[{"data":1,"prerenderedAt":174},["ShallowReactive",2],{"drug-zuranolone":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":19,"regimens":50,"contraindications":80,"warnings":81,"renal":89,"monitoring":90,"interactions":91,"review":92,"examples":95,"atc":101,"iran":103,"links":110,"populations":125,"usApproval":169},"zuranolone",1,{"fa":7,"en":8},"زورانولون","Zuranolone","nervous-system",{"fa":11,"en":12},"تعدیل‌کننده گیرنده GABA-A (ضدافسردگی پس از زایمان)","GABA-A receptor modulator (postpartum depression)",[14],{"name":15,"market":16},"Zurzuvae","US",[18,7],"zurzuvae",[20,34,42],{"id":21,"form":22,"route":23,"label":24,"concentration":25,"markets":29,"refs":30},"cap-20","capsule","oral","20 mg capsule",{"amount":26,"unit":27,"perUnit":22,"scored":28},20,"mg",false,[16],[31],{"source":32,"section":33},"fda-zurzuvae","3",{"id":35,"form":22,"route":23,"label":36,"concentration":37,"markets":39,"refs":40},"cap-25","25 mg capsule",{"amount":38,"unit":27,"perUnit":22,"scored":28},25,[16],[41],{"source":32,"section":33},{"id":43,"form":22,"route":23,"label":44,"concentration":45,"markets":47,"refs":48},"cap-30","30 mg capsule",{"amount":46,"unit":27,"perUnit":22,"scored":28},30,[16],[49],{"source":32,"section":33},[51],{"id":52,"disease":53,"label":54,"population":57,"type":61,"unit":27,"dose":62,"refs":64,"durationDays":67,"notes":69},"ppd","postpartum-depression",{"fa":55,"en":56},"افسردگی پس از زایمان — ۵۰ mg شب‌ها با غذای چرب، ۱۴ روز","Postpartum depression — 50 mg every evening with fatty food, 14 days",{"minAge":58},{"value":59,"unit":60},18,"year","fixed",{"perDose":63,"dosesPerDay":5},50,[65],{"source":32,"section":66},"2.1",{"min":68,"max":68},14,[70],{"text":71,"refs":74},{"fa":72,"en":73},"اگر عوارض سرکوب CNS: ۴۰ mg. نارسایی شدید کبد (Child-Pugh C) یا eGFR زیر ۶۰: ۳۰ mg. بیش از ۱۴ روز بررسی نشده.","If CNS depressant effects: 40 mg. Severe hepatic impairment (Child-Pugh C) or eGFR \u003C60: 30 mg. Not studied beyond 14 days.",[75,76,78],{"source":32,"section":66},{"source":32,"section":77},"2.3",{"source":32,"section":79},"2.4",[],[82],{"text":83,"refs":86},{"fa":84,"en":85},"هشدار جعبه‌ای: اختلال رانندگی — تا ۱۲ ساعت پس از هر دوز در طول ۱۴ روز رانندگی یا کار خطرناک نکند.","Boxed warning: impaired driving — no driving or hazardous activity until at least 12 h after each dose during the 14 days.",[87],{"source":32,"section":88},"Boxed Warning",[],[],[],{"status":93,"reviewer":94,"date":94},"unverified",null,[96],{"regimen":52,"formulation":35,"input":97,"expect":99},{"ageYears":46,"weightKg":98},65,{"perDose":63,"tabletsPerDoseRounded":100},2,[102],"N06AX31",{"status":104,"refs":105},"not-found",[106],{"source":107,"section":108,"url":109},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Zuranolone",[111,115,119,122],{"kind":112,"url":113,"label":114},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=217369","NDA217369",{"kind":116,"url":117,"label":118},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f18e53b0-d0bb-422d-8de7-ab64b7292b29","FDA Zurzuvae",{"kind":120,"url":121,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa623048.html",{"kind":123,"url":124,"label":102},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N06AX31",{"pregnancy":126,"lactation":135,"pediatric":144,"geriatric":153,"reproductive":161},{"level":127,"text":128,"quote":131,"refs":132},"avoid",{"fa":129,"en":130},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","… ntalhealth.org\u002Fresearch\u002Fpregnancyregistry\u002Fantidepressants\u002F Risk Summary Based on findings from animal studies, ZURZUVAE may cause fetal harm.",[133],{"source":32,"section":134},"8.1",{"level":136,"text":137,"quote":140,"refs":141},"caution",{"fa":138,"en":139},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk (see Data ).",[142],{"source":32,"section":143},"8.2",{"level":145,"text":146,"quote":149,"refs":150},"not-established",{"fa":147,"en":148},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of ZURZUVAE in pediatric patients have not been established.",[151],{"source":32,"section":152},"8.4",{"level":136,"text":154,"quote":157,"refs":158},{"fa":155,"en":156},"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.","PPD is a condition associated with pregnancy; there is no geriatric experience with ZURZUVAE in patients with PPD.",[159],{"source":32,"section":160},"8.5",{"level":136,"text":162,"quote":165,"refs":166},{"fa":163,"en":164},"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 Advise female patients of reproductive potential to use effective contraception during treatment with ZURZUVAE and for 1 week after the final dose.",[167],{"source":32,"section":168},"8.3",{"kind":170,"refs":171,"id":114},"NDA",[172],{"source":32,"section":173},"SPL approval \u002F marketing category",1792111472018]