[{"data":1,"prerenderedAt":427},["ShallowReactive",2],{"drug-risperidone":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":74,"contraindications":201,"warnings":211,"renal":263,"monitoring":273,"interactions":280,"review":281,"examples":283,"atc":311,"iran":313,"links":361,"populations":381,"usApproval":422},"risperidone",1,{"fa":7,"en":8},"ریسپریدون","Risperidone","nervous-system",{"fa":11,"en":12},"آنتی‌سایکوتیک آتیپیک","Atypical antipsychotic",[14],{"name":15,"market":16},"Risperdal","US",[18,7,19],"risperidon","risperdal",[21,33,43,50,58,66],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":28,"refs":29},"sol-1-1","solution","oral","1 mg \u002F mL oral solution",{"amount":5,"unit":27,"perVolumeMl":5},"mg",[16],[30],{"source":31,"section":32},"fda-risperdal","3",{"id":34,"form":35,"route":24,"label":36,"concentration":37,"markets":40,"refs":41},"tab-0-5","tablet","0.5 mg tablet",{"amount":38,"unit":27,"perUnit":35,"scored":39},0.5,false,[16],[42],{"source":31,"section":32},{"id":44,"form":35,"route":24,"label":45,"concentration":46,"markets":47,"refs":48},"tab-1","1 mg tablet",{"amount":5,"unit":27,"perUnit":35,"scored":39},[16],[49],{"source":31,"section":32},{"id":51,"form":35,"route":24,"label":52,"concentration":53,"markets":55,"refs":56},"tab-2","2 mg tablet",{"amount":54,"unit":27,"perUnit":35,"scored":39},2,[16],[57],{"source":31,"section":32},{"id":59,"form":35,"route":24,"label":60,"concentration":61,"markets":63,"refs":64},"tab-3","3 mg tablet",{"amount":62,"unit":27,"perUnit":35,"scored":39},3,[16],[65],{"source":31,"section":32},{"id":67,"form":35,"route":24,"label":68,"concentration":69,"markets":71,"refs":72},"tab-4","4 mg tablet",{"amount":70,"unit":27,"perUnit":35,"scored":39},4,[16],[73],{"source":31,"section":32},[75,114,139,159,183],{"id":76,"disease":76,"label":77,"population":80,"type":87,"unit":27,"dose":88,"refs":96,"notes":101},"autism-irritability",{"fa":78,"en":79},"تحریک‌پذیری در اوتیسم — ۵ تا ۱۷ سال","Irritability with autistic disorder — 5 to 17 years",{"minAge":81,"maxAge":84,"minWeightKg":86},{"value":82,"unit":83},5,"year",{"value":85,"unit":83},18,15,"titration",{"dividedDoses":5,"weightBands":89},[90,94],{"start":91,"increment":91,"incrementEveryDays":92,"targetMin":38,"targetMax":38,"max":62,"minWeightKg":86,"maxWeightKg":93},0.25,14,20,{"start":38,"increment":38,"incrementEveryDays":92,"targetMin":5,"targetMax":5,"max":62,"minWeightKg":93,"maxWeightKg":95},null,[97,99],{"source":31,"section":98},"2.3",{"source":31,"section":100},"1.3",[102,108],{"text":103,"refs":106},{"fa":104,"en":105},"پس از حداقل ۴ روز به دوز توصیه‌شده (زیر ۲۰ کیلوگرم: ۰٫۵ mg\u002Fday؛ ۲۰ کیلوگرم به بالا: ۱ mg\u002Fday) برسانید و حداقل ۱۴ روز ادامه دهید؛ سپس افزایش با فاصله ۲ هفته یا بیشتر.","After a minimum of 4 days increase to the recommended dose (\u003C20 kg: 0.5 mg\u002Fday; ≥20 kg: 1 mg\u002Fday) and maintain for at least 14 days; further increases at intervals of ≥2 weeks.",[107],{"source":31,"section":98},{"text":109,"refs":112},{"fa":110,"en":111},"محدوده مؤثر ۰٫۵ تا ۳ mg\u002Fday. برای وزن زیر ۱۵ کیلوگرم داده‌ای وجود ندارد. کل دوز یک‌بار یا نصف آن دو بار در روز.","Effective range 0.5–3 mg\u002Fday. No dosing data below 15 kg. Total daily dose