[{"data":1,"prerenderedAt":192},["ShallowReactive",2],{"drug-raltegravir":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":44,"contraindications":94,"warnings":95,"renal":103,"monitoring":104,"interactions":105,"review":106,"examples":109,"atc":118,"iran":120,"usApproval":136,"links":142,"populations":158},"raltegravir",1,{"fa":7,"en":8},"رالتگراویر","Raltegravir","anti-infectives",{"fa":11,"en":12},"مهارکننده اینتگراز (INSTI)","Integrase inhibitor (INSTI)",[14],{"name":15,"market":16},"Isentress","US",[18,19,7,20],"isentress","ایزنترس","RAL",[22,36],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-400","tablet","oral","400 mg film-coated tablet",{"amount":28,"unit":29,"perUnit":24,"scored":30},400,"mg",false,[16],[33],{"source":34,"section":35},"fda-isentress","3",{"id":37,"form":24,"route":25,"label":38,"concentration":39,"markets":41,"refs":42},"tab-600","600 mg HD tablet",{"amount":40,"unit":29,"perUnit":24,"scored":30},600,[16],[43],{"source":34,"section":35},[45,77],{"id":46,"disease":46,"label":47,"population":50,"type":54,"unit":29,"dose":55,"refs":57,"allowedFormulations":60,"notes":61},"hiv",{"fa":48,"en":49},"HIV-1 — بزرگسال: ۴۰۰ mg دو بار در روز (یا ۱۲۰۰ mg یک بار در درمان‌نشده)","HIV-1 — adult: 400 mg twice daily (or 1200 mg once daily if treatment-naive)",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":28,"dosesPerDay":56},2,[58],{"source":34,"section":59},"2.2, Table 1",[23],[62,69],{"text":63,"refs":66},{"fa":64,"en":65},"همیشه همراه سایر داروهای ضدرتروویروس (مگر فرآورده کامل).","Always with other antiretrovirals (unless a complete regimen).",[67],{"source":34,"section":68},"2.2",{"text":70,"refs":73},{"fa":71,"en":72},"با ریفامپین: ۸۰۰ mg دو بار. قرص جویدنی و سوسپانسیون جایگزین قرص روکش‌دار نیستند.","With rifampin: 800 mg twice daily. Chewable tablets and suspension are not interchangeable with film-coated tablets.",[74,75],{"source":34,"section":59},{"source":34,"section":76},"2.1",{"id":78,"disease":46,"label":79,"population":82,"type":54,"unit":29,"dose":84,"refs":86,"allowedFormulations":88,"notes":89},"hiv-hd",{"fa":80,"en":81},"HIV-1 درمان‌نشده یا سرکوب‌شده — ۱۲۰۰ mg (۲ × ۶۰۰ mg) یک بار در روز","HIV-1 naive or suppressed — 1200 mg (2 × 600 mg) once daily",{"minAge":83},{"value":52,"unit":53},{"perDose":85,"dosesPerDay":5},1200,[87],{"source":34,"section":59},[37],[90],{"text":91,"refs":92},{"fa":64,"en":65},[93],{"source":34,"section":68},[],[96],{"text":97,"refs":100},{"fa":98,"en":99},"واکنش شدید پوستی و حساسیت (SJS، DRESS)؛ رابدومیولیز؛ سندرم بازسازی ایمنی.","Severe skin and hypersensitivity reactions (SJS, DRESS); rhabdomyolysis; immune reconstitution syndrome.",[101],{"source":34,"section":102},"5",[],[],[],{"status":107,"reviewer":108,"date":108},"unverified",null,[110,115],{"regimen":46,"formulation":23,"input":111,"expect":114},{"ageYears":112,"weightKg":113},35,70,{"perDose":28,"tabletsPerDoseRounded":5},{"regimen":78,"formulation":37,"input":116,"expect":117},{"ageYears":112,"weightKg":113},{"perDose":85,"tabletsPerDoseRounded":56},[119],"J05AJ01",{"status":121,"forms":122,"refs":131},"registered",[123,127],{"code":124,"en":125,"fa":126},"22527","RALTEGRAVIR TABLET ORAL 400 mg","قرص رالتگراویر ۴۰۰ میلی‌گرم",{"code":128,"en":129,"fa":130},"24689","RALTEGRAVIR TABLET, CHEWABLE ORAL 100 mg","قرص جویدنی رالتگراویر ۱۰۰ میلی‌گرم",[132],{"source":133,"section":134,"url":135},"darooyab-generic","G-5318\u002FRaltegravir","https:\u002F\u002Fwww.darooyab.ir\u002FG-5318\u002FRaltegravir",{"kind":137,"refs":138,"id":141},"NDA",[139],{"source":34,"section":140},"SPL approval \u002F marketing category","NDA022145",[143,146,150,153,156],{"kind":144,"url":145,"label":141},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022145",{"kind":147,"url":148,"label":149},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3","FDA Isentress",{"kind":151,"url":152,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa608004.html",{"kind":154,"url":155,"label":119},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AJ01",{"kind":157,"url":135,"label":8},"darooyab",{"pregnancy":159,"lactation":168,"pediatric":176,"geriatric":184},{"level":160,"text":161,"quote":164,"refs":165},"caution",{"fa":162,"en":163},"برچسب: داده‌های رجیستری بارداری (APR) تفاوتی با میزان زمینه‌ای نقص مادرزادی نشان نمی‌دهد.","Label: Antiretroviral Pregnancy Registry data show no difference from the background birth-defect rate.","Available data from the APR show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).",[166],{"source":34,"section":167},"8.1",{"level":160,"text":169,"quote":172,"refs":173},{"fa":170,"en":171},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.",[174],{"source":34,"section":175},"8.2",{"level":160,"text":177,"quote":180,"refs":181},{"fa":178,"en":179},"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.","ISENTRESS HIV-1 Infected Children The safety, tolerability, pharmacokinetic profile, and efficacy of twice daily ISENTRESS were evaluated in HIV-1 infected infants, children and adolescents 4 weeks to 18 years of age in an open-label, multicenter clinical trial, IMPAACT P1066 [see Dosage and Administration (2.3) , …",[182],{"source":34,"section":183},"8.4",{"level":160,"text":185,"quote":188,"refs":189},{"fa":186,"en":187},"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.","In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.",[190],{"source":34,"section":191},"8.5",1792191563879]