[{"data":1,"prerenderedAt":222},["ShallowReactive",2],{"drug-dabigatran":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":105,"warnings":115,"renal":123,"monitoring":124,"interactions":125,"review":126,"examples":129,"atc":138,"iran":140,"links":160,"populations":174,"usApproval":217},"dabigatran",1,{"fa":7,"en":8},"دابیگاتران","Dabigatran","blood",{"fa":11,"en":12},"مهارکننده مستقیم ترومبین","Direct thrombin inhibitor",[14],{"name":15,"market":16},"Pradaxa","US",[18,19,7],"pradaxa","پرادکسا",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-75","capsule","oral","75 mg capsule",{"amount":27,"unit":28,"perUnit":23,"scored":29},75,"mg",false,[16],[32],{"source":33,"section":34},"fda-dabigatran","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"cap-110","110 mg capsule",{"amount":39,"unit":28,"perUnit":23,"scored":29},110,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"cap-150","150 mg capsule",{"amount":47,"unit":28,"perUnit":23,"scored":29},150,[16],[50],{"source":33,"section":34},[52,76,88],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":65,"allowedFormulations":68,"notes":69},"af","atrial-fibrillation",{"fa":56,"en":57},"فیبریلاسیون دهلیزی غیردریچه‌ای — ۱۵۰ mg دو بار در روز","Non-valvular AF — 150 mg twice daily",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":47,"dosesPerDay":64},2,[66],{"source":33,"section":67},"2.2",[44],[70],{"text":71,"refs":74},{"fa":72,"en":73},"کلیرانس کراتینین ۱۵ تا ۳۰: ۷۵ mg دو بار؛ زیر ۱۵ یا دیالیز: توصیه‌ای نیست. کپسول باز یا جویده نشود.","CrCl 15–30: 75 mg twice daily; \u003C15 or dialysis: no recommendation. Do not open or chew capsules.",[75],{"source":33,"section":67},{"id":77,"disease":78,"label":79,"population":82,"type":62,"unit":28,"dose":84,"refs":85,"allowedFormulations":87},"vte","venous-thromboembolism",{"fa":80,"en":81},"درمان DVT\u002FPE — ۱۵۰ mg دو بار در روز پس از ۵ تا ۱۰ روز ضدانعقاد تزریقی","DVT\u002FPE treatment — 150 mg twice daily after 5–10 days of parenteral anticoagulation",{"minAge":83},{"value":60,"unit":61},{"perDose":47,"dosesPerDay":64},[86],{"source":33,"section":67},[44],{"id":89,"disease":78,"label":90,"population":93,"type":97,"unit":28,"dose":98,"refs":102},"vte-child",{"fa":91,"en":92},"ترومبوآمبولی وریدی — کودک ۸ تا زیر ۱۸ سال: دوز بر اساس وزن (جدول برچسب)","VTE — child 8 to \u003C18 y: weight-based (label table)",{"minAge":94,"maxAge":96},{"value":95,"unit":61},8,{"value":60,"unit":61},"notCalculated",{"reason":99},{"fa":100,"en":101},"دو بار در روز بر اساس وزن: ۱۱ تا \u003C۱۶ kg ← ۷۵ mg؛ ۱۶ تا \u003C۲۶ ← ۱۱۰؛ ۲۶ تا \u003C۴۱ ← ۱۵۰؛ ۴۱ تا \u003C۶۱ ← ۱۸۵ (۱۱۰+۷۵)؛ ۶۱ تا \u003C۸۱ ← ۲۲۰؛ ۸۱ به بالا ← ۲۶۰ mg.","Twice daily by weight: 11 to \u003C16 kg → 75 mg; 16 to \u003C26 → 110; 26 to \u003C41 → 150; 41 to \u003C61 → 185 (110+75); 61 to \u003C81 → 220; ≥81 → 260 mg.",[103],{"source":33,"section":104},"2.3, Table 1",[106],{"id":107,"severity":108,"text":109,"refs":112},"ci","block",{"fa":110,"en":111},"خونریزی فعال؛ دریچه مصنوعی مکانیکی قلب؛ حساسیت شدید.","Active bleeding; mechanical prosthetic heart valve; serious hypersensitivity.",[113],{"source":33,"section":114},"4",[116],{"text":117,"refs":120},{"fa":118,"en":119},"هشدار جعبه‌ای: قطع زودهنگام خطر حوادث ترومبوتیک را بالا می‌برد؛ هماتوم نخاعی\u002Fاپیدورال.","Boxed warning: premature discontinuation increases thrombotic events; spinal\u002Fepidural haematoma.",[121],{"source":33,"section":122},"Boxed Warning",[],[],[],{"status":127,"reviewer":128,"date":128},"unverified",null,[130,134],{"regimen":53,"formulation":44,"input":131,"expect":133},{"ageYears":132,"weightKg":27},70,{"perDose":47,"tabletsPerDoseRounded":5},{"regimen":77,"formulation":44,"input":135,"expect":137},{"ageYears":136,"weightKg":27},50,{"perDose":47},[139],"B01AE07",{"status":141,"forms":142,"refs":155},"registered",[143,147,151],{"code":144,"en":145,"fa":146},"13583","DABIGATRAN 110MG CAP","کپسول دابیگاتران ۱۱۰ میلی‌گرم",{"code":148,"en":149,"fa":150},"19438","DABIGATRAN 150MG CAP","کپسول دابیگاتران ۱۵۰ میلی‌گرم",{"code":152,"en":153,"fa":154},"13584","DABIGATRAN 75MG CAP","کپسول دابیگاتران ۷۵ میلی‌گرم",[156],{"source":157,"section":158,"url":159},"darooyab-generic","G-4711\u002FDabigatran","https:\u002F\u002Fwww.darooyab.ir\u002FG-4711\u002FDabigatran",[161,165,169,172],{"kind":162,"url":163,"label":164},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208040","ANDA208040",{"kind":166,"url":167,"label":168},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=3a8ec82a-c367-40dc-9302-e1896fcb05ea","FDA Dabigatran",{"kind":170,"url":171,"label":139},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B01AE07",{"kind":173,"url":159,"label":8},"darooyab",{"pregnancy":175,"lactation":184,"pediatric":193,"geriatric":201,"reproductive":209},{"level":176,"text":177,"quote":180,"refs":181},"caution",{"fa":178,"en":179},"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 limited available data on Dabigatran Etexilate Capsules use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.",[182],{"source":33,"section":183},"8.1",{"level":185,"text":186,"quote":189,"refs":190},"avoid",{"fa":187,"en":188},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Breastfeeding is not recommended during treatment with Dabigatran Etexilate Capsules.",[191],{"source":33,"section":192},"8.2",{"level":176,"text":194,"quote":197,"refs":198},{"fa":195,"en":196},"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 Dabigatran Etexilate Capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age.",[199],{"source":33,"section":200},"8.4",{"level":176,"text":202,"quote":205,"refs":206},{"fa":203,"en":204},"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.","The risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see Warnings and Precautions (5), Adverse Reactions (6.1), and Clinical Studies (14.1)] .",[207],{"source":33,"section":208},"8.5",{"level":176,"text":210,"quote":213,"refs":214},{"fa":211,"en":212},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.",[215],{"source":33,"section":216},"8.3",{"kind":218,"refs":219,"id":164},"ANDA",[220],{"source":33,"section":221},"SPL approval \u002F marketing category",1792092029662]