[{"data":1,"prerenderedAt":163},["ShallowReactive",2],{"drug-plecanatide":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":63,"warnings":73,"renal":83,"monitoring":84,"interactions":85,"review":86,"examples":89,"atc":99,"iran":101,"usApproval":108,"links":114,"populations":128},"plecanatide",1,{"fa":7,"en":8},"پلکاناتاید","Plecanatide","alimentary-metabolism",{"fa":11,"en":12},"آگونیست گوانیلات سیکلاز-C","Guanylate cyclase-C agonist",[14],{"name":15,"market":16},"Trulance","US",[18,19,20],"trulance","ترولانس","پلکاناتید",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-3","tablet","oral","3 mg tablet",{"amount":28,"unit":29,"perUnit":24,"scored":30},3,"mg",false,[16],[33],{"source":34,"section":35},"fda-trulance","3",[37,52],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":49},"cic","chronic-idiopathic-constipation",{"fa":41,"en":42},"یبوست مزمن ایدیوپاتیک بزرگسال — ۳ mg یک بار","Chronic idiopathic constipation, adults — 3 mg once daily",{"minAge":44},{"value":45,"unit":46},18,"year","fixed",{"perDose":28,"dosesPerDay":5},[50],{"source":34,"section":51},"2.1",{"id":53,"disease":54,"label":55,"population":58,"type":47,"unit":29,"dose":60,"refs":61},"ibsc","ibs",{"fa":56,"en":57},"IBS با یبوست بزرگسال — ۳ mg یک بار","IBS with constipation, adults — 3 mg once daily",{"minAge":59},{"value":45,"unit":46},{"perDose":28,"dosesPerDay":5},[62],{"source":34,"section":51},[64],{"id":65,"severity":66,"text":67,"refs":70},"ci","block",{"fa":68,"en":69},"کودک زیر ۶ سال (کم‌آبی شدید)؛ انسداد مکانیکی گوارش.","Children under 6 years (serious dehydration); mechanical GI obstruction.",[71],{"source":34,"section":72},"4",[74],{"text":75,"refs":78},{"fa":76,"en":77},"هشدار جعبه‌ای: کم‌آبی شدید در کودکان — زیر ۶ سال منع، ۶ تا ۱۸ سال پرهیز. اسهال شدید.","Boxed warning: serious dehydration in children — contraindicated under 6 y, avoid 6–\u003C18 y. Severe diarrhoea.",[79,81],{"source":34,"section":80},"Boxed Warning",{"source":34,"section":82},"5",[],[],[],{"status":87,"reviewer":88,"date":88},"unverified",null,[90,95],{"regimen":38,"formulation":23,"input":91,"expect":94},{"ageYears":92,"weightKg":93},45,65,{"perDose":28,"tabletsPerDoseRounded":5},{"regimen":53,"formulation":23,"input":96,"expect":98},{"ageYears":97,"weightKg":93},35,{"perDose":28,"tabletsPerDoseRounded":5},[100],"A06AX07",{"status":102,"refs":103},"not-found",[104],{"source":105,"section":106,"url":107},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Plecanatide",{"kind":109,"refs":110,"id":113},"NDA",[111],{"source":34,"section":112},"SPL approval \u002F marketing category","NDA208745",[115,118,122,125],{"kind":116,"url":117,"label":113},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208745",{"kind":119,"url":120,"label":121},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=fe2895bf-71a6-493a-b0ca-e06b2dfefc82","FDA Trulance",{"kind":123,"url":124,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa617020.html",{"kind":126,"url":127,"label":100},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=A06AX07",{"pregnancy":129,"lactation":138,"pediatric":147,"geriatric":155},{"level":130,"text":131,"quote":134,"refs":135},"ok",{"fa":132,"en":133},"برچسب: جذب سیستمیک ناچیز؛ مواجهه جنین انتظار نمی‌رود.","Label: minimal systemic absorption; fetal exposure not expected.","Risk Summary Plecanatide and its active metabolite are negligibly absorbed systemically following oral administration [see Clinical Pharmacology (12.3) ] and maternal use is not expected to result in fetal exposure to the drug.",[136],{"source":34,"section":137},"8.1",{"level":139,"text":140,"quote":143,"refs":144},"caution",{"fa":141,"en":142},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary After administration of multiple doses of TRULANCE 3 mg once daily for 2 weeks to nursing mothers, plecanatide and its active metabolite were not measurable in breast milk collected at 2 hours, 6 hours, and 12 hours post-dosing.",[145],{"source":34,"section":146},"8.2",{"level":148,"text":149,"quote":152,"refs":153},"contraindicated",{"fa":150,"en":151},"برچسب: در کودکان زیر سن مشخص منع مصرف دارد.","Label: contraindicated in children below a stated age.","TRULANCE is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] .",[154],{"source":34,"section":72},{"level":139,"text":156,"quote":159,"refs":160},{"fa":157,"en":158},"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.","Chronic Idiopathic Constipation (CIC) Of 2,601 subjects in placebo-controlled clinical trials of TRULANCE, 273 (10%) were 65 years of age and over, and 47 (2%) were 75 years and over.",[161],{"source":34,"section":162},"8.5",1792191561663]