[{"data":1,"prerenderedAt":147},["ShallowReactive",2],{"drug-ivermectin-cream":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":34,"contraindications":53,"warnings":54,"renal":55,"monitoring":56,"interactions":57,"review":58,"examples":61,"atc":62,"iran":64,"links":92,"populations":107,"usApproval":142},"ivermectin-cream",1,{"fa":7,"en":8},"ایورمکتین کرم ۱٪ (روزاسه)","Ivermectin cream 1% (rosacea)","dermatology",{"fa":11,"en":12},"ضدالتهاب و ضدانگل موضعی","Topical anti-inflammatory\u002Fantiparasitic",[14],{"name":15,"market":16},"Soolantra","US",[18,19,20],"soolantra","سولانترا","ایورمکتین کرم",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":29,"refs":30},"cream-1","cream","topical","Ivermectin 1% cream (30, 45, 60 g)",{"amount":5,"unit":28,"perUnit":28},"application",[16],[31],{"source":32,"section":33},"fda-soolantra","3",[35],{"id":36,"disease":36,"label":37,"population":40,"type":44,"unit":45,"dose":46,"refs":50},"rosacea",{"fa":38,"en":39},"ضایعات التهابی روزاسه — یک بار در روز روی صورت","Inflammatory lesions of rosacea — once daily to the face",{"minAge":41},{"value":42,"unit":43},18,"year","notCalculated","mg",{"reason":47},{"fa":48,"en":49},"یک بار در روز به اندازه یک نخود برای هر ناحیه (پیشانی، چانه، بینی، هر گونه)؛ لایه نازک، دور از چشم و لب.","Once daily, a pea-sized amount for each area (forehead, chin, nose, each cheek); thin layer, away from eyes and lips.",[51],{"source":32,"section":52},"2",[],[],[],[],[],{"status":59,"reviewer":60,"date":60},"unverified",null,[],[63],"D11AX22",{"status":65,"forms":66,"refs":87},"registered",[67,71,75,79,83],{"code":68,"en":69,"fa":70},"05962","IVERMECTIN 3MG TAB","قرص ایورمکتین ۳ میلی‌گرم",{"code":72,"en":73,"fa":74},"24191","IVERMECTIN CREAM TOPICAL 1 % 30 GRAM","کرم ایورمکتین ۱ درصد ۳۰ گرم",{"code":76,"en":77,"fa":78},"51473","IVERMECTIN TABLET ORAL 6 mg","قرص ایورمکتین ۶ میلی‌گرم",{"code":80,"en":81,"fa":82},"52096","IVERMECTIN LOTION TOPICAL 0.5 % 120 g","لوسیون ایورمکتین ۰٫۵ درصد ۱۲۰ گرم",{"code":84,"en":85,"fa":86},"50902","IVERMECTIN CREAM TOPICAL 1 % 15 g","کرم ایورمکتین ۱ درصد ۱۵ گرم",[88],{"source":89,"section":90,"url":91},"darooyab-generic","G-239\u002FIvermectin","https:\u002F\u002Fwww.darooyab.ir\u002FG-239\u002FIvermectin",[93,97,101,104],{"kind":94,"url":95,"label":96},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=206255","NDA206255",{"kind":98,"url":99,"label":100},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=b1d5b166-ab06-4ab5-b0c6-31126238118a","FDA Soolantra",{"kind":102,"url":103,"label":63},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D11AX22",{"kind":105,"url":91,"label":106},"darooyab","Ivermectin",{"pregnancy":108,"lactation":117,"pediatric":125,"geriatric":134},{"level":109,"text":110,"quote":113,"refs":114},"caution",{"fa":111,"en":112},"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 on the use of ivermectin, including SOOLANTRA cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",[115],{"source":32,"section":116},"8.1",{"level":109,"text":118,"quote":121,"refs":122},{"fa":119,"en":120},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary The presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated.",[123],{"source":32,"section":124},"8.2",{"level":126,"text":127,"quote":130,"refs":131},"not-established",{"fa":128,"en":129},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of SOOLANTRA cream in pediatric patients have not been established.",[132],{"source":32,"section":133},"8.4",{"level":109,"text":135,"quote":138,"refs":139},{"fa":136,"en":137},"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 1371 subjects in the two pivotal clinical studies of SOOLANTRA cream, 170 (12.4%) were 65 and over, while 37 (2.7%) were 75 and over.",[140],{"source":32,"section":141},"8.5",{"kind":143,"refs":144,"id":96},"NDA",[145],{"source":32,"section":146},"SPL approval \u002F marketing category",1792191869398]