[{"data":1,"prerenderedAt":238},["ShallowReactive",2],{"drug-tacrolimus-ointment":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":42,"contraindications":72,"warnings":92,"renal":100,"monitoring":101,"interactions":102,"review":103,"examples":106,"atc":117,"iran":119,"links":179,"populations":198,"usApproval":233},"tacrolimus-ointment",1,{"fa":7,"en":8},"پماد تاکرولیموس","Tacrolimus ointment","dermatology",{"fa":11,"en":12},"مهارکننده کلسی‌نورین موضعی","Topical calcineurin inhibitor",[14],{"name":15,"market":16},"Protopic","US",[18,19,20,21],"protopic","پروتوپیک","تاکرولیموس پماد","اگزما",[23,35],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":30,"refs":31},"oint-0-03","ointment","topical","0.03% ointment",{"amount":5,"unit":29,"perUnit":29},"application",[16],[32],{"source":33,"section":34},"fda-tacrolimusoint","How Supplied",{"id":36,"form":25,"route":26,"label":37,"concentration":38,"markets":39,"refs":40},"oint-0-1","0.1% ointment",{"amount":5,"unit":29,"perUnit":29},[16],[41],{"source":33,"section":34},[43,59],{"id":44,"disease":45,"label":46,"population":49,"type":53,"unit":29,"dose":54,"refs":56},"adult","atopic-dermatitis",{"fa":47,"en":48},"درماتیت آتوپیک — بزرگسال: ۰٫۰۳٪ یا ۰٫۱٪ لایه نازک دو بار در روز","Atopic dermatitis — adult: 0.03% or 0.1% thin layer twice daily",{"minAge":50},{"value":51,"unit":52},16,"year","fixed",{"perDose":5,"dosesPerDay":55},2,[57],{"source":33,"section":58},"Dosage and Administration — Adult",{"id":60,"disease":45,"label":61,"population":64,"type":53,"unit":29,"dose":67,"refs":68,"allowedFormulations":71},"child",{"fa":62,"en":63},"درماتیت آتوپیک — ۲ تا ۱۵ سال: فقط ۰٫۰۳٪ دو بار در روز","Atopic dermatitis — 2–15 y: 0.03% only, twice daily",{"minAge":65,"maxAge":66},{"value":55,"unit":52},{"value":51,"unit":52},{"perDose":5,"dosesPerDay":55},[69],{"source":33,"section":70},"Dosage and Administration — Pediatric",[24],[73,82],{"id":74,"severity":75,"text":76,"refs":79},"hyper","block",{"fa":77,"en":78},"حساسیت به تاکرولیموس.","Hypersensitivity to tacrolimus.",[80],{"source":33,"section":81},"Contraindications",{"id":83,"severity":75,"rule":84,"text":86,"refs":89},"lt2",{"maxAge":85},{"value":55,"unit":52},{"fa":87,"en":88},"برای کودکان زیر ۲ سال اندیکاسیون ندارد.","Not indicated for children under 2.",[90],{"source":33,"section":91},"Indications and Usage",[93],{"text":94,"refs":97},{"fa":95,"en":96},"هشدار جعبه‌ای: گزارش‌های نادر بدخیمی (پوست و لنفوم)؛ مصرف طولانی مداوم پرهیز؛ فقط در درمان خط دوم.","Boxed warning: rare reports of malignancy (skin and lymphoma); avoid long-term continuous use; second-line only.",[98],{"source":33,"section":99},"Boxed Warning",[],[],[],{"status":104,"reviewer":105,"date":105},"unverified",null,[107,112],{"regimen":44,"formulation":36,"input":108,"expect":111},{"ageYears":109,"weightKg":110},30,70,{"perDose":5},{"regimen":60,"formulation":24,"input":113,"expect":116},{"ageYears":114,"weightKg":115},6,20,{"perDose":5},[118],"D11AH01",{"status":120,"forms":121,"refs":174},"registered",[122,126,130,134,138,142,146,150,154,158,162,166,170],{"code":123,"en":124,"fa":125},"18952","TACROLIMUS 0.03% 10G OINT","پماد تاکرولیموس ۰٫۰۳ درصد ۱۰ گرم",{"code":127,"en":128,"fa":129},"11622","TACROLIMUS 0.03% 30G OINT","پماد تاکرولیموس ۰٫۰۳ درصد ۳۰ گرم",{"code":131,"en":132,"fa":133},"08131","TACROLIMUS 0.03% 60G OINT","پماد تاکرولیموس ۰٫۰۳ درصد ۶۰ گرم",{"code":135,"en":136,"fa":137},"08187","TACROLIMUS 0.1% 10G OINT","پماد تاکرولیموس ۰٫۱ درصد ۱۰ گرم",{"code":139,"en":140,"fa":141},"06599","TACROLIMUS 0.1% 30G OINT","پماد تاکرولیموس ۰٫۱ درصد ۳۰ گرم",{"code":143,"en":144,"fa":145},"05804","TACROLIMUS 0.5MG CAP","کپسول تاکرولیموس ۰٫۵ میلی‌گرم",{"code":147,"en":148,"fa":149},"02083","TACROLIMUS 1MG CAP","کپسول تاکرولیموس ۱ میلی‌گرم",{"code":151,"en":152,"fa":153},"02084","TACROLIMUS 5MG CAP","کپسول تاکرولیموس ۵ میلی‌گرم",{"code":155,"en":156,"fa":157},"02087","TACROLIMUS 5MG\u002FML FOR INFU","محلول انفوزیون تاکرولیموس ۵ میلی‌گرم \u002F میلی‌لیتر",{"code":159,"en":160,"fa":161},"50539","TACROLIMUS 3MG CAP","کپسول تاکرولیموس ۳ میلی‌گرم",{"code":163,"en":164,"fa":165},"52291","TACROLIMUS CAPSULE, EXTENDED RELEASE ORAL 0.5 mg","کپسول آهسته‌رهش تاکرولیموس ۰٫۵ میلی‌گرم",{"code":167,"en":168,"fa":169},"52332","TACROLIMUS CAPSULE, EXTENDED RELEASE ORAL 1 mg","کپسول آهسته‌رهش تاکرولیموس ۱ میلی‌گرم",{"code":171,"en":172,"fa":173},"52333","TACROLIMUS CAPSULE, EXTENDED RELEASE ORAL 5 mg","کپسول آهسته‌رهش تاکرولیموس ۵ میلی‌گرم",[175],{"source":176,"section":177,"url":178},"darooyab-generic","G-2744\u002FTacrolimus","https:\u002F\u002Fwww.darooyab.ir\u002FG-2744\u002FTacrolimus",[180,184,188,192,195],{"kind":181,"url":182,"label":183},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=210393","ANDA210393",{"kind":185,"url":186,"label":187},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c2d2e3a1-f346-4245-b445-6dd44e371180","FDA Tacrolimus oint.",{"kind":189,"url":190,"label":191},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa602020.html","Tacrolimus Topical",{"kind":193,"url":194,"label":118},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D11AH01",{"kind":196,"url":178,"label":197},"darooyab","Tacrolimus",{"pregnancy":199,"lactation":208,"pediatric":217,"geriatric":225},{"level":200,"text":201,"quote":204,"refs":205},"caution",{"fa":202,"en":203},"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.","",[206],{"source":33,"section":207},"Pregnancy",{"level":209,"text":210,"quote":213,"refs":214},"avoid",{"fa":211,"en":212},"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 tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.",[215],{"source":33,"section":216},"Nursing Mothers",{"level":200,"text":218,"quote":221,"refs":222},{"fa":219,"en":220},"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.","Since the safety and efficacy of tacrolimus ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.",[223],{"source":33,"section":224},"Pediatric Use",{"level":200,"text":226,"quote":229,"refs":230},{"fa":227,"en":228},"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.","Four hundred and four (404) patients ≥ 65 years old received tacrolimus ointment in phase 3 studies.",[231],{"source":33,"section":232},"Geriatric Use",{"kind":234,"refs":235,"id":183},"ANDA",[236],{"source":33,"section":237},"SPL approval \u002F marketing category",1792092045004]