[{"data":1,"prerenderedAt":191},["ShallowReactive",2],{"drug-vigabatrin":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":36,"contraindications":92,"warnings":93,"renal":101,"monitoring":102,"interactions":103,"review":104,"examples":107,"atc":120,"iran":122,"usApproval":134,"links":140,"populations":156},"vigabatrin",1,{"fa":7,"en":8},"ویگاباترین","Vigabatrin","nervous-system",{"fa":11,"en":12},"مهارکننده GABA ترانس‌آمیناز","GABA transaminase inhibitor",[14],{"name":15,"market":16},"Sabril","US",[18,19,7],"sabril","سابریل",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"sol-50","solution","oral","500 mg packet dissolved in 10 mL water = 50 mg\u002FmL",{"amount":27,"unit":28,"perVolumeMl":5},50,"mg",[16],[31,34],{"source":32,"section":33},"fda-vigabatrin","3",{"source":32,"section":35},"2.3",[37,64],{"id":38,"disease":39,"label":40,"population":43,"type":49,"unit":28,"dose":50,"refs":52,"limits":54,"notes":57},"is","infantile-spasms",{"fa":41,"en":42},"اسپاسم شیرخواران (۱ ماه تا ۲ سال) — شروع ۵۰ mg\u002Fkg\u002Fروز در دو دوز، تا ۱۵۰ mg\u002Fkg\u002Fروز","Infantile spasms (1 month–2 y) — start 50 mg\u002Fkg\u002Fday in two doses, up to 150 mg\u002Fkg\u002Fday",{"minAge":44,"maxAge":46},{"value":5,"unit":45},"month",{"value":47,"unit":48},2,"year","weightBased",{"perKgPerDay":27,"perKgPerDayMax":51,"dividedDoses":47},150,[53],{"source":32,"section":35},{"maxPerKgPerDay":51,"refs":55},[56],{"source":32,"section":35},[58],{"text":59,"refs":62},{"fa":60,"en":61},"افزایش ۲۵ تا ۵۰ mg\u002Fkg\u002Fروز هر ۳ روز.","Increase by 25–50 mg\u002Fkg\u002Fday every 3 days.",[63],{"source":32,"section":35},{"id":65,"disease":66,"label":67,"population":70,"type":73,"unit":28,"dose":74,"refs":80,"notes":83},"cps","epilepsy",{"fa":68,"en":69},"تشنج پارشیل مقاوم بزرگسال (۱۷ سال به بالا) — ۵۰۰ mg دو بار، هر هفته ۵۰۰ mg\u002Fروز بیشتر تا ۱۵۰۰ mg دو بار","Refractory complex partial seizures, adult (≥17 y) — 500 mg twice daily, +500 mg\u002Fday weekly to 1500 mg twice daily",{"minAge":71},{"value":72,"unit":48},17,"titration",{"dividedDoses":47,"titration":75},{"start":76,"increment":77,"incrementEveryDays":78,"max":79},1000,500,7,3000,[81],{"source":32,"section":82},"2.2",[84],{"text":85,"refs":88},{"fa":86,"en":87},"۶۰۰۰ mg\u002Fروز سود بیشتری ندارد. نارسایی کلیه: ClCr ۵۰ تا ۸۰ ← ۲۵٪ کمتر؛ ۳۰ تا ۵۰ ← ۵۰٪ کمتر.","6000 mg\u002Fday adds no benefit. Renal impairment: CrCl 50–80 → 25% less; 30–50 → 50% less.",[89,90],{"source":32,"section":82},{"source":32,"section":91},"2.4",[],[94],{"text":95,"refs":98},{"fa":96,"en":97},"هشدار جعبه‌ای: کاهش دائمی میدان بینایی (دید تونلی) — معاینه بینایی پایه و هر ۳ ماه؛ فقط از طریق برنامه REMS.","Boxed warning: permanent bilateral visual field loss (tunnel vision) — baseline and 3-monthly vision assessment; available only through REMS.",[99],{"source":32,"section":100},"Boxed Warning",[],[],[],{"status":105,"reviewer":106,"date":106},"unverified",null,[108,114],{"regimen":38,"formulation":22,"input":109,"expect":111},{"ageMonths":110,"weightKg":110},6,{"perDose":51,"mlPerDose":112,"upperPerDose":113},3,450,{"regimen":65,"formulation":22,"input":115,"expect":118},{"ageYears":116,"weightKg":117},30,70,{"perDose":77,"mlPerDose":119},10,[121],"N03AG04",{"status":123,"forms":124,"refs":129},"registered",[125],{"code":126,"en":127,"fa":128},"01282","VIGABATRIN 500MG FC TAB","قرص روکش‌دار ویگاباترین ۵۰۰ میلی‌گرم",[130],{"source":131,"section":132,"url":133},"darooyab-generic","G-691\u002FVigabatrin","https:\u002F\u002Fwww.darooyab.ir\u002FG-691\u002FVigabatrin",{"kind":135,"refs":136,"id":139},"ANDA",[137],{"source":32,"section":138},"SPL approval \u002F marketing category","ANDA208218",[141,144,148,151,154],{"kind":142,"url":143,"label":139},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208218",{"kind":145,"url":146,"label":147},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e7cbc0a5-8c28-4451-9176-b608e228ba66","FDA Vigabatrin",{"kind":149,"url":150,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa610016.html",{"kind":152,"url":153,"label":121},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N03AG04",{"kind":155,"url":133,"label":8},"darooyab",{"pregnancy":157,"lactation":166,"pediatric":175,"geriatric":183},{"level":158,"text":159,"quote":162,"refs":163},"caution",{"fa":160,"en":161},"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 vigabatrin in pregnant women.",[164],{"source":32,"section":165},"8.1",{"level":167,"text":168,"quote":171,"refs":172},"avoid",{"fa":169,"en":170},"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 from vigabatrin in nursing infants, breastfeeding is not recommended.",[173],{"source":32,"section":174},"8.2",{"level":158,"text":176,"quote":179,"refs":180},{"fa":177,"en":178},"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 vigabatrin as adjunctive treatment of refractory complex partial seizures in pediatric patients 2 to 16 years of age have been established and is supported by three double-blind, placebo-controlled studies in patients 3 to 16 years of age, adequate and well-controlled studies in adult …",[181],{"source":32,"section":182},"8.4",{"level":158,"text":184,"quote":187,"refs":188},{"fa":185,"en":186},"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.","Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.",[189],{"source":32,"section":190},"8.5",1792156199492]