[{"data":1,"prerenderedAt":310},["ShallowReactive",2],{"drug-eltrombopag":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":24,"regimens":63,"contraindications":176,"warnings":177,"renal":192,"monitoring":193,"interactions":194,"review":195,"examples":198,"atc":226,"iran":228,"usApproval":244,"links":250,"populations":266},"eltrombopag",1,{"fa":7,"en":8},"التروم‌بوپاگ","Eltrombopag","blood",{"fa":11,"en":12},"آگونیست گیرنده ترومبوپویتین","Thrombopoietin receptor agonist",[14],{"name":15,"market":16},"Promacta","US",[18,19,20,21,22,23],"promacta","پروماکتا","revolade","رevolade","التromبوپاگ","التروم بوپاگ",[25,39,47,55],{"id":26,"form":27,"route":28,"label":29,"concentration":30,"markets":34,"refs":35},"tab-12-5","tablet","oral","12.5 mg tablet",{"amount":31,"unit":32,"perUnit":27,"scored":33},12.5,"mg",false,[16],[36],{"source":37,"section":38},"fda-promacta","3",{"id":40,"form":27,"route":28,"label":41,"concentration":42,"markets":44,"refs":45},"tab-25","25 mg tablet",{"amount":43,"unit":32,"perUnit":27,"scored":33},25,[16],[46],{"source":37,"section":38},{"id":48,"form":27,"route":28,"label":49,"concentration":50,"markets":52,"refs":53},"tab-50","50 mg tablet",{"amount":51,"unit":32,"perUnit":27,"scored":33},50,[16],[54],{"source":37,"section":38},{"id":56,"form":27,"route":28,"label":57,"concentration":58,"markets":60,"refs":61},"tab-75","75 mg tablet",{"amount":59,"unit":32,"perUnit":27,"scored":33},75,[16],[62],{"source":37,"section":38},[64,96,111,128,150,161],{"id":65,"disease":66,"label":67,"population":70,"type":74,"unit":32,"dose":75,"refs":76,"limits":79,"notes":82},"itp","immune-thrombocytopenia",{"fa":68,"en":69},"ITP مزمن (بزرگسال و کودک ۶ سال به بالا) — شروع ۵۰ mg یک بار","Chronic ITP (adults and children ≥6 y) — start 50 mg once daily",{"minAge":71},{"value":72,"unit":73},6,"year","fixed",{"perDose":51,"dosesPerDay":5},[77],{"source":37,"section":78},"2.1",{"maxPerDay":59,"refs":80},[81],{"source":37,"section":78},[83,89],{"text":84,"refs":87},{"fa":85,"en":86},"تبار آسیای شرقی یا نارسایی کبد: شروع ۲۵ mg. هدف پلاکت ≥۵۰ هزار، نه طبیعی کردن.","East-\u002FSoutheast-Asian ancestry or hepatic impairment: start 25 mg. Target platelets ≥50×10⁹\u002FL, not normalisation.",[88],{"source":37,"section":78},{"text":90,"refs":93},{"fa":91,"en":92},"ناشتا یا با غذای کم‌کلسیم؛ ۲ ساعت قبل یا ۴ ساعت بعد از آنتی‌اسید، لبنیات و مکمل‌های آهن\u002Fکلسیم\u002Fروی.","Fasting or with a low-calcium meal; 2 h before or 4 h after antacids, dairy and iron\u002Fcalcium\u002Fzinc supplements.",[94],{"source":37,"section":95},"2.4",{"id":97,"disease":66,"label":98,"population":101,"type":74,"unit":32,"dose":104,"refs":105,"limits":108},"itp-young",{"fa":99,"en":100},"ITP — کودک ۱ تا ۵ سال: شروع ۲۵ mg یک بار","ITP — children 1–5 y: start 25 mg once daily",{"minAge":102,"maxAge":103},{"value":5,"unit":73},{"value":72,"unit":73},{"perDose":43,"dosesPerDay":5},[106],{"source":37,"section":107},"2",{"maxPerDay":59,"refs":109},[110],{"source":37,"section":107},{"id":112,"disease":113,"label":114,"population":117,"type":74,"unit":32,"dose":120,"refs":121,"limits":124},"hcv","hepatitis-c",{"fa":115,"en":116},"ترومبوسیتوپنی هپاتیت C (برای شروع اینترفرون) — شروع ۲۵ mg یک بار","Hepatitis C thrombocytopenia (to start interferon) — start 25 mg once daily",{"minAge":118},{"value":119,"unit":73},18,{"perDose":43,"dosesPerDay":5},[122],{"source":37,"section":123},"2.2",{"maxPerDay":125,"refs":126},100,[127],{"source":37,"section":107},{"id":129,"disease":130,"label":131,"population":134,"type":74,"unit":32,"dose":137,"refs":139,"notes":142},"saa12","aplastic-anemia",{"fa":132,"en":133},"آنمی آپلاستیک شدید خط اول (۱۲ سال به بالا) — ۱۵۰ mg یک بار، ۶ ماه همراه درمان سرکوب ایمنی","First-line severe aplastic anaemia (≥12 y) — 150 mg once daily for 6 months with immunosuppressive therapy",{"minAge":135},{"value":136,"unit":73},12,{"perDose":138,"dosesPerDay":5},150,[140],{"source":37,"section":141},"2.3, Table 3",[143],{"text":144,"refs":147},{"fa":145,"en":146},"از دوز اولیه بالاتر نرود. تبار آسیای شرقی دوز کمتر طبق جدول.","Do not exceed the initial dose. East-\u002FSoutheast-Asian ancestry: reduced dose per table.",[148],{"source":37,"section":149},"2.3",{"id":151,"disease":130,"label":152,"population":155,"type":74,"unit":32,"dose":158,"refs":159},"saa6",{"fa":153,"en":154},"آنمی آپلاستیک شدید — کودک ۶ تا ۱۱ سال: ۷۵ mg یک بار، ۶ ماه","Severe aplastic anaemia — children 6–11 y: 75 mg once daily for 6 