[{"data":1,"prerenderedAt":280},["ShallowReactive",2],{"drug-bosentan":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":52,"contraindications":114,"warnings":148,"renal":171,"monitoring":172,"interactions":173,"review":174,"examples":177,"atc":196,"iran":198,"usApproval":214,"links":220,"populations":236},"bosentan",1,{"fa":7,"en":8},"بوسنتان","Bosentan","cardiovascular",{"fa":11,"en":12},"آنتاگونیست گیرنده اندوتلین","Endothelin receptor antagonist",[14],{"name":15,"market":16},"Tracleer","US",[18,19,7],"tracleer","تراکلیر",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-62-5","tablet","oral","62.5 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},62.5,"mg",false,[16],[32],{"source":33,"section":34},"fda-tracleer","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-125","125 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},125,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":49,"refs":50},"disp-32","32 mg tablet for oral suspension (scored)",{"amount":47,"unit":28,"perUnit":23,"scored":48},32,true,[16],[51],{"source":33,"section":34},[53,70,90],{"id":54,"disease":55,"label":56,"population":59,"type":63,"unit":28,"dose":64,"refs":66,"allowedFormulations":69},"start","pulmonary-arterial-hypertension",{"fa":57,"en":58},"PAH بالای ۱۲ سال — ۶۲٫۵ mg دو بار در روز (۴ هفته اول؛ زیر ۴۰ kg همین دوز ادامه)","PAH, over 12 years — 62.5 mg twice daily (first 4 weeks; continue this dose if under 40 kg)",{"minAge":60},{"value":61,"unit":62},12,"year","fixed",{"perDose":27,"dosesPerDay":65},2,[67],{"source":33,"section":68},"2.2, Table 1",[22],{"id":71,"disease":55,"label":72,"population":75,"type":63,"unit":28,"dose":78,"refs":79,"allowedFormulations":81,"notes":82},"maint",{"fa":73,"en":74},"PAH بالای ۱۲ سال و بالای ۴۰ kg — نگهدارنده ۱۲۵ mg دو بار در روز پس از ۴ هفته","PAH, over 12 years and over 40 kg — maintenance 125 mg twice daily after 4 weeks",{"minAge":76,"minWeightKg":77},{"value":61,"unit":62},40,{"perDose":39,"dosesPerDay":65},[80],{"source":33,"section":68},[36],[83],{"text":84,"refs":87},{"fa":85,"en":86},"بالاتر از ۱۲۵ mg دو بار در روز سود اضافه ندارد و خطر کبدی بیشتر است.","Doses above 125 mg twice daily gave no added benefit offsetting liver risk.",[88],{"source":33,"section":89},"2.2",{"id":91,"disease":55,"label":92,"population":95,"type":98,"unit":28,"dose":99,"refs":111,"allowedFormulations":113},"child",{"fa":93,"en":94},"PAH ۱۲ سال و کمتر — دو بار در روز بر اساس وزن: ۴ تا ۸ kg: ۱۶ mg؛ ۸ تا ۱۶: ۳۲؛ ۱۶ تا ۲۴: ۴۸؛ ۲۴ تا ۴۰: ۶۴ mg","PAH, 12 years and under — twice daily by weight: 4–8 kg: 16 mg; 8–16: 32; 16–24: 48; 24–40: 64 mg",{"maxAge":96,"minWeightKg":97,"maxWeightKg":77},{"value":61,"unit":62},4,"weightBand",{"weightBands":100},[101,105,106,109],{"minWeightKg":102,"maxWeightKg":103,"perDose":104,"dosesPerDay":65},3.99,8,16,{"minWeightKg":103,"maxWeightKg":104,"perDose":47,"dosesPerDay":65},{"minWeightKg":104,"maxWeightKg":107,"perDose":108,"dosesPerDay":65},24,48,{"minWeightKg":107,"maxWeightKg":77,"perDose":110,"dosesPerDay":65},64,[112],{"source":33,"section":68},[44],[115,124,132,140],{"id":116,"severity":117,"text":118,"refs":121},"preg","block",{"fa":119,"en":120},"بارداری.","Pregnancy.",[122],{"source":33,"section":123},"4.1",{"id":125,"severity":117,"text":126,"refs":129},"csa",{"fa":127,"en":128},"مصرف همزمان سیکلوسپورین A.","Concomitant cyclosporine A.",[130],{"source":33,"section":131},"4.2",{"id":133,"severity":117,"text":134,"refs":137},"glyb",{"fa":135,"en":136},"مصرف همزمان گلی‌بن‌کلامید (گلیبوراید).","Concomitant glyburide (glibenclamide).",[138],{"source":33,"section":139},"4.3",{"id":141,"severity":117,"text":142,"refs":145},"hyper",{"fa":143,"en":144},"حساسیت به بوسنتان (DRESS، آنافیلاکسی، آنژیوادم).","Hypersensitivity to bosentan (DRESS, anaphylaxis, angioedema).",[146],{"source":33,"section":147},"4.4",[149,158,164],{"text":150,"refs":153},{"fa":151,"en":152},"هشدار جعبه‌ای: سمیت کبدی — آنزیم‌های کبد پیش از شروع و ماهانه؛ فقط از طریق برنامه REMS.","Boxed warning: hepatotoxicity — liver enzymes before starting and monthly; available only through REMS.",[154,156],{"source":33,"section":155},"Boxed