
盐酸乙哌立松
中文参考化合物名称:
4-乙基-2-甲基-3-哌啶基苯丙酮盐酸盐
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Improve muscle tension
英文适应病症2:
Spastic paralysis
英文适应病症3:
Dizziness
英文适应病症4:
Tinnitus
临床试验期:
完成
中文适应病症参考翻译1:
改善肌紧张
中文适应病症参考翻译2:
痉挛性麻痹
中文适应病症参考翻译3:
头晕
中文适应病症参考翻译4:
耳鸣
药品信息:

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 详细处方信息以本药内容附件PDF文件(201082521391314.pdf)的“原文Priscribing Information”为准
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部分中文妙纳处方资料(仅供参考)

简介
妙纳:片剂 Myonal   
制造商:卫材   
本品化学名称为 :4-乙基-2-甲基-3-哌啶基苯丙酮盐酸盐,分子式为C17H25NO·HCl,分子量为295.85。盐酸乙哌立松(乙苯哌丙酮)为白色结晶性粉末,稍有特异的气味、味苦。易溶于水、甲醇、氯仿或冰醋酸,较易溶于乙醇,较难溶于无水醋酸,难溶于丙酮,几乎不溶于乙醚。无旋光性。熔点为约167°C,干燥后易分解。

药理作用
  作用于中枢神经系统,缓解骨骼肌紧张状态 :剂量依赖性地抑制猫、大白鼠的丘间切断去脑强直(γ-强直)以及缺血性大脑强直(α-强直)。抑制刺激猫脊髓后根引起的单突触性以及多突触性反射电位。在投药20分钟后,可抑制人的肌梭产生的传入神经(Ia纤维)活动,亦可抑制动物的γ-运动神经元自发发射,但不直接作用于肌梭。结果表明,本剂系借助于γ-系减轻肌梭的灵敏度。   
    改善血流 :通过对血管平滑肌的钙离子拮抗作用和肌交感神经抑制作用,扩张血管,增加皮肤、肌肉以及颈外动脉、颈内动脉、椎动脉的血流。   
    镇痛以及疼痛反射抑制作用 :拮抗大白鼠脊髓痛觉传递物质P,抑制尾部夹痛的疼痛反射。   
    抗眩晕作用 :本剂可使肌紧张恢复正常,改善眩晕现象。   
    无镇静、催眠作用 :对动物未发现有抑制自发作用以及增加戊巴比妥麻醉作用。   
    使随意运动自如 :用于中风患者等痉挛性麻痹病例中,可改善Cybex的转矩曲线以及肌电图。在不降低痉挛肌肌力的情况下,使上下肢的伸展,曲折动作轻快顺利,随意运动自如。

药代动力学
  健康成人1次/日口服本剂150 mg,连续服14天,第1、第8以及第14天血浆中浓度的变化(平均)如下 :服药后1.6-1.9小时达最高浓度(7.5-7.9 ng/mL),半衰期为1.6-1.8小时,血浆中浓度曲线下面积为19.7-21.1 ng/hr/ mL。与初次投药时相比较,第8天以及第14天均未发现显著性变化。

适应症
  改善下列疾病的肌紧张状态 :颈肩臂综合征、肩周炎、腰痛症。下列疾病引起的痉挛性麻痹 :脑血管障碍、痉挛性脊髓麻痹、颈部脊椎症、手术后遗症(包括脑、脊髓肿瘤)、外伤后遗症(脊髓损伤、头部外伤)、肌萎缩性侧索硬化症、婴儿大脑性轻瘫、脊髓小脑变性症、脊髓血管障碍、亚急性脊髓神经病(SMON)及其它脑脊髓疾病。缓解与脑血管病变和颈肌痉挛有关的头晕或耳鸣。

用法用量
  成人1片/次,一日3次饭后口服。可视年龄、症状酌情增减。

不良反应
  偶有休克现象,肝、肾功能、红细胞计数、血红蛋白值异常,当出现上述情况时,应停止用药。亦可见皮疹、瘙痒,失眠、头痛、身体僵硬、四肢麻木、颤抖,恶心、呕吐、食欲不振、胃部不适、口渴、便秘或腹泻、腹痛、腹部膨胀感、偶见口腔炎,尿闭、尿失禁、残余尿感,四肢无力、站立不稳、怠倦、头晕、肌张力减退、颜面发热、出汗等症状。