once daily, or half twice daily.",[113],{"source":31,"section":98},{"id":115,"disease":116,"label":117,"population":120,"type":87,"unit":27,"dose":124,"refs":127,"notes":132},"schizophrenia-adolescent","schizophrenia",{"fa":118,"en":119},"اسکیزوفرنی — نوجوانان ۱۳ تا ۱۷ سال","Schizophrenia — adolescents 13 to 17 years",{"minAge":121,"maxAge":123},{"value":122,"unit":83},13,{"value":85,"unit":83},{"dividedDoses":5,"titration":125},{"start":38,"increment":38,"incrementEveryDays":5,"targetMin":62,"targetMax":62,"max":126},6,[128,130],{"source":31,"section":129},"2.1",{"source":31,"section":131},"8.4",[133],{"text":134,"refs":137},{"fa":135,"en":136},"افزایش ۰٫۵ یا ۱ mg\u002Fday با فاصله ۲۴ ساعت یا بیشتر تا ۳ mg\u002Fday. بالاتر از ۳ mg\u002Fday سود اضافه دیده نشد؛ بالاتر از ۶ mg\u002Fday مطالعه نشده است.","Increase by 0.5 or 1 mg\u002Fday at intervals of ≥24 h to 3 mg\u002Fday. No added benefit above 3 mg\u002Fday; doses above 6 mg\u002Fday not studied.",[138],{"source":31,"section":129},{"id":140,"disease":116,"label":141,"population":144,"type":87,"unit":27,"dose":146,"refs":150,"notes":152},"schizophrenia-adult",{"fa":142,"en":143},"اسکیزوفرنی — بزرگسالان","Schizophrenia — adults",{"minAge":145},{"value":85,"unit":83},{"dividedDoses":5,"titration":147},{"start":54,"increment":5,"incrementEveryDays":5,"targetMin":70,"targetMax":148,"max":149},8,16,[151],{"source":31,"section":129},[153],{"text":154,"refs":157},{"fa":155,"en":156},"افزایش ۱ تا ۲ mg\u002Fday با فاصله ۲۴ ساعت یا بیشتر تا ۴ تا ۸ mg\u002Fday. بالاتر از ۶ mg\u002Fday در دو نوبت مؤثرتر نبود؛ بی‌خطری بالاتر از ۱۶ mg\u002Fday ارزیابی نشده است.","Increase by 1–2 mg\u002Fday at intervals of ≥24 h to 4–8 mg\u002Fday. Above 6 mg\u002Fday twice daily not more efficacious; safety above 16 mg\u002Fday not evaluated.",[158],{"source":31,"section":129},{"id":160,"disease":161,"label":162,"population":165,"type":87,"unit":27,"dose":169,"refs":172,"notes":176},"bipolar-pediatric","bipolar-mania",{"fa":163,"en":164},"مانیای دوقطبی — ۱۰ تا ۱۷ سال","Bipolar mania — 10 to 17 years",{"minAge":166,"maxAge":168},{"value":167,"unit":83},10,{"value":85,"unit":83},{"dividedDoses":5,"titration":170},{"start":38,"increment":38,"incrementEveryDays":5,"targetMin":5,"targetMax":171,"max":126},2.5,[173,175],{"source":31,"section":174},"2.2",{"source":31,"section":131},[177],{"text":178,"refs":181},{"fa":179,"en":180},"افزایش ۰٫۵ یا ۱ mg\u002Fday با فاصله ۲۴ ساعت یا بیشتر تا هدف ۱ تا ۲٫۵ mg\u002Fday. بالاتر از ۲٫۵ سود اضافه نداشت؛ بالاتر از ۶ mg\u002Fday مطالعه نشده است.","Increase by 0.5 or 1 mg\u002Fday at intervals of ≥24 h to target 1–2.5 mg\u002Fday. No added benefit above 2.5 mg\u002Fday; above 6 mg\u002Fday not studied.",[182],{"source":31,"section":174},{"id":184,"disease":161,"label":185,"population":188,"type":87,"unit":27,"dose":190,"refs":192,"notes":194},"bipolar-adult",{"fa":186,"en":187},"مانیای دوقطبی — بزرگسالان","Bipolar mania — adults",{"minAge":189},{"value":85,"unit":83},{"dividedDoses":5,"titration":191},{"start":54,"increment":5,"incrementEveryDays":5,"targetMin":5,"targetMax":126,"max":126},[193],{"source":31,"section":174},[195],{"text":196,"refs":199},{"fa":197,"en":198},"دوز اولیه ۲ تا ۳ mg\u002Fday؛ افزایش ۱ mg\u002Fday