[{"data":1,"prerenderedAt":138},["ShallowReactive",2],{"drug-azelaic-acid":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":32,"contraindications":48,"warnings":49,"renal":57,"monitoring":58,"interactions":59,"review":60,"examples":63,"atc":69,"iran":71,"links":83,"populations":98,"usApproval":133},"azelaic-acid",1,{"fa":7,"en":8},"آزلائیک اسید ژل ۱۵٪","Azelaic acid 15% gel","dermatology",{"fa":11,"en":12},"ضدروزاسه موضعی","Topical anti-rosacea",[14],{"name":15,"market":16},"Finacea","US",[18,19,20],"finacea","آزلائیک اسید","ژل آزلائیک",[22],{"id":23,"form":23,"route":24,"label":8,"concentration":25,"markets":27,"refs":28},"gel","topical",{"amount":5,"unit":26,"perUnit":26},"application",[16],[29],{"source":30,"section":31},"fda-azelaic","3",[33],{"id":34,"disease":34,"label":35,"population":38,"type":42,"unit":26,"dose":43,"refs":45},"rosacea",{"fa":36,"en":37},"روزاسه (پاپول و پوستول) — لایه نازک دو بار در روز","Rosacea (papules\u002Fpustules) — thin layer twice daily",{"minAge":39},{"value":40,"unit":41},18,"year","fixed",{"perDose":5,"dosesPerDay":44},2,[46],{"source":30,"section":47},"2",[],[50],{"text":51,"refs":54},{"fa":52,"en":53},"واکنش حساسیت (آنژیوادم، تورم چشم و صورت، کهیر)؛ تماس با چشم و مخاط پرهیز شود.","Hypersensitivity (angioedema, eye\u002Fface swelling, urticaria); avoid eyes and mucosa.",[55],{"source":30,"section":56},"5",[],[],[],{"status":61,"reviewer":62,"date":62},"unverified",null,[64],{"regimen":34,"formulation":23,"input":65,"expect":68},{"ageYears":66,"weightKg":67},40,65,{"perDose":5},[70],"D10AX03",{"status":72,"forms":73,"refs":78},"registered",[74],{"code":75,"en":76,"fa":77},"05997","AZELAIC ACID 20% 30G CREAM","کرم آزلائیک اسید ۲۰ درصد ۳۰ گرم",[79],{"source":80,"section":81,"url":82},"darooyab-generic","G-2251\u002FAzelaic-Acid","https:\u002F\u002Fwww.darooyab.ir\u002FG-2251\u002FAzelaic-Acid",[84,88,92,95],{"kind":85,"url":86,"label":87},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208724","ANDA208724",{"kind":89,"url":90,"label":91},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=ab3f174c-a3c4-4ae9-b0bc-954efaadf8de","FDA Azelaic acid 15%",{"kind":93,"url":94,"label":70},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D10AX03",{"kind":96,"url":82,"label":97},"darooyab","Azelaic-Acid",{"pregnancy":99,"lactation":108,"pediatric":116,"geriatric":125},{"level":100,"text":101,"quote":104,"refs":105},"ok",{"fa":102,"en":103},"برچسب: جذب سیستمیک ناچیز؛ مواجهه جنین انتظار نمی‌رود.","Label: minimal systemic absorption; fetal exposure not expected.","Risk Summary Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [ see Clinical Pharmacology (12.3) ].",[106],{"source":30,"section":107},"8.1",{"level":100,"text":109,"quote":112,"refs":113},{"fa":110,"en":111},"برچسب: مواجهه شیرخوار انتظار نمی‌رود.","Label: infant exposure not expected.","… elevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to Azelaic Acid Gel, 15%.",[114],{"source":30,"section":115},"8.2",{"level":117,"text":118,"quote":121,"refs":122},"caution",{"fa":119,"en":120},"برچسب برای کودکان شرط، محدودیت سنی یا نکته دارد؛ جمله برچسب در زیر آمده است.","The label has conditions, age limits or notes for children; the label sentence is quoted below.","The safety and effectiveness of Azelaic Acid Gel, 15% have not been established in pediatric patients.",[123],{"source":30,"section":124},"8.4",{"level":117,"text":126,"quote":129,"refs":130},{"fa":127,"en":128},"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.","Clinical studies of Azelaic Acid Gel, 15% did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.",[131],{"source":30,"section":132},"8.5",{"kind":134,"refs":135,"id":87},"ANDA",[136],{"source":30,"section":137},"SPL approval \u002F marketing category",1792100093545]