|
Information on Bronuck
What is this medicine?
This is a non-steroidal anti-inflammatory drug (NSAID). The eye drops are used to treat pain and swelling after eye surgery.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•asthma
•bleeding problems
•diabetes
•dry eye syndrome, other eye problems, or recent eye surgery
•wear soft contact lenses
•an unusual or allergic reaction to bromfenac, aspirin, other NSAIDS, sulfites, other medicines, foods, dyes or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Remove contact lenses before use. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye gently to spread the drops. Your vision may blur for a few minutes. Use your doses at regular intervals. Do not use your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What may interact with this medicine?
•agents that may increase bleeding time such as warfarin or other blood thinners
•corticosteroid eye drops or ointments
Do not use any other eye products without asking your doctor or health care professional.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or health care professional if your eye symptoms do not get better within 2 to 3 days. Do not use for longer than directed by your doctor or health care professional.
Unless your doctor or health care professional gives you other instructions, you should not wear contact lenses while you are using this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•bleeding in the white part of your eye
•breathing problems
•sores in the eye or eye irritation that gets worse
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•burning or stinging after instilling the drops
•dry, red, or itchy eyes
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date on the label.
ブロナック点眼液0.1%
薬効分類名
非ステロイド性抗炎症点眼剤
商標名
BRONUCK OPHTHALMIC SOLUTION 0.1%
一般名
ブロムフェナクナトリウム水和物
(Bromfenac Sodium Hydrate)〔JAN〕
化学名
sodium 2-amino-3-(4-bromobenzoyl)phenylacetate sesquihydrate
分子式
C15H11BrNNaO3・11/2H2O
分子量
383.17
構造式
性状
*ブロムフェナクナトリウム水和物は、黄色～橙色の結晶性の粉末で、においはない。
水に溶けやすく、メタノールにやや溶けやすく、エタノール(99.5)に溶けにくく、アセトニトリル又はジエチルエーテルにほとんど溶けない。
包装
5mL×10
5mL×50中文
Bronuck 处方信息
中文名称：溴芬酸钠
化学名： [2-氨基-3-(4-溴苯甲酰基)苯基]乙酸钠
英文名称：Bromfenac sodium
Sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate
2-Amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt
分子式：C15H11BrNNaO3
分子量： 356.15
溴芬酸钠滴眼液开发概况 溴芬酸钠滴眼液由日本Senju公司开发，于2000 年在日本上市，商品名ブロナック®点眼液,为5ml/支的 0.1%溴芬酸钠眼用溶液，每日两次，用于外眼部及前眼部的炎症性疾病的对症治疗：眼睑炎、结膜炎、强膜炎（包括上强膜炎）、术后炎症等。在美国已完成治疗白内障术后眼部发炎、疼痛及畏光症状的Ⅲ期临床研究，于2004年第二季度向FDA提出新药申请，现已以商品名XibromTM于2005年3月初在美国上市。
溴芬酸钠是2-氨基-3-苯甲酰基苯乙酸类衍生物之一，结构与酮洛芬和双氯芬酸类似，能抑制环氧合酶介导的前列腺素类炎症介质的合成，是最有效的环氧合酶抑制剂，具有强力消炎镇痛作用，作用强度是其它的非甾体抗炎药的10倍。
1.溴芬酸钠滴眼液的特点：
（1） 优越的效力：环氧合酶抑制作用强度是其它的非甾体抗炎药（NSAIDs）的10倍；
（2）一日2次的用药方案，相比其它非甾体抗炎药滴眼液一般一日四次的给药方式，使用方便，病人的依从性高；
（3）临床研究表明溴芬酸钠滴眼液具有很好的耐受性，对眼内压无影响，眼部副作用发生率很低，在日本认证时副作用发生率为3.78%（16/423）。
2. 药物经济效益和市场潜力
（1） 市场规模炎症是有机体对化学和物理损伤或感染因子等刺激的反应。炎症一般可去除发病因子或克服其发病过程。然而，对于眼球或眼眶，炎症反应本身可造成很大的损伤；为了保护重要的和敏感组织的结构和功能，炎症需要控制。抗炎治疗的目的就在于保证炎症反应在组织耐受的限度内，而同时允许有机体的愈合和防御。
非甾体类抗炎药是眼科常用药物，也是眼科手术的常规用药，用于抗炎镇痛。根据IMS Health积累的处方资料，美国每年治疗眼科炎症的局部用非甾体类抗炎药物的处方量约为5.4百万张，在美国眼科抗炎市场约为每年2.5亿美元。
（2）现有药物使用情况及溴芬酸钠滴眼液的优势现在临床上常用的非甾体类抗炎滴眼液有1%吲哚美辛、0.1%双氯芬酸、0.03% 氟比洛芬、1%舒洛芬、0.5%酮洛芬滴眼液等，使用方法都是4次/d。而溴芬酸钠滴眼液用药方案比较简单，只需2次/d，在日本其销售增长快的原因除了其优越的效力外主要是由于其2次/d的给药方案。
规格：5毫升/瓶 10瓶/盒
生产厂家:日本千寿制药株式会社(Senju)
| 
