[{"data":1,"prerenderedAt":206},["ShallowReactive",2],{"drug-darunavir":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":44,"contraindications":87,"warnings":97,"renal":105,"monitoring":106,"interactions":107,"review":108,"examples":111,"atc":120,"iran":122,"usApproval":142,"links":148,"populations":164},"darunavir",1,{"fa":7,"en":8},"داروناویر","Darunavir","anti-infectives",{"fa":11,"en":12},"مهارکننده پروتئاز (با ریتوناویر)","Protease inhibitor (boosted with ritonavir)",[14],{"name":15,"market":16},"Prezista","US",[18,19,7,20],"prezista","پرزیستا","DRV",[22,36],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-800","tablet","oral","800 mg tablet",{"amount":28,"unit":29,"perUnit":24,"scored":30},800,"mg",false,[16],[33],{"source":34,"section":35},"fda-prezista","3",{"id":37,"form":24,"route":25,"label":38,"concentration":39,"markets":41,"refs":42},"tab-600","600 mg tablet",{"amount":40,"unit":29,"perUnit":24,"scored":30},600,[16],[43],{"source":34,"section":35},[45,68],{"id":46,"disease":47,"label":48,"population":51,"type":55,"unit":29,"dose":56,"refs":57,"allowedFormulations":60,"notes":61},"naive","hiv",{"fa":49,"en":50},"HIV-1 درمان‌نشده یا بدون جهش مقاومت — ۸۰۰ mg + ریتوناویر ۱۰۰ mg یک بار با غذا","HIV-1 naive or no darunavir resistance — 800 mg + ritonavir 100 mg once daily with food",{"minAge":52},{"value":53,"unit":54},18,"year","fixed",{"perDose":28,"dosesPerDay":5},[58],{"source":34,"section":59},"2.3",[23],[62],{"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":59},{"id":69,"disease":47,"label":70,"population":73,"type":55,"unit":29,"dose":75,"refs":77,"allowedFormulations":81,"notes":82},"exp",{"fa":71,"en":72},"HIV-1 با دست‌کم یک جهش مقاومت، یا بارداری — ۶۰۰ mg + ریتوناویر ۱۰۰ mg دو بار با غذا","HIV-1 with ≥1 darunavir resistance substitution, or pregnancy — 600 mg + ritonavir 100 mg twice daily with food",{"minAge":74},{"value":53,"unit":54},{"perDose":40,"dosesPerDay":76},2,[78,79],{"source":34,"section":59},{"source":34,"section":80},"2.4",[37],[83],{"text":84,"refs":85},{"fa":64,"en":65},[86],{"source":34,"section":59},[88],{"id":89,"severity":90,"text":91,"refs":94},"ci","block",{"fa":92,"en":93},"داروهای با پاکسازی وابسته به CYP3A و دامنه درمانی باریک (آلفوزوسین، رانولازین، دروندارون، کلشی‌سین در نارسایی کلیه\u002Fکبد، لوراسیدون، پیموزاید، میدازولام خوراکی، تریازولام، سیلدنافیل برای PAH، سیمواستاتین، لواستاتین، ارگوت…) و القاگرهای قوی (ریفامپین، گل راعی).","Drugs highly dependent on CYP3A with narrow therapeutic index (alfuzosin, ranolazine, dronedarone, colchicine in renal\u002Fhepatic impairment, lurasidone, pimozide, oral midazolam, triazolam, sildenafil for PAH, simvastatin, lovastatin, ergots…) and strong inducers (rifampin, St John’s wort).",[95],{"source":34,"section":96},"4",[98],{"text":99,"refs":102},{"fa":100,"en":101},"سمیت کبد؛ واکنش شدید پوستی؛ داروناویر سولفونامید دارد (احتیاط در حساسیت به سولفا).","Hepatotoxicity; severe skin reactions; contains a sulfonamide moiety (caution in sulfa allergy).",[103],{"source":34,"section":104},"5",[],[],[],{"status":109,"reviewer":110,"date":110},"unverified",null,[112,117],{"regimen":46,"formulation":23,"input":113,"expect":116},{"ageYears":114,"weightKg":115},35,70,{"perDose":28,"tabletsPerDoseRounded":5},{"regimen":69,"formulation":37,"input":118,"expect":119},{"ageYears":114,"weightKg":115},{"perDose":40,"tabletsPerDoseRounded":5},[121],"J05AE10",{"status":123,"forms":124,"refs":137},"registered",[125,129,133],{"code":126,"en":127,"fa":128},"50333","DARUNAVIR (AS ETHANOLATE) TABLET ORAL 150 mg","قرص داروناویر (معادل اتانولات) ۱۵۰ میلی‌گرم",{"code":130,"en":131,"fa":132},"22525","DARUNAVIR (AS ETHANOLATE) TABLET ORAL 600 mg","قرص داروناویر (معادل اتانولات) ۶۰۰ میلی‌گرم",{"code":134,"en":135,"fa":136},"52875","DARUNAVIR (AS ETHANOLATE) TABLET ORAL 800 mg","قرص داروناویر (معادل اتانولات) ۸۰۰ میلی‌گرم",[138],{"source":139,"section":140,"url":141},"darooyab-generic","G-4695\u002FDarunavir","https:\u002F\u002Fwww.darooyab.ir\u002FG-4695\u002FDarunavir",{"kind":143,"refs":144,"id":147},"NDA",[145],{"source":34,"section":146},"SPL approval \u002F marketing category","NDA021976",[149,152,156,159,162],{"kind":150,"url":151,"label":147},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021976",{"kind":153,"url":154,"label":155},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=814301f9-c990-46a5-b481-2879a521a16f","FDA Prezista",{"kind":157,"url":158,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607042.html",{"kind":160,"url":161,"label":121},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AE10",{"kind":163,"url":141,"label":8},"darooyab",{"pregnancy":165,"lactation":174,"pediatric":182,"geriatric":190,"reproductive":198},{"level":166,"text":167,"quote":170,"refs":171},"caution",{"fa":168,"en":169},"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 Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects or miscarriage.",[172],{"source":34,"section":173},"8.1",{"level":166,"text":175,"quote":178,"refs":179},{"fa":176,"en":177},"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-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.",[180],{"source":34,"section":181},"8.2",{"level":166,"text":183,"quote":186,"refs":187},{"fa":184,"en":185},"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.","PREZISTA\u002Fritonavir is not recommended in pediatric patients below 3 years of age because of toxicity and mortality observed in juvenile rats dosed with darunavir (from 20 mg\u002Fkg to 1000 mg\u002Fkg) up to days 23 to 26 of age [see Warnings and Precautions (5.10) , Use in Specific Populations (8.1) and Clinical Pharmacology …",[188],{"source":34,"section":189},"8.4",{"level":166,"text":191,"quote":194,"refs":195},{"fa":192,"en":193},"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, caution should be exercised in the administration and monitoring of PREZISTA in elderly patients, reflecting the greater frequency of decreased hepatic function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .",[196],{"source":34,"section":197},"8.5",{"level":166,"text":199,"quote":202,"refs":203},{"fa":200,"en":201},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Use of PREZISTA may reduce the efficacy of combined hormonal contraceptives and the progestin only pill.",[204],{"source":34,"section":205},"8.3",1792191536217]