[{"data":1,"prerenderedAt":203},["ShallowReactive",2],{"drug-hydroxyurea":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":37,"contraindications":91,"warnings":101,"renal":109,"monitoring":110,"interactions":111,"review":112,"examples":115,"atc":128,"iran":130,"links":146,"populations":163,"usApproval":198},"hydroxyurea",1,{"fa":7,"en":8},"هیدروکسی‌اوره","Hydroxyurea","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌متابولیت","Antimetabolite",[14],{"name":15,"market":16},"Siklos","US",[18,19,20,21],"siklos","hydrea","هیدروکسی اوره","هیدرآ",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":32,"refs":33},"tab-100","tablet","oral","100 mg tablet (scored)",{"amount":29,"unit":30,"perUnit":25,"scored":31},100,"mg",true,[16],[34],{"source":35,"section":36},"fda-siklos","3",[38,67],{"id":39,"disease":40,"label":41,"population":44,"type":48,"unit":30,"dose":49,"refs":51,"limits":54,"notes":58},"adult","sickle-cell",{"fa":42,"en":43},"کم‌خونی داسی‌شکل — بزرگسال: شروع ۱۵ mg\u002Fkg یک بار در روز","Sickle cell anaemia — adult: start 15 mg\u002Fkg once daily",{"minAge":45},{"value":46,"unit":47},18,"year","weightBased",{"perKgPerDay":50,"dividedDoses":5},15,[52],{"source":35,"section":53},"2.1, Table 1",{"maxPerKgPerDay":55,"refs":56},35,[57],{"source":35,"section":53},[59],{"text":60,"refs":63},{"fa":61,"en":62},"بر اساس وزن واقعی یا ایده‌آل (هر کدام کمتر). شمارش خون هر ۲ هفته؛ هر ۸ هفته ۵ mg\u002Fkg افزایش تا حداکثر ۳۵ mg\u002Fkg. CrCl زیر ۶۰: نصف دوز.","Use actual or ideal weight, whichever is less. Blood count every 2 weeks; increase 5 mg\u002Fkg every 8 weeks up to 35 mg\u002Fkg. CrCl \u003C60: half dose.",[64,65],{"source":35,"section":53},{"source":35,"section":66},"2.2",{"id":68,"disease":40,"label":69,"population":72,"type":48,"unit":30,"dose":76,"refs":78,"limits":80,"notes":83},"child",{"fa":70,"en":71},"کم‌خونی داسی‌شکل — کودک ۲ سال به بالا: شروع ۲۰ mg\u002Fkg یک بار در روز","Sickle cell anaemia — child ≥2 y: start 20 mg\u002Fkg once daily",{"minAge":73,"maxAge":75},{"value":74,"unit":47},2,{"value":46,"unit":47},{"perKgPerDay":77,"dividedDoses":5},20,[79],{"source":35,"section":53},{"maxPerKgPerDay":55,"refs":81},[82],{"source":35,"section":53},[84],{"text":85,"refs":88},{"fa":86,"en":87},"شمارش خون هر ۲ هفته؛ هر ۸ هفته ۵ mg\u002Fkg افزایش تا حداکثر ۳۵ mg\u002Fkg. CrCl زیر ۶۰: ۱۰ mg\u002Fkg.","Blood count every 2 weeks; increase 5 mg\u002Fkg every 8 weeks up to 35 mg\u002Fkg. CrCl \u003C60: 10 mg\u002Fkg.",[89,90],{"source":35,"section":53},{"source":35,"section":66},[92],{"id":93,"severity":94,"text":95,"refs":98},"hyper","block",{"fa":96,"en":97},"حساسیت به هیدروکسی‌اوره.","Hypersensitivity to hydroxyurea.",[99],{"source":35,"section":100},"4",[102],{"text":103,"refs":106},{"fa":104,"en":105},"هشدار جعبه‌ای: سرکوب مغز استخوان و بدخیمی؛ شمارش خون مکرر و محافظت از آفتاب.","Boxed warning: myelosuppression and malignancies; frequent blood counts and sun protection.",[107],{"source":35,"section":108},"Boxed Warning",[],[],[],{"status":113,"reviewer":114,"date":114},"unverified",null,[116,122],{"regimen":39,"formulation":24,"input":117,"expect":120},{"ageYears":118,"weightKg":119},30,70,{"perDose":121},1050,{"regimen":68,"formulation":24,"input":123,"expect":125},{"ageYears":124,"weightKg":77},6,{"perDose":126,"tabletsPerDoseRounded":127},400,4,[129],"L01XX05",{"status":131,"forms":132,"refs":141},"registered",[133,137],{"code":134,"en":135,"fa":136},"16887","HYDROXYCARBAMIDE 500MG CAP","کپسول هیدروکسیکاربامید ۵۰۰ میلی‌گرم",{"code":138,"en":139,"fa":140},"00648","HYDROXYUREA 500MG CAP","کپسول هیدروکسی‌اوره ۵۰۰ میلی‌گرم",[142],{"source":143,"section":144,"url":145},"darooyab-generic","G-1012\u002FHydroxyurea","https:\u002F\u002Fwww.darooyab.ir\u002FG-1012\u002FHydroxyurea",[147,151,155,158,161],{"kind":148,"url":149,"label":150},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208843","NDA208843",{"kind":152,"url":153,"label":154},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=76957c0d-0f98-4376-bb06-eee651adc09d","FDA Siklos",{"kind":156,"url":157,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa682004.html",{"kind":159,"url":160,"label":129},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01XX05",{"kind":162,"url":145,"label":8},"darooyab",{"pregnancy":164,"lactation":173,"pediatric":181,"reproductive":190},{"level":165,"text":166,"quote":169,"refs":170},"avoid",{"fa":167,"en":168},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary SIKLOS can cause fetal harm based on findings from animal studies and the drug's mechanism of action [see Clinical Pharmacology (12.1) ] .",[171],{"source":35,"section":172},"8.1",{"level":165,"text":174,"quote":177,"refs":178},{"fa":175,"en":176},"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 a breastfed child from SIKLOS, including carcinogenicity, advise patients not to breastfeed during treatment with SIKLOS.",[179],{"source":35,"section":180},"8.2",{"level":182,"text":183,"quote":186,"refs":187},"caution",{"fa":184,"en":185},"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 SIKLOS have been established in pediatric patients aged 2-18 years with sickle cell anemia with recurrent moderate to severe painful crises.",[188],{"source":35,"section":189},"8.4",{"level":182,"text":191,"quote":194,"refs":195},{"fa":192,"en":193},"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 Females Advise females of reproductive potential to use effective contraception during and after treatment with SIKLOS for at least 6 months after therapy.",[196],{"source":35,"section":197},"8.3",{"kind":199,"refs":200,"id":150},"NDA",[201],{"source":35,"section":202},"SPL approval \u002F marketing category",1792111456597]