注意事项
  用药期间不宜驾驶车辆或操作机械。肝功能障碍患者慎用。   

孕妇及哺乳期妇女用药   
    对孕妇的安全性尚未确立,故应慎用。哺乳妇女应避免用药或用药时停止哺乳。   

儿童用药   
    对儿童的安全性尚未确立。   

药物相互作用   
    本剂和盐酸甲苯哌丙酮相似,与甲氧卡巴莫合用时,可见眼调节功能障碍。   

贮藏/有效期   
    开封后防潮保存。

Introduction
Eperisone Hcl. Tablet is a prescribed antispasmodic drug available under the brand name of Generic Myonal, which relaxes both skeletal muscles and vascular smooth muscles by reducing myotonia, improving circulation, and suppressing pain reflexes. The drug alleviates stiffness and spasticity, and facilitates muscle movement by inhibiting the vicious cycle of myotonia which is evidential by decreasing pain, ischaemia, and hypertonia in skeletal muscles. During subsequent rehabilitative therapy, it is used as a supporting drug at the initial stage of rehabilitation.

Indication
The Generic Myonal tablets are indicated for cerebrovascular disease and cervical spondylosis. Cerebrovascular disease is a condition in which the endothelium exposing the underlying collagen is damaged. The most important cause of this damage is hypertension. In cervical spondylosis, the space between two adjacent vertebrae narrows resulting in compression of a nerve root emerging from the spinal cord. It is characterized by severe pain in the neck, shoulder, arm, back, and/or leg, accompanied by muscle weakness, gait dysfunction, loss of balance, and loss of bowel and/or bladder control.

Mechanism of Action
Possessing the property of a Ca antagonist, Eperisone Hcl. tablets antagonize the smooth muscle tissues of the guinea-pig basilar artery and blocks the voltage-dependent influx of Ca at the smooth muscle membrane but it never hampers the voltage-dependent influx of Ca at the nerve terminals. By the inhibition of the contractile protein, these tablets inhibit the action of Ca in cells and thus help in relaxing skeletal muscles and vascular smooth muscles.

Dosage and Administration
The Generic Myonal tablets should be taken either as directed by your physician or instructed on the medicine label. The dosage of this drug depends on the severity of symptoms, the age of the patient and the responsiveness of the patient to the drug. Adults may be administered with a dose of 50-150 mg per day in divided doses. These tablets should be taken after meals. Elderly persons should be administered with the lowest dose.

Side Effects
The most commonly seen side effects of the Generic Myonal tablets are anaemia, rash, pruritus, sleepiness, insomnia, headache, nausea and vomiting, anorexia, abdominal pain, diarrhoea, constipation, urinary retention or incontinence. If the symptoms of redness, itching, urticaria, oedema of the face and other parts of the body, dyspnoea is seen, the administration of the tablets should be stopped and immediate assistance of the doctor should be sought for.
Side effects such as occurrence of toxic epidermal necrolysis and depletion of myelin sheath of nerves have been reported in some cases. In such cases, the treatment should be discontinued with the medication.

Drug Interaction
The Generic Myonal tablets are interactive with tolperisone hydrochloride and methocarbamol. Concomitant usage of Eperisone Hcl. tablets with these drugs have resulted in ocular accommodation. These tablets should be carefully administered with any kind of piperidine derivative and any drug containing carbamate to bring down the interaction to the minimum.

Precautions
The following precautionary steps should be taken:
· The dosage and the period of drug administration should be followed as directed by your doctor.
· If you are pregnant, you must ensure from your doctor about safety of the baby in the fetus while using this drug.
· If you are breast feeding, then don't take these tablets because they have been contradicted during lactation.
· Always take these tablets after meal, never take them empty stomach.

Contraindications
The usage of these tablets is contradicted with patients having hypersensitivity towards Eperisone Hcl or any other component of the drug. Its usage is also contradicted during lactation.

Storage
Store these tablets in a cool dry place, away from the reach of the children and pets. Avoid its contact with moisture. Keep away from direct heat and light.

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 详细处方信息以本药内容附件PDF文件(201082521391314.pdf)的“原文Priscribing Information”为准
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更新日期: 2010-8-26
附件:








201082521391314.pdf    

 
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