等待内容更新

英文药名：Viviant（Bazedoxifene Acetate tablets）

中文药名：醋酸巴多昔芬片

生产厂家：辉瑞制药

ビビアント錠20mg

类别名称
骨质疏松症治疗剂
批准日期：2010年7月23日
商標名 
Viviant Tablets 
一般名
バゼドキシフェン酢酸塩（Bazedoxifene Acetate） 
化学名
1-｛4-［2-（Hexahydro-1H-azepin-1-yl）ethoxy］benzyl｝-2-（4-hydroxyphenyl）-3-methyl-1H-indol-5-ol monoacetate 
分子式
C30H34N2O3・C2H4O2 
分子量
530.65 
構造式

 

性状
白色〜黄褐色の粉末である。
融点
约176℃
分配系数（LogD）
>3（pH6.56,1-オクタノール/水系）
药效药理
1. 对骨密度和骨强度的影响
在卵巢切除的大鼠模型中，6周口服给药作为巴多昔芬的结果，在为0.1mg/kg/天或更多胫骨密度降低，腰椎骨强度降低被抑制在为0.3mg/kg/天或更多。这些效应也出现在政府为一年。在猴子，巴多昔芬0.2〜18个月给药，结果为25mg/ kg/天，减少腰椎和胫骨由卵巢切除术的骨密度被抑制，骨密度的增加作用和骨强度改进巴多昔芬的积极的效果观察到的相关性。此外，巴多昔芬，抑制骨转换通过骨代谢指标和骨微结构的改变所指示的去卵巢猴子的提高。
2. 骨组织形式的影响
在卵巢切除的大鼠模型中，施用巴多昔芬为1.5mg/kg/天的一年抑制在松质骨小梁骨部体积减小，以形成与正常微结构的骨。此外，即使当巴多昔芬为25mg/ kg /天去势猴18个月，每月给药，观察到对骨微观结构产生不利影响。
3. 对骨折愈合的影响
使用巴多昔芬为1mg/kg/天在卵巢切除大鼠中，进行了检查愈伤组织形成和股骨骨折部位，正常骨痂形成，骨折愈合的过程，由维修或类似的骨强度支持的机械性能观察的不良影响。
4. 作用机序 
巴多昔芬，是选择性雌激素受体调节剂（SERM）。这种药物是，结合到雌激素受体后，增强或抑制了根据组织的受体和活性。在骨，通过调节分化和破骨细胞功能的细胞因子，表明雌激素激动剂活性。此外，它显示了对脂质代谢的雌激素样作用。施用巴多昔芬一个（0.15〜1.5毫克/公斤/天）为一年到切除卵巢的老鼠，但子宫重量增加至溶剂对照组的约1.6倍于任何剂量的，在切除卵巢的猴子巴多昔芬（0.2〜25毫克/ kg /天）可能18个月给药，对生长的影响，和乳腺小叶组织重量子宫重量与本药物的给药未观察到。
适应病症
绝经后骨质疏松
用法用量
每日口服一次，每次为20mg。
包装规格
片剂：20毫克
100粒，140粒，500粒，700粒（PTP）

 

Description

This medicine normalizes bone metabolic imbalance due to depressed secretion of female hormone (estrogen) in postmenopausal women. Consequently, improves the low bone mass and reduces the risk of bone fracture.
Usually, used for treatment of postmenopausal osteoporosis.

Presentation

20 Tablets

Feature

Active Ingredients

Bazedoxifene acetate

Effect/Efficacy

This medicine normalizes bone metabolic imbalance due to depressed secretion of female hormone (estrogen) in postmenopausal women. Consequently, improves the low bone mass and reduces the risk of bone fracture.
Usually, used for treatment of postmenopausal osteoporosis.

Usage/Dosage

General dosage regimen: For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day. Strictly follow the instructions of your doctor/pharmacist.
If you missed a dose, take the missed dose as soon as possible. DO NOT take double doses to make up for the missed dose.
If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
Do not stop taking the medicine without the instructions of your doctor.

Cautions

Check with your doctor/pharmacist beforehand in case you are intending to be in a state of prolonged immobilization, such as travelling long distances by aircraft or by car.

Contraindication

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: muscle spasm (muscle cramp), fibrocystic breast diseases (mastopathy, breast cyst), vasodilation (glow), leg cramp, etc.
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.
pain/swelling of the feet, sudden difficulty in breathing, shortness of breath, chest pain, sudden decrease of visual acuity [venous thromboembolism]
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.