[{"data":1,"prerenderedAt":224},["ShallowReactive",2],{"drug-thalidomide":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":59,"contraindications":91,"warnings":109,"renal":124,"monitoring":125,"interactions":126,"review":127,"examples":130,"atc":136,"iran":138,"usApproval":158,"links":164,"populations":180},"thalidomide",1,{"fa":7,"en":8},"تالیدومید","Thalidomide","antineoplastic-immunomodulating",{"fa":11,"en":12},"تعدیل‌کننده ایمنی","Immunomodulatory agent",[14],{"name":15,"market":16},"Thalomid","US",[18,19,7],"thalomid","تالومید",[21,35,43,51],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-50","capsule","oral","50 mg capsule",{"amount":27,"unit":28,"perUnit":23,"scored":29},50,"mg",false,[16],[32],{"source":33,"section":34},"fda-thalomid","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"cap-100","100 mg capsule",{"amount":39,"unit":28,"perUnit":23,"scored":29},100,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"cap-150","150 mg capsule",{"amount":47,"unit":28,"perUnit":23,"scored":29},150,[16],[50],{"source":33,"section":34},{"id":52,"form":23,"route":24,"label":53,"concentration":54,"markets":56,"refs":57},"cap-200","200 mg capsule",{"amount":55,"unit":28,"perUnit":23,"scored":29},200,[16],[58],{"source":33,"section":34},[60],{"id":61,"disease":62,"label":63,"population":66,"type":70,"unit":28,"dose":71,"refs":72,"notes":75},"mm","multiple-myeloma",{"fa":64,"en":65},"مولتیپل میلوما تازه (با دگزامتازون) — ۲۰۰ mg یک بار در روز (شب)","Newly diagnosed multiple myeloma (with dexamethasone) — 200 mg once daily (bedtime)",{"minAge":67},{"value":68,"unit":69},18,"year","fixed",{"perDose":55,"dosesPerDay":5},[73],{"source":33,"section":74},"2.2",[76,82],{"text":77,"refs":80},{"fa":78,"en":79},"فقط زیر نظر متخصص انکولوژی؛ ادامه تا پیشرفت بیماری یا سمیت غیرقابل‌قبول. تنظیم دوز برای عوارض و تداخل‌ها طبق برچسب.","Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label.",[81],{"source":33,"section":74},{"text":83,"refs":86},{"fa":84,"en":85},"اریتم ندوزوم لپروزوم پوستی: ۱۰۰ تا ۳۰۰ mg\u002Fروز (شدید تا ۴۰۰). فقط از طریق برنامه REMS؛ تست بارداری پیش و حین درمان.","Cutaneous erythema nodosum leprosum: 100–300 mg\u002Fday (severe up to 400). Only through REMS; pregnancy testing before and during treatment.",[87,89],{"source":33,"section":88},"2.3",{"source":33,"section":90},"2.1",[92,101],{"id":93,"severity":94,"text":95,"refs":98},"preg","block",{"fa":96,"en":97},"بارداری.","Pregnancy.",[99],{"source":33,"section":100},"4.1",{"id":102,"severity":94,"text":103,"refs":106},"hyper",{"fa":104,"en":105},"حساسیت به تالیدومید یا اجزا.","Hypersensitivity to thalidomide or its components.",[107],{"source":33,"section":108},"4.2",[110,117],{"text":111,"refs":114},{"fa":112,"en":113},"هشدار جعبه‌ای: سمیت جنینی شدید (نقص مادرزادی، مرگ جنین) — حتی یک دوز؛ ترومبوآمبولی وریدی و شریانی (پروفیلاکسی در میلوما).","Boxed warning: severe embryo-fetal toxicity (birth defects, fetal death) — even a single dose; venous and arterial thromboembolism (prophylaxis in myeloma).",[115],{"source":33,"section":116},"Boxed Warning",{"text":118,"refs":121},{"fa":119,"en":120},"خواب‌آلودگی؛ نوروپاتی محیطی؛ سرگیجه و افت فشار وضعیتی؛ نوتروپنی؛ برادیکاردی؛ واکنش پوستی شدید؛ تشنج.","Somnolence; peripheral neuropathy; dizziness and orthostatic hypotension; neutropenia; bradycardia; severe skin reactions; seizures.",[122],{"source":33,"section":123},"5",[],[],[],{"status":128,"reviewer":129,"date":129},"unverified",null,[131],{"regimen":61,"formulation":52,"input":132,"expect":135},{"ageYears":133,"weightKg":134},65,70,{"perDose":55,"tabletsPerDoseRounded":5},[137],"L04AX02",{"status":139,"forms":140,"refs":153},"registered",[141,145,149],{"code":142,"en":143,"fa":144},"21850","THALIDOMIDE 100MG CAP","کپسول تالیدوماید ۱۰۰ میلی‌گرم",{"code":146,"en":147,"fa":148},"04339","THALIDOMIDE 100MG TAB","قرص تالیدوماید ۱۰۰ میلی‌گرم",{"code":150,"en":151,"fa":152},"51822","THALIDOMIDE 50MG CAP","کپسول تالیدوماید ۵۰ میلی‌گرم",[154],{"source":155,"section":156,"url":157},"darooyab-generic","G-4285\u002FThalidomide","https:\u002F\u002Fwww.darooyab.ir\u002FG-4285\u002FThalidomide",{"kind":159,"refs":160,"id":163},"NDA",[161],{"source":33,"section":162},"SPL approval \u002F marketing category","NDA020785",[165,168,172,175,178],{"kind":166,"url":167,"label":163},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=020785",{"kind":169,"url":170,"label":171},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=2eda833b-1357-4ed4-a093-194524fcb061","FDA Thalomid",{"kind":173,"url":174,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa699032.html",{"kind":176,"url":177,"label":137},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AX02",{"kind":179,"url":157,"label":8},"darooyab",{"pregnancy":181,"lactation":190,"pediatric":199,"geriatric":208,"reproductive":216},{"level":182,"text":183,"quote":186,"refs":187},"contraindicated",{"fa":184,"en":185},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","• Pregnancy ( Boxed Warning , 4.1 , 5.1 , 5.2 , 8.1 , 17 ) • Demonstrated hypersensitivity to the drug or its components ( 4.2 , 5.16 , 6.2 ) 4.1 Pregnancy THALOMID is contraindicated in females who are pregnant.",[188],{"source":33,"section":189},"4",{"level":191,"text":192,"quote":195,"refs":196},"avoid",{"fa":193,"en":194},"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 many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from THALOMID, advise women not to breastfeed during treatment with THALOMID.",[197],{"source":33,"section":198},"8.2",{"level":200,"text":201,"quote":204,"refs":205},"caution",{"fa":202,"en":203},"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.","Safety and effectiveness in pediatric patients below the age of 12 years have not been established.",[206],{"source":33,"section":207},"8.4",{"level":200,"text":209,"quote":212,"refs":213},{"fa":210,"en":211},"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.","One hundred and seventy-six (52%) of 336 patients treated with THALOMID in combination with dexamethasone were ≥65 of age while 50 (15%) were ≥75.",[214],{"source":33,"section":215},"8.5",{"level":200,"text":217,"quote":220,"refs":221},{"fa":218,"en":219},"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 Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, IUD, hormonal (birth control pills, injections, hormonal …",[222],{"source":33,"section":223},"8.3",1792444425947]