英文药名：Betanis Tablets（Mirabegron） 中文药名：米拉贝隆片 生产厂家：安斯泰来制药 ベタニス錠25mg／ベタニス錠50mg 治疗类别名称 选择性β3肾上腺素能受体激动剂治疗膀胱过度活动症剂 批准日期：2011年9月 商標名 Betanis Tablets 25mg Betanis Tablets 50mg 一般名 ミラベグロン（Mirabegron） 化学名 2-（2-Amino-1,3-thiazol-4-yl）-N -［4-（2-｛［（2R ）-2-hydroxy-2-phenylethyl］ amino｝ethyl）phenyl］acetamide 構造式 分子式 C21H24N4O2S 分子量 396.51 融点 約144℃ 性状 Mirabegron是结晶或粉末白色至浅带褐色的白色。易溶于二甲亚砜，略溶于甲醇，微溶于乙醇（99.5），在乙腈中微溶，和几乎不溶于水。 操作注意事项 注意： 该产品具有的质量由内袋的高防潮性保留的目。 药效药理 1. 对β3肾上腺素受体刺激作用 在表达人β3肾上腺素能受体的细胞显示出浓度依赖性的细胞内cAMP浓度增加作用。在表达人类β1和β2肾上腺素能受体细胞几乎没有表现出细胞内cAMP浓度的增加作用。 2. 膀胱松弛作用 在分离的大鼠膀胱，它表现出组织cAMP浓度增加作用。在大鼠和人类膀胱切除松弛显示效果是通过诱导乙酰胆碱持续收缩。 3. 对膀胱的压力作用 在麻醉的大鼠中，显示静息膀胱压力降低效果。 4. 对膀胱功能的作用 在无麻醉下的食蟹猴中显示的平均单排尿量增加效果和排尿降低效果的频率。此外，在非麻醉脑梗死大鼠表现出的平均单排尿量增加的效果。 5. 作用机序 它刺激β3肾上腺素受体的膀胱平滑肌，增强由放松膀胱，紧迫性膀胱过动症的储尿功能，改善了尿频和急迫性尿失禁。 适应病症 紧迫性膀胱过度活动症，尿频和急迫性尿失禁。 用法与用量 成人，每天口服一次，每次50毫克。 包装规格 片剂 25毫克：100片（10片×10） 50毫克：100片（10片×10） 50毫克：500片（10片×50） 50毫克：500片（瓶装） 生产和销售 安斯泰来制药公司 完整资料附件： http://www.info.pmda.go.jp/go/pack/2590014F1021_1_10/ 米拉贝隆片：Myrbetriq(mirabegron) [美国商品名]  Betanis Tablets(Mirabegron)[日本商品名] Betmiga Tablets(Mirabegron)[欧洲商品名] Betanis: The world's first β3-stimulated overactive bladder therapeutic agent On September 16, 2011, Mirabegron (trade name Betanis Tablet 25 mg, same tablet 50 mg) for overactive bladder remedy was released. Ezetimibe already acquired production approval on July 1, the indication is "urgency urgency, urinary frequency and urge incontinence in overactive bladder", and the usage and dosage are "adults once a day after a meal 50 mg oral administration ". In recent years, lower urinary tract dysfunction (LUTD) such as urinary incontinence is closely up as a typical disease of the urological field affecting QOL, one of which is overactive bladder (OAB). Overactive bladder is a disease condition that causes urinary urgency and urge incontinence due to urinary retention disorder, 33 million in the United States, 22 million in Europe, 8.1 million in Japan (12.4% of the population over 40 years old) It is estimated that there are patients. Overactive bladder is thought to be caused by latent detrusor hyperactivity state, and muscarinic receptor antagonists having a bladder contraction suppressing action are widely used as a therapeutic agent. Specifically, propiverine hydrochloride (trade name: Bop Four, etc.), solifenacin succinate (trade name Vesicare), tolterodine tartrate (trade name: detritol), imidafenacin (trade name Uritos, Stabra) and the like. However, these drugs can cause side effects such as intraoral desiccation, constipation, blurred vision and the like, as muscarinic receptors also exist in salivary glands, intestinal tracts and ciliary bodies other than bladder, as well as difficulty in urination, residual urine Increase in amount and expression of urinary retention may be concerned. Unlike existing drugs, mirabegron released this time selectively acts on β 3 adrenergic receptor of bladder and shows a bladder relaxing action. Although it increases the urine storage function, it has no anticholinergic effect and it is characterized by not being adversely affected on urinary function. Mirabegron is a drug developed in Japan and is the world's first selective β 3 adrenoceptor agonistic overactive bladder therapeutic agent. In clinical trials, excellent efficacy and safety have been confirmed even for long-term administration. In clinical trials, 25.9% of side effects (including abnormal laboratory test values) are recognized. Main side effects were γ - GTP increase (3.7%), constipation (2.9%), CK increase (2.6%), Al - P increase (2.5%), etc. Also, in animal experiments, the effects on the reproductive system (semen, prostate, uterus weight reduction or uterus weight reduction or atrophy etc.) are recognized, so in the warning column "Avoid administration as much as possible for patients with reproductive age" It is alerted to attention. product name Betanith ® tablet 25 mg/50 mg (English name: Betanis) common name Mirabegron (English name: mirabegron) Indication Urinary urgency, overpowering urinary frequency and urge urinary incontinence in overactive bladder Dosage regimen Usually, adults receive 50 mg as mirabegron orally once a day after meals. Packaging Betanith ® tablet 25 mg: 100 tablets Betanis tablet 50 mg: 100 tablets Betanith ® tablet 25 mg: Betanith ® tablet 50 mg: Drug Price Listing Date September 12, 2011