部份中文酒石酸溴莫尼定处方资料(仅供参考)
通用名称:酒石酸溴莫尼定滴眼液
英文名称:Brimonidine Tartrate Eye Drops
成份
本品主要成份为酒石酸溴莫尼定。
性状
本品为微黄绿色的澄明液体。
适应症
本品适用于降低开角型青光眼及高眼压症患者的眼内压。
用法用量
滴入眼睑内。常规剂量滴患眼每日2次,每次1滴。眼内压在下午达高峰的患者或眼内压需额外控制的患者,下午可增加一滴。0.2%酒石酸溴莫尼定滴眼液可能会与其他眼表应用的降眼内压药物合用,但用药间隔应大于5分钟。
不良反应
约有10~30%的受试者曾出现以下不良反应,按降序排列,包括口干,眼部充血,烧灼感及刺痛感,头痛,视物模糊,异物感,疲劳/倦怠,结膜滤泡,眼部过敏反应以及眼部瘙痒。
约有3~9%的受试者曾出现以下不良反应,按降序排列,包括角膜染色/糜烂,畏光,眼睑红斑,眼部酸痛/疼痛,眼部干燥,流泪,上呼吸道症状,眼睑水肿,结膜水肿,头晕,睑炎,眼部刺激,胃肠道症状,虚弱无力,结膜变白,视物异常以及肌肉痛。
有不足3%的患者曾出现以下不良反应,包括眼睑痂,结膜出血,味觉异常,失眠,结膜分泌物增多,精神抑郁,高血压,焦虑,心悸,鼻干以及晕厥。
禁忌
本品禁用于对酒石酸溴莫尼定或本品中任何成份过敏者。亦禁用于使用单胺氧化酶抑制剂治疗的患者。
贮藏
遮光,密闭保存。
包装
5mL×5、5mL×10
有效期
24个月
製造販売元
千寿製薬株式会社 http://www.info.pmda.go.jp/go/pack/1319761Q1023_1_05/
Acquisition of manufacturing and marketing approval for eye glossing / ocular hypertension treatment agent "Eifagan® ophthalmic solution 0.1%"
We are pleased to inform you today that MHLW has approved the manufacture and sale of "Eye Fergon® Eye Drop 0.1%" (generic name: brimonidine tartrate), a treatment for glaucoma and ocular hypertension.
Brimonidine tartrate is a novel intraocular pressure-lowering drug which shows high selectivity to adrenergic α 2 receptor developed in Allergan, USA, and it inhibits aqueous humor production, while aqueous humor via the uveoscleral outflow tract It promotes spillage and shows intraocular pressure lowering effect. This eye drop of brimonidine tartrate has been approved as "indication for open angle glaucoma or ocular hypertension" in the United States in 1996 and currently approved in 84 countries and regions including the United States, It is widely used in the medical field. (As of September 2011)
"Eyefagan® Eye Drop 0.1%" approved this time is a long-term stable intraocular pressure by single-agent treatment or combination therapy with other glaucoma treatment drugs for primary open-angle glaucoma (broad sense) in domestic clinical trials It showed a descent effect.
The summary of approval contents is as follows.
Approval date
January 18, 2012
product name
Eyefagan® Eye drops 0.1%
common name
Brimonidine tartrate
Dosage type/content
An aqueous eye drop containing 1.0 mg of brimonidine tartrate salt in 1 mL
Indication
In the following diseases, other glaucoma treatment drugs are insufficiently effective or can not be used:
Glaucoma, ocular hypertension
Dosage regimen
Usually, drop once a day, twice a day.
Characteristics of this drug:
(1) It is a novel treatment for glaucoma and ocular hypertension which shows high selectivity for adrenergic α2 receptor *.
* If other glaucoma treatment is inadequate or can not be used
(2) Suppressing intraocular pressure by suppression of aqueous production and promotion of outflow of aqueous humor (uveoscleral scleral outflow tract).
(3) It showed good ocular hypotensive effect even in combination with PG related drugs in primary open angle glaucoma (broad sense) and ocular hypertension, and showed stable ocular hypotensive effect over a long period of time.