药品信息:
Information on GELNIQUE
Gelnique (oxybutynin chloride) is an antispasmodic, antimuscarinic agent. It acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
Mechanism of Action Gelnique (oxybutynin chloride) is an antispasmodic, antimuscarinic agent. It acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
Indication Gelnique is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
USAGE Dosage Gelnique is supplied as a gel designed for topical administration. The recommended initial dose of the drug is one sachet (a 1 gram unit dose (1.14 mL) of 100 mg/g) applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated.
Side Effects Adverse events associated with the use of Gelnique may include, but are not limited to, the following: dry mouth urinary tract infection application site reactions upper respiratory tract infections dizziness nasopharyngitis
Storage Store at 25°C (77°F);excursions permitted to 15-30°C (59-86°F).See USP controlled room temperature. Protect from moisture and humidity. Apply immediately after the sachets are opened and contents expelled.Discard used sachets in household trash in a manner that prevents accidental application or ingestion by children, pets, or others. Keep out of reach of children.
------------------------------------------------------ 详细处方信息以本药内容附件PDF文件(201011209350133.pdf)的“原文Priscribing Information”为准 ------------------------------------------------------ 部分中文 GELNIQUE 处方信息(仅供参考)
美国FDA批准沃森公司(Watson)的10%氯化奥昔布宁凝胶(oxybutynin chloride,Gelnique)上市,首个和唯一用于治疗以尿急、失禁和尿频为症状的膀胱过度活动症(OAB)。目前美国的OAB治疗药市场年销售额逾18亿美元,且逐年增长。 本品为OAB患者提供了不同于口服的新有效治疗理念。由于本品中的药物经皮释药,不会像口服奥昔布宁制剂被肝脏代谢。因而,诸如口干和便秘等不良反应的发生率低。 临床研究显示,本品作用强、患者耐受性好和此独特的释药系统可作为OAB患者的一线治疗药。 本品是可快速干燥清澈无色无芳香剂的氯化奥昔布宁亲水凝胶制剂,一日1次涂于大腿、腹部、上臂或肩,1 g凝胶(含氯化奥昔布宁100 mg)可持续释药24小时,提供了强效且耐受性好的外用制剂。 本品获准上市是基于对789例OAB患者双盲安慰剂对照的Ⅲ期临床评价的研究结果。12周以上的研究,一日1次本品用药组解除OAB症状(减少尿失禁的发生率和尿频的次数,增加尿排空量)优于安慰剂组。治疗组患者耐受性好,不良反应发生率低,无治疗引起的严重不良反应。最常见的不良反应为口干和用药部位局部反应。 另外的药理学研究证明,本品使用1小时或以后、用前或用后30分钟使用遮光剂均不显著影响药物的吸收。
------------------------------------------------------ 详细处方信息以本药内容附件PDF文件(201011209350133.pdf)的“原文Priscribing Information”为准 ------------------------------------------------------
更新于2011年1月12日 |