[{"data":1,"prerenderedAt":213},["ShallowReactive",2],{"drug-miltefosine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":86,"warnings":110,"renal":118,"monitoring":119,"interactions":120,"review":121,"examples":123,"atc":133,"iran":135,"links":151,"populations":165,"usApproval":208},"miltefosine",1,{"fa":7,"en":8},"میلتفوسین","Miltefosine","antiparasitic",{"fa":11,"en":12},"ضدلیشمانیا خوراکی","Oral antileishmanial",[14],{"name":15,"market":16},"Impavido","US",[18,19,7],"impavido","ایمپاویدو",[21],{"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-impavido","3",[36,71],{"id":37,"disease":38,"label":39,"population":42,"type":47,"unit":28,"dose":48,"refs":57,"durationDays":60,"notes":62},"cl","cutaneous-leishmaniasis",{"fa":40,"en":41},"لیشمانیوز جلدی — ۵۰ mg دو یا سه بار در روز بر اساس وزن، ۲۸ روز","Cutaneous leishmaniasis — 50 mg two or three times daily by weight, 28 days",{"minAge":43,"minWeightKg":46},{"value":44,"unit":45},12,"year",30,"weightBand",{"weightBands":49},[50,54],{"minWeightKg":51,"maxWeightKg":52,"perDose":27,"dosesPerDay":53},29.99,44.99,2,{"minWeightKg":52,"maxWeightKg":55,"perDose":27,"dosesPerDay":56},null,3,[58],{"source":33,"section":59},"2, Table 1",{"min":61,"max":61},28,[63],{"text":64,"refs":67},{"fa":65,"en":66},"همراه غذا. گونه‌های تأییدشده در برچسب برای فرم جلدی: L. braziliensis، L. guyanensis و L. panamensis (آمریکای لاتین)؛ گونه‌های شایع ایران (L. major و L. tropica) در برچسب نیستند.","With food. Label-approved species for cutaneous disease: L. braziliensis, L. guyanensis, L. panamensis; the species common in Iran (L. major, L. tropica) are not in the label.",[68,69],{"source":33,"section":59},{"source":33,"section":70},"1",{"id":72,"disease":73,"label":74,"population":77,"type":47,"unit":28,"dose":79,"refs":83,"durationDays":85},"vl","visceral-leishmaniasis",{"fa":75,"en":76},"لیشمانیوز احشایی (L. donovani) — ۵۰ mg دو یا سه بار در روز بر اساس وزن، ۲۸ روز","Visceral leishmaniasis (L. donovani) — 50 mg two or three times daily by weight, 28 days",{"minAge":78,"minWeightKg":46},{"value":44,"unit":45},{"weightBands":80},[81,82],{"minWeightKg":51,"maxWeightKg":52,"perDose":27,"dosesPerDay":53},{"minWeightKg":52,"maxWeightKg":55,"perDose":27,"dosesPerDay":56},[84],{"source":33,"section":59},{"min":61,"max":61},[87,96,103],{"id":88,"severity":89,"text":90,"refs":93},"preg","block",{"fa":91,"en":92},"بارداری — ممنوع (مرگ و ناهنجاری جنین).","Pregnancy — contraindicated (fetal death and malformation).",[94],{"source":33,"section":95},"4",{"id":97,"severity":89,"text":98,"refs":101},"sls",{"fa":99,"en":100},"سندرم شوگرن-لارسون.","Sjögren-Larsson syndrome.",[102],{"source":33,"section":95},{"id":104,"severity":89,"text":105,"refs":108},"hyper",{"fa":106,"en":107},"حساسیت به میلتفوسین.","Hypersensitivity to miltefosine.",[109],{"source":33,"section":95},[111],{"text":112,"refs":115},{"fa":113,"en":114},"هشدار جعبه‌ای: سمیت جنینی. پیش از شروع تست بارداری؛ پیشگیری مؤثر از بارداری در طول درمان و تا ۵ ماه پس از آن.","Boxed warning: embryo-fetal toxicity. Pregnancy test before starting; effective contraception during treatment and for 5 months after.",[116],{"source":33,"section":117},"Boxed Warning",[],[],[],{"status":122,"reviewer":55,"date":55},"unverified",[124,128],{"regimen":37,"formulation":22,"input":125,"expect":127},{"ageYears":46,"weightKg":126},60,{"perDose":27,"tabletsPerDoseRounded":5,"dosesPerDay":56},{"regimen":72,"formulation":22,"input":129,"expect":132},{"ageYears":130,"weightKg":131},14,40,{"perDose":27,"dosesPerDay":53},[134],"P01CX04",{"status":136,"forms":137,"refs":146},"registered",[138,142],{"code":139,"en":140,"fa":141},"18499","MILTEFOSIN 50MG  CAP.","کپسول میلتفوسین ۵۰ میلی‌گرم .",{"code":143,"en":144,"fa":145},"51441","MILTEFOSINE CAPSULE ORAL 50 mg","کپسول میلتفوسین ۵۰ میلی‌گرم",[147],{"source":148,"section":149,"url":150},"darooyab-generic","G-1029\u002FMiltefosine","https:\u002F\u002Fwww.darooyab.ir\u002FG-1029\u002FMiltefosine",[152,156,160,163],{"kind":153,"url":154,"label":155},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=204684","NDA204684",{"kind":157,"url":158,"label":159},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=bcb387ac-2e90-4f5e-94b2-d3635190678e","FDA Impavido",{"kind":161,"url":162,"label":134},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=P01CX04",{"kind":164,"url":150,"label":8},"darooyab",{"pregnancy":166,"lactation":174,"pediatric":183,"geriatric":192,"reproductive":200},{"level":167,"text":168,"quote":171,"refs":172},"contraindicated",{"fa":169,"en":170},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","IMPAVIDO is contraindicated in pregnant women.",[173],{"source":33,"section":95},{"level":175,"text":176,"quote":179,"refs":180},"caution",{"fa":177,"en":178},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from IMPAVIDO, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.",[181],{"source":33,"section":182},"8.3",{"level":184,"text":185,"quote":188,"refs":189},"not-established",{"fa":186,"en":187},"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 \u003C 12 years have not been established.",[190],{"source":33,"section":191},"8.4",{"level":175,"text":193,"quote":196,"refs":197},{"fa":194,"en":195},"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.","Clinical studies of IMPAVIDO did not include sufficient numbers of subjects 65 years of age and over to determine if they respond differently than younger subjects.",[198],{"source":33,"section":199},"8.5",{"level":175,"text":201,"quote":204,"refs":205},{"fa":202,"en":203},"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 IMPAVIDO may cause fetal harm when used during pregnancy.",[206],{"source":33,"section":207},"8.8",{"kind":209,"refs":210,"id":155},"NDA",[211],{"source":33,"section":212},"SPL approval \u002F marketing category",1792108430972]