英文药名: Enablex(Darifenacin Extended Release Tablets) 中文药名: 达非那新缓释片 生产品牌药厂家: Novartis 药品简介 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。 制剂规格：7.5，15mg/片。 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。 药理作用 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，是强效毒覃碱受体阻断剂，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。 适应症 用于治疗:尿失禁、尿急和尿频等膀胱活动过度症。 用法用量 该药为缓释片，初始剂量通常为7.5mg/d，可在用药开始后２周内将剂量增加至15mg/d。每日一次用水服用，可与食物同服。 或遵医嘱！ 不良反应 在临床试验中达非那新缓释片最常见的不良反应为口干和便秘（发生率超过安慰剂对照组），少数病例出现消化不良和头痛。 禁 忌 症 狭角性青光眼患者、尿潴留或胃潴留患者禁用该药。 ENABLEX® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.  CONTRAINDICATIONS ENABLEX® (darifenacin) extended-release tablets are contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX is also contraindicated in patients with known hypersensitivity to the drug or its ingredients. PRECAUTIONS General Risk of Urinary Retention ENABLEX® (darifenacin) extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Decreased Gastrointestinal Motility ENABLEX should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. ENABLEX, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as severe constipation, ulcerative colitis, and myasthenia gravis. Controlled Narrow-Angle Glaucoma ENABLEX should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks. Patients with Hepatic Impairment There are no dosing adjustments for patients with mild hepatic impairment. The daily dose of ENABLEX should not exceed 7.5 mg for patients with moderate hepatic impairment. ENABLEX has not been studied in patients with severe hepatic impairment and therefore is not recommended for use in this patient population   Enablex , Emselex , Darifenacin ER ( Darifenacin Extended-Release ) This medicine is an anticholinergic used to treat overactive bladder in patients who frequently experience symptoms such as an urgent need to urinate, a need to urinate often, or leakage of urine when there is an urgent need to urinate. It may also be used to treat other conditions as determined by your doctor. Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other anticholinergics (such as hyoscyamine, scopolamine), cimetidine, digoxin, flecainide, nefazodone, thioridazine, certain HIV medicines (such as nelfinavir or ritonavir), macrolide antibiotics (such as clarithromycin), certain antifungal medicines (such as itraconazole or ketoconazole), or tricyclic antidepressants (such as amitriptyline or imipramine). DO NOT START OR STOP any medicine without doctor approval. Inform your doctor of any other medical conditions, including liver problems, urinary problems (such as bladder outflow obstruction), certain stomach or bowel problems (such as ulcerative colitis or gastrointestinal obstructive disorders), severe constipation, myasthenia gravis, glaucoma, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of certain stomach problems (gastric retention), certain urinary problems (urinary retention), uncontrolled narrow-angle glaucoma, or if you are at risk for these problems. Use of this medicine is not recommended if you have a history of severe liver problems. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine. How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. This medicine may be taken on an empty stomach or with food. TAKE THIS MEDICINE with a full glass of water. . Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once. Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. DO NOT STOP USING THIS MEDICINE without first checking with your doctor. Laboratory and/or medical tests may be performed to monitor you progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. DO NOT BECOME OVERHEATED in hot weather or during exercise or other activities since heatstroke may occur. If you become overheated and you experience sudden or severe tiredness, weakness, anxiety, dizziness, or fainting, seek immediate medical attention. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor to discuss the risks to your baby. Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include dizziness, constipation, dry mouth, dry eyes, blurred vision, decreased amount of urine produced, stomach upset or pain, nausea, or weakness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience an unusual or severe headache, back pain, pain below the ribs, fever, chills, bloody or cloudy urine, painful urination, or if you are unable to urinate despite an urge to do so. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor. Overdose: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include abnormal vision. Additional Information: If you symptoms do not improve or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary it before your supply runs out.