[{"data":1,"prerenderedAt":180},["ShallowReactive",2],{"drug-dutasteride":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":62,"warnings":72,"renal":80,"monitoring":81,"interactions":82,"review":83,"examples":86,"atc":92,"iran":94,"links":114,"populations":131,"usApproval":175},"dutasteride",1,{"fa":7,"en":8},"دوتاستراید","Dutasteride","genitourinary-sex-hormones",{"fa":11,"en":12},"مهارکننده ۵-آلفا ردوکتاز","5-alpha-reductase inhibitor",[14],{"name":15,"market":16},"Avodart","US",[18,19,7],"avodart","آوودارت",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-05","capsule","oral","0.5 mg soft capsule (swallow whole)",{"amount":27,"unit":28,"perUnit":23,"scored":29},0.5,"mg",false,[16],[32],{"source":33,"section":34},"fda-avodart","3",[36],{"id":37,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":47,"notes":52},"bph",{"fa":39,"en":40},"BPH علامت‌دار — ۰٫۵ mg یک بار در روز (تنها یا همراه تامسولوسین ۰٫۴ mg)","Symptomatic BPH — 0.5 mg once daily (alone or with tamsulosin 0.4 mg)",{"minAge":42},{"value":43,"unit":44},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[48,50],{"source":33,"section":49},"2.1",{"source":33,"section":51},"2.2",[53],{"text":54,"refs":57},{"fa":55,"en":56},"کپسول باز یا جویده نشود (تحریک دهان و حلق). زنان باردار یا احتمال بارداری کپسول را لمس نکنند (جذب پوستی).","Do not open or chew (oropharyngeal irritation). Pregnant women or those who may become pregnant must not handle capsules (skin absorption).",[58,60],{"source":33,"section":59},"2",{"source":33,"section":61},"16",[63],{"id":64,"severity":65,"text":66,"refs":69},"ci","block",{"fa":67,"en":68},"بارداری؛ حساسیت قابل‌توجه به دوتاستراید یا سایر مهارکننده‌های ۵-آلفا ردوکتاز.","Pregnancy; clinically significant hypersensitivity to dutasteride or other 5-alpha-reductase inhibitors.",[70],{"source":33,"section":71},"4",[73],{"text":74,"refs":77},{"fa":75,"en":76},"PSA را حدود ۵۰٪ کاهش می‌دهد؛ افزایش تأییدشده PSA بررسی شود. احتمال افزایش سرطان پروستات درجه بالا. ۶ ماه پس از قطع خون اهدا نشود.","Lowers PSA by about 50%; evaluate any confirmed PSA rise. May increase high-grade prostate cancer. Do not donate blood until 6 months after the last dose.",[78],{"source":33,"section":79},"5",[],[],[],{"status":84,"reviewer":85,"date":85},"unverified",null,[87],{"regimen":37,"formulation":22,"input":88,"expect":91},{"ageYears":89,"weightKg":90},65,75,{"perDose":27,"tabletsPerDoseRounded":5},[93],"G04CB02",{"status":95,"forms":96,"refs":109},"registered",[97,101,105],{"code":98,"en":99,"fa":100},"06735","DUTASTERIDE 0.5MG CAP","کپسول دوتاستراید ۰٫۵ میلی‌گرم",{"code":102,"en":103,"fa":104},"06617","DUTASTERIDE 0.5MG TAB","قرص دوتاستراید ۰٫۵ میلی‌گرم",{"code":106,"en":107,"fa":108},"17497","DUTASTERIDE 15MG TAB","قرص دوتاستراید ۱۵ میلی‌گرم",[110],{"source":111,"section":112,"url":113},"darooyab-generic","G-3248\u002FDutasteride","https:\u002F\u002Fwww.darooyab.ir\u002FG-3248\u002FDutasteride",[115,119,123,126,129],{"kind":116,"url":117,"label":118},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021319","NDA021319",{"kind":120,"url":121,"label":122},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4","FDA Avodart",{"kind":124,"url":125,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa603001.html",{"kind":127,"url":128,"label":93},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=G04CB02",{"kind":130,"url":113,"label":8},"darooyab",{"pregnancy":132,"lactation":140,"pediatric":149,"geriatric":158,"reproductive":167},{"level":133,"text":134,"quote":137,"refs":138},"contraindicated",{"fa":135,"en":136},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","AVODART is contraindicated for use in: • Pregnancy.",[139],{"source":33,"section":71},{"level":141,"text":142,"quote":145,"refs":146},"caution",{"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 AVODART is not indicated for use in women.",[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 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 these subjects and younger subjects.",[165],{"source":33,"section":166},"8.5",{"level":141,"text":168,"quote":171,"refs":172},{"fa":169,"en":170},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Infertility Males: The effects of dutasteride 0.5 mg\u002Fday on semen characteristics were evaluated in normal volunteers aged 18 to 52 years (n = 27 dutasteride, n = 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up.",[173],{"source":33,"section":174},"8.3",{"kind":176,"refs":177,"id":118},"NDA",[178],{"source":33,"section":179},"SPL approval \u002F marketing category",1792115178292]