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Above 300 not recommended.",[130],{"source":34,"section":117},{"id":132,"disease":104,"label":133,"population":136,"type":112,"unit":29,"dose":138,"refs":140,"limits":143,"notes":147},"phn",{"fa":134,"en":135},"درد پس از زونا — ۷۵ mg دو بار (یا ۵۰ mg سه بار)","Postherpetic neuralgia — 75 mg twice daily (or 50 mg three times daily)",{"minAge":137},{"value":110,"unit":111},{"perDose":48,"perDoseMax":64,"dosesPerDay":139},2,[141],{"source":119,"section":142},"2.3",{"maxPerDay":144,"refs":145},600,[146],{"source":119,"section":120},[148],{"text":149,"refs":152},{"fa":150,"en":151},"۱۵۰ تا ۳۰۰ mg\u002Fday؛ بالای ۳۰۰ فقط اگر درد ادامه دارد و ۳۰۰ تحمل شده (حداکثر ۶۰۰).","150–300 mg\u002Fday; above 300 only if pain persists and 300 is tolerated (max 600).",[153],{"source":119,"section":142},{"id":155,"disease":156,"label":157,"population":160,"type":112,"unit":29,"dose":162,"refs":163,"limits":167},"fibro","fibromyalgia",{"fa":158,"en":159},"فیبرومیالژیا — شروع ۱۵۰ mg\u002Fday، هدف ۳۰۰ تا ۴۵۰","Fibromyalgia — start 150 mg\u002Fday, target 300–450",{"minAge":161},{"value":110,"unit":111},{"perDose":48,"dosesPerDay":139},[164,166],{"source":119,"section":165},"2.5",{"source":119,"section":120},{"maxPerDay":168,"refs":169},450,[170],{"source":119,"section":165},{"id":172,"disease":173,"label":174,"population":177,"type":112,"unit":29,"dose":180,"refs":181,"limits":184},"epi-adult","epilepsy",{"fa":175,"en":176},"صرع پارشیل (کمکی) — ۱۷ سال به بالا: شروع ۱۵۰ mg\u002Fday","Partial seizures (adjunct) — ≥17 y: start 150 mg\u002Fday",{"minAge":178},{"value":179,"unit":111},17,{"perDose":48,"dosesPerDay":139},[182],{"source":34,"section":183},"2.4, Table 1",{"maxPerDay":144,"refs":185},[186],{"source":34,"section":183},{"id":188,"disease":173,"label":189,"population":192,"type":197,"unit":29,"dose":198,"refs":200,"limits":202},"epi-ge30",{"fa":190,"en":191},"صرع پارشیل (کمکی) — کودک ۳۰ kg به بالا: شروع ۲٫۵ mg\u002Fkg\u002Fday","Partial seizures (adjunct) — child ≥30 kg: start 2.5 mg\u002Fkg\u002Fday",{"minAge":193,"maxAge":195,"minWeightKg":196},{"value":5,"unit":194},"month",{"value":179,"unit":111},30,"weightBased",{"perKgPerDay":199,"dividedDoses":139},2.5,[201],{"source":34,"section":183},{"maxPerKgPerDay":203,"maxPerDay":144,"refs":204},10,[205],{"source":34,"section":183},{"id":207,"disease":173,"label":208,"population":211,"type":197,"unit":29,"dose":215,"refs":217,"limits":219,"notes":223},"epi-lt30",{"fa":209,"en":210},"صرع پارشیل (کمکی) — کودک زیر ۳۰ kg: شروع ۳٫۵ mg\u002Fkg\u002Fday","Partial seizures (adjunct) — child \u003C30 kg: start 3.5 mg\u002Fkg\u002Fday",{"minAge":212,"maxAge":213,"maxWeightKg":214},{"value":5,"unit":194},{"value":179,"unit":111},29.99,{"perKgPerDay":216,"dividedDoses":114},3.5,[218],{"source":34,"section":183},{"maxPerKgPerDay":220,"refs":221},14,[222],{"source":34,"section":183},[224],{"text":225,"refs":228},{"fa":226,"en":227},"حداکثر ۱۴ mg\u002Fkg\u002Fday. ۱ ماه تا ۴ سال: سه نوبت؛ ۴ سال به بالا: دو یا سه نوبت.","Max 14 mg\u002Fkg\u002Fday. 1 month–4 y: three doses; ≥4 y: two or three doses.",[229],{"source":34,"section":183},[231],{"id":232,"severity":233,"text":234,"refs":237},"ci","block",{"fa":235,"en":236},"حساسیت به پرگابالین.","Hypersensitivity to pregabalin.",[238],{"source":119,"section":239},"4",[],[],[],[],{"status":245,"reviewer":246,"date":246},"unverified",null,[248,253,257,262,265,269],{"regimen":103,"formulation":37,"input":249,"expect":252},{"ageYears":250,"weightKg":251},60,80,{"perDose":40,"perDay":64},{"regimen":132,"formulation":45,"input":254,"expect":256},{"ageYears":255,"weightKg":255},70,{"perDose":48,"upperPerDose":64},{"regimen":155,"formulation":45,"input":258,"expect":261},{"ageYears":259,"weightKg":260},45,65,{"perDay":64},{"regimen":172,"formulation":45,"input":263,"expect":264},{"ageYears":196,"weightKg":255},{"perDay":64},{"regimen":188,"formulation":93,"input":266,"expect":268},{"ageYears":203,"weightKg":267},40,{"perDose":40,"mlPerDose":199},{"regimen":207,"formulation":93,"input":270,"expect":271},{"ageYears":114,"weightKg":97},{"perDose":272},23.33,[274],"N02BF02",{"status":276,"forms":277,"refs":326},"registered",[278,282,286,290,294,298,302,306,310,314,318,322],{"code":279,"en":280,"fa":281},"09417","PREGABALIN 