[{"data":1,"prerenderedAt":230},["ShallowReactive",2],{"drug-topiramate":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":59,"contraindications":108,"warnings":118,"renal":119,"monitoring":120,"interactions":121,"review":122,"examples":125,"atc":139,"iran":141,"links":165,"populations":182,"usApproval":225},"topiramate",1,{"fa":7,"en":8},"توپیرامات","Topiramate","nervous-system",{"fa":11,"en":12},"ضدتشنج","Anticonvulsant",[14],{"name":15,"market":16},"Topamax","US",[18,19,7],"topamax","توپاماکس",[21,35,43,51],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-25","tablet","oral","25 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},25,"mg",false,[16],[32],{"source":33,"section":34},"fda-topiramate","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-50","50 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},50,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"tab-100","100 mg tablet",{"amount":47,"unit":28,"perUnit":23,"scored":29},100,[16],[50],{"source":33,"section":34},{"id":52,"form":23,"route":24,"label":53,"concentration":54,"markets":56,"refs":57},"tab-200","200 mg tablet",{"amount":55,"unit":28,"perUnit":23,"scored":29},200,[16],[58],{"source":33,"section":34},[60,85],{"id":61,"disease":62,"label":63,"population":66,"type":70,"unit":28,"dose":71,"refs":73,"notes":76},"migraine-prev","migraine-prophylaxis",{"fa":64,"en":65},"پیشگیری از میگرن — ۱۲ سال به بالا: دوز هدف ۵۰ mg دو بار در روز (پس از تیتراسیون)","Migraine prevention — ≥12 y: target 50 mg twice daily (after titration)",{"minAge":67},{"value":68,"unit":69},12,"year","fixed",{"perDose":39,"dosesPerDay":72},2,[74],{"source":33,"section":75},"2.3, Table 3",[77],{"text":78,"refs":81},{"fa":79,"en":80},"تیتراسیون هفتگی: هفته ۱: ۲۵ mg فقط شب؛ هفته ۲: ۲۵ صبح + ۲۵ شب؛ هفته ۳: ۲۵ صبح + ۵۰ شب؛ هفته ۴: ۵۰ + ۵۰ (۱۰۰ mg\u002Fday). قرص شکسته نشود (تلخ).","Weekly titration: week 1: 25 mg evening only; week 2: 25 am + 25 pm; week 3: 25 am + 50 pm; week 4: 50 + 50 (100 mg\u002Fday). Do not break tablets (bitter).",[82,83],{"source":33,"section":75},{"source":33,"section":84},"2.4",{"id":86,"disease":87,"label":88,"population":91,"type":94,"unit":28,"dose":95,"refs":98,"notes":101},"epi-mono","epilepsy",{"fa":89,"en":90},"صرع تک‌درمانی — ۱۰ سال به بالا: هدف ۴۰۰ mg\u002Fday در دو نوبت","Epilepsy monotherapy — ≥10 y: target 400 mg\u002Fday in two doses",{"minAge":92},{"value":93,"unit":69},10,"titration",{"dividedDoses":72,"titration":96},{"start":39,"targetMin":97,"targetMax":97,"max":97},400,[99],{"source":33,"section":100},"2.1, Table 1",[102],{"text":103,"refs":106},{"fa":104,"en":105},"هفته ۱ تا ۶ (صبح\u002Fشب): ۲۵\u002F۲۵، ۵۰\u002F۵۰، ۷۵\u002F۷۵، ۱۰۰\u002F۱۰۰، ۱۵۰\u002F۱۵۰، ۲۰۰\u002F۲۰۰ mg.","Weeks 1–6 (am\u002Fpm): 25\u002F25, 50\u002F50, 75\u002F75, 100\u002F100, 150\u002F150, 200\u002F200 mg.",[107],{"source":33,"section":100},[109],{"id":110,"severity":111,"text":112,"refs":115},"hyper","block",{"fa":113,"en":114},"حساسیت به توپیرامات.","Hypersensitivity to topiramate.",[116],{"source":33,"section":117},"4",[],[],[],[],{"status":123,"reviewer":124,"date":124},"unverified",null,[126,130,136],{"regimen":61,"formulation":36,"input":127,"expect":129},{"ageYears":128,"weightKg":39},14,{"perDose":39,"tabletsPerDoseRounded":5},{"regimen":61,"formulation":36,"input":131,"expect":134},{"ageYears":132,"weightKg":133},11,40,{"status":135},"blocked",{"regimen":86,"formulation":22,"input":137,"expect":138},{"ageYears":128,"weightKg":39},{"perDose":27,"tabletsPerDoseRounded":5},[140],"N03AX11",{"status":142,"forms":143,"refs":160},"registered",[144,148,152,156],{"code":145,"en":146,"fa":147},"01883","TOPIRAMATE 100MG TAB","قرص توپیرامات ۱۰۰ میلی‌گرم",{"code":149,"en":150,"fa":151},"01884","TOPIRAMATE 200MG TAB","قرص توپیرامات ۲۰۰ میلی‌گرم",{"code":153,"en":154,"fa":155},"01885","TOPIRAMATE 25MG TAB","قرص توپیرامات ۲۵ میلی‌گرم",{"code":157,"en":158,"fa":159},"01886","TOPIRAMATE 50MG TAB","قرص توپیرامات ۵۰ میلی‌گرم",[161],{"source":162,"section":163,"url":164},"darooyab-generic","G-688\u002FTopiramate","https:\u002F\u002Fwww.darooyab.ir\u002FG-688\u002FTopiramate",[166,170,174,177,180],{"kind":167,"url":168,"label":169},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=078235","ANDA078235",{"kind":171,"url":172,"label":173},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=88156c4e-bc29-497d-8110-e59d800ff38a","FDA Topiramate",{"kind":175,"url":176,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa697012.html",{"kind":178,"url":179,"label":140},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N03AX11",{"kind":181,"url":164,"label":8},"darooyab",{"pregnancy":183,"lactation":192,"pediatric":201,"geriatric":209,"reproductive":217},{"level":184,"text":185,"quote":188,"refs":189},"avoid",{"fa":186,"en":187},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Topiramate can cause fetal harm when administered to a pregnant woman.",[190],{"source":33,"section":191},"8.1",{"level":193,"text":194,"quote":197,"refs":198},"caution",{"fa":195,"en":196},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Topiramate is excreted in human milk [see Data].",[199],{"source":33,"section":200},"8.2",{"level":193,"text":202,"quote":205,"refs":206},{"fa":203,"en":204},"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.","Adjunctive Treatment for Epilepsy Pediatric Patients 2 Years of Age and Older The safety and effectiveness of topiramate as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome have been established in pediatric …",[207],{"source":33,"section":208},"8.4",{"level":193,"text":210,"quote":213,"refs":214},{"fa":211,"en":212},"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.","Dosage adjustment may be necessary for elderly with age-related renal impairment (creatinine clearance rate \u003C 70 mL\u002Fmin\u002F1.73 m 2 ) resulting in reduced clearance [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )] .",[215],{"source":33,"section":216},"8.5",{"level":193,"text":218,"quote":221,"refs":222},{"fa":219,"en":220},"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 Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risk of major congenital malformations, including oral clefts and the risk of infants being SGA [see Drug Interactions ( 7.4 ) and Use in Specific Populations ( 8.1 )] .",[223],{"source":33,"section":224},"8.3",{"kind":226,"refs":227,"id":169},"ANDA",[228],{"source":33,"section":229},"SPL approval \u002F marketing category",1792191878551]