[{"data":1,"prerenderedAt":167},["ShallowReactive",2],{"drug-ramelteon":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":65,"warnings":75,"renal":83,"monitoring":84,"interactions":85,"review":86,"examples":89,"atc":95,"iran":97,"usApproval":109,"links":115,"populations":131},"ramelteon",1,{"fa":7,"en":8},"راملتئون","Ramelteon","nervous-system",{"fa":11,"en":12},"آگونیست گیرنده ملاتونین","Melatonin receptor agonist",[14],{"name":15,"market":16},"Rozerem","US",[18,19,7],"rozerem","روزرم",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-8","tablet","oral","8 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},8,"mg",false,[16],[32],{"source":33,"section":34},"fda-rozerem","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":28,"dose":47,"refs":48,"limits":51,"notes":54},"ins","insomnia",{"fa":40,"en":41},"بی‌خوابی (دشواری به خواب رفتن) بزرگسال — ۸ mg ظرف ۳۰ دقیقه پیش از خواب","Insomnia (sleep onset), adults — 8 mg within 30 min of going to bed",{"minAge":43},{"value":44,"unit":45},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[49],{"source":33,"section":50},"2.1",{"maxPerDay":27,"refs":52},[53],{"source":33,"section":50},[55],{"text":56,"refs":59},{"fa":57,"en":58},"نه با غذای پرچرب. نارسایی شدید کبد توصیه نمی‌شود. با مهارکننده‌های CYP1A2 احتیاط.","Not with a high-fat meal. Not recommended in severe hepatic impairment. Caution with CYP1A2 inhibitors.",[60,61,63],{"source":33,"section":50},{"source":33,"section":62},"2.2",{"source":33,"section":64},"2.3",[66],{"id":67,"severity":68,"text":69,"refs":72},"ci","block",{"fa":70,"en":71},"سابقه آنژیوادم با راملتئون؛ فلووکسامین همزمان.","History of angioedema with ramelteon; concomitant fluvoxamine.",[73],{"source":33,"section":74},"4",[76],{"text":77,"refs":80},{"fa":78,"en":79},"آنافیلاکسی و آنژیوادم؛ تفکر و رفتار غیرطبیعی؛ اثرات تولیدمثلی (پرولاکتین، تستوسترون).","Anaphylaxis and angioedema; abnormal thinking and behaviour; reproductive effects (prolactin, testosterone).",[81],{"source":33,"section":82},"5",[],[],[],{"status":87,"reviewer":88,"date":88},"unverified",null,[90],{"regimen":37,"formulation":22,"input":91,"expect":94},{"ageYears":92,"weightKg":93},40,70,{"perDose":27,"tabletsPerDoseRounded":5},[96],"N05CH02",{"status":98,"forms":99,"refs":104},"registered",[100],{"code":101,"en":102,"fa":103},"53509","RAMELTEON TABLET ORAL 8 mg","قرص راملتون ۸ میلی‌گرم",[105],{"source":106,"section":107,"url":108},"darooyab-generic","G-5319\u002FRamelteon","https:\u002F\u002Fwww.darooyab.ir\u002FG-5319\u002FRamelteon",{"kind":110,"refs":111,"id":114},"NDA",[112],{"source":33,"section":113},"SPL approval \u002F marketing category","NDA021782",[116,119,123,126,129],{"kind":117,"url":118,"label":114},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021782",{"kind":120,"url":121,"label":122},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=9de82310-70e8-47b9-b1fc-6c6848b99455","FDA Rozerem",{"kind":124,"url":125,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605038.html",{"kind":127,"url":128,"label":96},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N05CH02",{"kind":130,"url":108,"label":8},"darooyab",{"pregnancy":132,"lactation":141,"pediatric":149,"geriatric":158},{"level":133,"text":134,"quote":137,"refs":138},"caution",{"fa":135,"en":136},"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 data from postmarketing reports with ROZEREM use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",[139],{"source":33,"section":140},"8.1",{"level":133,"text":142,"quote":145,"refs":146},{"fa":143,"en":144},"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 regarding the presence of ramelteon or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.",[147],{"source":33,"section":148},"8.2",{"level":150,"text":151,"quote":154,"refs":155},"not-established",{"fa":152,"en":153},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of ROZEREM in pediatric patients have not been established.",[156],{"source":33,"section":157},"8.4",{"level":159,"text":160,"quote":163,"refs":164},"ok",{"fa":161,"en":162},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety or efficacy were observed between elderly and younger adult subjects.",[165],{"source":33,"section":166},"8.5",1792191563899]