英文药名：Zaditen Ophthalmic Solution UD 0.05%（Ketotifen Fumarate ）
中文药名：富马酸酮替芬点眼液
生产厂家：爱尔康
ザジテン点眼液UD0.05％
治疗类别名称
抗过敏眼药水
商標名
Zaditen ophthalmic solution UD 0.05％
構造式
一般名
ケトチフェンフマル酸塩（Ketotifen Fumarate）
化学名
4-(1-Methylpiperidin-4-ylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-10(9H)-one monofumarate
分子式
C19H19NOS・C4H4O4
分子量
425.50
性状
它是白色结晶粉末，以淡黄白色。难溶在甲醇或乙酸（100），水，乙醇（99.5），或在乙酸酐中微溶。
熔点
约190℃（分解）
分配系数
0.7（1-辛醇/0.1mol/L盐酸）
操作注意事项
1.保险待遇的注意事项
该药物是病人“变应性结膜炎”，保险福利仅限于其中的“患者到患者或过敏的嫌疑的苯扎氯铵。”
2.储存的注意事项
打开铝袋，未使用的容器，通过弯曲开口返回到铝袋关闭后，在一个月内使用。
药效药理
1. 抗过敏作用
酮替芬PCA（被动皮肤过敏），抑制反应（鼠）。
组胺，抑制化学介质如SRS-A（大鼠腹腔肥大细胞，嗜碱性粒细胞，在体外培养的人白细胞淋巴细胞中性粒细胞）的释放。
此外，为通过抗原和PAF（血小板活化因子）（豚鼠，狒狒）抑制嗜酸性粒细胞的活化。
2. 抗组胺作用
组胺（豚鼠）酮替芬支气管收缩，增加血管通透性，抑制皮肤反应（大鼠），和类似物。
3. 在动物模型结膜炎动作
在动物模型结膜炎（大鼠，豚鼠，眼药水），酮替芬的IgE结膜炎和抑制Compound48/ 80诱发结膜炎（大鼠，眼药水）。
嗜酸性粒细胞与结膜炎症状由嗜中性粒细胞的抗原诱导的，但是结膜渗透可以看出，酮替芬抑制这个（豚鼠，滴眼液）
适应病症
过敏性结膜炎
用法用量
通常一次1-2滴，每日四次（早上，中午，傍晚和睡前），以眼药水
包装规格
点眼液UD0.05％：0.4mL×100本（5本×20）
制造商（进口商）
爱尔康日本公司
Zaditen Ophthalmic Solution UD 0.05%（ザジテン点眼液UD0.05％）
Brand name : Zaditen Ophthalmic Solution UD 0.05%
Active ingredient: Ketotifen Fumarate
Dosage form: colorless to slightly yellow ophthalmic solution(plastic bottle) 0.4mL (five bottles in a aluminum bag)
Print on wrapping:
Effects of this medicine
This medicine improves symptoms like eye itching and hyperemia by inhibiting production or release of allergic substances (histamine, etc.).It is usually used to treat allergic conjunctivitis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•General dosage regimen: Apply 1 to 2 drops at a time, 4 times a day (in the morning, afternoon, evening, and before going to bed).
Strictly follow the instructions.
•Before applying eye-drops, open the cap of the bottle and discard first 2 drops. Avoid touching the dropper tip against the eye.
•After applying, wipe off any excess liquid with a clean gauze or tissue.
•If you need to use other eye drops at the same time, take more than 5 minutes intervals between medicines.
•If you aware your missed dose, apply as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never use two doses at one time.
•If you accidentally used more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include smarting eyes, eye irritation, blepharitis and sleepiness. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store at room temperature. After opening aluminum bag, keep unopened bottles in aluminum bag and close the mouth of the bag by folding. After opening aluminum bag, do not use the bottles which are kept in the opened aluminum bag for more than 1 month.
•Discard the remainder. Do not store them.
ALCON JAPAN LIMITEDExternal
Published: 4/2012
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.info.pmda.go.jp/go/pack/1319730Q2024_3_01/