[{"data":1,"prerenderedAt":177},["ShallowReactive",2],{"drug-colesevelam":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":44,"contraindications":69,"warnings":79,"renal":87,"monitoring":88,"interactions":89,"review":90,"examples":93,"atc":103,"iran":105,"links":112,"populations":129,"usApproval":172},"colesevelam",1,{"fa":7,"en":8},"کولسولام","Colesevelam","cardiovascular",{"fa":11,"en":12},"جاذب اسید صفراوی","Bile acid sequestrant",[14],{"name":15,"market":16},"Welchol","US",[18,19,7],"welchol","ولکول",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-625","tablet","oral","625 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},625,"mg",false,[16],[32],{"source":33,"section":34},"fda-welchol","3",{"id":36,"form":37,"route":24,"label":38,"concentration":39,"markets":41,"refs":42},"pkt-3750","sachet","3.75 g packet for oral suspension",{"amount":40,"unit":28,"perUnit":37},3750,[16],[43],{"source":33,"section":34},[45],{"id":46,"disease":47,"label":48,"population":51,"type":55,"unit":28,"dose":56,"refs":57,"notes":60},"lip","hyperlipidemia",{"fa":49,"en":50},"هیپرلیپیدمی اولیه (بزرگسال و ۱۰ تا ۱۷ سال) یا دیابت نوع ۲ — ۳٫۷۵ g\u002Fروز (۶ قرص یک بار یا ۳ قرص دو بار) با غذا","Primary hyperlipidaemia (adults and 10–17 y) or type 2 diabetes — 3.75 g\u002Fday (6 tablets once or 3 twice daily) with a meal",{"minAge":52},{"value":53,"unit":54},10,"year","fixed",{"perDose":40,"dosesPerDay":5},[58],{"source":33,"section":59},"2.2",[61],{"text":62,"refs":65},{"fa":63,"en":64},"یا یک بسته ۳٫۷۵ g روزانه. پیش از شروع تری‌گلیسرید؛ داروهای دیگر طبق برچسب با فاصله.","Or one 3.75 g packet daily. Check triglycerides first; separate other drugs per label.",[66,67],{"source":33,"section":59},{"source":33,"section":68},"2.1",[70],{"id":71,"severity":72,"text":73,"refs":76},"ci","block",{"fa":74,"en":75},"تری‌گلیسرید بالای ۵۰۰ mg\u002FdL؛ سابقه پانکراتیت ناشی از تری‌گلیسرید؛ سابقه انسداد روده.","Triglycerides >500 mg\u002FdL; history of hypertriglyceridaemia-induced pancreatitis; history of bowel obstruction.",[77],{"source":33,"section":78},"4",[80],{"text":81,"refs":84},{"fa":82,"en":83},"افزایش تری‌گلیسرید و پانکراتیت؛ انسداد گوارش؛ کمبود ویتامین‌های محلول در چربی؛ تداخل جذب داروها؛ فنیل‌کتونوری (سوسپانسیون).","Raised triglycerides and pancreatitis; GI obstruction; fat-soluble vitamin deficiency; drug absorption interactions; PKU (suspension).",[85],{"source":33,"section":86},"5",[],[],[],{"status":91,"reviewer":92,"date":92},"unverified",null,[94,100],{"regimen":46,"formulation":22,"input":95,"expect":98},{"ageYears":96,"weightKg":97},55,80,{"perDose":40,"tabletsPerDoseRounded":99},6,{"regimen":46,"formulation":36,"input":101,"expect":102},{"ageYears":96,"weightKg":97},{"perDose":40,"tabletsPerDoseRounded":5},[104],"C10AC04",{"status":106,"refs":107},"not-found",[108],{"source":109,"section":110,"url":111},"darooyab-generic","G-1608\u002FColesevelam","https:\u002F\u002Fwww.darooyab.ir\u002FG-1608\u002FColesevelam",[113,117,121,124,127],{"kind":114,"url":115,"label":116},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021176","NDA021176",{"kind":118,"url":119,"label":120},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=89cbd0a3-2d1b-41db-8c97-35ec67b7b09f","FDA Welchol",{"kind":122,"url":123,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa699050.html",{"kind":125,"url":126,"label":104},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C10AC04",{"kind":128,"url":111,"label":8},"darooyab",{"pregnancy":130,"lactation":139,"pediatric":147,"geriatric":156,"reproductive":164},{"level":131,"text":132,"quote":135,"refs":136},"ok",{"fa":133,"en":134},"برچسب: جذب سیستمیک ناچیز؛ مواجهه جنین انتظار نمی‌رود.","Label: minimal systemic absorption; fetal exposure not expected.","Risk Summary WELCHOL is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.",[137],{"source":33,"section":138},"8.1",{"level":131,"text":140,"quote":143,"refs":144},{"fa":141,"en":142},"برچسب: مواجهه شیرخوار انتظار نمی‌رود.","Label: infant exposure not expected.","Risk Summary WELCHOL is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to WELCHOL.",[145],{"source":33,"section":146},"8.2",{"level":148,"text":149,"quote":152,"refs":153},"caution",{"fa":150,"en":151},"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.","Primary Hyperlipidemia The safety and effectiveness of WELCHOL to reduce LDL-C levels in boys and postmenarchal girls 10 to 17 years of age with HeFH who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification have been established.",[154],{"source":33,"section":155},"8.4",{"level":148,"text":157,"quote":160,"refs":161},{"fa":158,"en":159},"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.","Primary Hyperlipidemia Of the 1350 patients enrolled in the hyperlipidemia clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old.",[162],{"source":33,"section":163},"8.5",{"level":148,"text":165,"quote":168,"refs":169},{"fa":166,"en":167},"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 Use of WELCHOL may reduce the efficacy of oral contraceptives.",[170],{"source":33,"section":171},"8.3",{"kind":173,"refs":174,"id":116},"NDA",[175],{"source":33,"section":176},"SPL approval \u002F marketing category",1792444703871]