[{"data":1,"prerenderedAt":266},["ShallowReactive",2],{"drug-paliperidone":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":111,"warnings":121,"renal":136,"monitoring":137,"interactions":138,"review":147,"examples":150,"atc":165,"iran":167,"links":199,"populations":219,"usApproval":261},"paliperidone",1,{"fa":7,"en":8},"پالیپریدون","Paliperidone","nervous-system",{"fa":11,"en":12},"آنتی‌سایکوتیک آتیپیک","Atypical antipsychotic",[14],{"name":15,"market":16},"Invega","US",[18,19,7],"invega","اینوگا",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"er-3","tablet","oral","3 mg extended-release tablet (swallow whole)",{"amount":27,"unit":28,"perUnit":23,"scored":29},3,"mg",false,[16],[32],{"source":33,"section":34},"fda-invega","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"er-6","6 mg extended-release tablet (swallow whole)",{"amount":39,"unit":28,"perUnit":23,"scored":29},6,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"er-9","9 mg extended-release tablet (swallow whole)",{"amount":47,"unit":28,"perUnit":23,"scored":29},9,[16],[50],{"source":33,"section":34},[52,78,96],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":64,"limits":67,"notes":71},"scz","schizophrenia",{"fa":56,"en":57},"اسکیزوفرنی — بزرگسال ۶ mg یک بار در روز (۳ تا ۱۲ mg)","Schizophrenia — adult 6 mg once daily (3–12 mg)",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":39,"dosesPerDay":5},[65],{"source":33,"section":66},"2.1",{"maxPerDay":68,"refs":69},12,[70],{"source":33,"section":66},[72],{"text":73,"refs":76},{"fa":74,"en":75},"افزایش بالای ۶ mg فقط پس از ارزیابی، با فاصله بیش از ۵ روز و پله‌های ۳ mg.","Increase above 6 mg only after reassessment, at >5-day intervals, in 3 mg steps.",[77],{"source":33,"section":66},{"id":79,"disease":54,"label":80,"population":83,"type":62,"unit":28,"dose":86,"refs":87,"notes":89},"scz-teen",{"fa":81,"en":82},"اسکیزوفرنی نوجوان ۱۲ تا ۱۷ سال — ۳ mg یک بار در روز (حداکثر ۶ mg زیر ۵۱ kg، ۱۲ mg از ۵۱ kg)","Schizophrenia, adolescents 12–17 y — 3 mg once daily (max 6 mg \u003C51 kg, 12 mg ≥51 kg)",{"minAge":84,"maxAge":85},{"value":68,"unit":61},{"value":60,"unit":61},{"perDose":27,"dosesPerDay":5},[88],{"source":33,"section":66},[90],{"text":91,"refs":94},{"fa":92,"en":93},"افزایش با پله ۳ mg و فاصله بیش از ۵ روز.","Increase in 3 mg steps at intervals of more than 5 days.",[95],{"source":33,"section":66},{"id":97,"disease":98,"label":99,"population":102,"type":62,"unit":28,"dose":104,"refs":105,"limits":108},"sza","schizoaffective-disorder",{"fa":100,"en":101},"اسکیزوافکتیو — بزرگسال ۶ mg یک بار در روز (۳ تا ۱۲ mg)","Schizoaffective disorder — adult 6 mg once daily (3–12 mg)",{"minAge":103},{"value":60,"unit":61},{"perDose":39,"dosesPerDay":5},[106],{"source":33,"section":107},"2.2",{"maxPerDay":68,"refs":109},[110],{"source":33,"section":107},[112],{"id":113,"severity":114,"text":115,"refs":118},"hyper","block",{"fa":116,"en":117},"حساسیت به پالیپریدون، ریسپریدون یا اجزای فرآورده.","Hypersensitivity to paliperidone, risperidone or excipients.",[119],{"source":33,"section":120},"4",[122,129],{"text":123,"refs":126},{"fa":124,"en":125},"هشدار جعبه‌ای: افزایش مرگ در سالمندان با سایکوز ناشی از دمانس.","Boxed warning: increased mortality in elderly patients with dementia-related psychosis.",[127],{"source":33,"section":128},"Boxed Warning",{"text":130,"refs":133},{"fa":131,"en":132},"سندرم نورولپتیک بدخیم؛ طولانی شدن QT؛ دیسکینزی دیررس؛ تغییرات متابولیک؛ هیپرپرولاکتینمی.","Neuroleptic malignant syndrome; QT prolongation; tardive dyskinesia; metabolic changes; hyperprolactinaemia.",[134],{"source":33,"section":135},"5",[],[],[139],{"with":140,"text":141,"refs":144},"risperidone",{"fa":142,"en":143},"ریسپریدون: پالیپریدون متابولیت آن است؛ مواجهه جمعی در نظر گرفته شود.","Risperidone: paliperidone is its metabolite; consider additive