[{"data":1,"prerenderedAt":283},["ShallowReactive",2],{"drug-sacubitril-valsartan":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":86,"contraindications":165,"warnings":175,"renal":183,"monitoring":184,"interactions":185,"review":186,"examples":188,"atc":206,"iran":208,"links":228,"populations":243,"usApproval":278},"sacubitril-valsartan",1,{"fa":7,"en":8},"ساکوبیتریل + والسارتان","Sacubitril + valsartan","cardiovascular",{"fa":11,"en":12},"مهارکننده نپریلیزین و گیرنده آنژیوتانسین (ARNI)","Angiotensin receptor–neprilysin inhibitor (ARNI)",[14],{"name":15,"market":16},"Entresto","US",[18,19,20,21],"entresto","انترستو","ساکوبیتریل","ARNI",[23,46,61,76],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":31,"refs":32,"components":36},"tab-24-26","tablet","oral","Sacubitril 24 mg \u002F valsartan 26 mg tablet",{"amount":29,"unit":30,"perUnit":25},50,"mg",[16],[33],{"source":34,"section":35},"fda-entresto","3",{"sacubitril":37,"valsartan":41},{"name":38,"amount":40,"unit":30},{"fa":20,"en":39},"Sacubitril",24,{"name":42,"amount":45,"unit":30},{"fa":43,"en":44},"والسارتان","Valsartan",26,{"id":47,"form":25,"route":26,"label":48,"concentration":49,"markets":51,"refs":52,"components":54},"tab-49-51","Sacubitril 49 mg \u002F valsartan 51 mg tablet",{"amount":50,"unit":30,"perUnit":25},100,[16],[53],{"source":34,"section":35},{"sacubitril":55,"valsartan":58},{"name":56,"amount":57,"unit":30},{"fa":20,"en":39},49,{"name":59,"amount":60,"unit":30},{"fa":43,"en":44},51,{"id":62,"form":25,"route":26,"label":63,"concentration":64,"markets":66,"refs":67,"components":69},"tab-97-103","Sacubitril 97 mg \u002F valsartan 103 mg tablet",{"amount":65,"unit":30,"perUnit":25},200,[16],[68],{"source":34,"section":35},{"sacubitril":70,"valsartan":73},{"name":71,"amount":72,"unit":30},{"fa":20,"en":39},97,{"name":74,"amount":75,"unit":30},{"fa":43,"en":44},103,{"id":77,"form":78,"route":26,"label":79,"concentration":80,"markets":82,"refs":83},"susp-4","suspension","4 mg\u002FmL oral suspension (prepared from 49\u002F51 mg tablets; combined)",{"amount":81,"unit":30,"perVolumeMl":5},4,[16],[84],{"source":34,"section":85},"2.4",[87,116,139],{"id":88,"disease":89,"label":90,"population":93,"type":97,"unit":30,"dose":98,"refs":103,"allowedFormulations":106,"notes":107},"adult","heart-failure",{"fa":91,"en":92},"نارسایی قلب بزرگسال — شروع ۴۹\u002F۵۱ mg دو بار در روز، هدف ۹۷\u002F۱۰۳ mg","Adult heart failure — start 49\u002F51 mg twice daily, target 97\u002F103 mg",{"minAge":94},{"value":95,"unit":96},18,"year","titration",{"dividedDoses":99,"titration":100},2,{"start":65,"increment":65,"incrementEveryDays":101,"targetMin":102,"targetMax":102,"max":102},14,400,[104],{"source":34,"section":105},"2.2",[24,47,62],[108],{"text":109,"refs":112},{"fa":110,"en":111},"اعداد بر حسب مجموع ساکوبیتریل + والسارتان (۴۹\u002F۵۱ = ۱۰۰ mg). دوز پس از ۲ تا ۴ هفته دو برابر شود. از مهارکننده ACE دست‌کم ۳۶ ساعت فاصله.","Amounts are sacubitril + valsartan combined (49\u002F51 = 100 mg). Double the dose after 2–4 weeks. At least 36 h apart from an ACE inhibitor.",[113,114],{"source":34,"section":105},{"source":34,"section":115},"2.1",{"id":117,"disease":89,"label":118,"population":121,"type":124,"unit":30,"dose":125,"refs":128,"allowedFormulations":131,"notes":132},"child-lt40",{"fa":119,"en":120},"کودک ۱ سال به بالا زیر ۴۰ kg — شروع ۱٫۶ mg\u002Fkg دو بار در روز (مجموع)","Child ≥1 y, \u003C40 kg — start 1.6 mg\u002Fkg twice daily (combined)",{"minAge":122,"maxWeightKg":123},{"value":5,"unit":96},39.99,"weightBased",{"perKgPerDose":126,"intervalHours":127},1.6,12,[129],{"source":34,"section":130},"2.3, Table 1",[77],[133],{"text":134,"refs":137},{"fa":135,"en":136},"هر ۲ هفته به ۲٫۳ و سپس ۳٫۱ mg\u002Fkg دو بار در روز. سوسپانسیون یا پلت توصیه می‌شود.","Every 2 weeks increase to 2.3 then 3.1 mg\u002Fkg twice daily. Suspension or pellets recommended.",[138],{"source":34,"section":130},{"id":140,"disease":89,"label":141,"population":144,"type":148,"unit":30,"dose":149,"refs":155,"allowedFormulations":157,"notes":158},"child-40plus",{"fa":142,"en":143},"کودک ۴۰ kg و بیشتر — شروع بر