[{"data":1,"prerenderedAt":172},["ShallowReactive",2],{"drug-darifenacin":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":66,"warnings":76,"renal":84,"monitoring":85,"interactions":86,"review":87,"examples":90,"atc":96,"iran":98,"usApproval":114,"links":120,"populations":136},"darifenacin",1,{"fa":7,"en":8},"داریفناسین","Darifenacin","genitourinary-sex-hormones",{"fa":11,"en":12},"آنتی‌موسکارینی M3","M3 antimuscarinic",[14],{"name":15,"market":16},"Enablex","US",[18,19,7],"enablex","emselex",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"er-7-5","tablet","oral","7.5 mg extended-release tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},7.5,"mg",false,[16],[32],{"source":33,"section":34},"fda-darifenacin","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"er-15","15 mg extended-release tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},15,[16],[42],{"source":33,"section":34},[44],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":56,"notes":59},"oab","overactive-bladder",{"fa":48,"en":49},"مثانه بیش‌فعال بزرگسال — ۷٫۵ mg یک بار؛ پس از ۲ هفته تا ۱۵ mg","Overactive bladder, adults — 7.5 mg once daily; after 2 weeks up to 15 mg",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":27,"perDoseMax":39,"dosesPerDay":5},[57],{"source":33,"section":58},"2",[60],{"text":61,"refs":64},{"fa":62,"en":63},"کامل بلعیده شود. نارسایی متوسط کبد یا مهارکننده قوی CYP3A4: حداکثر ۷٫۵ mg؛ نارسایی شدید کبد توصیه نمی‌شود.","Swallow whole. Moderate hepatic impairment or potent CYP3A4 inhibitors: max 7.5 mg; severe hepatic impairment not recommended.",[65],{"source":33,"section":58},[67],{"id":68,"severity":69,"text":70,"refs":73},"ci","block",{"fa":71,"en":72},"احتباس ادرار؛ احتباس معده؛ گلوکوم زاویه بسته کنترل‌نشده.","Urinary retention; gastric retention; uncontrolled narrow-angle glaucoma.",[74],{"source":33,"section":75},"4",[77],{"text":78,"refs":81},{"fa":79,"en":80},"احتباس ادرار (به‌ویژه با انسداد خروجی مثانه)؛ آنژیوادم؛ کاهش حرکات گوارش؛ عوارض CNS (گیجی، خواب‌آلودگی).","Urinary retention (especially with bladder outlet obstruction); angioedema; decreased GI motility; CNS effects (confusion, somnolence).",[82],{"source":33,"section":83},"5",[],[],[],{"status":88,"reviewer":89,"date":89},"unverified",null,[91],{"regimen":45,"formulation":22,"input":92,"expect":95},{"ageYears":93,"weightKg":94},60,70,{"perDose":27,"tabletsPerDoseRounded":5,"upperPerDose":39},[97],"G04BD10",{"status":99,"forms":100,"refs":109},"registered",[101,105],{"code":102,"en":103,"fa":104},"18533","DARIFENACIN 15 MG TAB","قرص داریفناسین ۱۵ میلی‌گرم",{"code":106,"en":107,"fa":108},"11433","DARIFENACIN 7.5MG TAB","قرص داریفناسین ۷٫۵ میلی‌گرم",[110],{"source":111,"section":112,"url":113},"darooyab-generic","G-878\u002FDarifenacin","https:\u002F\u002Fwww.darooyab.ir\u002FG-878\u002FDarifenacin",{"kind":115,"refs":116,"id":119},"ANDA",[117],{"source":33,"section":118},"SPL approval \u002F marketing category","ANDA205209",[121,124,128,131,134],{"kind":122,"url":123,"label":119},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=205209",{"kind":125,"url":126,"label":127},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e84f1ae3-b9a2-4a15-a299-c75373891cc1","FDA Darifenacin ER",{"kind":129,"url":130,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605039.html",{"kind":132,"url":133,"label":97},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=G04BD10",{"kind":135,"url":113,"label":8},"darooyab",{"pregnancy":137,"lactation":146,"pediatric":154,"geriatric":163},{"level":138,"text":139,"quote":142,"refs":143},"caution",{"fa":140,"en":141},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary There are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.",[144],{"source":33,"section":145},"8.1",{"level":138,"text":147,"quote":150,"refs":151},{"fa":148,"en":149},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of darifenacin in human milk, the effects on the breastfed infant, or the effects of darifenacin on milk production.",[152],{"source":33,"section":153},"8.2",{"level":155,"text":156,"quote":159,"refs":160},"not-established",{"fa":157,"en":158},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of darifenacin extended-release tablets in pediatric patients have not been established.",[161],{"source":33,"section":162},"8.4",{"level":164,"text":165,"quote":168,"refs":169},"ok",{"fa":166,"en":167},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No dose adjustment is recommended for elderly patients [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )] .",[170],{"source":33,"section":171},"8.5",1792191536160]