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Regnite(GABAPENtin Enacarbil Tablets)

2012-11-18 05:43:13  作者:新特药房  来源:中国新特药网天津分站  浏览次数:366  文字大小:【】【】【
简介: 不宁腿综合征治疗新药,近日;美国食品与药物管理局(FDA)发布公告,批准Horizant缓释片(活性成分gabapentin enacarbil)用于治疗中度至重度不宁腿综合征(RLS)。该药物每日服用一次。 两项为期12周 ...

英文药名:Regnite Tablets(Gabapentin Enacarbil)

中文药名:加巴喷丁/丁恩那卡比缓释片

生产厂家:安斯泰来制药

レグナイト錠300mg

治疗类别名称
不宁腿综合征的治疗剂
商標名
Regnite Tablets 300mg
一般名
ガバペンチン エナカルビル(Gabapentin Enacarbil)
化学名
(1-{[({(1RS)-1-[(2-Methylpropanoyl)oxy]ethoxy}carbonyl)amino]methyl}cyclohexyl)acetic acid
構造式

分子式
C16H27NO6
分子量
329.39
融点
約67℃
性状
加巴喷丁Enakarubiru为白色结晶或粉末。乙腈,N,N  - 二甲基甲酰胺,易溶于甲醇或乙醇(99.5),在极微溶于水。此外,它不允许吸湿性的。
操作注意事项
注意:
1. 本品有时变黄由于热,避免在高温下贮存,它可以储存在阴凉处。
2. 内袋开口后保存,以避免高的温度和湿度在专用存储袋干燥剂是密封的,并尽快使用它。
3. 从PTP包装中取出,在品质的降低高温和高下潮湿条件左无包装状态是公认的,它没有的小袋。
适应病症
中度原发性不宁腿综合征(不宁腿综合征)
用法用量
成人;每日一次,每次600毫克(晚餐口服)
药效药理
加巴喷丁Enakarubiru是前药,在体内被迅速水解,以产生加巴喷丁时,活性代谢物。为不宁腿综合征的加巴喷丁的作用机制的未知的细节,但可能的通过结合到α2δ依赖性钙通道,在兴奋性神经递质的突触前的亚基,抑制钙离子的流入游离抑制17的动作)的机制假定作出贡献。
包装规格
缓释片:300毫克
56片(14片×4)


制造和销售
安斯泰来制药公司


完整处方资料附件:http://www.info.pmda.go.jp/go/pack/1190020F1020_1_07/
Regnite (Gabapentin Enacarbil) - 300mg (56 Tablets)
Brand Name: Regnite 
Generic Name: Gabapentin Enacarbil
Form: Tablets
Manufacturer: Astellas Pharma Inc. 
*Please note: The product packaging is available in Japanese language only.
What is Regnite?
Regnite containing the active ingredient gabapentin enacarbil is considered an anti-seizure or anticonvulsant type of medication. The drug works by being converted into gabapentin in the body, which binds to specific proteins that regulate neuronal activity in the brain. The medication is used for the treatment of moderate to severe restless legs syndrome (RLS).
How is Regnite used?
Regnite is usually taken orally once per day at 5pm or as directed by a doctor. The tablets should be taken with some food along with a full glass of water. The dosing schedule is for patients who are awake during the day and asleep during the night. Contact a doctor for the correct dosage, length of treatment and dosing schedule as it will depend on the patient�s condition and their response to the therapy. The extended released tablets should be swallowed whole and not crushed, chewed or split to prevent the release of all the drug at once.
Adverse effects
Patients using Regnite may encounter unwanted side effects such as:
Drowsiness
Dizziness
Loss of coordination
Blurred vision
Mental or mood changes
Suicidal thoughts or attempts
Jaundice
Change in amount of urine
Signs of infection
Contact a doctor immediately should side effects persist or worsen.
Warnings
Immediately proceed to your nearest emergency department if you suffer an allergic reaction. Symptoms usually associated with such a reaction include difficulty breathing or swallowing, chest tightness, swelling, skin rashes, and hives.
Regnite is not always suitable for all patients. Always consult your health care provider prior to using this medication if you are pregnant, breastfeeding, trying to conceive, using any other medication (prescription or non-prescription), using any herbal products or supplements, or if you have any allergies or other health problems.
The correct dosage and prescription commonly depend on the patient and the condition being treated. Do not adjust your dosage without the approval of your health care provider. This product is only for use as prescribed and instructed.
Regnite(gabapentin enacarbil)缓释片在日本推出
2012年7月10日,安斯泰来(Astellas)与XenoPort公司宣布,在日本推出Regnite(加巴喷丁enacarbil,gabapentin enacarbil)缓释片。Regnite已在日本获批,用于治疗中度至重度原发性不宁腿综合症(RLS)。
Regnite是日服一次的药物,在肠道中能够被高效吸收进入人体。一旦吸收,Regnite则会迅速转变成加巴喷丁(gabapentin),而加巴喷丁被认为通过结合神经末梢的钙离子通道发挥作用。
Regnite获批用于治疗RLS的每日剂量为600mg。300mg/片的(National Health Insurance)。
Regnite于2012年1月18日获日本卫生劳动福利部批准,用于治疗RLS。
不宁腿综合症(RLS)又称不安腿综合征,是一种感觉运动障碍疾病,其主要临床表现为夜间睡眠时,双下肢出现极度的不适感,迫使患者不停地移动下肢或下地行走,导致患者严重的睡眠障碍。

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