英文药名: ZAGALLO（Dutasteride  Capsules）

中文药名: 度他雄胺胶囊

生产厂家: 葛兰素史克公司

ザガーロカプセル0.1mg／ザガーロカプセル0.5mg

治疗类别名称
5α还原酶1型/2型抑制剂
-男性型秃发的治疗药物-
商標名
ZAGALLO Capsules
一般名
デュタステリド（Dutasteride）
化学名
N-［2,5-Bis（trifluoromethyl）phenyl］-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide
分子式
C27H30F6N2O2
分子量
528.53
構造式

性状
本品为白色粉末至浅黄色。
融点
242〜250℃
分配系数（logP值）
4.9（1-辛醇/水系统）
操作注意事项
这从药正在通过你不要碰从胶囊中泄漏的药物皮肤，妇女和儿童的吸收。如果触摸泄露的药物，应立即用肥皂和水。
条件批准
在建立药品风险管理计划的顶部，要正确实施。
药效药理
度他雄胺抑制了转换睾酮双氢的1型和2型5α还原酶。双氢睾酮是一种参与男性型脱发的主要雄激素。
(1) 5α还原酶抑制效应
在体外，它抑制了1型和2型5α还原酶的人。
(2) 降低血清的浓度，双氢效果
这种药物在0.1和0.5mg的24周在男性每天一次重复口服给药男性脱发的病人，在24周的血清双氢浓度通过分别83.6和从基线90.9％的降低。
（见表3）
(3) 减少在头皮上的浓度的双氢效果
当它一旦反复口服每日给予这种药物0.1和0.5mg至男性男性脱发患者，施用六个月基线血清中分别由65和90％下降双氢浓度，在头皮它是由40和52％（调整平均值）减小。另外，通过这种药物（从头发基线的数目的增加量）的施用在双氢浓度头皮的下降和头发生长的影响之间的关联被看见（外国数据）。
适应病症
男性型脱发、脂溢性脱发、遗传性脱发 (女性及儿童切忌服用)
用法与用量
雄性成年口服，每日为0.1mg。此外，口服，每日一次0.5毫克。
包装规格
胶囊剂
0.1mg：30胶囊（10粒×3）PTP
0.5mg：30胶囊（10粒×3）PTP

生产商：葛兰素史克公司

完整处方资料附件：http://www.info.pmda.go.jp/go/pack/249900AM1023_1_03/
Zagallo Capsules（Dutasteride）
Zagallo Capsules 0.5mg（ザガーロカプセル0.5mg） 
Brand name : Zagallo Capsules 0.5mg
　Active ingredient: Dutasteride
　Dosage form: rose pink capsule, diameter: approx. 19.3 mm, thickness: approx. 6.6 mm
　Print on wrapping: ザガーロ0.5mg
Zagallo Capsules 0.1mg（ザガーロカプセル0.1mg）
Brand name : Zagallo Capsules 0.1mg
　Active ingredient: Dutasteride
　Dosage form: pale orange capsule, diameter: approx. 19.3 mm, thickness: approx. 6.6 mm
　Print on wrapping: ザガーロ0.1mg
Effects of this medicine
This medicine inhibits the action of type 1 and type 2 isoforms of 5-alpha-reductase suppressing the conversion of dihydrotestosterone from testosterone which is related to androgenetic alopecia and retard the progression of male pattern hair loss.
It is usually used to treat male pattern alopecia.
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 planning to undergo prostate cancer screening (PSA test).
•If you have severe hepatic dysfunction.
•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>>
•In general, for male adults, take 1 capsule (0.1mg of the active ingredient) once a day. This medicine may be replaced with a high-dose capsule (0.5 mg of the active ingredient) once a day as needed. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as possible. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Women and children must not handle the leaking capsules, as it is absorbed through the skin. If this medicine gets on the skin, wash the area with soap and water immediately. The pharmacological action (decrease in dihydrotestosterone) may inhibit the development of external genitalia in male fetus.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include erectile dysfunction, loss of sexual desire, ejaculation disorder, decrease in semen volume. 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.
•loss of appetite, general malaise, yellowness in skin and/or mucosa [liver function disorder, jaundice]
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 away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them. Ask the pharmacy or medical institution on how to discard them.
GlaxoSmithKline K.K.Internal
Revised: 10/2015
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.