با فاصله ۲۴ ساعت یا بیشتر. محدوده مؤثر ۱ تا ۶ mg\u002Fday.","Initial 2–3 mg\u002Fday; adjust by 1 mg\u002Fday at intervals of ≥24 h. Effective range 1–6 mg\u002Fday.",[200],{"source":31,"section":174},[202],{"id":203,"severity":204,"text":205,"refs":208},"hypersensitivity","block",{"fa":206,"en":207},"حساسیت شناخته‌شده به ریسپریدون، پالیپریدون یا اجزای فرآورده.","Known hypersensitivity to risperidone, paliperidone or any excipient.",[209],{"source":31,"section":210},"4",[212,221,228,235,242,249,256],{"text":213,"refs":216},{"fa":214,"en":215},"هشدار جعبه‌ای: افزایش مرگ‌ومیر در سالمندان مبتلا به سایکوز ناشی از دمانس؛ برای این کاربرد تأیید نشده است.","Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for this use.",[217,219],{"source":31,"section":218},"Boxed Warning",{"source":31,"section":220},"5.1",{"text":222,"refs":225},{"fa":223,"en":224},"سندرم نورولپتیک بدخیم","Neuroleptic malignant syndrome",[226],{"source":31,"section":227},"5.3",{"text":229,"refs":232},{"fa":230,"en":231},"دیسکینزی دیررس","Tardive dyskinesia",[233],{"source":31,"section":234},"5.4",{"text":236,"refs":239},{"fa":237,"en":238},"تغییرات متابولیک","Metabolic changes",[240],{"source":31,"section":241},"5.5",{"text":243,"refs":246},{"fa":244,"en":245},"هایپرپرولاکتینمی","Hyperprolactinemia",[247],{"source":31,"section":248},"5.6",{"text":250,"refs":253},{"fa":251,"en":252},"افت فشار ارتوستاتیک","Orthostatic hypotension",[254],{"source":31,"section":255},"5.7",{"text":257,"refs":260},{"fa":258,"en":259},"سقوط","Falls",[261],{"source":31,"section":262},"5.8",[264],{"egfrBelow":265,"severity":266,"text":267,"refs":270},30,"warn",{"fa":268,"en":269},"نارسایی شدید کلیه (Clcr \u003C ۳۰): شروع ۰٫۵ mg دو بار در روز؛ افزایش ۰٫۵ mg یا کمتر؛ بالاتر از ۱٫۵ mg دو بار در روز با فاصله یک هفته یا بیشتر.","Severe renal impairment (Clcr \u003C30): start 0.5 mg twice daily; increase by ≤0.5 mg twice daily; above 1.5 mg twice daily at intervals of ≥1 week.",[271],{"source":31,"section":272},"2.4",[274],{"text":275,"refs":278},{"fa":276,"en":277},"پایش متابولیک (قند، چربی، وزن)","Metabolic monitoring (glucose, lipids, weight)",[279],{"source":31,"section":241},[],{"status":282,"reviewer":95,"date":95},"unverified",[284,287,291,295,299,303,308],{"regimen":76,"formulation":22,"input":285,"expect":286},{"ageYears":126,"weightKg":85},{"perDose":91,"mlPerDose":91},{"regimen":76,"formulation":22,"input":288,"expect":290},{"ageYears":289,"weightKg":265},9,{"perDose":38,"mlPerDose":38},{"regimen":76,"formulation":22,"input":292,"expect":293},{"ageYears":82,"weightKg":92},{"status":294},"blocked",{"regimen":115,"formulation":22,"input":296,"expect":298},{"ageYears":86,"weightKg":297},55,{"perDose":38},{"regimen":140,"formulation":51,"input":300,"expect":302},{"ageYears":265,"weightKg":301},70,{"perDose":54,"tabletsPerDoseRounded":5},{"regimen":160,"formulation":22,"input":304,"expect":307},{"ageYears":305,"weightKg":306},12,40,{"perDose":38},{"regimen":184,"formulation":51,"input":309,"expect":310},{"ageYears":265,"weightKg":301},{"tabletsPerDoseRounded":5},[312],"N05AX08",{"status":314,"forms":315,"refs":356},"registered",[316,320,324,328,332,336,340,344,348,352],{"code":317,"en":318,"fa":319},"01773","RISPERIDONE 1MG