[{"data":1,"prerenderedAt":157},["ShallowReactive",2],{"drug-esketamine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":59,"warnings":69,"renal":77,"monitoring":78,"interactions":79,"review":80,"examples":83,"atc":84,"iran":86,"usApproval":93,"links":99,"populations":114},"esketamine",1,{"fa":7,"en":8},"اس‌کتامین (اسپری بینی)","Esketamine (nasal)","nervous-system",{"fa":11,"en":12},"آنتاگونیست NMDA","NMDA antagonist",[14],{"name":15,"market":16},"Spravato","US",[18,19,20],"spravato","اسپراواتو","اسکتامین",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"device","nasal-spray","nasal","28 mg per device (two sprays)",{"amount":28,"unit":29,"perUnit":30},28,"mg","spray",[16],[33],{"source":34,"section":35},"fda-spravato","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":52},"trd","mdd",{"fa":41,"en":42},"افسردگی مقاوم به درمان — ۵۶ یا ۸۴ mg دو بار در هفته (القا)، سپس کمتر","Treatment-resistant depression — 56 or 84 mg twice weekly (induction), then less often",{"minAge":44},{"value":45,"unit":46},18,"year","notCalculated",{"reason":49},{"fa":50,"en":51},"فقط در مرکز درمانی تحت نظر و پایش دست‌کم ۲ ساعت پس از هر نوبت؛ فشار خون قبل و بعد. برنامه هفته‌ها طبق جدول ۱ برچسب. افکار خودکشی حاد: ۸۴ mg دو بار در هفته ۴ هفته همراه ضدافسردگی.","Only in a certified healthcare setting with ≥2 h observation after each session; check BP before and after. Weekly schedule per label Table 1. Acute suicidal ideation: 84 mg twice weekly for 4 weeks with an antidepressant.",[53,55,57],{"source":34,"section":54},"2.2",{"source":34,"section":56},"2.3",{"source":34,"section":58},"2.5",[60],{"id":61,"severity":62,"text":63,"refs":66},"ci","block",{"fa":64,"en":65},"بیماری آنوریسمی عروق یا AVM؛ سابقه خونریزی داخل مغز؛ حساسیت به اس‌کتامین یا کتامین.","Aneurysmal vascular disease or AVM; history of intracerebral haemorrhage; hypersensitivity to esketamine or ketamine.",[67],{"source":34,"section":68},"4",[70],{"text":71,"refs":74},{"fa":72,"en":73},"هشدار جعبه‌ای: آرام‌بخشی، تجزیه (دیسوسیاسیون)، دپرسیون تنفسی، سوءمصرف، افکار خودکشی؛ فقط از طریق REMS.","Boxed warning: sedation, dissociation, respiratory depression, abuse and misuse, suicidal thoughts; REMS only.",[75],{"source":34,"section":76},"Boxed Warning",[],[],[],{"status":81,"reviewer":82,"date":82},"unverified",null,[],[85],"N06AX27",{"status":87,"refs":88},"not-found",[89],{"source":90,"section":91,"url":92},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Esketamine",{"kind":94,"refs":95,"id":98},"NDA",[96],{"source":34,"section":97},"SPL approval \u002F marketing category","NDA211243",[100,103,107,111],{"kind":101,"url":102,"label":98},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=211243",{"kind":104,"url":105,"label":106},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=d81a6a79-a74a-44b7-822c-0dfa3036eaed","FDA Spravato",{"kind":108,"url":109,"label":110},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619017.html","Esketamine Nasal Spray",{"kind":112,"url":113,"label":85},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N06AX27",{"pregnancy":115,"lactation":124,"pediatric":133,"geriatric":140,"reproductive":149},{"level":116,"text":117,"quote":120,"refs":121},"avoid",{"fa":118,"en":119},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Based on published findings from pregnant animals treated with ketamine, the racemic mixture of arketamine and esketamine, SPRAVATO may cause fetal harm when administered to pregnant women (see Data ) .",[122],{"source":34,"section":123},"8.1",{"level":125,"text":126,"quote":129,"refs":130},"caution",{"fa":127,"en":128},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Esketamine is present in human milk.",[131],{"source":34,"section":132},"8.2",{"level":116,"text":134,"quote":137,"refs":138},{"fa":135,"en":136},"هشدار جعبه‌ای برچسب درباره کودکان.","Boxed warning in the label about children.","( 5.5 ) Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants.",[139],{"source":34,"section":76},{"level":141,"text":142,"quote":145,"refs":146},"ok",{"fa":143,"en":144},"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 the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age.",[147],{"source":34,"section":148},"8.5",{"level":125,"text":150,"quote":153,"refs":154},{"fa":151,"en":152},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Based on published animal reproduction studies, SPRAVATO may cause embryo-fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1) ].",[155],{"source":34,"section":156},"8.3",1792156177416]