[{"data":1,"prerenderedAt":193},["ShallowReactive",2],{"drug-stiripentol":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":59,"contraindications":94,"warnings":95,"renal":103,"monitoring":104,"interactions":105,"review":106,"examples":109,"atc":115,"iran":117,"usApproval":137,"links":143,"populations":159},"stiripentol",1,{"fa":7,"en":8},"استیری‌پنتول","Stiripentol","nervous-system",{"fa":11,"en":12},"ضدتشنج","Antiseizure",[14],{"name":15,"market":16},"Diacomit","US",[18,19,20],"diacomit","دیاکومیت","استیریپنتول",[22,35,43,52],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"sach-250","sachet","oral","250 mg powder for oral suspension (packet)",{"amount":28,"unit":29,"perUnit":24},250,"mg",[16],[32],{"source":33,"section":34},"fda-diacomit","3",{"id":36,"form":24,"route":25,"label":37,"concentration":38,"markets":40,"refs":41},"sach-500","500 mg powder for oral suspension (packet)",{"amount":39,"unit":29,"perUnit":24},500,[16],[42],{"source":33,"section":34},{"id":44,"form":45,"route":25,"label":46,"concentration":47,"markets":49,"refs":50},"cap-250","capsule","250 mg capsule",{"amount":28,"unit":29,"perUnit":45,"scored":48},false,[16],[51],{"source":33,"section":34},{"id":53,"form":45,"route":25,"label":54,"concentration":55,"markets":56,"refs":57},"cap-500","500 mg capsule",{"amount":39,"unit":29,"perUnit":45,"scored":48},[16],[58],{"source":33,"section":34},[60],{"id":61,"disease":62,"label":63,"population":66,"type":71,"unit":29,"dose":72,"refs":75,"limits":78,"notes":83},"dravet","dravet-syndrome",{"fa":64,"en":65},"سندرم دراوه (همراه کلوبازام) — ۶ ماه و ≥۷ kg: ۵۰ mg\u002Fkg\u002Fروز در ۲ دوز","Dravet syndrome (with clobazam) — ≥6 months and ≥7 kg: 50 mg\u002Fkg\u002Fday in 2 doses",{"minAge":67,"minWeightKg":70},{"value":68,"unit":69},6,"month",7,"weightBased",{"perKgPerDay":73,"dividedDoses":74},50,2,[76],{"source":33,"section":77},"2.2, Table 1",{"maxPerDay":79,"refs":80},3000,[81],{"source":33,"section":82},"2.2",[84],{"text":85,"refs":88},{"fa":86,"en":87},"۱ سال و ≥۱۰ kg: می‌تواند ۳ دوز (۱۶٫۶۷ mg\u002Fkg) باشد. به نزدیک‌ترین دوز ممکن گرد شود (معمولاً ۵۰ تا ۱۵۰ mg از ۵۰ mg\u002Fkg\u002Fروز). با غذا؛ کپسول باز نشود. CBC پیش از شروع.","≥1 y and ≥10 kg: may use 3 doses (16.67 mg\u002Fkg). Round to the nearest achievable dose (usually within 50–150 mg of 50 mg\u002Fkg\u002Fday). With a meal; do not open capsules. CBC before starting.",[89,90,92],{"source":33,"section":82},{"source":33,"section":91},"2.3",{"source":33,"section":93},"2.1",[],[96],{"text":97,"refs":100},{"fa":98,"en":99},"خواب‌آلودگی؛ کاهش اشتها و وزن؛ نوتروپنی و ترومبوسیتوپنی؛ فنیل‌کتونوری (پودر)؛ افکار خودکشی؛ قطع تدریجی.","Somnolence; decreased appetite and weight; neutropenia and thrombocytopenia; phenylketonuria (powder); suicidal thoughts; withdraw gradually.",[101],{"source":33,"section":102},"5",[],[],[],{"status":107,"reviewer":108,"date":108},"unverified",null,[110],{"regimen":61,"formulation":23,"input":111,"expect":114},{"ageYears":112,"weightKg":113},5,20,{"perDose":39,"tabletsPerDoseRounded":74},[116],"N03AX17",{"status":118,"forms":119,"refs":132},"registered",[120,124,128],{"code":121,"en":122,"fa":123},"14155","STRIPENTOL 250MG CAP","کپسول ستریپنتول ۲۵۰ میلی‌گرم",{"code":125,"en":126,"fa":127},"14157","STRIPENTOL 500MG CAP","کپسول ستریپنتول ۵۰۰ میلی‌گرم",{"code":129,"en":130,"fa":131},"53029","STIRIPENTOL POWDER, FOR SUSPENSION ORAL 250 mg","سوسپانسیون خوراکی ستیریپنتول ۲۵۰ میلی‌گرم",[133],{"source":134,"section":135,"url":136},"darooyab-generic","G-685\u002FStiripentol","https:\u002F\u002Fwww.darooyab.ir\u002FG-685\u002FStiripentol",{"kind":138,"refs":139,"id":142},"NDA",[140],{"source":33,"section":141},"SPL approval \u002F marketing category","NDA206709",[144,147,151,154,157],{"kind":145,"url":146,"label":142},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=206709",{"kind":148,"url":149,"label":150},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=58304ba8-9779-4658-811e-94ffe08c3f16","FDA Diacomit",{"kind":152,"url":153,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa618069.html",{"kind":155,"url":156,"label":116},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N03AX17",{"kind":158,"url":136,"label":8},"darooyab",{"pregnancy":160,"lactation":169,"pediatric":177,"geriatric":185},{"level":161,"text":162,"quote":165,"refs":166},"caution",{"fa":163,"en":164},"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 risks associated with the use of DIACOMIT in pregnant women.",[167],{"source":33,"section":168},"8.1",{"level":161,"text":170,"quote":173,"refs":174},{"fa":171,"en":172},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of stiripentol in human milk, the effects on the breastfed infant, or the effects on milk production.",[175],{"source":33,"section":176},"8.2",{"level":161,"text":178,"quote":181,"refs":182},{"fa":179,"en":180},"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 DIACOMIT have been established for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months and older and weighing 7 kg or more.",[183],{"source":33,"section":184},"8.4",{"level":161,"text":186,"quote":189,"refs":190},{"fa":187,"en":188},"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.","Clinical studies of DIACOMIT in Dravet syndrome did not include patients ≥65 years of age to determine whether they respond differently from younger patients.",[191],{"source":33,"section":192},"8.5",1792191567384]