[{"data":1,"prerenderedAt":233},["ShallowReactive",2],{"drug-cyclosporine-oral":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":24,"regimens":55,"contraindications":129,"warnings":139,"renal":147,"monitoring":148,"interactions":149,"review":150,"examples":153,"atc":165,"iran":167,"usApproval":174,"links":180,"populations":198},"cyclosporine-oral",1,{"fa":7,"en":8},"سیکلوسپورین خوراکی (Neoral)","Cyclosporine (oral, modified)","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده کلسی‌نورین","Calcineurin inhibitor",[14],{"name":15,"market":16},"Neoral","US",[18,19,20,21,22,23],"neoral","sandimmune","gengraf","سیکلوسپورین","ایمونورال","ciclosporin",[25,38,48],{"id":26,"form":27,"route":28,"label":29,"concentration":30,"markets":33,"refs":34},"sol-100","solution","oral","100 mg\u002FmL oral solution",{"amount":31,"unit":32,"perVolumeMl":5},100,"mg",[16],[35],{"source":36,"section":37},"fda-neoral","How Supplied",{"id":39,"form":40,"route":28,"label":41,"concentration":42,"markets":45,"refs":46},"cap-25","capsule","25 mg capsule",{"amount":43,"unit":32,"perUnit":40,"scored":44},25,false,[16],[47],{"source":36,"section":37},{"id":49,"form":40,"route":28,"label":50,"concentration":51,"markets":52,"refs":53},"cap-100","100 mg capsule",{"amount":31,"unit":32,"perUnit":40,"scored":44},[16],[54],{"source":36,"section":37},[56,90,115],{"id":57,"disease":58,"label":59,"population":62,"type":66,"unit":32,"dose":67,"refs":70,"limits":73,"notes":77},"ra","rheumatoid-arthritis",{"fa":60,"en":61},"آرتریت روماتوئید — شروع ۲٫۵ mg\u002Fkg\u002Fروز در دو دوز","Rheumatoid arthritis — start 2.5 mg\u002Fkg\u002Fday in two doses",{"minAge":63},{"value":64,"unit":65},18,"year","weightBased",{"perKgPerDay":68,"dividedDoses":69},2.5,2,[71],{"source":36,"section":72},"Dosage and Administration",{"maxPerKgPerDay":74,"refs":75},4,[76],{"source":36,"section":72},[78,84],{"text":79,"refs":82},{"fa":80,"en":81},"Neoral و Sandimmune هم‌ارز زیستی نیستند و بدون نظارت پزشک جایگزین نمی‌شوند. همیشه در دو دوز. فشار خون و کراتینین پایش شود.","Neoral and Sandimmune are not bioequivalent and must not be interchanged without physician supervision. Always in two doses. Monitor BP and creatinine.",[83],{"source":36,"section":72},{"text":85,"refs":88},{"fa":86,"en":87},"اثر پس از ۴ تا ۸ هفته. افزایش ۰٫۵ تا ۰٫۷۵ mg\u002Fkg\u002Fروز پس از ۸ و ۱۲ هفته تا حداکثر ۴ mg\u002Fkg\u002Fروز.","Onset 4–8 weeks. Increase by 0.5–0.75 mg\u002Fkg\u002Fday after 8 and 12 weeks up to 4 mg\u002Fkg\u002Fday.",[89],{"source":36,"section":72},{"id":91,"disease":92,"label":93,"population":96,"type":66,"unit":32,"dose":98,"refs":99,"limits":101,"notes":104},"pso","psoriasis",{"fa":94,"en":95},"پسوریازیس شدید — شروع ۲٫۵ mg\u002Fkg\u002Fروز (۱٫۲۵ mg\u002Fkg دو بار)","Severe psoriasis — start 2.5 mg\u002Fkg\u002Fday (1.25 mg\u002Fkg twice daily)",{"minAge":97},{"value":64,"unit":65},{"perKgPerDay":68,"dividedDoses":69},[100],{"source":36,"section":72},{"maxPerKgPerDay":74,"refs":102},[103],{"source":36,"section":72},[105,109],{"text":106,"refs":107},{"fa":80,"en":81},[108],{"source":36,"section":72},{"text":110,"refs":113},{"fa":111,"en":112},"دست‌کم ۴ هفته؛ سپس هر ۲ هفته حدود ۰٫۵ mg\u002Fkg\u002Fروز افزایش تا حداکثر ۴ mg\u002Fkg\u002Fروز.","At least 4 weeks; then increase about 0.5 mg\u002Fkg\u002Fday every 2 weeks up to 4 mg\u002Fkg\u002Fday.",[114],{"source":36,"section":72},{"id":116,"disease":117,"label":118,"population":121,"type":122,"unit":32,"dose":123,"refs":127},"tx","transplant-rejection",{"fa":119,"en":120},"پیوند عضو — دوز اولیه بر اساس عضو و پروتکل (میانگین ۷ تا ۹ mg\u002Fkg\u002Fروز)","Organ transplant — initial dose by organ and protocol (mean 7–9 mg\u002Fkg\u002Fday)",{},"notCalculated",{"reason":124},{"fa":125,"en":126},"برچسب فقط میانگین مراکز را ذکر کرده (کلیه ۹±۳، کبد ۸±۴، قلب ۷±۳ mg\u002Fkg\u002Fروز) و دوز بر اساس سطح خونی تنظیم