[{"data":1,"prerenderedAt":186},["ShallowReactive",2],{"drug-apremilast":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":88,"warnings":98,"renal":106,"monitoring":107,"interactions":108,"review":109,"examples":112,"atc":121,"iran":123,"usApproval":130,"links":136,"populations":152},"apremilast",1,{"fa":7,"en":8},"آپرمیلاست","Apremilast","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده PDE4","PDE4 inhibitor",[14],{"name":15,"market":16},"Otezla","US",[18,19,7],"otezla","اوتزلا",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-10","tablet","oral","10 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},10,"mg",false,[16],[32],{"source":33,"section":34},"fda-otezla","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-20","20 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},20,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"tab-30","30 mg tablet",{"amount":47,"unit":28,"perUnit":23,"scored":29},30,[16],[50],{"source":33,"section":34},[52,77],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":65,"notes":68},"pso","psoriasis",{"fa":56,"en":57},"پسوریازیس پلاک، آرتریت پسوریاتیک، بهجت — بزرگسال نگهدارنده ۳۰ mg دو بار در روز (پس از تیتراسیون ۵ روزه)","Plaque psoriasis, PsA, Behçet’s — adult maintenance 30 mg twice daily (after 5-day titration)",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":47,"dosesPerDay":64},2,[66],{"source":33,"section":67},"2.1",[69],{"text":70,"refs":73},{"fa":71,"en":72},"تیتراسیون روز ۱ تا ۵ طبق جدول ۱ برچسب (از ۱۰ mg صبح) برای کاهش عوارض گوارشی. نارسایی شدید کلیه: ۳۰ mg یک بار در روز.","Days 1–5 titration per label Table 1 (from 10 mg in the morning) to reduce GI effects. Severe renal impairment: 30 mg once daily.",[74,75],{"source":33,"section":67},{"source":33,"section":76},"2",{"id":78,"disease":79,"label":80,"population":83,"type":62,"unit":28,"dose":85,"refs":86},"psa","psoriatic-arthritis",{"fa":81,"en":82},"آرتریت پسوریاتیک — ۳۰ mg دو بار در روز","Psoriatic arthritis — 30 mg twice daily",{"minAge":84},{"value":60,"unit":61},{"perDose":47,"dosesPerDay":64},[87],{"source":33,"section":67},[89],{"id":90,"severity":91,"text":92,"refs":95},"hyper","block",{"fa":93,"en":94},"حساسیت به آپرمیلاست.","Hypersensitivity to apremilast.",[96],{"source":33,"section":97},"4",[99],{"text":100,"refs":103},{"fa":101,"en":102},"اسهال، تهوع و استفراغ شدید؛ افسردگی و افکار خودکشی؛ کاهش وزن.","Severe diarrhoea, nausea and vomiting; depression and suicidal thoughts; weight loss.",[104],{"source":33,"section":105},"5",[],[],[],{"status":110,"reviewer":111,"date":111},"unverified",null,[113,118],{"regimen":53,"formulation":44,"input":114,"expect":117},{"ageYears":115,"weightKg":116},40,75,{"perDose":47,"tabletsPerDoseRounded":5},{"regimen":78,"formulation":44,"input":119,"expect":120},{"ageYears":115,"weightKg":116},{"perDose":47,"tabletsPerDoseRounded":5},[122],"L04AA32",{"status":124,"refs":125},"registered",[126],{"source":127,"section":128,"url":129},"darooyab-generic","G-5537\u002FApremilast","https:\u002F\u002Fwww.darooyab.ir\u002FG-5537\u002FApremilast",{"kind":131,"refs":132,"id":135},"NDA",[133],{"source":33,"section":134},"SPL approval \u002F marketing category","NDA205437",[137,140,144,147,150],{"kind":138,"url":139,"label":135},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=205437",{"kind":141,"url":142,"label":143},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f6b1f516-4972-4d82-bced-113e47b41cc5","FDA Otezla",{"kind":145,"url":146,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614022.html",{"kind":148,"url":149,"label":122},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AA32",{"kind":151,"url":129,"label":8},"darooyab",{"pregnancy":153,"lactation":162,"pediatric":170,"geriatric":178},{"level":154,"text":155,"quote":158,"refs":159},"caution",{"fa":156,"en":157},"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 Available data with OTEZLA use in pregnant women have not identified a drug-associated risk of major birth defects or adverse maternal or fetal outcomes (see Data ) .",[160],{"source":33,"section":161},"8.1",{"level":154,"text":163,"quote":166,"refs":167},{"fa":164,"en":165},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of apremilast in human milk, its effects on the breastfed infant, or its effects on milk production.",[168],{"source":33,"section":169},"8.2",{"level":154,"text":171,"quote":174,"refs":175},{"fa":172,"en":173},"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.","OTEZLA Plaque Psoriasis The safety and effectiveness of OTEZLA have been established in pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.",[176],{"source":33,"section":177},"8.4",{"level":154,"text":179,"quote":182,"refs":183},{"fa":180,"en":181},"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.","… om severe diarrhea, nausea, or vomiting, monitor geriatric patients closely for such complications [see Warnings and Precautions (5.2) ] .",[184],{"source":33,"section":185},"8.5",1792156162602]