[{"data":1,"prerenderedAt":214},["ShallowReactive",2],{"drug-fenfluramine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":85,"warnings":95,"renal":110,"monitoring":120,"interactions":121,"review":122,"examples":125,"atc":136,"iran":138,"usApproval":150,"links":156,"populations":172},"fenfluramine",1,{"fa":7,"en":8},"فن‌فلورامین","Fenfluramine","nervous-system",{"fa":11,"en":12},"ضدتشنج (عامل سروتونرژیک)","Antiseizure (serotonergic agent)",[14],{"name":15,"market":16},"Fintepla","US",[18,19,20],"fintepla","فینتپلا","فنفلورامین",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"sol-2-2","solution","oral","2.2 mg\u002FmL oral solution",{"amount":28,"unit":29,"perVolumeMl":5},2.2,"mg",[16],[32],{"source":33,"section":34},"fda-fintepla","3",[36,71],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":51,"limits":54,"notes":58},"std","dravet-syndrome",{"fa":40,"en":41},"دراوه و لنوکس-گاستو (۲ سال به بالا) — شروع ۰٫۱ mg\u002Fkg دو بار؛ هفتگی تا ۰٫۳۵ mg\u002Fkg دو بار (حداکثر ۲۶ mg\u002Fروز)","Dravet and Lennox-Gastaut (≥2 y) — start 0.1 mg\u002Fkg twice daily; weekly up to 0.35 mg\u002Fkg twice daily (max 26 mg\u002Fday)",{"minAge":43},{"value":44,"unit":45},2,"year","weightBased",{"perKgPerDose":48,"perKgPerDoseMax":49,"intervalHours":50},0.1,0.35,12,[52],{"source":33,"section":53},"2.2",{"maxPerDay":55,"refs":56},26,[57],{"source":33,"section":53},[59],{"text":60,"refs":63},{"fa":61,"en":62},"با استیری‌پنتول + کلوبازام: حداکثر ۰٫۲ mg\u002Fkg دو بار (۱۷ mg\u002Fروز). مهارکننده قوی CYP1A2\u002F2D6: حداکثر ۲۰ mg\u002Fروز (۱۷ با استیری‌پنتول). نارسایی کبد طبق جدول ۲. اکوکاردیوگرافی پیش، هر ۶ ماه و پس از درمان.","With stiripentol + clobazam: max 0.2 mg\u002Fkg twice daily (17 mg\u002Fday). Strong CYP1A2\u002F2D6 inhibitors: max 20 mg\u002Fday (17 with stiripentol). Hepatic impairment per Table 2. Echocardiogram before, every 6 months and after.",[64,65,67,69],{"source":33,"section":53},{"source":33,"section":66},"2.3",{"source":33,"section":68},"2.5",{"source":33,"section":70},"2.6",{"id":72,"disease":73,"label":74,"population":77,"type":46,"unit":29,"dose":79,"refs":80,"limits":82},"lgs","lennox-gastaut",{"fa":75,"en":76},"لنوکس-گاستو (۲ سال به بالا) — شروع ۰٫۱ mg\u002Fkg دو بار؛ نگهدارنده ۰٫۳۵ mg\u002Fkg دو بار (حداکثر ۲۶ mg\u002Fروز)","Lennox-Gastaut (≥2 y) — start 0.1 mg\u002Fkg twice daily; maintenance 0.35 mg\u002Fkg twice daily (max 26 mg\u002Fday)",{"minAge":78},{"value":44,"unit":45},{"perKgPerDose":48,"perKgPerDoseMax":49,"intervalHours":50},[81],{"source":33,"section":53},{"maxPerDay":55,"refs":83},[84],{"source":33,"section":53},[86],{"id":87,"severity":88,"text":89,"refs":92},"ci","block",{"fa":90,"en":91},"حساسیت به فن‌فلورامین؛ مهارکننده MAO همزمان یا ظرف ۱۴ روز (سندرم سروتونین).","Hypersensitivity to fenfluramine; MAOIs concomitantly or within 14 days (serotonin syndrome).",[93],{"source":33,"section":94},"4",[96,103],{"text":97,"refs":100},{"fa":98,"en":99},"هشدار جعبه‌ای: بیماری دریچه قلب و فشار خون شریانی ریوی — اکو اجباری؛ فقط از طریق برنامه REMS.","Boxed warning: valvular heart disease and pulmonary arterial hypertension — echocardiograms required; available only through a REMS.",[101],{"source":33,"section":102},"Boxed Warning",{"text":104,"refs":107},{"fa":105,"en":106},"کاهش