英文药名：DITROPAN XL(oxybutynin chloride Extended Release Tablets) 中文药名：奥昔布宁缓释片 生产厂家：扬森制药公司 药品介绍 DITROPAN XL®（奥昔布宁氯化物 oxybutynin chloride）缓释片   供口服使用 最初美国批准：1975 目前的主要变化 警告和注意事项 02/2015 作用机理 奥昔布宁松弛膀胱平滑肌。盐酸羟丁宁上施加平滑肌直接解痉作用，抑制乙酰胆碱对平滑肌毒蕈碱作用。没有阻断作用发生在骨骼神经肌肉接头或自主神经节（抗烟效果）。 抗毒蕈碱活性R-异构体主要位于。代谢产物，去乙基奥，具有类似于奥昔布宁在体外研究的药理活性。 适应症和用法 DITROPANXL®（奥昔布宁氯化物）是用于与急迫性尿失禁，尿急和频率的症状膀胱过动症的治疗中指示的毒蕈碱性拮抗剂。 DITROPANXL®也表示为儿科患者年龄在6岁及以上与神经系统疾病（例如，脊柱裂）相关联的逼尿肌过度活动的症状的治疗。 用法用量 DITROPANXL®必须整颗吞服与液体的援助，并不能咀嚼，划分，或粉碎。 DITROPANXL®可以与或不与食物施用。 成人： 开始用5毫克或10毫克，每天一次在大约相同的时间的每一天。剂量不应超过每天30毫克。 小儿患者（6岁或以上）：开始用5毫克，每天一次，每天在大约相同的时间。剂量不应超过每天20毫克。 剂型和规格 延长释放片剂：5毫克，10毫克和15毫克 禁忌症 尿潴留 胃逗留 不受控制的窄角型青光眼 已知过敏DITROPANXL®，奥昔布宁或DITROPANXL®的任何组件 警告和注意事项 血管性水肿：血管性水肿已报告与奥昔布宁。如果血管神经性水肿的症状，请停止DITROPANXL®立即并采取适当的治疗。 中枢神经系统（CNS）的影响：中枢神经系统的影响，已报告有奥昔布宁。如果患者经历抗胆碱CNS效应，考虑DITROPANXL®的调整剂量或停药。 谨慎使用因症状加重： 患者预先现有痴呆与胆碱酯酶抑制剂治疗， 帕金森氏病， 重症肌无力 患者的自主神经病变降低肠胃蠕动。 尿潴留：患者慎用使用与临床显著膀胱流出道梗阻，因为尿潴留的危险 胃肠道不良反应：在胃肠道阻塞性疾病或降低肠道蠕动谨慎使用因胃潴留的风险。与患者的胃食管反流或患者同时服用药物可加重食管炎谨慎使用。 不良反应 最常见的（发生率≥5％）的不良反应是口干，便秘，腹泻，头痛，嗜睡，头晕等。 要报告疑似不良反应，请联系扬森1-800-扬森（1-800-526-7736）或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。 药物相互作用 共同施用与其它抗胆碱药物可能会增加的抗胆碱能样作用的频率和/或严重程度。 具有很强的细胞色素P450（CYP）共同施用3A4抑制剂（例如，酮康唑）增加奥昔布宁的全身性暴露。 特殊人群中使用 儿童用药：儿童患者不加咀嚼，6岁以下的分割或破碎，或者谁的孩子不能吞咽药片全不建议DITROPANXL®。 肾或肝损伤：目前还没有患者的肾或肝功能损害进行的研究。 包装规格/储存与处理 DITROPANXL®缓释片剂有三种剂量强度可用，5毫克（淡黄色），10毫克（粉），和15毫克（灰色）中，用“5 XL”被印在一侧，“10 XL”，或者“15 XL”用黑色墨水。 DITROPANXL®缓释片在100瓶片供应。 5毫克100计数瓶NDC50458-805-01 10毫克100计数瓶NDC50458-810-01 15毫克100计数瓶NDC50458-815-01 储存储存在25°C（77°F）;允许15-30°C（59-86°F）游览[见USP控制室温。从水分和湿度的保护。 DESCRIPTION Patent Information from TFL Oxybutynin is sometimes used to treat urinary incontinence and bladder control. Visit TFL for additional health information on urinary incontinence and bladder control. DITROPAN ® XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN ® XL Extended Release Tablet contains 5 mg or 10 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4- diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3 · HCl. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. DITROPAN ® XL also contains the following inert ingredients: cellulose acetate, hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycol, polyethylene oxide, synthetic iron oxides, titanium dioxide, polysorbate 80, sodium chloride, and butylated hydroxytoluene. System Components and Performance DITROPAN ® XL uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the push layer to expand. This expansion pushes the suspended drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of DITROPAN ® XL depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. INDICATIONS DITROPAN ® XL is a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. DOSAGE AND ADMINISTRATION DITROPAN ® XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. DITROPAN ® XL may be administered with or without food. The recommended starting dose of DITROPAN ® XL is 5 mg once daily. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36CC9115-BEF3-48FA-93FF-BCDA24CF26E2