[{"data":1,"prerenderedAt":174},["ShallowReactive",2],{"drug-pitolisant":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":73,"warnings":83,"renal":91,"monitoring":92,"interactions":93,"review":94,"examples":97,"atc":103,"iran":105,"usApproval":112,"links":118,"populations":132},"pitolisant",1,{"fa":7,"en":8},"پیتولیسانت","Pitolisant","nervous-system",{"fa":11,"en":12},"آنتاگونیست\u002Fآگونیست معکوس H3","H3 antagonist\u002Finverse agonist",[14],{"name":15,"market":16},"Wakix","US",[18,19,7],"wakix","واکیکس",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-17","tablet","oral","17.8 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},17.8,"mg",false,[16],[32],{"source":33,"section":34},"fda-wakix","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-4","4.45 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},4.45,[16],[42],{"source":33,"section":34},[44],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":57,"notes":60},"narco","narcolepsy",{"fa":48,"en":49},"خواب‌آلودگی روزانه یا کاتاپلکسی در نارکولپسی — بزرگسال ۱۷٫۸ تا ۳۵٫۶ mg صبح","Daytime sleepiness or cataplexy in narcolepsy — adult 17.8–35.6 mg in the morning",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":27,"perDoseMax":56,"dosesPerDay":5},35.6,[58],{"source":33,"section":59},"2.2",[61],{"text":62,"refs":65},{"fa":63,"en":64},"هفته ۱: ۸٫۹ mg؛ هفته ۲: ۱۷٫۸؛ هفته ۳: تا ۳۵٫۶ mg. eGFR زیر ۶۰، نارسایی متوسط کبد یا متابولیزر ضعیف CYP2D6: حداکثر ۱۷٫۸ mg.","Week 1: 8.9 mg; week 2: 17.8; week 3: up to 35.6 mg. eGFR \u003C60, moderate hepatic impairment or CYP2D6 poor metabolisers: max 17.8 mg.",[66,67,69,71],{"source":33,"section":59},{"source":33,"section":68},"2.4",{"source":33,"section":70},"2.5",{"source":33,"section":72},"2.7",[74],{"id":75,"severity":76,"text":77,"refs":80},"ci","block",{"fa":78,"en":79},"حساسیت به پیتولیسانت؛ نارسایی شدید کبد.","Hypersensitivity to pitolisant; severe hepatic impairment.",[81],{"source":33,"section":82},"4",[84],{"text":85,"refs":88},{"fa":86,"en":87},"طولانی شدن QT — با سایر داروهای افزاینده QT پرهیز.","QT prolongation — avoid with other QT-prolonging drugs.",[89],{"source":33,"section":90},"5",[],[],[],{"status":95,"reviewer":96,"date":96},"unverified",null,[98],{"regimen":45,"formulation":22,"input":99,"expect":102},{"ageYears":100,"weightKg":101},30,70,{"perDose":27,"tabletsPerDoseRounded":5,"upperPerDose":56},[104],"N07XX11",{"status":106,"refs":107},"not-found",[108],{"source":109,"section":110,"url":111},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Pitolisant",{"kind":113,"refs":114,"id":117},"NDA",[115],{"source":33,"section":116},"SPL approval \u002F marketing category","NDA211150",[119,122,126,129],{"kind":120,"url":121,"label":117},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=211150",{"kind":123,"url":124,"label":125},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=8daa5562-824e-476c-9652-26ceef3d4b0e","FDA Wakix",{"kind":127,"url":128,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619055.html",{"kind":130,"url":131,"label":104},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N07XX11",{"pregnancy":133,"lactation":142,"pediatric":150,"geriatric":158,"reproductive":166},{"level":134,"text":135,"quote":138,"refs":139},"caution",{"fa":136,"en":137},"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 Available case reports from clinical trials and postmarketing reports with WAKIX use in pregnant women have not determined a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",[140],{"source":33,"section":141},"8.1",{"level":134,"text":143,"quote":146,"refs":147},{"fa":144,"en":145},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary The transfer of pitolisant into breastmilk is low based on data from a lactation study.",[148],{"source":33,"section":149},"8.2",{"level":134,"text":151,"quote":154,"refs":155},{"fa":152,"en":153},"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 WAKIX have been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients 6 years of age and older with narcolepsy.",[156],{"source":33,"section":157},"8.4",{"level":134,"text":159,"quote":162,"refs":163},{"fa":160,"en":161},"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, and cardiac function, concomitant diseases, and other drug therapy.",[164],{"source":33,"section":165},"8.5",{"level":134,"text":167,"quote":170,"refs":171},{"fa":168,"en":169},"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 WAKIX may reduce the effectiveness of hormonal contraceptives.",[172],{"source":33,"section":173},"8.3",1792156191889]