[{"data":1,"prerenderedAt":216},["ShallowReactive",2],{"drug-isotretinoin":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":20,"formulations":25,"regimens":56,"contraindications":83,"warnings":102,"renal":109,"monitoring":110,"interactions":111,"review":112,"examples":115,"atc":121,"iran":123,"links":151,"populations":168,"usApproval":211},"isotretinoin",1,{"fa":7,"en":8},"ایزوترتینوئین (راکوتان)","Isotretinoin","dermatology",{"fa":11,"en":12},"رتینوئید خوراکی","Oral retinoid",[14,17],{"name":15,"market":16},"Accutane","US",{"name":18,"market":19},"Roaccutane","GB",[21,22,23,24],"roaccutane","accutane","راکوتان","ایزوترتینوئین",[26,40,48],{"id":27,"form":28,"route":29,"label":30,"concentration":31,"markets":35,"refs":36},"cap-10","capsule","oral","10 mg capsule",{"amount":32,"unit":33,"perUnit":28,"scored":34},10,"mg",false,[16],[37],{"source":38,"section":39},"fda-isotretinoin","3",{"id":41,"form":28,"route":29,"label":42,"concentration":43,"markets":45,"refs":46},"cap-20","20 mg capsule",{"amount":44,"unit":33,"perUnit":28,"scored":34},20,[16],[47],{"source":38,"section":39},{"id":49,"form":28,"route":29,"label":50,"concentration":51,"markets":53,"refs":54},"cap-40","40 mg capsule",{"amount":52,"unit":33,"perUnit":28,"scored":34},40,[16],[55],{"source":38,"section":39},[57],{"id":58,"disease":59,"label":60,"population":63,"type":67,"unit":33,"dose":68,"refs":71,"notes":74},"acne","severe-acne",{"fa":61,"en":62},"آکنه ندولر شدید مقاوم — ۰٫۵ تا ۱ mg\u002Fkg\u002Fروز در ۲ دوز با غذا (۱۵ تا ۲۰ هفته)","Severe nodular acne — 0.5–1 mg\u002Fkg\u002Fday in 2 doses with food (15–20 weeks)",{"minAge":64},{"value":65,"unit":66},12,"year","weightBased",{"perKgPerDay":69,"perKgPerDayMax":5,"dividedDoses":70},0.5,2,[72],{"source":38,"section":73},"2.1",[75],{"text":76,"refs":79},{"fa":77,"en":78},"بزرگسال با بیماری بسیار شدید تا ۲ mg\u002Fkg\u002Fروز. فقط در برنامه iPLEDGE (آمریکا).","Adults with very severe disease up to 2 mg\u002Fkg\u002Fday. Only within the iPLEDGE programme (US).",[80,81],{"source":38,"section":73},{"source":38,"section":82},"5.2",[84,95],{"id":85,"severity":86,"text":87,"refs":90},"preg","block",{"fa":88,"en":89},"بارداری — ناهنجاری شدید جنین. دو روش پیشگیری و تست بارداری لازم است.","Pregnancy — severe birth defects. Two forms of contraception and pregnancy tests required.",[91,93],{"source":38,"section":92},"4",{"source":38,"section":94},"Boxed Warning",{"id":96,"severity":86,"text":97,"refs":100},"hyper",{"fa":98,"en":99},"حساسیت به ایزوترتینوئین یا ویتامین A.","Hypersensitivity to isotretinoin or vitamin A.",[101],{"source":38,"section":92},[103],{"text":104,"refs":107},{"fa":105,"en":106},"هشدار جعبه‌ای: سمیت جنینی؛ مصرف در بارداری منع مطلق.","Boxed warning: embryo-fetal toxicity; contraindicated in pregnancy.",[108],{"source":38,"section":94},[],[],[],{"status":113,"reviewer":114,"date":114},"unverified",null,[116],{"regimen":58,"formulation":41,"input":117,"expect":120},{"ageYears":118,"weightKg":119},18,80,{"perDose":44,"tabletsPerDoseRounded":5,"upperPerDose":52},[122],"D10BA01",{"status":124,"forms":125,"refs":146},"registered",[126,130,134,138,142],{"code":127,"en":128,"fa":129},"06184","ISOTRETINOIN 0.05% GEL","ژل ایزوترتینوئین ۰٫۰۵ درصد",{"code":131,"en":132,"fa":133},"12056","ISOTRETINOIN 10MG CAP","کپسول ایزوترتینوئین ۱۰ میلی‌گرم",{"code":135,"en":136,"fa":137},"20711","ISOTRETINOIN 16MG CAP","کپسول ایزوترتینوئین ۱۶ میلی‌گرم",{"code":139,"en":140,"fa":141},"00720","ISOTRETINOIN 20MG CAP","کپسول ایزوترتینوئین ۲۰ میلی‌گرم",{"code":143,"en":144,"fa":145},"53031","ISOTRETINOIN CAPSULE, LIQUID FILLED ORAL 10 mg","کپسول ایزوترتینوئین پرشده ۱۰ میلی‌گرم",[147],{"source":148,"section":149,"url":150},"darooyab-generic","G-2284\u002FIsotretinoin","https:\u002F\u002Fwww.darooyab.ir\u002FG-2284\u002FIsotretinoin",[152,156,160,163,166],{"kind":153,"url":154,"label":155},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=202099","ANDA202099",{"kind":157,"url":158,"label":159},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=27b3cf26-f22e-5b70-1c24-009933b7c6ee","FDA Zenatane",{"kind":161,"url":162,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa681043.html",{"kind":164,"url":165,"label":122},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D10BA01",{"kind":167,"url":150,"label":8},"darooyab",{"pregnancy":169,"lactation":177,"pediatric":186,"geriatric":195,"reproductive":203},{"level":170,"text":171,"quote":174,"refs":175},"contraindicated",{"fa":172,"en":173},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","Zenatane is contraindicated in: Pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].",[176],{"source":38,"section":92},{"level":178,"text":179,"quote":182,"refs":183},"avoid",{"fa":180,"en":181},"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 in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with Zenatane, and for at least 8 days after the last dose of Zenatane.",[184],{"source":38,"section":185},"8.2",{"level":187,"text":188,"quote":191,"refs":192},"caution",{"fa":189,"en":190},"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 Zenatane for the treatment of severe recalcitrant nodular acne have been established in non-pregnant pediatric patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are unresponsive to conventional treatment, including systemic …",[193],{"source":38,"section":194},"8.4",{"level":187,"text":196,"quote":199,"refs":200},{"fa":197,"en":198},"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.","Clinical studies of Zenatane did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.",[201],{"source":38,"section":202},"8.5",{"level":187,"text":204,"quote":207,"refs":208},{"fa":205,"en":206},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","… of Zenatane treatment, AND (2) after the patient has used their chosen pregnancy prevention methods (i.e., two forms of contraception or committed to abstinence) for at least 30 days.",[209],{"source":38,"section":210},"8.3",{"kind":212,"refs":213,"id":155},"ANDA",[214],{"source":38,"section":215},"SPL approval \u002F marketing category",1792092036666]