药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20125120312210.PDF,200942704233940.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文ENABLEX处方资料(仅供参考)
美国FDA批准诺华制药公司的达非那新 (darifenacin)缓释片(Enablex)上市,用于治疗尿失禁、尿急和尿频等膀胱活动过度症(OAB)。
达非那新通过阻断主要对膀胱肌肉收缩反应的M3受体发挥作用,是强效毒蕈碱受体阻断剂,有助于减轻尿失禁的发生率,增加膀胱尿储量,减少排尿次数和减少急于排尿的压迫感和尿急感。 达非那新的M3作用在所有OAB治疗药物中具有独特性,制成缓释片可减少中枢神经和心血管不良反应的发生率。Enablex以新观念治疗膀胱活动过度症非常有用。
美国FDA批准Enablex上市是基于采用其不同剂量对7000多例平均58岁患者治疗的4项关键研究的有效数据和安全性数据。在这些研究中,本品组患者减少了尿失禁和排尿的频率,增加了膀胱的尿储量。本品在治疗的开始2周内每周减少尿失禁率高达83%。12周治疗期间维持疗效,长期安全性研究长达1年。
对Enablex总共进行了涉及1万多例98项临床研究,最常见的不良反应是口干和便秘,病人因不良反应停药率较低。本品禁用于尿潴留、胃液潴留或未控制的狭角型青光眼和有这些疾病危险的患者,也禁用于对本品过敏者。
Enablex® is a prescription medicine used in adults to treat the following symptoms of Overactive Bladder: a strong need to urinate with leaking or wetting accidents (“urge urinary incontinence”), a strong need to urinate right away (“urgency”), and having to urinate often (“urinary frequency”).
Important Safety Information for Enablex® (darifenacin) extended-release tablets Enablex is not for everyone. You should not take Enablex if you are not able to empty your bladder (“urinary retention”), have delayed or slow emptying of your stomach (“gastric retention”), or have an eye problem called “uncontrolled narrow-angle glaucoma.”
Enablex may cause allergic reactions that may be serious. If you have hives, skin rash, or swelling, severe itching, experience swelling of the face, mouth or tongue, or if you have trouble breathing, stop taking Enablex and get medical help right away. Medicines like Enablex can cause blurred vision or dizziness. Do not drive or operate heavy machinery until you know how Enablex affects you.
The most common side effects include dry mouth, constipation, headache, heartburn, nausea, urinary tract infection, blurred vision, heat exhaustion or heat stroke which can happen when Enablex is used in hot environments. Symptoms of heat exhaustion may include: decreased sweating, dizziness, tiredness, nausea, and increased body temperature.
Tell your doctor about all of the medicines you take. Enablex and certain other medicines may affect each other, causing side effects.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20125120312210.PDF,200942704233940.pdf)的“原文 Priscribing Information”为准 --------------------------------------------------------------- |