[{"data":1,"prerenderedAt":154},["ShallowReactive",2],{"drug-safinamide":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":67,"warnings":77,"renal":78,"monitoring":79,"interactions":80,"review":81,"examples":84,"atc":90,"iran":92,"usApproval":99,"links":105,"populations":119},"safinamide",1,{"fa":7,"en":8},"سافینامید","Safinamide","nervous-system",{"fa":11,"en":12},"مهارکننده MAO-B","MAO-B inhibitor",[14],{"name":15,"market":16},"Xadago","US",[18,19,7],"xadago","زاداگو",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-50","tablet","oral","50 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},50,"mg",false,[16],[32],{"source":33,"section":34},"fda-xadago","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-100","100 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},100,[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},"pd","parkinsons",{"fa":48,"en":49},"پارکینسون (کمکی لوودوپا) — ۵۰ mg روزانه، پس از ۲ هفته تا ۱۰۰ mg","Parkinson’s (adjunct to levodopa) — 50 mg daily, up to 100 mg after 2 weeks",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":27,"perDoseMax":39,"dosesPerDay":5},[57],{"source":33,"section":58},"2.1",[60],{"text":61,"refs":64},{"fa":62,"en":63},"نارسایی متوسط کبد: حداکثر ۵۰ mg؛ شدید: منع مصرف.","Moderate hepatic impairment: max 50 mg; severe: contraindicated.",[65],{"source":33,"section":66},"2.2",[68],{"id":69,"severity":70,"text":71,"refs":74},"ci","block",{"fa":72,"en":73},"سایر MAOI یا مهارکننده قوی MAO (از جمله لاینزولید)؛ اپیوئیدها (مپریدین، متادون، ترامادول)، SNRI، ضدافسردگی سه‌حلقه‌ای و چهارحلقه‌ای، سیکلوبنزاپرین، متیل‌فنیدیت و آمفتامین، گل راعی؛ دکسترومتورفان؛ نارسایی شدید کبد.","Other MAOIs or potent MAO inhibitors (including linezolid); opioids (meperidine, methadone, tramadol), SNRIs, tri-\u002Ftetracyclic antidepressants, cyclobenzaprine, methylphenidate and amphetamines, St John’s wort; dextromethorphan; severe hepatic impairment.",[75],{"source":33,"section":76},"4",[],[],[],[],{"status":82,"reviewer":83,"date":83},"unverified",null,[85],{"regimen":45,"formulation":22,"input":86,"expect":89},{"ageYears":87,"weightKg":88},65,70,{"perDose":27,"tabletsPerDoseRounded":5,"upperPerDose":39},[91],"N04BD03",{"status":93,"refs":94},"not-found",[95],{"source":96,"section":97,"url":98},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Safinamide",{"kind":100,"refs":101,"id":104},"NDA",[102],{"source":33,"section":103},"SPL approval \u002F marketing category","NDA207145",[106,109,113,116],{"kind":107,"url":108,"label":104},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=207145",{"kind":110,"url":111,"label":112},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c4d65f28-983f-42b4-bb23-023ae0fe81b2","FDA Xadago",{"kind":114,"url":115,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa617025.html",{"kind":117,"url":118,"label":91},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N04BD03",{"pregnancy":120,"lactation":129,"pediatric":137,"geriatric":146},{"level":121,"text":122,"quote":125,"refs":126},"caution",{"fa":123,"en":124},"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 adequate data on the developmental risk associated with the use of XADAGO in pregnant women.",[127],{"source":33,"section":128},"8.1",{"level":121,"text":130,"quote":133,"refs":134},{"fa":131,"en":132},"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 XADAGO or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.",[135],{"source":33,"section":136},"8.2",{"level":138,"text":139,"quote":142,"refs":143},"not-established",{"fa":140,"en":141},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness in pediatric patients have not been established.",[144],{"source":33,"section":145},"8.4",{"level":121,"text":147,"quote":150,"refs":151},{"fa":148,"en":149},"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 1516 subjects exposed to XADAGO in clinical studies, 38% were 65 and over, while 4% were 75 and over.",[152],{"source":33,"section":153},"8.5",1792156194798]