100MG CAP","کپسول پرگابالین ۱۰۰ میلی‌گرم",{"code":283,"en":284,"fa":285},"07928","PREGABALIN 150MG CAP","کپسول پرگابالین ۱۵۰ میلی‌گرم",{"code":287,"en":288,"fa":289},"15775","PREGABALIN 150MG TAB","قرص پرگابالین ۱۵۰ میلی‌گرم",{"code":291,"en":292,"fa":293},"12199","PREGABALIN 200MG CAP","کپسول پرگابالین ۲۰۰ میلی‌گرم",{"code":295,"en":296,"fa":297},"15311","PREGABALIN 225MG CAP","کپسول پرگابالین ۲۲۵ میلی‌گرم",{"code":299,"en":300,"fa":301},"09628","PREGABALIN 25MG CAP","کپسول پرگابالین ۲۵ میلی‌گرم",{"code":303,"en":304,"fa":305},"15566","PREGABALIN 25MG TAB","قرص پرگابالین ۲۵ میلی‌گرم",{"code":307,"en":308,"fa":309},"08525","PREGABALIN 300MG CAP","کپسول پرگابالین ۳۰۰ میلی‌گرم",{"code":311,"en":312,"fa":313},"14295","PREGABALIN 300MG TAB","قرص پرگابالین ۳۰۰ میلی‌گرم",{"code":315,"en":316,"fa":317},"08526","PREGABALIN 50MG CAP","کپسول پرگابالین ۵۰ میلی‌گرم",{"code":319,"en":320,"fa":321},"07239","PREGABALIN 75MG CAP","کپسول پرگابالین ۷۵ میلی‌گرم",{"code":323,"en":324,"fa":325},"15567","PREGABALIN 75MG TAB","قرص پرگابالین ۷۵ میلی‌گرم",[327],{"source":328,"section":329,"url":330},"darooyab-generic","G-680\u002FPregabalin","https:\u002F\u002Fwww.darooyab.ir\u002FG-680\u002FPregabalin",[332,336,340,343,346,349],{"kind":333,"url":334,"label":335},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021446","NDA021446",{"kind":337,"url":338,"label":339},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9","FDA Lyrica",{"kind":337,"url":341,"label":342},"https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=44ec2918-4e0c-4e2d-9157-81295a15df57","FDA Pregabalin",{"kind":344,"url":345,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605045.html",{"kind":347,"url":348,"label":274},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N02BF02",{"kind":350,"url":330,"label":8},"darooyab",{"pregnancy":352,"lactation":361,"pediatric":370,"geriatric":378,"reproductive":387},{"level":353,"text":354,"quote":357,"refs":358},"caution",{"fa":355,"en":356},"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 Observational studies on the use of Lyrica during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified ( see Data ).",[359],{"source":34,"section":360},"8.1",{"level":362,"text":363,"quote":366,"refs":367},"avoid",{"fa":364,"en":365},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with LYRICA.",[368],{"source":34,"section":369},"8.2",{"level":353,"text":371,"quote":374,"refs":375},{"fa":372,"en":373},"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.","… ents below the age of 1 month have not been established. 4 to Less Than 17 Years of Age with Partial-Onset Seizures The safety and effectiveness of LYRICA as adjunctive treatment for partial‑onset seizures in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, …",[376],{"source":34,"section":377},"8.4",{"level":379,"text":380,"quote":383,"refs":384},"ok",{"fa":381,"en":382},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety and efficacy were observed between these patients and younger patients.",[385],{"source":34,"section":386},"8.5",{"level":353,"text":388,"quote":391,"refs":392},{"fa":389,"en":390},"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 Males Effects on Spermatogenesis In a randomized, double-blind, placebo-controlled non-inferiority study to assess the effect of pregabalin on sperm characteristics, healthy male subjects received pregabalin at a daily dose up to 600 mg (n=111) or placebo (n=109) for 13 weeks (one complete sperm cycle) …",[393],{"source":34,"section":394},"8.3",{"kind":396,"refs":397,"id":335},"NDA",[398],{"source":34,"section":399},"SPL approval \u002F marketing category",1792191876546]