[{"data":1,"prerenderedAt":164},["ShallowReactive",2],{"drug-roflumilast":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":42,"contraindications":66,"warnings":76,"renal":83,"monitoring":84,"interactions":85,"review":86,"examples":89,"atc":95,"iran":97,"links":104,"populations":124,"usApproval":159},"roflumilast",1,{"fa":7,"en":8},"روفلومیلاست","Roflumilast","respiratory",{"fa":11,"en":12},"مهارکننده PDE4","PDE4 inhibitor",[14],{"name":15,"market":16},"Daliresp","US",[18,19,7],"daliresp","دالیرسپ",[21,34],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"tab-250","tablet","oral","250 mcg tablet (starter)",{"amount":27,"unit":28,"perUnit":23},250,"mcg",[16],[31],{"source":32,"section":33},"fda-daliresp","3",{"id":35,"form":23,"route":24,"label":36,"concentration":37,"markets":39,"refs":40},"tab-500","500 mcg tablet",{"amount":38,"unit":28,"perUnit":23},500,[16],[41],{"source":32,"section":33},[43],{"id":44,"disease":44,"label":45,"population":48,"type":52,"unit":28,"dose":53,"refs":54,"notes":57},"copd",{"fa":46,"en":47},"COPD شدید با برونشیت مزمن و سابقه تشدید — ۵۰۰ mcg یک بار در روز","Severe COPD with chronic bronchitis and exacerbations — 500 mcg once daily",{"minAge":49},{"value":50,"unit":51},18,"year","fixed",{"perDose":38,"dosesPerDay":5},[55],{"source":32,"section":56},"2",[58],{"text":59,"refs":62},{"fa":60,"en":61},"اختیاری: ۲۵۰ mcg روزانه ۴ هفته برای کاهش قطع درمان، سپس ۵۰۰ mcg (۲۵۰ دوز درمانی نیست). برای برونکواسپاسم حاد نه.","Optional: 250 mcg daily for 4 weeks to improve tolerability, then 500 mcg (250 is not a therapeutic dose). Not for acute bronchospasm.",[63,64],{"source":32,"section":56},{"source":32,"section":65},"5",[67],{"id":68,"severity":69,"text":70,"refs":73},"liver","block",{"fa":71,"en":72},"نارسایی متوسط تا شدید کبد (Child-Pugh B یا C).","Moderate to severe liver impairment (Child-Pugh B or C).",[74],{"source":32,"section":75},"4",[77],{"text":78,"refs":81},{"fa":79,"en":80},"رویدادهای روانی از جمله افکار خودکشی؛ کاهش وزن.","Psychiatric events including suicidality; weight loss.",[82],{"source":32,"section":65},[],[],[],{"status":87,"reviewer":88,"date":88},"unverified",null,[90],{"regimen":44,"formulation":35,"input":91,"expect":94},{"ageYears":92,"weightKg":93},65,70,{"perDose":38,"tabletsPerDoseRounded":5},[96],"R03DX07",{"status":98,"refs":99},"not-found",[100],{"source":101,"section":102,"url":103},"darooyab-generic","G-1488\u002FRoflumilast","https:\u002F\u002Fwww.darooyab.ir\u002FG-1488\u002FRoflumilast",[105,109,113,116,119,122],{"kind":106,"url":107,"label":108},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022522","NDA022522",{"kind":110,"url":111,"label":112},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c9a1d0a8-581f-4f91-a2b8-f419192d0ebf","FDA Daliresp",{"kind":114,"url":115,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa611034.html",{"kind":114,"url":117,"label":118},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa625108.html","Roflumilast topical",{"kind":120,"url":121,"label":96},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=R03DX07",{"kind":123,"url":103,"label":8},"darooyab",{"pregnancy":125,"lactation":134,"pediatric":142,"geriatric":151},{"level":126,"text":127,"quote":130,"refs":131},"caution",{"fa":128,"en":129},"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 randomized clinical studies of DALIRESP in pregnant women.",[132],{"source":32,"section":133},"8.1",{"level":126,"text":135,"quote":138,"refs":139},{"fa":136,"en":137},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of DALIRESP in human milk, the effects on the breastfed infant, or the effects on milk production.",[140],{"source":32,"section":141},"8.2",{"level":143,"text":144,"quote":147,"refs":148},"not-established",{"fa":145,"en":146},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of DALIRESP in pediatric patients have not been established.",[149],{"source":32,"section":150},"8.4",{"level":126,"text":152,"quote":155,"refs":156},{"fa":153,"en":154},"برچسب: در سالمندان با احتیاط و معمولاً از دوز پایین شروع شود.","Label: use with caution in older adults, usually starting at the low end of the dose range.","Of the 4438 COPD subjects exposed to DALIRESP for up to 12 months in 8 controlled clinical trials, 2022 were >65 years of age and 471 were >75 years of age.",[157],{"source":32,"section":158},"8.5",{"kind":160,"refs":161,"id":108},"NDA",[162],{"source":32,"section":163},"SPL approval \u002F marketing category",1792156194398]