اشتها و وزن؛ خواب‌آلودگی؛ افکار خودکشی؛ سندرم سروتونین؛ افزایش فشار خون؛ گلوکوم.","Decreased appetite and weight; somnolence; suicidal thoughts; serotonin syndrome; increased blood pressure; glaucoma.",[108],{"source":33,"section":109},"5",[111],{"egfrBelow":112,"severity":113,"text":114,"refs":117},30,"warn",{"fa":115,"en":116},"eGFR ۱۵ تا ۲۹: حداکثر ۲۰ mg\u002Fروز (۱۷ با استیری‌پنتول + کلوبازام).","eGFR 15–29: max 20 mg\u002Fday (17 with stiripentol + clobazam).",[118],{"source":33,"section":119},"2.4",[],[],{"status":123,"reviewer":124,"date":124},"unverified",null,[126,133],{"regimen":37,"formulation":23,"input":127,"expect":130},{"ageYears":128,"weightKg":129},6,20,{"perDose":44,"mlPerDose":131,"upperPerDose":132},0.91,7,{"regimen":72,"formulation":23,"input":134,"expect":135},{"ageYears":128,"weightKg":129},{"perDose":44,"mlPerDose":131,"upperPerDose":132},[137],"N03AX26",{"status":139,"forms":140,"refs":145},"registered",[141],{"code":142,"en":143,"fa":144},"00529","FENFLURAMINE HCL 20MG TAB","قرص فنفلورامین هیدروکلراید ۲۰ میلی‌گرم",[146],{"source":147,"section":148,"url":149},"darooyab-generic","G-3384\u002FFenfluramine","https:\u002F\u002Fwww.darooyab.ir\u002FG-3384\u002FFenfluramine",{"kind":151,"refs":152,"id":155},"NDA",[153],{"source":33,"section":154},"SPL approval \u002F marketing category","NDA212102",[157,160,164,167,170],{"kind":158,"url":159,"label":155},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=212102",{"kind":161,"url":162,"label":163},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e88f360e-33ad-4cd6-b2de-5ef885857c5d","FDA Fintepla",{"kind":165,"url":166,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa620045.html",{"kind":168,"url":169,"label":137},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N03AX26",{"kind":171,"url":149,"label":8},"darooyab",{"pregnancy":173,"lactation":182,"pediatric":190,"geriatric":198,"reproductive":206},{"level":174,"text":175,"quote":178,"refs":179},"caution",{"fa":176,"en":177},"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 data on FINTEPLA use in pregnant women.",[180],{"source":33,"section":181},"8.1",{"level":174,"text":183,"quote":186,"refs":187},{"fa":184,"en":185},"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 fenfluramine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.",[188],{"source":33,"section":189},"8.2",{"level":174,"text":191,"quote":194,"refs":195},{"fa":192,"en":193},"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 FINTEPLA for the treatment of seizures associated with DS and LGS have been established in patients 2 years of age and older.",[196],{"source":33,"section":197},"8.4",{"level":174,"text":199,"quote":202,"refs":203},{"fa":200,"en":201},"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.",[204],{"source":33,"section":205},"8.5",{"level":174,"text":207,"quote":210,"refs":211},{"fa":208,"en":209},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Infertility In animal studies, oral administration of fenfluramine resulted in adverse reproductive effects in males and females at clinically relevant doses in the presence of parental toxicity [see Nonclinical Toxicology (13.1) ] .",[212],{"source":33,"section":213},"8.3",1792191543805]