[{"data":1,"prerenderedAt":162},["ShallowReactive",2],{"drug-dofetilide":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":50,"contraindications":70,"warnings":80,"renal":89,"monitoring":90,"interactions":91,"review":92,"examples":95,"atc":96,"iran":98,"links":105,"populations":122,"usApproval":157},"dofetilide",1,{"fa":7,"en":8},"دوفتیلید","Dofetilide","cardiovascular",{"fa":11,"en":12},"ضدآریتمی کلاس III","Class III antiarrhythmic",[14],{"name":15,"market":16},"Tikosyn","US",[18,19,7],"tikosyn","دوفتیلاید",[21,34,42],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"cap-125","capsule","oral","125 mcg capsule",{"amount":27,"unit":28,"perUnit":23},125,"mcg",[16],[31],{"source":32,"section":33},"fda-tikosyn","How Supplied",{"id":35,"form":23,"route":24,"label":36,"concentration":37,"markets":39,"refs":40},"cap-250","250 mcg capsule",{"amount":38,"unit":28,"perUnit":23},250,[16],[41],{"source":32,"section":33},{"id":43,"form":23,"route":24,"label":44,"concentration":45,"markets":47,"refs":48},"cap-500","500 mcg capsule",{"amount":46,"unit":28,"perUnit":23},500,[16],[49],{"source":32,"section":33},[51],{"id":52,"disease":53,"label":54,"population":57,"type":61,"unit":62,"dose":63,"refs":67},"af","atrial-fibrillation",{"fa":55,"en":56},"تبدیل و حفظ ریتم سینوسی در AF\u002Fفلوتر — دوز بر اساس ClCr: >۶۰ ← ۵۰۰ mcg؛ ۴۰ تا ۶۰ ← ۲۵۰؛ ۲۰ تا \u003C۴۰ ← ۱۲۵ mcg دو بار در روز","Conversion\u002Fmaintenance of sinus rhythm in AF\u002FAFL — by CrCl: >60 → 500 mcg; 40–60 → 250; 20–\u003C40 → 125 mcg twice daily",{"minAge":58},{"value":59,"unit":60},18,"year","notCalculated","mg",{"reason":64},{"fa":65,"en":66},"فقط در مرکز با پایش مداوم ECG دست‌کم ۳ روز. QTc پایه بالای ۴۴۰ نه. ۲ تا ۳ ساعت پس از دوز اول QTc؛ افزایش بیش از ۱۵٪ یا بالای ۵۰۰ ms: کاهش دوز طبق برچسب. ClCr زیر ۲۰ منع مصرف.","Start only in a facility with continuous ECG monitoring for ≥3 days. Not if baseline QTc >440 ms. QTc 2–3 h after the first dose; increase >15% or >500 ms: reduce per label. CrCl \u003C20 contraindicated.",[68],{"source":32,"section":69},"Dosage and Administration",[71],{"id":72,"severity":73,"text":74,"refs":77},"ci","block",{"fa":75,"en":76},"سندرم QT طولانی؛ QTc پایه بالای ۴۴۰ ms (۵۰۰ با اختلال هدایت بطنی)؛ ClCr زیر ۲۰؛ وراپامیل، سایمتیدین، تری‌متوپریم، کتوکونازول، پروکلرپرازین، مژسترول، دولوتگراویر، هیدروکلروتیازید.","Long QT syndrome; baseline QTc >440 ms (500 with ventricular conduction abnormalities); CrCl \u003C20; verapamil, cimetidine, trimethoprim, ketoconazole, prochlorperazine, megestrol, dolutegravir, hydrochlorothiazide.",[78],{"source":32,"section":79},"Contraindications",[81],{"text":82,"refs":85},{"fa":83,"en":84},"هشدار جعبه‌ای: آریتمی بطنی (تورساد) — شروع یا شروع مجدد فقط با پایش ECG و محاسبه ClCr.","Boxed warning: ventricular arrhythmia (torsade) — initiate or re-initiate only with ECG monitoring and CrCl calculation.",[86,88],{"source":32,"section":87},"Boxed Warning",{"source":32,"section":69},[],[],[],{"status":93,"reviewer":94,"date":94},"unverified",null,[],[97],"C01BD04",{"status":99,"refs":100},"not-found",[101],{"source":102,"section":103,"url":104},"darooyab-generic","G-1650\u002FDofetilide","https:\u002F\u002Fwww.darooyab.ir\u002FG-1650\u002FDofetilide",[106,110,114,117,120],{"kind":107,"url":108,"label":109},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=020931","NDA020931",{"kind":111,"url":112,"label":113},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=02438044-d6a3-49e9-a1ac-3aad21ef2c8c","FDA Tikosyn",{"kind":115,"url":116,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa601235.html",{"kind":118,"url":119,"label":97},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C01BD04",{"kind":121,"url":104,"label":8},"darooyab",{"pregnancy":123,"lactation":132,"pediatric":140,"geriatric":149},{"level":124,"text":125,"quote":128,"refs":129},"caution",{"fa":126,"en":127},"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.","Dofetilide has been shown to adversely affect in utero growth and survival of rats and mice when orally administered during organogenesis at doses of 2 or more mg\u002Fkg\u002Fday.",[130],{"source":32,"section":131},"Pregnancy",{"level":124,"text":133,"quote":136,"refs":137},{"fa":134,"en":135},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","There is no information on the presence of dofetilide in breast milk.",[138],{"source":32,"section":139},"Nursing Mothers",{"level":141,"text":142,"quote":145,"refs":146},"not-established",{"fa":143,"en":144},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of TIKOSYN in children (\u003C18 years old) has not been established.",[147],{"source":32,"section":148},"Pediatric Use",{"level":124,"text":150,"quote":153,"refs":154},{"fa":151,"en":152},"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.","Because elderly patients are more likely to have decreased renal function with a reduced creatinine clearance, care must be taken in dose selection (see DOSAGE AND ADMINISTRATION ).",[155],{"source":32,"section":156},"Geriatric Use",{"kind":158,"refs":159,"id":109},"NDA",[160],{"source":32,"section":161},"SPL approval \u002F marketing category",1792191539048]