می‌شود؛ طبق پروتکل مرکز پیوند.","The label only gives centre survey means (kidney 9±3, liver 8±4, heart 7±3 mg\u002Fkg\u002Fday); dose is adjusted by blood levels — follow the transplant centre protocol.",[128],{"source":36,"section":72},[130],{"id":131,"severity":132,"text":133,"refs":136},"ci","block",{"fa":134,"en":135},"حساسیت به سیکلوسپورین. RA و پسوریازیس: نارسایی کلیه، فشار خون کنترل‌نشده یا بدخیمی. پسوریازیس: همراه PUVA یا UVB، متوترکسات یا سایر سرکوب‌کننده‌ها، قطران یا پرتودرمانی نه.","Hypersensitivity to cyclosporine. RA and psoriasis: abnormal renal function, uncontrolled hypertension or malignancy. Psoriasis: not with PUVA or UVB, methotrexate or other immunosuppressants, coal tar or radiation.",[137],{"source":36,"section":138},"Contraindications",[140],{"text":141,"refs":144},{"fa":142,"en":143},"هشدار جعبه‌ای: فقط توسط پزشک مجرب در سرکوب ایمنی؛ عفونت و لنفوم؛ سمیت کلیه و فشار خون؛ پسوریازیس با PUVA قبلی خطر سرطان پوست.","Boxed warning: only by physicians experienced in immunosuppression; infection and lymphoma; nephrotoxicity and hypertension; psoriasis after PUVA — skin cancer risk.",[145],{"source":36,"section":146},"Boxed Warning",[],[],[],{"status":151,"reviewer":152,"date":152},"unverified",null,[154,161],{"regimen":57,"formulation":26,"input":155,"expect":158},{"ageYears":156,"weightKg":157},50,70,{"perDose":159,"mlPerDose":160},87.5,0.88,{"regimen":91,"formulation":26,"input":162,"expect":164},{"ageYears":163,"weightKg":157},40,{"perDose":159,"mlPerDose":160},[166],"L04AD01",{"status":168,"refs":169},"not-found",[170],{"source":171,"section":172,"url":173},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Cyclosporine",{"kind":175,"refs":176,"id":179},"NDA",[177],{"source":36,"section":178},"SPL approval \u002F marketing category","NDA050715",[181,184,188,192,195],{"kind":182,"url":183,"label":179},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=050715",{"kind":185,"url":186,"label":187},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=94461af3-11f1-4670-95d4-2965b9538ae3","FDA Neoral",{"kind":189,"url":190,"label":191},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa601207.html","Cyclosporine",{"kind":189,"url":193,"label":194},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa684054.html","Cyclosporine Injection",{"kind":196,"url":197,"label":166},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AD01",{"pregnancy":199,"lactation":208,"pediatric":216,"geriatric":225},{"level":200,"text":201,"quote":204,"refs":205},"caution",{"fa":202,"en":203},"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 Available data from published literature, including the Transplant Pregnancy Registry International, observational cohort studies, case-controlled studies, meta-analysis, case series, and case reports, over decades of use with cyclosporine in pregnancy have not identified a drug associated risk of major …",[206],{"source":36,"section":207},"Pregnancy",{"level":200,"text":209,"quote":212,"refs":213},{"fa":210,"en":211},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Cyclosporine and its metabolites are present in human milk following oral and intravenous administration.",[214],{"source":36,"section":215},"Nursing Mothers",{"level":217,"text":218,"quote":221,"refs":222},"not-established",{"fa":219,"en":220},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and efficacy of Neoral treatment in children with juvenile rheumatoid arthritis or psoriasis below the age of 18 have not been established.",[223],{"source":36,"section":224},"Pediatric Use",{"level":200,"text":226,"quote":229,"refs":230},{"fa":227,"en":228},"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, dose selection for an elderly patient should be cautious, 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.",[231],{"source":36,"section":232},"Geriatric Use",1792156172561]