[{"data":1,"prerenderedAt":155},["ShallowReactive",2],{"drug-bedaquiline":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":44,"contraindications":68,"warnings":69,"renal":77,"monitoring":78,"interactions":79,"review":80,"examples":83,"atc":84,"iran":86,"usApproval":98,"links":104,"populations":120},"bedaquiline",1,{"fa":7,"en":8},"بداکیلین","Bedaquiline","anti-infectives",{"fa":11,"en":12},"دی‌آریل‌کینولین (ضدسل)","Diarylquinoline (antimycobacterial)",[14],{"name":15,"market":16},"Sirturo","US",[18,19,7],"sirturo","سیرتورو",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-100","tablet","oral","100 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},100,"mg",false,[16],[32],{"source":33,"section":34},"fda-sirturo","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":41,"refs":42},"tab-20","20 mg tablet (functionally scored)",{"amount":39,"unit":28,"perUnit":23,"scored":40},20,true,[16],[43],{"source":33,"section":34},[45],{"id":46,"disease":47,"label":48,"population":51,"type":56,"unit":28,"dose":57,"refs":61},"mdr","tuberculosis",{"fa":49,"en":50},"سل مقاوم به چند دارو (ریوی) — بزرگسال: ۴۰۰ mg روزانه ۲ هفته، سپس ۲۰۰ mg سه بار در هفته تا هفته ۲۴","Pulmonary MDR-TB — adult: 400 mg daily for 2 weeks, then 200 mg three times weekly to week 24",{"minAge":52,"minWeightKg":55},{"value":53,"unit":54},2,"year",8,"notCalculated",{"reason":58},{"fa":59,"en":60},"همراه دست‌کم ۳ داروی مؤثر دیگر، با غذا، تحت نظارت مستقیم. سه بار در هفته با دست‌کم ۴۸ ساعت فاصله. کودک ۲ سال و ۸ kg به بالا طبق جدول ۲ برچسب بر اساس وزن. ECG پایه و دوره‌ای.","With at least 3 other active drugs, with food, under directly observed therapy. Three-times-weekly doses at least 48 h apart. Children ≥2 y and ≥8 kg per label Table 2 by weight. Baseline and periodic ECG.",[62,64,66],{"source":33,"section":63},"2.3, Table 1",{"source":33,"section":65},"2.4, Table 2",{"source":33,"section":67},"2.6",[],[70],{"text":71,"refs":74},{"fa":72,"en":73},"هشدار جعبه‌ای: طولانی شدن QTc — ECG؛ قطع در آریتمی بطنی مهم یا QTc بالای ۵۰۰ ms.","Boxed warning: QTc prolongation — monitor ECGs; stop for significant ventricular arrhythmia or QTc >500 ms.",[75],{"source":33,"section":76},"Boxed Warning",[],[],[],{"status":81,"reviewer":82,"date":82},"unverified",null,[],[85],"J04AK05",{"status":87,"forms":88,"refs":93},"registered",[89],{"code":90,"en":91,"fa":92},"51945","BEDAQUILINE TABLET ORAL 100 mg","قرص بداکویلین ۱۰۰ میلی‌گرم",[94],{"source":95,"section":96,"url":97},"darooyab-generic","G-5465\u002FBedaquiline","https:\u002F\u002Fwww.darooyab.ir\u002FG-5465\u002FBedaquiline",{"kind":99,"refs":100,"id":103},"NDA",[101],{"source":33,"section":102},"SPL approval \u002F marketing category","NDA204384",[105,108,112,115,118],{"kind":106,"url":107,"label":103},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=204384",{"kind":109,"url":110,"label":111},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e","FDA Sirturo",{"kind":113,"url":114,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa613022.html",{"kind":116,"url":117,"label":85},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J04AK05",{"kind":119,"url":97,"label":8},"darooyab",{"pregnancy":121,"lactation":130,"pediatric":139,"geriatric":147},{"level":122,"text":123,"quote":126,"refs":127},"caution",{"fa":124,"en":125},"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 published literature of SIRTURO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",[128],{"source":33,"section":129},"8.1",{"level":131,"text":132,"quote":135,"refs":136},"avoid",{"fa":133,"en":134},"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 in a breastfed infant, including hepatotoxicity, advise patients that breastfeeding is not recommended during treatment with SIRTURO and for 27.5 months (5 times the half-life) after the last dose unless infant formula is not available.",[137],{"source":33,"section":138},"8.2",{"level":122,"text":140,"quote":143,"refs":144},{"fa":141,"en":142},"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 SIRTURO have been established in pediatric patients 2 years and older weighing at least 8 kg.",[145],{"source":33,"section":146},"8.4",{"level":122,"text":148,"quote":151,"refs":152},{"fa":149,"en":150},"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 SIRTURO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients [see Clinical Pharmacology (12.3) ] .",[153],{"source":33,"section":154},"8.5",1792191528048]