[{"data":1,"prerenderedAt":197},["ShallowReactive",2],{"drug-tapentadol":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":19,"regimens":50,"contraindications":86,"warnings":96,"renal":113,"monitoring":114,"interactions":115,"review":116,"examples":119,"atc":124,"iran":126,"links":133,"populations":150,"usApproval":192},"tapentadol",1,{"fa":7,"en":8},"تاپنتادول","Tapentadol","nervous-system",{"fa":11,"en":12},"آگونیست اپیوئیدی و مهارکننده بازجذب نوراپی‌نفرین","Opioid agonist and norepinephrine reuptake inhibitor",[14],{"name":15,"market":16},"Nucynta","US",[18,7],"nucynta",[20,34,42],{"id":21,"form":22,"route":23,"label":24,"concentration":25,"markets":29,"refs":30},"tab-50","tablet","oral","50 mg tablet",{"amount":26,"unit":27,"perUnit":22,"scored":28},50,"mg",false,[16],[31],{"source":32,"section":33},"fda-nucynta","3",{"id":35,"form":22,"route":23,"label":36,"concentration":37,"markets":39,"refs":40},"tab-75","75 mg tablet",{"amount":38,"unit":27,"perUnit":22,"scored":28},75,[16],[41],{"source":32,"section":33},{"id":43,"form":22,"route":23,"label":44,"concentration":45,"markets":47,"refs":48},"tab-100","100 mg tablet",{"amount":46,"unit":27,"perUnit":22,"scored":28},100,[16],[49],{"source":32,"section":33},[51],{"id":52,"disease":53,"label":54,"population":57,"type":62,"unit":27,"dose":63,"refs":65,"limits":68,"notes":72},"pain","severe-pain",{"fa":55,"en":56},"درد حاد شدید — ۵۰ تا ۱۰۰ mg هر ۴ تا ۶ ساعت در صورت نیاز (بزرگسال و ۶ سال به بالا با وزن ≥۴۰ kg)","Severe acute pain — 50–100 mg every 4–6 h as needed (adults and ≥6 y weighing ≥40 kg)",{"minAge":58,"minWeightKg":61},{"value":59,"unit":60},6,"year",40,"fixed",{"perDose":26,"perDoseMax":46,"dosesPerDay":64},4,[66],{"source":32,"section":67},"2.3",{"maxPerDay":69,"refs":70},600,[71],{"source":32,"section":67},[73,79],{"text":74,"refs":77},{"fa":75,"en":76},"روز اول: دوز دوم می‌تواند ۱ ساعت پس از اول باشد. بیش از ۷۰۰ mg در روز اول و ۶۰۰ mg در روزهای بعد بررسی نشده است. عدد دفعات در ماشین‌حساب برای ۶ ساعت است.","Day 1: the second dose may be given 1 h after the first. Over 700 mg on day 1 and 600 mg thereafter not studied. The calculator shows 6-hourly.",[78],{"source":32,"section":67},{"text":80,"refs":83},{"fa":81,"en":82},"نارسایی کبدی متوسط: ۵۰ mg حداکثر هر ۸ ساعت؛ شدید: توصیه نمی‌شود.","Moderate hepatic impairment: 50 mg no more often than every 8 h; severe: not recommended.",[84],{"source":32,"section":85},"2.5",[87],{"id":88,"severity":89,"text":90,"refs":93},"ci","block",{"fa":91,"en":92},"دپرسیون تنفسی قابل‌توجه؛ آسم حاد یا شدید بدون پایش؛ انسداد گوارشی یا ایلئوس فلجی؛ حساسیت؛ MAOI همزمان یا ظرف ۱۴ روز.","Significant respiratory depression; acute or severe asthma without monitoring; GI obstruction or paralytic ileus; hypersensitivity; MAOIs now or within 14 days.",[94],{"source":32,"section":95},"4",[97,106],{"text":98,"refs":101},{"fa":99,"en":100},"هشدار جعبه‌ای: اعتیاد و سوءمصرف، دپرسیون تنفسی کشنده، مصرف تصادفی در کودک، سندرم ترک نوزادی، تداخل با بنزودیازپین‌ها و مهارکننده‌های CYP3A4. نالوکسان در دسترس باشد.","Boxed warning: addiction and misuse, life-threatening respiratory depression, accidental ingestion in children, neonatal opioid withdrawal, interactions with benzodiazepines and CYP3A4 inhibitors. Keep naloxone available.",[102,104],{"source":32,"section":103},"Boxed Warning",{"source":32,"section":105},"2.2",{"text":107,"refs":110},{"fa":108,"en":109},"سندرم سروتونین با داروهای سروتونرژیک؛ تشنج.","Serotonin syndrome with serotonergic drugs; seizures.",[111],{"source":32,"section":112},"5",[],[],[],{"status":117,"reviewer":118,"date":118},"unverified",null,[120],{"regimen":52,"formulation":21,"input":121,"expect":123},{"ageYears":61,"weightKg":122},70,{"perDose":26,"upperPerDose":46},[125],"N02AX06",{"status":127,"refs":128},"not-found",[129],{"source":130,"section":131,"url":132},"darooyab-generic","G-5336\u002FTapentadol","https:\u002F\u002Fwww.darooyab.ir\u002FG-5336\u002FTapentadol",[134,138,142,145,148],{"kind":135,"url":136,"label":137},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022304","NDA022304",{"kind":139,"url":140,"label":141},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=80938c30-9fe3-4c7d-9d9c-5476638cfb2d","FDA Nucynta",{"kind":143,"url":144,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa610006.html",{"kind":146,"url":147,"label":125},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N02AX06",{"kind":149,"url":132,"label":8},"darooyab",{"pregnancy":151,"lactation":159,"pediatric":168,"geriatric":176,"reproductive":184},{"level":152,"text":153,"quote":156,"refs":157},"avoid",{"fa":154,"en":155},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","( 5.2 ) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated.",[158],{"source":32,"section":103},{"level":160,"text":161,"quote":164,"refs":165},"caution",{"fa":162,"en":163},"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 tapentadol in human milk, the effects on the breastfed infant, or the effects on milk production.",[166],{"source":32,"section":167},"8.2",{"level":160,"text":169,"quote":172,"refs":173},{"fa":170,"en":171},"برچسب: فقط ۶ سال به بالا با وزن دست‌کم ۴۰ kg. مصرف تصادفی در کودک کشنده است.","Label: only ≥6 years weighing at least 40 kg. Accidental ingestion by a child can be fatal.","The safety and effectiveness of NUCYNTA (tapentadol) tablets in pediatric patients ages 6 years and older who weigh at least 40 kg have been established.",[174],{"source":32,"section":175},"8.4",{"level":160,"text":177,"quote":180,"refs":181},{"fa":178,"en":179},"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, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.",[182],{"source":32,"section":183},"8.5",{"level":160,"text":185,"quote":188,"refs":189},{"fa":186,"en":187},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential.",[190],{"source":32,"section":191},"8.3",{"kind":193,"refs":194,"id":137},"NDA",[195],{"source":32,"section":196},"SPL approval \u002F marketing category",1792156196632]