اساس وزن، دو بار در روز","Child ≥40 kg — starting dose by weight, twice daily",{"minAge":145,"maxAge":146,"minWeightKg":147},{"value":5,"unit":96},{"value":95,"unit":96},40,"weightBand",{"weightBands":150},[151,153],{"minWeightKg":123,"maxWeightKg":152,"perDose":29,"dosesPerDay":99},49.99,{"minWeightKg":152,"maxWeightKg":154,"perDose":50,"dosesPerDay":99},null,[156],{"source":34,"section":130},[24,47,62],[159],{"text":160,"refs":163},{"fa":161,"en":162},"۴۰ تا ۵۰ kg: ۲۴\u002F۲۶ → ۴۹\u002F۵۱ → ۷۲\u002F۷۸ mg؛ ۵۰ kg و بیشتر: ۴۹\u002F۵۱ → ۷۲\u002F۷۸ → ۹۷\u002F۱۰۳ mg، هر ۲ هفته.","40–50 kg: 24\u002F26 → 49\u002F51 → 72\u002F78 mg; ≥50 kg: 49\u002F51 → 72\u002F78 → 97\u002F103 mg, every 2 weeks.",[164],{"source":34,"section":130},[166],{"id":167,"severity":168,"text":169,"refs":172},"ci","block",{"fa":170,"en":171},"سابقه آنژیوادم با ACEi یا ARB؛ مصرف همزمان مهارکننده ACE (۳۶ ساعت فاصله)؛ آلیسکیرن در دیابت؛ حساسیت.","History of angioedema with ACEi or ARB; concomitant ACE inhibitor (36 h washout); aliskiren in diabetes; hypersensitivity.",[173],{"source":34,"section":174},"4",[176],{"text":177,"refs":180},{"fa":178,"en":179},"هشدار جعبه‌ای: سمیت جنینی — با تشخیص بارداری فوراً قطع شود.","Boxed warning: fetal toxicity — stop as soon as pregnancy is detected.",[181],{"source":34,"section":182},"Boxed Warning",[],[],[],{"status":187,"reviewer":154,"date":154},"unverified",[189,194,201],{"regimen":88,"formulation":47,"input":190,"expect":193},{"ageYears":191,"weightKg":192},60,80,{"perDose":50,"tabletsPerDoseRounded":5},{"regimen":117,"formulation":77,"input":195,"expect":198},{"ageYears":196,"weightKg":197},6,20,{"perDose":199,"mlPerDose":200},32,8,{"regimen":140,"formulation":47,"input":202,"expect":205},{"ageYears":203,"weightKg":204},15,55,{"perDose":50,"tabletsPerDoseRounded":5},[207],"C09DX04",{"status":209,"forms":210,"refs":223},"registered",[211,215,219],{"code":212,"en":213,"fa":214},"51005","SACUBITRIL\u002FVALSARTAN 49\u002F51MG TAB","قرص ساکوبیتریل \u002F والسارتان ۴۹ \u002F ۵۱ میلی‌گرم",{"code":216,"en":217,"fa":218},"50702","SACUBITRIL\u002FVALSARTAN 24\u002F26MG TAB","قرص ساکوبیتریل \u002F والسارتان ۲۴ \u002F ۲۶ میلی‌گرم",{"code":220,"en":221,"fa":222},"52234","SACUBITRIL\u002FVALSARTAN 103\u002F97MG TAB","قرص ساکوبیتریل \u002F والسارتان ۱۰۳ \u002F ۹۷ میلی‌گرم",[224],{"source":225,"section":226,"url":227},"darooyab-generic","G-4847\u002FSacubitril-Valsartan","https:\u002F\u002Fwww.darooyab.ir\u002FG-4847\u002FSacubitril-Valsartan",[229,233,237,240],{"kind":230,"url":231,"label":232},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=207620","NDA207620",{"kind":234,"url":235,"label":236},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f","FDA Entresto",{"kind":238,"url":239,"label":207},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C09DX04",{"kind":241,"url":227,"label":242},"darooyab","Sacubitril-Valsartan",{"pregnancy":244,"lactation":252,"pediatric":260,"geriatric":269},{"level":245,"text":246,"quote":249,"refs":250},"avoid",{"fa":247,"en":248},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.",[251],{"source":34,"section":182},{"level":245,"text":253,"quote":256,"refs":257},{"fa":254,"en":255},"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 breastfed infants from exposure to sacubitril\u002Fvalsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.",[258],{"source":34,"section":259},"8.2",{"level":261,"text":262,"quote":265,"refs":266},"caution",{"fa":263,"en":264},"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 ENTRESTO have been established for the treatment of heart failure in pediatric patients 1 year to less than 18 years.",[267],{"source":34,"section":268},"8.4",{"level":270,"text":271,"quote":274,"refs":275},"ok",{"fa":272,"en":273},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety or effectiveness of ENTRESTO have been observed between patients 65 years of age and older and younger adult patients in either study.",[276],{"source":34,"section":277},"8.5",{"kind":279,"refs":280,"id":232},"NDA",[281],{"source":34,"section":282},"SPL approval \u002F marketing category",1792111467662]