[{"data":1,"prerenderedAt":223},["ShallowReactive",2],{"drug-edoxaban":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":104,"warnings":114,"renal":122,"monitoring":132,"interactions":133,"review":134,"examples":137,"atc":151,"iran":153,"usApproval":160,"links":166,"populations":180},"edoxaban",1,{"fa":7,"en":8},"ادوکسابان","Edoxaban","blood",{"fa":11,"en":12},"مهارکننده مستقیم فاکتور Xa","Direct factor Xa inhibitor",[14],{"name":15,"market":16},"Savaysa \u002F Lixiana","US",[18,19,7],"savaysa","lixiana",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-15","tablet","oral","15 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},15,"mg",false,[16],[32],{"source":33,"section":34},"fda-savaysa","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-30","30 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},30,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"tab-60","60 mg tablet",{"amount":47,"unit":28,"perUnit":23,"scored":29},60,[16],[50],{"source":33,"section":34},[52,74,94],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":64,"notes":67},"af","atrial-fibrillation",{"fa":56,"en":57},"AF غیردریچه‌ای — ClCr ۵۰ تا ۹۵: ۶۰ mg یک بار در روز","Non-valvular AF — CrCl 50–95: 60 mg once daily",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":47,"dosesPerDay":5},[65],{"source":33,"section":66},"2.1",[68],{"text":69,"refs":72},{"fa":70,"en":71},"ClCr بالای ۹۵ استفاده نشود (اثر کمتر). ClCr ۱۵ تا ۵۰: ۳۰ mg یک بار در روز.","Do not use with CrCl >95 (reduced efficacy). CrCl 15–50: 30 mg once daily.",[73],{"source":33,"section":66},{"id":75,"disease":76,"label":77,"population":80,"type":62,"unit":28,"dose":83,"refs":84,"notes":87},"vte","venous-thromboembolism",{"fa":78,"en":79},"درمان DVT و PE — ۶۰ mg یک بار در روز پس از ۵ تا ۱۰ روز ضدانعقاد تزریقی","DVT and PE treatment — 60 mg once daily after 5–10 days of parenteral anticoagulation",{"minAge":81,"minWeightKg":82},{"value":60,"unit":61},60.01,{"perDose":47,"dosesPerDay":5},[85],{"source":33,"section":86},"2.2",[88],{"text":89,"refs":92},{"fa":90,"en":91},"۳۰ mg یک بار: ClCr ۱۵ تا ۵۰، وزن ۶۰ kg یا کمتر، یا مهارکننده P-gp خاص.","30 mg once daily: CrCl 15–50, weight ≤60 kg, or certain P-gp inhibitors.",[93],{"source":33,"section":86},{"id":95,"disease":76,"label":96,"population":99,"type":62,"unit":28,"dose":101,"refs":102},"vte-low",{"fa":97,"en":98},"درمان DVT و PE — وزن ۶۰ kg یا کمتر: ۳۰ mg یک بار در روز","DVT and PE treatment — weight ≤60 kg: 30 mg once daily",{"minAge":100,"maxWeightKg":47},{"value":60,"unit":61},{"perDose":39,"dosesPerDay":5},[103],{"source":33,"section":86},[105],{"id":106,"severity":107,"text":108,"refs":111},"bleed","block",{"fa":109,"en":110},"خونریزی پاتولوژیک فعال.","Active pathological bleeding.",[112],{"source":33,"section":113},"4",[115],{"text":116,"refs":119},{"fa":117,"en":118},"هشدار جعبه‌ای: در AF با ClCr بالای ۹۵ اثر کمتر (سکته بیشتر)؛ قطع زودهنگام خطر ترومبوز را بالا می‌برد؛ هماتوم نخاعی\u002Fاپیدورال با بی‌حسی نخاعی.","Boxed warning: reduced efficacy in AF with CrCl >95 (more strokes); premature discontinuation raises ischaemic risk; spinal\u002Fepidural haematoma with neuraxial procedures.",[120],{"source":33,"section":121},"Boxed Warning",[123],{"egfrBelow":124,"severity":125,"text":126,"refs":129},51,"warn",{"fa":127,"en":128},"ClCr ۱۵ تا ۵۰: ۳۰ mg یک بار در روز؛ زیر ۱۵ توصیه نمی‌شود.","CrCl 15–50: 30 mg once daily; \u003C15 not recommended.",[130,131],{"source":33,"section":66},{"source":33,"section":86},[],[],{"status":135,"reviewer":136,"date":136},"unverified",null,[138,143,147],{"regimen":53,"formulation":44,"input":139,"expect":142},{"ageYears":140,"weightKg":141},70,80,{"perDose":47,"tabletsPerDoseRounded":5},{"regimen":75,"formulation":44,"input":144,"expect":146},{"ageYears":145,"weightKg":141},50,{"perDose":47,"tabletsPerDoseRounded":5},{"regimen":95,"formulation":36,"input":148,"expect":150},{"ageYears":145,"weightKg":149},55,{"perDose":39,"tabletsPerDoseRounded":5},[152],"B01AF03",{"status":154,"refs":155},"not-found",[156],{"source":157,"section":158,"url":159},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Edoxaban",{"kind":161,"refs":162,"id":165},"NDA",[163],{"source":33,"section":164},"SPL approval \u002F marketing category","NDA206316",[167,170,174,177],{"kind":168,"url":169,"label":165},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=206316",{"kind":171,"url":172,"label":173},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66","FDA Savaysa",{"kind":175,"url":176,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614055.html",{"kind":178,"url":179,"label":152},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B01AF03",{"pregnancy":181,"lactation":190,"pediatric":199,"geriatric":207,"reproductive":215},{"level":182,"text":183,"quote":186,"refs":187},"caution",{"fa":184,"en":185},"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 about SAVAYSA use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes.",[188],{"source":33,"section":189},"8.1",{"level":191,"text":192,"quote":195,"refs":196},"avoid",{"fa":193,"en":194},"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 nursing infants, including hemorrhage, advise patients that breastfeeding is not recommended during treatment with SAVAYSA.",[197],{"source":33,"section":198},"8.2",{"level":182,"text":200,"quote":203,"refs":204},{"fa":201,"en":202},"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 SAVAYSA have not been established in pediatric patients with confirmed VTE (PE and\u002For DVT).",[205],{"source":33,"section":206},"8.4",{"level":182,"text":208,"quote":211,"refs":212},{"fa":209,"en":210},"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.","Of the total patients in the ENGAGE AF-TIMI 48 study, 5182 (74%) were 65 years and older, while 2838 (41%) were 75 years and older.",[213],{"source":33,"section":214},"8.5",{"level":182,"text":216,"quote":219,"refs":220},{"fa":217,"en":218},"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.",[221],{"source":33,"section":222},"8.3",1792156176470]