[{"data":1,"prerenderedAt":227},["ShallowReactive",2],{"drug-ceftolozane-tazobactam":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":108,"warnings":118,"renal":126,"monitoring":136,"interactions":137,"review":138,"examples":141,"atc":160,"iran":162,"links":169,"populations":188,"usApproval":222},"ceftolozane-tazobactam",1,{"fa":7,"en":8},"سفتولوزان-تازوباکتام","Ceftolozane-tazobactam","anti-infectives",{"fa":11,"en":12},"سفالوسپورین + مهارکننده بتالاکتاماز","Cephalosporin + beta-lactamase inhibitor",[14],{"name":15,"market":16},"Zerbaxa","US",[18,19,20],"zerbaxa","زرباکسا","سفتولوزان تازوباکتام",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"vial-1-5","powder-for-injection","iv","1.5 g vial (ceftolozane 1 g + tazobactam 0.5 g)",{"amount":28,"unit":29,"perUnit":30},1500,"mg","vial",[16],[33],{"source":34,"section":35},"fda-zerbaxa","3",[37,64,83],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":50,"durationDays":53,"notes":56},"ciai","intra-abdominal-infection",{"fa":41,"en":42},"عفونت عارضه‌دار داخل شکم (۴ تا ۱۴ روز) و ادراری\u002Fپیلونفریت (۷ روز) — بزرگسال ۱٫۵ g هر ۸ ساعت","Complicated intra-abdominal (4–14 days) and urinary\u002Fpyelonephritis (7 days) — adult 1.5 g every 8 h",{"minAge":44},{"value":45,"unit":46},18,"year","fixed",{"perDose":28,"dosesPerDay":49},3,[51],{"source":34,"section":52},"2.1, Table 1",{"min":54,"max":55},4,14,[57],{"text":58,"refs":61},{"fa":59,"en":60},"دوز به‌صورت مجموع سفتولوزان + تازوباکتام (۲:۱). انفوزیون ۱ ساعته هر ۸ ساعت. cIAI همراه مترونیدازول.","Dose as total ceftolozane + tazobactam (2:1). 1-hour infusion every 8 h. cIAI with metronidazole.",[62],{"source":34,"section":63},"2.1",{"id":65,"disease":66,"label":67,"population":70,"type":47,"unit":29,"dose":72,"refs":74,"durationDays":76,"notes":78},"hap","hospital-acquired-pneumonia",{"fa":68,"en":69},"پنومونی بیمارستانی و ونتیلاتور — بزرگسال ۳ g هر ۸ ساعت، ۸ تا ۱۴ روز","HABP\u002FVABP — adult 3 g every 8 h for 8–14 days",{"minAge":71},{"value":45,"unit":46},{"perDose":73,"dosesPerDay":49},3000,[75],{"source":34,"section":52},{"min":77,"max":55},8,[79],{"text":80,"refs":81},{"fa":59,"en":60},[82],{"source":34,"section":63},{"id":84,"disease":39,"label":85,"population":88,"type":90,"unit":29,"dose":91,"refs":93,"limits":96,"durationDays":99,"notes":101},"child",{"fa":86,"en":87},"کودکان (از ۳۲ هفته سن بارداری) cIAI و cUTI — ۳۰ mg\u002Fkg هر ۸ ساعت (حداکثر ۱٫۵ g)","Children (from 32 weeks gestational age), cIAI and cUTI — 30 mg\u002Fkg every 8 h (max 1.5 g)",{"maxAge":89},{"value":45,"unit":46},"weightBased",{"perKgPerDose":92,"intervalHours":77},30,[94],{"source":34,"section":95},"2.2, Table 2",{"maxPerDose":28,"refs":97},[98],{"source":34,"section":95},{"min":100,"max":55},5,[102],{"text":103,"refs":106},{"fa":104,"en":105},"پنومونی بیمارستانی کودکان: دوز بالاتر و انفوزیون ۲ ساعته طبق جدول ۲.","Paediatric HABP\u002FVABP: higher dose and 2-hour infusion per Table 2.",[107],{"source":34,"section":95},[109],{"id":110,"severity":111,"text":112,"refs":115},"hyper","block",{"fa":113,"en":114},"حساسیت جدی به سفتولوزان، تازوباکتام، پیپراسیلین-تازوباکتام یا سایر بتالاکتام‌ها.","Serious hypersensitivity to ceftolozane, tazobactam, piperacillin-tazobactam or other beta-lactams.",[116],{"source":34,"section":117},"4",[119],{"text":120,"refs":123},{"fa":121,"en":122},"کاهش