Warning",{"source":33,"section":157},"2.1",{"text":159,"refs":162},{"fa":160,"en":161},"هشدار جعبه‌ای: سمیت جنینی — در بارداری منع مصرف؛ پیش از شروع و ماهانه تست بارداری، پیشگیری مؤثر تا ۱ ماه پس از قطع (برنامه REMS).","Boxed warning: embryo-fetal toxicity — contraindicated in pregnancy; pregnancy test before and monthly, effective contraception until 1 month after stopping (REMS).",[163],{"source":33,"section":155},{"text":165,"refs":168},{"fa":166,"en":167},"احتباس مایع؛ ادم ریه با بیماری انسدادی وریدهای ریه؛ کاهش اسپرم؛ کاهش هموگلوبین.","Fluid retention; pulmonary oedema with veno-occlusive disease; decreased sperm counts; haemoglobin decrease.",[169],{"source":33,"section":170},"5",[],[],[],{"status":175,"reviewer":176,"date":176},"unverified",null,[178,182,185,190],{"regimen":54,"formulation":22,"input":179,"expect":181},{"ageYears":77,"weightKg":180},70,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":71,"formulation":36,"input":183,"expect":184},{"ageYears":77,"weightKg":180},{"perDose":39,"tabletsPerDoseRounded":5},{"regimen":91,"formulation":44,"input":186,"expect":188},{"ageYears":5,"weightKg":187},7,{"perDose":104,"tabletsPerDoseRounded":189},0.5,{"regimen":91,"formulation":44,"input":191,"expect":194},{"ageYears":192,"weightKg":193},6,20,{"perDose":108,"tabletsPerDoseRounded":195},1.5,[197],"C02KX01",{"status":199,"forms":200,"refs":209},"registered",[201,205],{"code":202,"en":203,"fa":204},"07848","BOSENTAN 125MG TAB","قرص بوسنتان ۱۲۵ میلی‌گرم",{"code":206,"en":207,"fa":208},"12114","BOSENTAN 62.5MG TAB","قرص بوسنتان ۶۲٫۵ میلی‌گرم",[210],{"source":211,"section":212,"url":213},"darooyab-generic","G-1563\u002FBosentan","https:\u002F\u002Fwww.darooyab.ir\u002FG-1563\u002FBosentan",{"kind":215,"refs":216,"id":219},"NDA",[217],{"source":33,"section":218},"SPL approval \u002F marketing category","NDA021290",[221,224,228,231,234],{"kind":222,"url":223,"label":219},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021290",{"kind":225,"url":226,"label":227},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=749e42fb-2fe0-45dd-9268-b43bb3f4081c","FDA Tracleer",{"kind":229,"url":230,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605001.html",{"kind":232,"url":233,"label":197},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C02KX01",{"kind":235,"url":213,"label":8},"darooyab",{"pregnancy":237,"lactation":246,"pediatric":255,"geriatric":264,"reproductive":272},{"level":238,"text":239,"quote":242,"refs":243},"contraindicated",{"fa":240,"en":241},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","Hypersensitivity ( 4.4 ). 4.1 Pregnancy Use of TRACLEER is contraindicated in females who are pregnant [see Boxed Warning , Dosage and Administration (2.1) , Warnings and Precautions (5.3) , Use in Specific Populations (8.1) ] . 4.2 Use with Cyclosporine A Co-administration of cyclosporine A and bosentan resulted in …",[244],{"source":33,"section":245},"4",{"level":247,"text":248,"quote":251,"refs":252},"avoid",{"fa":249,"en":250},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for serious adverse reactions, such as fluid retention and hepatotoxicity, in breastfed infants from TRACLEER, advise women not to breastfeed during treatment with TRACLEER.",[253],{"source":33,"section":254},"8.2",{"level":256,"text":257,"quote":260,"refs":261},"caution",{"fa":258,"en":259},"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 efficacy of TRACLEER in patients \u003C18 years is supported by data from an uncontrolled trial in which 19 pediatric patients were treated with TRACLEER.",[262],{"source":33,"section":263},"8.4",{"level":256,"text":265,"quote":268,"refs":269},{"fa":266,"en":267},"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 TRACLEER did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.",[270],{"source":33,"section":271},"8.5",{"level":256,"text":273,"quote":276,"refs":277},{"fa":274,"en":275},"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 Drug interaction studies show that bosentan reduces serum levels of the estrogen and progestin in oral contraceptives.",[278],{"source":33,"section":279},"8.3",1792444383210]