[{"data":1,"prerenderedAt":292},["ShallowReactive",2],{"drug-temozolomide":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":76,"contraindications":128,"warnings":138,"renal":146,"monitoring":147,"interactions":148,"review":149,"examples":152,"atc":167,"iran":169,"links":224,"populations":244,"usApproval":287},"temozolomide",1,{"fa":7,"en":8},"تموزولوماید","Temozolomide","antineoplastic-immunomodulating",{"fa":11,"en":12},"عامل آلکیله‌کننده خوراکی","Oral alkylating agent",[14],{"name":15,"market":16},"Temodar","US",[18,19,20,7],"temodar","temodal","تمودال",[22,36,44,52,60,68],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"cap-5","capsule","oral","5 mg capsule",{"amount":28,"unit":29,"perUnit":24,"scored":30},5,"mg",false,[16],[33],{"source":34,"section":35},"fda-temodar","3",{"id":37,"form":24,"route":25,"label":38,"concentration":39,"markets":41,"refs":42},"cap-20","20 mg capsule",{"amount":40,"unit":29,"perUnit":24,"scored":30},20,[16],[43],{"source":34,"section":35},{"id":45,"form":24,"route":25,"label":46,"concentration":47,"markets":49,"refs":50},"cap-100","100 mg capsule",{"amount":48,"unit":29,"perUnit":24,"scored":30},100,[16],[51],{"source":34,"section":35},{"id":53,"form":24,"route":25,"label":54,"concentration":55,"markets":57,"refs":58},"cap-140","140 mg capsule",{"amount":56,"unit":29,"perUnit":24,"scored":30},140,[16],[59],{"source":34,"section":35},{"id":61,"form":24,"route":25,"label":62,"concentration":63,"markets":65,"refs":66},"cap-180","180 mg capsule",{"amount":64,"unit":29,"perUnit":24,"scored":30},180,[16],[67],{"source":34,"section":35},{"id":69,"form":24,"route":25,"label":70,"concentration":71,"markets":73,"refs":74},"cap-250","250 mg capsule",{"amount":72,"unit":29,"perUnit":24,"scored":30},250,[16],[75],{"source":34,"section":35},[77,111],{"id":78,"disease":79,"label":80,"population":83,"type":87,"unit":29,"dose":88,"refs":90,"durationDays":93,"notes":96},"gbm-rt","malignant-glioma",{"fa":81,"en":82},"گلیوبلاستوم تازه — همزمان با رادیوتراپی ۷۵ mg\u002Fm² روزانه ۴۲ تا ۴۹ روز","Newly diagnosed glioblastoma — with radiotherapy 75 mg\u002Fm² daily for 42–49 days",{"minAge":84},{"value":85,"unit":86},18,"year","bsa",{"perM2PerDay":89,"dividedDoses":5},75,[91],{"source":34,"section":92},"2.2",{"min":94,"max":95},42,49,[97,103],{"text":98,"refs":101},{"fa":99,"en":100},"فقط زیر نظر پزشک متخصص شیمی‌درمانی و در مرکز مجهز. عدد ماشین‌حساب = mg\u002Fm² برچسب × سطح بدن (Mosteller)؛ پروتکل، فاصله دوره‌ها، تنظیم بر اساس CBC و عملکرد کلیه\u002Fکبد با تیم انکولوژی.","Only under an oncologist in an equipped centre. Calculator = label mg\u002Fm² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal\u002Fhepatic function rest with the oncology team.",[102],{"source":34,"section":92},{"text":104,"refs":107},{"fa":105,"en":106},"پیشگیری پنوموسیستیس در فاز همزمان. شروع فقط با ANC ۱۵۰۰ و پلاکت ۱۰۰ هزار به بالا.","Pneumocystis prophylaxis during the concomitant phase. Start only with ANC ≥1.5 × 10⁹\u002FL and platelets ≥100 × 10⁹\u002FL.",[108,109],{"source":34,"section":92},{"source":34,"section":110},"2.1",{"id":112,"disease":79,"label":113,"population":116,"type":87,"unit":29,"dose":118,"refs":120,"durationDays":122,"notes":123},"gbm-maint",{"fa":114,"en":115},"گلیوبلاستوم — نگهدارنده ۱۵۰ mg\u002Fm² روز ۱ تا ۵ هر ۲۸ روز، ۶ دوره (از دوره ۲ تا ۲۰۰ mg\u002Fm²)","Glioblastoma — maintenance 150 mg\u002Fm² on days 1–5 every 28 days for 6 cycles (from cycle 2 up to 200 mg\u002Fm²)",{"minAge":117},{"value":85,"unit":86},{"perM2PerDay":119,"dividedDoses":5},150,[121],{"source":34,"section":92},{"min":28,"max":28},[124],{"text":125,"refs":126},{"fa":99,"en":100},[127],{"source":34,"section":92},[129],{"id":130,"severity":131,"text":132,"refs":135},"hyper","block",{"fa":133,"en":134},"سابقه حساسیت جدی به تموزولوماید یا داکاربازین.","History of serious hypersensitivity to temozolomide or dacarbazine.",[136],{"source":34,"section":137},"4",[139],{"text":140,"refs":143},{"fa":141,"en":142},"سرکوب مغز استخوان؛ سمیت کبدی؛ پنومونی پنوموسیستیس؛ بدخیمی ثانویه؛ سمیت جنینی؛ کپسول باز نشود.","Myelosuppression; hepatotoxicity; Pneumocystis pneumonia; secondary malignancies; embryo-fetal