months",{"minAge":156,"maxAge":157},{"value":72,"unit":73},{"value":136,"unit":73},{"perDose":59,"dosesPerDay":5},[160],{"source":37,"section":141},{"id":162,"disease":130,"label":163,"population":166,"type":170,"unit":32,"dose":171,"refs":174},"saa2",{"fa":164,"en":165},"آنمی آپلاستیک شدید — کودک ۲ تا ۵ سال: ۲٫۵ mg\u002Fkg یک بار، ۶ ماه","Severe aplastic anaemia — children 2–5 y: 2.5 mg\u002Fkg once daily for 6 months",{"minAge":167,"maxAge":169},{"value":168,"unit":73},2,{"value":72,"unit":73},"weightBased",{"perKgPerDose":172,"intervalHours":173},2.5,24,[175],{"source":37,"section":141},[],[178,185],{"text":179,"refs":182},{"fa":180,"en":181},"هشدار جعبه‌ای: جبران‌ناپذیری کبد در هپاتیت C با اینترفرون\u002Fریباویرین؛ سمیت کبدی — آزمایش کبد پایش شود.","Boxed warning: hepatic decompensation in hepatitis C with interferon\u002Fribavirin; hepatotoxicity — monitor liver tests.",[183],{"source":37,"section":184},"Boxed Warning",{"text":186,"refs":189},{"fa":187,"en":188},"ترومبوز؛ آب مروارید؛ خطر پیشرفت MDS.","Thrombotic events; cataracts; risk of MDS progression.",[190],{"source":37,"section":191},"5",[],[],[],{"status":196,"reviewer":197,"date":197},"unverified",null,[199,204,209,212,216,220],{"regimen":65,"formulation":48,"input":200,"expect":203},{"ageYears":201,"weightKg":202},40,70,{"perDose":51,"tabletsPerDoseRounded":5},{"regimen":97,"formulation":40,"input":205,"expect":208},{"ageYears":206,"weightKg":207},3,14,{"perDose":43,"tabletsPerDoseRounded":5},{"regimen":112,"formulation":40,"input":210,"expect":211},{"ageYears":51,"weightKg":202},{"perDose":43,"tabletsPerDoseRounded":5},{"regimen":129,"formulation":56,"input":213,"expect":215},{"ageYears":214,"weightKg":202},30,{"perDose":138,"tabletsPerDoseRounded":168},{"regimen":151,"formulation":56,"input":217,"expect":219},{"ageYears":218,"weightKg":43},8,{"perDose":59,"tabletsPerDoseRounded":5},{"regimen":162,"formulation":26,"input":221,"expect":224},{"ageYears":222,"weightKg":223},4,15,{"perDose":225,"tabletsPerDoseRounded":206},37.5,[227],"B02BX05",{"status":229,"forms":230,"refs":239},"registered",[231,235],{"code":232,"en":233,"fa":234},"51000","ELTROMBOPAG 25 mg TABLET","قرص الترومبوپاگ ۲۵ میلی‌گرم",{"code":236,"en":237,"fa":238},"51001","ELTROMBOPAG 50 mg TABLET","قرص الترومبوپاگ ۵۰ میلی‌گرم",[240],{"source":241,"section":242,"url":243},"darooyab-generic","G-4913\u002FEltrombopag","https:\u002F\u002Fwww.darooyab.ir\u002FG-4913\u002FEltrombopag",{"kind":245,"refs":246,"id":249},"NDA",[247],{"source":37,"section":248},"SPL approval \u002F marketing category","NDA022291",[251,254,258,261,264],{"kind":252,"url":253,"label":249},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022291",{"kind":255,"url":256,"label":257},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7714a0ed-34bb-46e6-a0a5-b363908b22c2","FDA Promacta",{"kind":259,"url":260,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa609011.html",{"kind":262,"url":263,"label":227},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B02BX05",{"kind":265,"url":243,"label":8},"darooyab",{"pregnancy":267,"lactation":276,"pediatric":285,"geriatric":293,"reproductive":302},{"level":268,"text":269,"quote":272,"refs":273},"caution",{"fa":270,"en":271},"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 from a small number of published case reports and postmarketing experience with PROMACTA use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.",[274],{"source":37,"section":275},"8.1",{"level":277,"text":278,"quote":281,"refs":282},"avoid",{"fa":279,"en":280},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Due to the potential for serious adverse reactions in a breastfed child from PROMACTA, breastfeeding is not recommended during treatment.",[283],{"source":37,"section":284},"8.2",{"level":268,"text":286,"quote":289,"refs":290},{"fa":287,"en":288},"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 efficacy of PROMACTA have been established in pediatric patients 1 year and older with persistent or chronic ITP and in pediatric patients 2 years and older with IST-naïve severe aplastic anemia (in combination with h-ATG and cyclosporine).",[291],{"source":37,"section":292},"8.4",{"level":294,"text":295,"quote":298,"refs":299},"ok",{"fa":296,"en":297},"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 patients.",[300],{"source":37,"section":301},"8.5",{"level":268,"text":303,"quote":306,"refs":307},{"fa":304,"en":305},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Based on animal reproduction studies, PROMACTA can cause fetal harm when administered to a pregnant woman.",[308],{"source":37,"section":309},"8.3",1792191540860]