اثر در ClCr پایه ۳۰ تا ۵۰؛ حساسیت؛ اسهال C. difficile؛ مقاومت دارویی.","Decreased efficacy with baseline CrCl 30–50; hypersensitivity; C. difficile diarrhoea; drug-resistant bacteria.",[124],{"source":34,"section":125},"5",[127],{"egfrBelow":128,"severity":129,"text":130,"refs":133},51,"warn",{"fa":131,"en":132},"ClCr ۵۰ و کمتر: cIAI\u002FcUTI ۳۰ تا ۵۰ → ۷۵۰ mg، ۱۵ تا ۲۹ → ۳۷۵ mg هر ۸ ساعت؛ پنومونی ۳۰ تا ۵۰ → ۱٫۵ g، ۱۵ تا ۲۹ → ۷۵۰ mg؛ ESRD طبق جدول ۳.","CrCl ≤50: cIAI\u002FcUTI 30–50 → 750 mg, 15–29 → 375 mg every 8 h; pneumonia 30–50 → 1.5 g, 15–29 → 750 mg; ESRD per Table 3.",[134],{"source":34,"section":135},"2.3, Table 3",[],[],{"status":139,"reviewer":140,"date":140},"unverified",null,[142,147,151,156],{"regimen":38,"formulation":23,"input":143,"expect":146},{"ageYears":144,"weightKg":145},50,70,{"perDose":28,"dosesPerDay":49},{"regimen":65,"formulation":23,"input":148,"expect":150},{"ageYears":149,"weightKg":145},60,{"perDose":73,"dosesPerDay":49},{"regimen":84,"formulation":23,"input":152,"expect":154},{"ageYears":100,"weightKg":153},20,{"perDose":155},600,{"regimen":84,"formulation":23,"input":157,"expect":159},{"ageYears":158,"weightKg":149},15,{"perDose":28},[161],"J01DI54",{"status":163,"refs":164},"not-found",[165],{"source":166,"section":167,"url":168},"darooyab-generic","G-5364\u002FCeftolozane-Tazobactam","https:\u002F\u002Fwww.darooyab.ir\u002FG-5364\u002FCeftolozane-Tazobactam",[170,174,178,182,185],{"kind":171,"url":172,"label":173},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=206829","NDA206829",{"kind":175,"url":176,"label":177},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=70ac1d90-eff3-4f0b-9f46-5846c571b32f","FDA Zerbaxa",{"kind":179,"url":180,"label":181},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615010.html","Ceftolozane and Tazobactam Injection",{"kind":183,"url":184,"label":161},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J01DI54",{"kind":186,"url":168,"label":187},"darooyab","Ceftolozane-Tazobactam",{"pregnancy":189,"lactation":198,"pediatric":206,"geriatric":214},{"level":190,"text":191,"quote":194,"refs":195},"caution",{"fa":192,"en":193},"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.","Risk Summary There are no data available on ZERBAXA, ceftolozane or tazobactam use in pregnant women to allow assessment of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",[196],{"source":34,"section":197},"8.1",{"level":190,"text":199,"quote":202,"refs":203},{"fa":200,"en":201},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of ceftolozane or tazobactam in human milk.",[204],{"source":34,"section":205},"8.2",{"level":190,"text":207,"quote":210,"refs":211},{"fa":208,"en":209},"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.","The safety and effectiveness of ZERBAXA for the treatment of cIAI, cUTI, and HABP\u002FVABP have been established in pediatric patients at least 32 weeks gestational age and older.",[212],{"source":34,"section":213},"8.4",{"level":190,"text":215,"quote":218,"refs":219},{"fa":216,"en":217},"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.","Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.",[220],{"source":34,"section":221},"8.5",{"kind":223,"refs":224,"id":173},"NDA",[225],{"source":34,"section":226},"SPL approval \u002F marketing category",1792444387015]