toxicity; do not open capsules.",[144],{"source":34,"section":145},"5",[],[],[],{"status":150,"reviewer":151,"date":151},"unverified",null,[153,161],{"regimen":78,"formulation":37,"input":154,"expect":158},{"ageYears":155,"weightKg":156,"heightCm":157},55,57.6,160,{"perDose":159,"tabletsPerDoseRounded":160},120,6,{"regimen":112,"formulation":45,"input":162,"expect":164},{"ageYears":155,"weightKg":163,"heightCm":64},80,{"perDose":165,"tabletsPerDoseRounded":166},300,3,[168],"L01AX03",{"status":170,"forms":171,"refs":219},"registered",[172,176,180,184,188,192,196,200,204,208,212,216],{"code":173,"en":174,"fa":175},"05949","TEMOZOLOMIDE 100MG CAP","کپسول تموزولوماید ۱۰۰ میلی‌گرم",{"code":177,"en":178,"fa":179},"19412","TEMOZOLOMIDE 140MG CAP","کپسول تموزولوماید ۱۴۰ میلی‌گرم",{"code":181,"en":182,"fa":183},"19413","TEMOZOLOMIDE 180MG CAP","کپسول تموزولوماید ۱۸۰ میلی‌گرم",{"code":185,"en":186,"fa":187},"19416","TEMOZOLOMIDE 2.5MG\u002FML VIAL","ویال تموزولوماید ۲٫۵ میلی‌گرم \u002F میلی‌لیتر",{"code":189,"en":190,"fa":191},"06532","TEMOZOLOMIDE 20MG CAP","کپسول تموزولوماید ۲۰ میلی‌گرم",{"code":193,"en":194,"fa":195},"07593","TEMOZOLOMIDE 20MG TAB","قرص تموزولوماید ۲۰ میلی‌گرم",{"code":197,"en":198,"fa":199},"05950","TEMOZOLOMIDE 250MG CAP","کپسول تموزولوماید ۲۵۰ میلی‌گرم",{"code":201,"en":202,"fa":203},"06100","TEMOZOLOMIDE 250MG TAB","قرص تموزولوماید ۲۵۰ میلی‌گرم",{"code":205,"en":206,"fa":207},"07384","TEMOZOLOMIDE 5MG CAP","کپسول تموزولوماید ۵ میلی‌گرم",{"code":209,"en":210,"fa":211},"06637","TEMOZOLOMIDE 5MG TAB","قرص تموزولوماید ۵ میلی‌گرم",{"code":213,"en":214,"fa":215},"50624","TEMOZOLOMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 100 mg","پودر تزریقی تموزولوماید ۱۰۰ میلی‌گرم",{"code":217,"en":218,"fa":183},"51888","TEMOZOLOMIDE CAPSULE ORAL 180 mg",[220],{"source":221,"section":222,"url":223},"darooyab-generic","G-1072\u002FTemozolomide","https:\u002F\u002Fwww.darooyab.ir\u002FG-1072\u002FTemozolomide",[225,229,233,236,239,242],{"kind":226,"url":227,"label":228},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021029","NDA021029",{"kind":230,"url":231,"label":232},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=046a9011-3911-4d3f-a15f-fbb56d5aad56","FDA Temodar",{"kind":234,"url":235,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa601250.html",{"kind":234,"url":237,"label":238},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa613002.html","Temozolomide Injection",{"kind":240,"url":241,"label":168},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01AX03",{"kind":243,"url":223,"label":8},"darooyab",{"pregnancy":245,"lactation":254,"pediatric":262,"geriatric":271,"reproductive":279},{"level":246,"text":247,"quote":250,"refs":251},"avoid",{"fa":248,"en":249},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , TEMODAR can cause fetal harm when administered to a pregnant woman.",[252],{"source":34,"section":253},"8.1",{"level":246,"text":255,"quote":258,"refs":259},{"fa":256,"en":257},"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, including myelosuppression from temozolomide in the breastfed children, advise women not to breastfeed during treatment with TEMODAR and for 1 week after the last dose.",[260],{"source":34,"section":261},"8.2",{"level":263,"text":264,"quote":267,"refs":268},"caution",{"fa":265,"en":266},"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 of TEMODAR have not been established in pediatric patients.",[269],{"source":34,"section":270},"8.4",{"level":263,"text":272,"quote":275,"refs":276},{"fa":273,"en":274},"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.","… ade 4 thrombocytopenia (20%) in the first cycle of therapy than patients less than 70 years of age [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] .",[277],{"source":34,"section":278},"8.5",{"level":263,"text":280,"quote":283,"refs":284},{"fa":281,"en":282},"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 treatment with TEMODAR and for 6 months after the last dose.",[285],{"source":34,"section":286},"8.3",{"kind":288,"refs":289,"id":228},"NDA",[290],{"source":34,"section":291},"SPL approval \u002F marketing category",1792444707671]