[{"data":1,"prerenderedAt":157},["ShallowReactive",2],{"drug-icosapent-ethyl":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":35,"contraindications":61,"warnings":71,"renal":79,"monitoring":80,"interactions":81,"review":82,"examples":85,"atc":91,"iran":93,"usApproval":100,"links":106,"populations":121},"icosapent-ethyl",1,{"fa":7,"en":8},"ایکوزاپنت اتیل (امگا-۳ خالص EPA)","Icosapent ethyl","cardiovascular",{"fa":11,"en":12},"اتیل استر EPA","EPA ethyl ester",[14],{"name":15,"market":16},"Vascepa","US",[18,19,20,21],"vascepa","واسپا","EPA","ایکوزاپنت",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":30,"refs":31},"cap-1g","capsule","oral","1 g capsule (also 0.5 g)",{"amount":5,"unit":29,"perUnit":25},"g",[16],[32],{"source":33,"section":34},"fda-vascepa","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":49,"notes":52},"tg","hypertriglyceridemia",{"fa":40,"en":41},"تری‌گلیسرید بالا یا پیشگیری قلبی — ۲ g دو بار در روز با غذا (۴ g\u002Fروز)","High triglycerides or CV risk reduction — 2 g twice daily with food (4 g\u002Fday)",{"minAge":43},{"value":44,"unit":45},18,"year","fixed",{"perDose":48,"dosesPerDay":48},2,[50],{"source":33,"section":51},"2.2",[53],{"text":54,"refs":57},{"fa":55,"en":56},"کپسول کامل بلعیده شود. رژیم غذایی و فعالیت ادامه یابد.","Swallow whole. Continue diet and exercise.",[58,59],{"source":33,"section":51},{"source":33,"section":60},"2.1",[62],{"id":63,"severity":64,"text":65,"refs":68},"hyper","block",{"fa":66,"en":67},"حساسیت به ایکوزاپنت اتیل.","Hypersensitivity to icosapent ethyl.",[69],{"source":33,"section":70},"4",[72],{"text":73,"refs":76},{"fa":74,"en":75},"فیبریلاسیون دهلیزی؛ خونریزی (به‌ویژه با ضدانعقاد)؛ احتیاط در حساسیت به ماهی.","Atrial fibrillation\u002Fflutter; bleeding (especially with anticoagulants); caution with fish allergy.",[77],{"source":33,"section":78},"5",[],[],[],{"status":83,"reviewer":84,"date":84},"unverified",null,[86],{"regimen":37,"formulation":24,"input":87,"expect":90},{"ageYears":88,"weightKg":89},60,85,{"perDose":48,"tabletsPerDoseRounded":48},[92],"C10AX06",{"status":94,"refs":95},"not-found",[96],{"source":97,"section":98,"url":99},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Icosapent%20ethyl",{"kind":101,"refs":102,"id":105},"NDA",[103],{"source":33,"section":104},"SPL approval \u002F marketing category","NDA202057",[107,110,114,118],{"kind":108,"url":109,"label":105},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=202057",{"kind":111,"url":112,"label":113},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508","FDA Vascepa",{"kind":115,"url":116,"label":117},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa613024.html","Icosapent Ethyl",{"kind":119,"url":120,"label":92},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C10AX06",{"pregnancy":122,"lactation":131,"pediatric":139,"geriatric":148},{"level":123,"text":124,"quote":127,"refs":128},"caution",{"fa":125,"en":126},"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 The available data from published case reports and the pharmacovigilance database on the use of VASCEPA in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.",[129],{"source":33,"section":130},"8.1",{"level":123,"text":132,"quote":135,"refs":136},{"fa":133,"en":134},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk.",[137],{"source":33,"section":138},"8.2",{"level":140,"text":141,"quote":144,"refs":145},"not-established",{"fa":142,"en":143},"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.",[146],{"source":33,"section":147},"8.4",{"level":149,"text":150,"quote":153,"refs":154},"ok",{"fa":151,"en":152},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety or effectiveness were observed between these patients and younger groups.",[155],{"source":33,"section":156},"8.5",1792156181888]