exposure.",[145],{"source":33,"section":146},"2.4",{"status":148,"reviewer":149,"date":149},"unverified",null,[151,156,161],{"regimen":53,"formulation":36,"input":152,"expect":155},{"ageYears":153,"weightKg":154},30,75,{"perDose":39,"tabletsPerDoseRounded":5},{"regimen":79,"formulation":22,"input":157,"expect":160},{"ageYears":158,"weightKg":159},15,55,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":97,"formulation":36,"input":162,"expect":164},{"ageYears":163,"weightKg":154},35,{"perDose":39,"tabletsPerDoseRounded":5},[166],"N05AX13",{"status":168,"forms":169,"refs":194},"registered",[170,174,178,182,186,190],{"code":171,"en":172,"fa":173},"14603","PALIPERIDONE 3MG TAB","قرص پالی‌پریدون ۳ میلی‌گرم",{"code":175,"en":176,"fa":177},"16426","PALIPERIDONE 6MG TAB","قرص پالی‌پریدون ۶ میلی‌گرم",{"code":179,"en":180,"fa":181},"16427","PALIPERIDONE 9MG TAB","قرص پالی‌پریدون ۹ میلی‌گرم",{"code":183,"en":184,"fa":185},"52748","PALIPERIDONE TABLET, EXTENDED RELEASE ORAL 9 mg","قرص آهسته‌رهش پالی‌پریدون ۹ میلی‌گرم",{"code":187,"en":188,"fa":189},"51865","PALIPERIDONE TABLET, EXTENDED RELEASE ORAL 3 mg","قرص آهسته‌رهش پالی‌پریدون ۳ میلی‌گرم",{"code":191,"en":192,"fa":193},"51202","PALIPERIDONE PALMITATE INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 117 mg\u002F0.75mL","فرآورده تزریقی پالی‌پریدون پالمیتات ۱۱۷ میلی‌گرم \u002F ۰٫۷۵ میلی‌لیتر",[195],{"source":196,"section":197,"url":198},"darooyab-generic","G-4786\u002FPaliperidone","https:\u002F\u002Fwww.darooyab.ir\u002FG-4786\u002FPaliperidone",[200,204,208,211,214,217],{"kind":201,"url":202,"label":203},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021999","NDA021999",{"kind":205,"url":206,"label":207},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7b8e5b26-b9e4-4704-921b-3c3c0d159916","FDA Invega",{"kind":209,"url":210,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607005.html",{"kind":209,"url":212,"label":213},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615032.html","Paliperidone Injection",{"kind":215,"url":216,"label":166},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N05AX13",{"kind":218,"url":198,"label":8},"darooyab",{"pregnancy":220,"lactation":229,"pediatric":237,"geriatric":245,"reproductive":253},{"level":221,"text":222,"quote":225,"refs":226},"caution",{"fa":223,"en":224},"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 Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and\u002For withdrawal symptoms following delivery (see Clinical Considerations ) .",[227],{"source":33,"section":228},"8.1",{"level":221,"text":230,"quote":233,"refs":234},{"fa":231,"en":232},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Limited data from published literature report the presence of paliperidone in human breast milk.",[235],{"source":33,"section":236},"8.2",{"level":221,"text":238,"quote":241,"refs":242},{"fa":239,"en":240},"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.","Safety and effectiveness of INVEGA in the treatment of schizophrenia were evaluated in 150 adolescent subjects 12–17 years of age with schizophrenia who received INVEGA in the dose range of 1.5 mg to 12 mg\u002Fday in a 6-week, double-blind, placebo-controlled trial.",[243],{"source":33,"section":244},"8.4",{"level":246,"text":247,"quote":250,"refs":251},"avoid",{"fa":248,"en":249},"برچسب: در سالمندان هشدار جدی یا پرهیز.","Label: serious warning or avoid in older adults.","Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.",[252],{"source":33,"section":128},{"level":221,"text":254,"quote":257,"refs":258},{"fa":255,"en":256},"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 Females Based on the pharmacologic action of paliperidone (D 2 receptor antagonism), treatment with INVEGA may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see Warnings and Precautions (5.7) ].",[259],{"source":33,"section":260},"8.3",{"kind":262,"refs":263,"id":203},"NDA",[264],{"source":33,"section":265},"SPL approval \u002F marketing category",1792115191427]