[{"data":1,"prerenderedAt":170},["ShallowReactive",2],{"drug-tolvaptan":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":70,"warnings":80,"renal":87,"monitoring":88,"interactions":89,"review":90,"examples":93,"atc":99,"iran":101,"usApproval":108,"links":114,"populations":134},"tolvaptan",1,{"fa":7,"en":8},"تولواپتان","Tolvaptan","cardiovascular",{"fa":11,"en":12},"آنتاگونیست گیرنده وازوپرسین V2","Vasopressin V2 receptor antagonist",[14],{"name":15,"market":16},"Samsca","US",[18,19,7],"samsca","سامسکا",[21,35],{"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-samsca","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},[44],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":58,"notes":61},"hyponat","hyponatremia",{"fa":48,"en":49},"هیپوناترمی هیپرولمیک یا یوولمیک — شروع ۱۵ mg روزانه در بیمارستان (تا ۶۰ mg)","Hypervolaemic or euvolaemic hyponatraemia — start 15 mg daily in hospital (up to 60 mg)",{"minAge":51},{"value":52,"unit":53},18,"year","titration",{"dividedDoses":5,"titration":56},{"start":27,"increment":27,"incrementEveryDays":5,"max":57},60,[59],{"source":33,"section":60},"2.1",[62],{"text":63,"refs":66},{"fa":64,"en":65},"فقط در بیمارستان شروع شود؛ اصلاح سریع سدیم دمیلیناسیون اسمزی می‌دهد. افزایش به ۳۰ و سپس حداکثر ۶۰ mg با فاصله دست‌کم ۲۴ ساعت.","Start only in hospital; over-rapid correction causes osmotic demyelination. Increase to 30 then up to 60 mg at ≥24-h intervals.",[67,68],{"source":33,"section":60},{"source":33,"section":69},"Boxed Warning",[71],{"id":72,"severity":73,"text":74,"refs":77},"ci","block",{"fa":75,"en":76},"هیپوناترمی هیپوولمیک؛ ناتوانی در حس یا پاسخ به تشنگی؛ مهارکننده‌های قوی CYP3A؛ آنوری؛ ADPKD خارج از REMS؛ حساسیت.","Hypovolaemic hyponatraemia; inability to sense or respond to thirst; strong CYP3A inhibitors; anuria; ADPKD outside REMS; hypersensitivity.",[78],{"source":33,"section":79},"4",[81],{"text":82,"refs":85},{"fa":83,"en":84},"هشدار جعبه‌ای: شروع و شروع مجدد فقط در بیمارستان با پایش سدیم؛ برای ADPKD نیست.","Boxed warning: initiate and re-initiate only in hospital with sodium monitoring; not for ADPKD.",[86],{"source":33,"section":69},[],[],[],{"status":91,"reviewer":92,"date":92},"unverified",null,[94],{"regimen":45,"formulation":22,"input":95,"expect":98},{"ageYears":96,"weightKg":97},70,65,{"perDose":27,"tabletsPerDoseRounded":5},[100],"C03XA01",{"status":102,"refs":103},"registered",[104],{"source":105,"section":106,"url":107},"darooyab-generic","G-4897\u002FTolvaptan","https:\u002F\u002Fwww.darooyab.ir\u002FG-4897\u002FTolvaptan",{"kind":109,"refs":110,"id":113},"NDA",[111],{"source":33,"section":112},"SPL approval \u002F marketing category","NDA022275",[115,118,122,126,129,132],{"kind":116,"url":117,"label":113},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022275",{"kind":119,"url":120,"label":121},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=5526617c-c7b9-4556-886d-729bbabbc566","FDA Samsca",{"kind":123,"url":124,"label":125},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa620041.html","Tolvaptan (kidney disease)",{"kind":123,"url":127,"label":128},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa609033.html","Tolvaptan (low blood sodium)",{"kind":130,"url":131,"label":100},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C03XA01",{"kind":133,"url":107,"label":8},"darooyab",{"pregnancy":135,"lactation":144,"pediatric":153,"geriatric":162},{"level":136,"text":137,"quote":140,"refs":141},"caution",{"fa":138,"en":139},"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 with SAMSCA use in pregnant women are insufficient to determine if there is a drug-associated risk of adverse developmental outcomes.",[142],{"source":33,"section":143},"8.1",{"level":145,"text":146,"quote":149,"refs":150},"avoid",{"fa":147,"en":148},"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, including electrolyte abnormalities (e.g., hypernatremia), hypotension, and volume depletion in breastfed infants, advise women not to breastfeed during treatment with SAMSCA.",[151],{"source":33,"section":152},"8.2",{"level":154,"text":155,"quote":158,"refs":159},"not-established",{"fa":156,"en":157},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of SAMSCA in pediatric patients have not been established.",[160],{"source":33,"section":161},"8.4",{"level":136,"text":163,"quote":166,"refs":167},{"fa":164,"en":165},"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 number of hyponatremic subjects treated with SAMSCA in clinical studies, 42% were 65 years old and over, while 19% were 75 years old and over.",[168],{"source":33,"section":169},"8.5",1792156197989]