[{"data":1,"prerenderedAt":148},["ShallowReactive",2],{"drug-sodium-oxybate":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":36,"contraindications":60,"warnings":70,"renal":78,"monitoring":79,"interactions":80,"review":81,"examples":84,"atc":85,"iran":87,"usApproval":94,"links":100,"populations":114},"sodium-oxybate",1,{"fa":7,"en":8},"سدیم اکسی‌بات","Sodium oxybate","nervous-system",{"fa":11,"en":12},"مضعف CNS (GHB)","CNS depressant (GHB)",[14],{"name":15,"market":16},"Xyrem","US",[18,19,20,21],"xyrem","زایرم","GHB","اکسی بات",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":31,"refs":32},"sol","solution","oral","0.5 g\u002FmL oral solution",{"amount":29,"unit":30,"perVolumeMl":5},0.5,"g",[16],[33],{"source":34,"section":35},"fda-xyrem","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":48,"dose":49,"refs":53},"narco","narcolepsy",{"fa":41,"en":42},"نارکولپسی (کاتاپلکسی یا خواب‌آلودگی) — بزرگسال ۴٫۵ g شبانه در دو دوز، تا ۶ تا ۹ g","Narcolepsy (cataplexy or sleepiness) — adult 4.5 g per night in two doses, up to 6–9 g",{"minAge":44},{"value":45,"unit":46},18,"year","notCalculated","mg",{"reason":50},{"fa":51,"en":52},"شبانه در دو نوبت: نیمی هنگام رفتن به رختخواب و نیمی ۲٫۵ تا ۴ ساعت بعد. افزایش هفتگی ۱٫۵ g\u002Fشب تا ۶ تا ۹ g. کودک ۷ سال به بالا: بر اساس جدول وزن برچسب. شروع دیوالپروکس: ۲۰٪ کاهش.","At night in two doses: half at bedtime, half 2.5–4 h later. Increase by 1.5 g\u002Fnight weekly to 6–9 g. Children ≥7 y: per label weight table. Starting divalproex: reduce by 20%.",[54,56,58],{"source":34,"section":55},"2.1",{"source":34,"section":57},"2.2",{"source":34,"section":59},"2.5",[61],{"id":62,"severity":63,"text":64,"refs":67},"ci","block",{"fa":65,"en":66},"همراه داروهای خواب‌آور یا الکل؛ کمبود سوکسینیک سمی‌آلدئید دهیدروژناز.","With sedative hypnotics or alcohol; succinic semialdehyde dehydrogenase deficiency.",[68],{"source":34,"section":69},"4",[71],{"text":72,"refs":75},{"fa":73,"en":74},"هشدار جعبه‌ای: دپرسیون CNS و تنفس؛ سوءمصرف (GHB)؛ فقط از طریق برنامه REMS.","Boxed warning: CNS and respiratory depression; abuse and misuse (GHB); available only through REMS.",[76],{"source":34,"section":77},"Boxed Warning",[],[],[],{"status":82,"reviewer":83,"date":83},"unverified",null,[],[86],"N07XX04",{"status":88,"refs":89},"not-found",[90],{"source":91,"section":92,"url":93},"darooyab-generic","G-2678\u002FSodium-Oxybate","https:\u002F\u002Fwww.darooyab.ir\u002FG-2678\u002FSodium-Oxybate",{"kind":95,"refs":96,"id":99},"NDA",[97],{"source":34,"section":98},"SPL approval \u002F marketing category","NDA021196",[101,104,108,111],{"kind":102,"url":103,"label":99},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021196",{"kind":105,"url":106,"label":107},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=926eb076-a4a8-45e4-91ef-411f0aa4f3ca","FDA Xyrem",{"kind":109,"url":110,"label":86},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N07XX04",{"kind":112,"url":93,"label":113},"darooyab","Sodium-Oxybate",{"pregnancy":115,"lactation":124,"pediatric":132,"geriatric":140},{"level":116,"text":117,"quote":120,"refs":121},"caution",{"fa":118,"en":119},"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 There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women.",[122],{"source":34,"section":123},"8.1",{"level":116,"text":125,"quote":128,"refs":129},{"fa":126,"en":127},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary GHB is excreted in human milk after oral administration of sodium oxybate.",[130],{"source":34,"section":131},"8.2",{"level":116,"text":133,"quote":136,"refs":137},{"fa":134,"en":135},"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 Xyrem in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients (7 years of age and older) with narcolepsy have been established in a double-blind, placebo-controlled, randomized-withdrawal study [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 )] .",[138],{"source":34,"section":139},"8.4",{"level":116,"text":141,"quote":144,"refs":145},{"fa":142,"en":143},"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.","In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.",[146],{"source":34,"section":147},"8.5",1792156195641]