TAB","قرص ریسپریدون ۱ میلی‌گرم",{"code":321,"en":322,"fa":323},"16293","RISPERIDONE 1MG\u002FML SYRUP","شربت ریسپریدون ۱ میلی‌گرم \u002F میلی‌لیتر",{"code":325,"en":326,"fa":327},"08127","RISPERIDONE 25MG LA INJ","فرآورده تزریقی ریسپریدون ۲۵ میلی‌گرم طولانی‌اثر",{"code":329,"en":330,"fa":331},"01774","RISPERIDONE 2MG TAB","قرص ریسپریدون ۲ میلی‌گرم",{"code":333,"en":334,"fa":335},"19736","RISPERIDONE 37.5MG LA INJ","فرآورده تزریقی ریسپریدون ۳۷٫۵ میلی‌گرم طولانی‌اثر",{"code":337,"en":338,"fa":339},"01869","RISPERIDONE 3MG TAB","قرص ریسپریدون ۳ میلی‌گرم",{"code":341,"en":342,"fa":343},"01870","RISPERIDONE 4MG TAB","قرص ریسپریدون ۴ میلی‌گرم",{"code":345,"en":346,"fa":347},"50088","RISPERIDONE SOLUTION ORAL 1 mg\u002F1mL 100 mL","محلول خوراکی ریسپریدون ۱ میلی‌گرم \u002F ۱ میلی‌لیتر ۱۰۰ میلی‌لیتر",{"code":349,"en":350,"fa":351},"50996","RISPERIDONE INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE PARENTERAL 50 mg","پودر تزریقی ریسپریدون ۵۰ میلی‌گرم",{"code":353,"en":354,"fa":355},"52191","RISPERIDONE SOLUTION ORAL 1 mg\u002F1mL 30 mL","محلول خوراکی ریسپریدون ۱ میلی‌گرم \u002F ۱ میلی‌لیتر ۳۰ میلی‌لیتر",[357],{"source":358,"section":359,"url":360},"darooyab-generic","G-1343\u002FRisperidone","https:\u002F\u002Fwww.darooyab.ir\u002FG-1343\u002FRisperidone",[362,366,370,373,376,379],{"kind":363,"url":364,"label":365},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=020272","NDA020272",{"kind":367,"url":368,"label":369},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0","FDA Risperdal",{"kind":371,"url":372,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa694015.html",{"kind":371,"url":374,"label":375},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615012.html","Risperidone Injection",{"kind":377,"url":378,"label":312},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N05AX08",{"kind":380,"url":360,"label":8},"darooyab",{"pregnancy":382,"lactation":391,"pediatric":399,"geriatric":406,"reproductive":414},{"level":383,"text":384,"quote":387,"refs":388},"caution",{"fa":385,"en":386},"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 ) .",[389],{"source":31,"section":390},"8.1",{"level":383,"text":392,"quote":395,"refs":396},{"fa":393,"en":394},"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 reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% of the maternal weight-adjusted dosage.",[397],{"source":31,"section":398},"8.2",{"level":383,"text":400,"quote":403,"refs":404},{"fa":401,"en":402},"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 RISPERDAL in children less than 13 years of age with schizophrenia have not been established.",[405],{"source":31,"section":131},{"level":407,"text":408,"quote":411,"refs":412},"avoid",{"fa":409,"en":410},"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.",[413],{"source":31,"section":218},{"level":383,"text":415,"quote":418,"refs":419},{"fa":416,"en":417},"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 risperidone (D 2 receptor antagonism), treatment with RISPERDAL 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 (5.6) ].",[420],{"source":31,"section":421},"8.3",{"kind":423,"refs":424,"id":365},"NDA",[425],{"source":31,"section":426},"SPL approval \u002F marketing category",1792440739573]