[{"data":1,"prerenderedAt":258},["ShallowReactive",2],{"drug-baloxavir":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":54,"contraindications":146,"warnings":156,"renal":157,"monitoring":158,"interactions":159,"review":167,"examples":169,"atc":194,"iran":196,"links":203,"populations":219,"usApproval":253},"baloxavir",1,{"fa":7,"en":8},"بالوکساویر","Baloxavir marboxil","anti-infectives",{"fa":11,"en":12},"ضد آنفلوانزا (مهارکننده اندونوکلئاز)","Anti-influenza (endonuclease inhibitor)",[14],{"name":15,"market":16},"Xofluza","US",[18,19,7],"xofluza","زوفلوزا",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-40","tablet","oral","40 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},40,"mg",false,[16],[32],{"source":33,"section":34},"fda-xofluza","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-80","80 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},80,[16],[42],{"source":33,"section":34},{"id":44,"form":45,"route":24,"label":46,"concentration":47,"markets":49,"refs":50},"susp-2","suspension","2 mg\u002FmL suspension (40 mg\u002F20 mL bottle after reconstitution)",{"amount":27,"unit":28,"perVolumeMl":48},20,[16],[51,52],{"source":33,"section":34},{"source":33,"section":53},"2.4",[55,87,107,128],{"id":56,"disease":57,"label":58,"population":61,"type":65,"unit":28,"dose":66,"refs":73,"durationDays":76,"notes":77},"treat","influenza",{"fa":59,"en":60},"آنفلوانزای بدون عارضه — یک دوز بر اساس وزن (۵ سال به بالا، ۲۰ kg به بالا)","Uncomplicated influenza — single dose by weight (≥5 y, ≥20 kg)",{"minAge":62,"minWeightKg":48},{"value":63,"unit":64},5,"year","weightBand",{"weightBands":67},[68,71],{"minWeightKg":69,"maxWeightKg":70,"perDose":27,"dosesPerDay":5},19.99,79.99,{"minWeightKg":70,"maxWeightKg":72,"perDose":39,"dosesPerDay":5},null,[74],{"source":33,"section":75},"2.2, Tables 1–3",{"min":5,"max":5},[78],{"text":79,"refs":82},{"fa":80,"en":81},"یک دوز، هرچه زودتر و ظرف ۴۸ ساعت از شروع علائم یا تماس. همزمان با لبنیات، نوشیدنی غنی از کلسیم، آنتی‌اسید، ملین یا مکمل کلسیم، آهن، منیزیم، سلنیوم یا روی مصرف نشود.","Single dose, as soon as possible and within 48 h of symptom onset or contact. Not with dairy, calcium-fortified drinks, antacids, laxatives or calcium, iron, magnesium, selenium or zinc supplements.",[83,85],{"source":33,"section":84},"2.2",{"source":33,"section":86},"2.1",{"id":88,"disease":57,"label":89,"population":92,"type":94,"unit":28,"dose":95,"refs":97,"durationDays":99,"allowedFormulations":100,"notes":101},"treat-small",{"fa":90,"en":91},"آنفلوانزا — زیر ۲۰ kg (۵ سال به بالا): ۲ mg\u002Fkg یک دوز سوسپانسیون","Influenza — under 20 kg (≥5 y): 2 mg\u002Fkg single dose of suspension",{"minAge":93,"maxWeightKg":69},{"value":63,"unit":64},"weightBased",{"perKgPerDay":96,"dividedDoses":5},2,[98],{"source":33,"section":75},{"min":5,"max":5},[44],[102],{"text":103,"refs":104},{"fa":80,"en":81},[105,106],{"source":33,"section":84},{"source":33,"section":86},{"id":108,"disease":109,"label":110,"population":113,"type":65,"unit":28,"dose":115,"refs":119,"durationDays":121,"notes":122},"pep","influenza-prophylaxis",{"fa":111,"en":112},"پیشگیری پس از تماس — یک دوز بر اساس وزن (۵ سال به بالا، ۲۰ kg به بالا)","Post-exposure prophylaxis — single dose by weight (≥5 y, ≥20 kg)",{"minAge":114,"minWeightKg":48},{"value":63,"unit":64},{"weightBands":116},[117,118],{"minWeightKg":69,"maxWeightKg":70,"perDose":27,"dosesPerDay":5},{"minWeightKg":70,"maxWeightKg":72,"perDose":39,"dosesPerDay":5},[120],{"source":33,"section":75},{"min":5,"max":5},[123],{"text":124,"refs":125},{"fa":80,"en":81},[126,127],{"source":33,"section":84},{"source":33,"section":86},{"id":129,"disease":109,"label":130,"population":133,"type":94,"unit":28,"dose":135,"refs":136,"durationDays":138,"allowedFormulations":139,"notes":140},"pep-small",{"fa":131,"en":132},"پیشگیری پس از تماس — زیر ۲۰ kg (۵ سال به بالا): ۲ mg\u002Fkg سوسپانسیون","Post-exposure prophylaxis — under 20 kg (≥5 y): 2 mg\u002Fkg suspension",{"minAge":134,"maxWeightKg":69},{"value":63,"unit":64},{"perKgPerDay":96,"dividedDoses":5},[137],{"source":33,"section":75},{"min":5,"max":5},[44],[141],{"text":142,"refs":143},{"fa":80,"en":81},[144,145],{"source":33,"section":84},{"source":33,"section":86},[147],{"id":148,"severity":149,"text":150,"refs":153},"hyper","block",{"fa":151,"en":152},"سابقه حساسیت به بالوکساویر (آنافیلاکسی، آنژیوادم، کهیر، اریتم مولتی‌فرم).","History of hypersensitivity to baloxavir (anaphylaxis, angioedema, urticaria, erythema multiforme).",[154],{"source":33,"section":155},"4",[],[],[],[160],{"with":161,"text":162,"refs":165},"cations",{"fa":163,"en":164},"لبنیات، آنتی‌اسید و مکمل‌های کلسیم، آهن، منیزیم، سلنیوم و روی جذب را کم می‌کنند.","Dairy, antacids and calcium, iron, magnesium, selenium and zinc supplements reduce absorption.",[166],{"source":33,"section":86},{"status":168,"reviewer":72,"date":72},"unverified",[170,175,179,185,189],{"regimen":56,"formulation":22,"input":171,"expect":174},{"ageYears":172,"weightKg":173},30,70,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":56,"formulation":36,"input":176,"expect":178},{"ageYears":27,"weightKg":177},90,{"perDose":39,"tabletsPerDoseRounded":5},{"regimen":88,"formulation":44,"input":180,"expect":183},{"ageYears":181,"weightKg":182},6,18,{"perDose":184,"mlPerDose":182},36,{"regimen":108,"formulation":22,"input":186,"expect":188},{"ageYears":187,"weightKg":27},12,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":129,"formulation":44,"input":190,"expect":192},{"ageYears":63,"weightKg":191},17,{"perDose":193,"mlPerDose":191},34,[195],"J05AX25",{"status":197,"refs":198},"not-found",[199],{"source":200,"section":201,"url":202},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Baloxavir%20marboxil",[204,208,212,216],{"kind":205,"url":206,"label":207},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=210854","NDA210854",{"kind":209,"url":210,"label":211},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e49e1a61-1b7c-4be5-ac84-af6240b511e7","FDA Xofluza",{"kind":213,"url":214,"label":215},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa618062.html","Baloxavir Marboxil",{"kind":217,"url":218,"label":195},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AX25",{"pregnancy":220,"lactation":229,"pediatric":237,"geriatric":245},{"level":221,"text":222,"quote":225,"refs":226},"caution",{"fa":223,"en":224},"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 There are no adequate and well-controlled studies with XOFLUZA in pregnant women to inform a drug-associated risk of adverse developmental outcomes.",[227],{"source":33,"section":228},"8.1",{"level":221,"text":230,"quote":233,"refs":234},{"fa":231,"en":232},"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 baloxavir marboxil in human milk, the effects on the breastfed infant, or the effects on milk production.",[235],{"source":33,"section":236},"8.2",{"level":221,"text":238,"quote":241,"refs":242},{"fa":239,"en":240},"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.","Pediatric Subjects (\u003C 5 Years of Age) The safety and effectiveness of XOFLUZA for treatment and post-exposure prophylaxis of influenza in pediatric subjects less than 5 years of age, including neonates, have not been established [see Warnings and Precautions (5.2) and Microbiology (12.4) ].",[243],{"source":33,"section":244},"8.4",{"level":221,"text":246,"quote":249,"refs":250},{"fa":247,"en":248},"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 safety and effectiveness of XOFLUZA in subjects 65 years of age and older has been established and is supported by one randomized, double-blind, controlled trial [see Clinical Studies (14.2) ] .",[251],{"source":33,"section":252},"8.5",{"kind":254,"refs":255,"id":207},"NDA",[256],{"source":33,"section":257},"SPL approval \u002F marketing category",1792108414059]