[{"data":1,"prerenderedAt":123},["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,"usApproval":71,"links":77,"populations":88},"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,"refs":66},"not-found",[67],{"source":68,"section":69,"url":70},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Ivermectin%20cream%201%25",{"kind":72,"refs":73,"id":76},"NDA",[74],{"source":32,"section":75},"SPL approval \u002F marketing category","NDA206255",[78,81,85],{"kind":79,"url":80,"label":76},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=206255",{"kind":82,"url":83,"label":84},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=b1d5b166-ab06-4ab5-b0c6-31126238118a","FDA Soolantra",{"kind":86,"url":87,"label":63},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D11AX22",{"pregnancy":89,"lactation":98,"pediatric":106,"geriatric":115},{"level":90,"text":91,"quote":94,"refs":95},"caution",{"fa":92,"en":93},"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.",[96],{"source":32,"section":97},"8.1",{"level":90,"text":99,"quote":102,"refs":103},{"fa":100,"en":101},"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.",[104],{"source":32,"section":105},"8.2",{"level":107,"text":108,"quote":111,"refs":112},"not-established",{"fa":109,"en":110},"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.",[113],{"source":32,"section":114},"8.4",{"level":90,"text":116,"quote":119,"refs":120},{"fa":117,"en":118},"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.",[121],{"source":32,"section":122},"8.5",1792111458004]