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  药店国别: 美国药房
产地国家: 美国
所属类别: 眼科药物->抗炎滴眼液
处方药:处方药
包装规格: 1.7毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
ISTA PHARMS INC
生产厂家英文名:
ISTA PHARMS INC
该药品相关信息网址1:
http://www.istavision.com/products/bromday.html
该药品相关信息网址2:
http://www.drugs.com/bromday.html
该药品相关信息网址3:
http://www.rxlist.com/bromday-drug.htm
原产地英文商品名:
BROMDAY 0.09% EYE DROPS 1.7ML/BOTTLE
原产地英文药品名:
BROMFENAC SODIUM
中文参考商品译名:
BROMDAY 0.09%滴眼液 1.7毫升/瓶
中文参考药品译名:
溴芬酸纳
原产地国家批准上市年份:
2005/03/24
英文适应病症1:
Anti-inflammatory
英文适应病症2:
Postoperative ocular inflammation
英文适应病症3:
Reduce pain after cataract surgery
临床试验期:
完成
中文适应病症参考翻译1:
抗炎
中文适应病症参考翻译2:
术后眼部炎症
中文适应病症参考翻译3:
疼痛减轻后白内障摘除术
药品信息:

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 详细处方信息以本药内容附件PDF文件(20118501321035.pdf)的“原文Priscribing Information”为准
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部分中文溴芬酸处方资料(仅供参考)

Bromday滴眼液(溴芬酸滴眼液)
制造商:
Ista药厂

药理分类:
甾体抗炎药。

活性成分:
溴芬酸溶液0.09%;含有苯扎氯铵,亚硫酸盐。
 
适应症:
术后眼部炎症和疼痛减轻后白内障摘除术。

药理作用:
溴芬是一种非类固醇消炎药(NSAID)具有抗炎活性。其作用机制被认为是由于它能够阻止通过抑制环氧合酶1和2前列腺素的合成。

临床试验:
临床疗效评价三,随机,双盲,安慰剂对照,其中白内障手术的病人需要被分配到Bromday或安​慰剂试验。剂量患者每眼滴用一开始的前一天,手术持续了14天。主要终点是清除眼部炎症15天。额外的疗效终点是病人谁是白内障手术后的疼痛,第1天的免费电话。
在这三项研究二,Bromday滴眼液有统计学意义完全清除炎症(46-47主场迎战25-29%%)和较高的发病率也有较高的科目statisitically signficant在第1天被白内障后疼痛的发生率手术(83-89主场迎战51-71%%)。

成人:
≥18yrs:1,在受影响的眼药水(s),每天一次手术前1天开始,在手术当天继续进行,14天后,同前。可考虑与其他专题ophthalmics(例如,α-受体激动剂,β-阻断剂,碳酸酐酶抑制剂,cycloplegics,mydriatics);管理至少5分钟的间隔。

儿童:
“18yrs:不推荐。

警告/注意事项:
出血倾向。可能会减缓或延迟伤口愈合。复杂/重复眼部手术。角膜缺陷/神经。眼表疾病。类风湿关节炎。糖尿病。监视器角膜;停止,如果故障发生角膜上皮。角膜不良事件的风险可能增加,如果在手术前使用> 24小时,或超出14天后运。隐形眼镜(治疗过程中消除)。妊娠(Cat.C,避免在妊娠后期)。哺乳的母亲。

互动:
伴随局部皮质类固醇,会增强愈合问题。伴药物警告说,延长出血时间。

不良反应:
眼效果(例如,感觉异常,眼结膜充血,灼热,刺痛,疼痛,瘙痒,红肿,虹膜炎),头痛,角膜炎,角膜反应(例如,上皮破裂,变薄,糜烂,溃疡/穿孔)。

剂型、包装:
溶液,1.7mL

BROMDAY
Manufacturer:
ISTA Pharmaceuticals

Pharmacological Class:NSAID.

Active Ingredient(s):Bromfenac 0.09%, oph soln; contains benzalkonium chloride, sulfites.

Indication(s):Post-operative inflammation and reduction of ocular pain following cataract extraction.

Pharmacology:Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Clinical Trials:Clinical efficacy was evaluated in three, randomized, double-masked, placebo-controlled trials in which patients requiring cataract surgery were assigned to Bromday or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15. An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery.

In two of the three studies, Bromday ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46–47% vs. 25–29%) and also had a statisitically signficant higher incidence of subjects that were pain free at day 1 post cataract surgery (83–89% vs. 51–71%).

Legal Classification:Rx

Adults:≥18yrs: 1 drop in affected eye(s) once daily starting 1 day before surgery, continued on day of surgery, and for 14 days post-op. May be given with other topical ophthalmics (eg, alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, mydriatics); administer at least 5 minutes apart.

Children:<18yrs: not recommended.

Warnings/Precautions:Bleeding tendencies. May slow or delay wound healing. Complicated/repeat ocular surgeries. Corneal defects/denervation. Ocular surface diseases. Rheumatoid arthritis. Diabetes. Monitor cornea; discontinue if corneal epithelial breakdown occurs. Risk of corneal adverse events may be increased if used >24hrs before surgery, or beyond 14-days post-op. Contact lenses (remove during therapy). Pregnancy (Cat.C; avoid during late pregnancy). Nursing mothers.

Interaction(s):Concomitant topical corticosteroids may potentiate healing problems. Caution with concomitant drugs that prolong bleeding time.

Adverse Reaction(s):Ocular effects (eg, abnormal sensation, conjunctival hyperemia, burning, stinging, pain, pruritus, redness, iritis), headache; keratitis, corneal reactions (eg, epithelial breakdown, thinning, erosion, ulceration/perforation).

How Supplied:Soln—1.7mL

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 详细处方信息以本药内容附件PDF文件(20118501321035.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2011-8-5
附件:






20118501321035.PDF    

 
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