[{"data":1,"prerenderedAt":196},["ShallowReactive",2],{"drug-dapagliflozin":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":20,"formulations":25,"regimens":48,"contraindications":85,"warnings":105,"renal":106,"monitoring":107,"interactions":108,"review":109,"examples":112,"atc":123,"iran":125,"links":141,"populations":158,"usApproval":191},"dapagliflozin",1,{"fa":7,"en":8},"داپاگلیفلوزین","Dapagliflozin","alimentary-metabolism",{"fa":11,"en":12},"مهارکننده SGLT2","SGLT2 inhibitor",[14,17],{"name":15,"market":16},"Farxiga","US",{"name":18,"market":19},"Forxiga","GB",[21,22,23,7,24],"farxiga","forxiga","فورزیگا","SGLT2",[26,40],{"id":27,"form":28,"route":29,"label":30,"concentration":31,"markets":35,"refs":36},"tab-5","tablet","oral","5 mg tablet",{"amount":32,"unit":33,"perUnit":28,"scored":34},5,"mg",false,[16],[37],{"source":38,"section":39},"fda-farxiga","3",{"id":41,"form":28,"route":29,"label":42,"concentration":43,"markets":45,"refs":46},"tab-10","10 mg tablet",{"amount":44,"unit":33,"perUnit":28,"scored":34},10,[16],[47],{"source":38,"section":39},[49,73],{"id":50,"disease":51,"label":52,"population":55,"type":58,"unit":33,"dose":59,"refs":60,"limits":63,"notes":66},"t2dm","type-2-diabetes",{"fa":53,"en":54},"دیابت نوع ۲ — ۱۰ سال به بالا: ۵ mg یک بار","Type 2 diabetes — ≥10 y: 5 mg once daily",{"minAge":56},{"value":44,"unit":57},"year","fixed",{"perDose":32,"dosesPerDay":5},[61],{"source":38,"section":62},"2",{"maxPerDay":44,"refs":64},[65],{"source":38,"section":62},[67],{"text":68,"refs":71},{"fa":69,"en":70},"برای کنترل بیشتر تا ۱۰ mg. کم‌آبی پیش از شروع اصلاح شود.","Up to 10 mg for more control. Correct volume depletion first.",[72],{"source":38,"section":62},{"id":74,"disease":75,"label":76,"population":79,"type":58,"unit":33,"dose":82,"refs":83},"hf-ckd","heart-failure",{"fa":77,"en":78},"نارسایی قلبی \u002F بیماری مزمن کلیه — ۱۰ mg یک بار","Heart failure \u002F CKD — 10 mg once daily",{"minAge":80},{"value":81,"unit":57},18,{"perDose":44,"dosesPerDay":5},[84],{"source":38,"section":62},[86,95],{"id":87,"severity":88,"text":89,"refs":92},"ci","block",{"fa":90,"en":91},"سابقه واکنش حساسیتی جدی به داپاگلیفلوزین.","History of serious hypersensitivity to dapagliflozin.",[93],{"source":38,"section":94},"4",{"id":96,"severity":88,"rule":97,"text":99,"refs":102},"under-10",{"maxAge":98},{"value":44,"unit":57},{"fa":100,"en":101},"زیر ۱۰ سال ثابت نشده.","Not established under 10 years.",[103],{"source":38,"section":104},"8.4",[],[],[],[],{"status":110,"reviewer":111,"date":111},"unverified",null,[113,118],{"regimen":50,"formulation":27,"input":114,"expect":117},{"ageYears":115,"weightKg":116},55,85,{"perDose":32},{"regimen":74,"formulation":41,"input":119,"expect":122},{"ageYears":120,"weightKg":121},65,80,{"perDose":44},[124],"A10BK01",{"status":126,"forms":127,"refs":136},"registered",[128,132],{"code":129,"en":130,"fa":131},"52201","DAPAGLIFLOZIN 5MG TAB","قرص داپاگلیفلوزین ۵ میلی‌گرم",{"code":133,"en":134,"fa":135},"52167","DAPAGLIFLOZIN 10MG TAB","قرص داپاگلیفلوزین ۱۰ میلی‌گرم",[137],{"source":138,"section":139,"url":140},"darooyab-generic","G-5458\u002FDapagliflozin","https:\u002F\u002Fwww.darooyab.ir\u002FG-5458\u002FDapagliflozin",[142,146,150,153,156],{"kind":143,"url":144,"label":145},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=202293","NDA202293",{"kind":147,"url":148,"label":149},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69","FDA Farxiga",{"kind":151,"url":152,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614015.html",{"kind":154,"url":155,"label":124},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=A10BK01",{"kind":157,"url":140,"label":8},"darooyab",{"pregnancy":159,"lactation":168,"pediatric":176,"geriatric":183},{"level":160,"text":161,"quote":164,"refs":165},"caution",{"fa":162,"en":163},"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 Based on animal data showing adverse renal effects, FARXIGA is not recommended during the second and third trimesters of pregnancy.",[166],{"source":38,"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 There is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production.",[174],{"source":38,"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.","The safety and effectiveness of FARXIGA as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients aged 10 years and older.",[182],{"source":38,"section":104},{"level":160,"text":184,"quote":187,"refs":188},{"fa":185,"en":186},"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 patients ≥65 years of age, a higher proportion of patients treated with FARXIGA for glycemic control had adverse reactions of hypotension [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] .",[189],{"source":38,"section":190},"8.5",{"kind":192,"refs":193,"id":145},"NDA",[194],{"source":38,"section":195},"SPL approval \u002F marketing category",1792444701183]