[{"data":1,"prerenderedAt":222},["ShallowReactive",2],{"drug-simvastatin":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":68,"contraindications":113,"warnings":132,"renal":133,"monitoring":134,"interactions":135,"review":136,"examples":139,"atc":148,"iran":150,"links":166,"populations":183,"usApproval":217},"simvastatin",1,{"fa":7,"en":8},"سیمواستاتین","Simvastatin","cardiovascular",{"fa":11,"en":12},"استاتین","Statin (HMG-CoA reductase inhibitor)",[14],{"name":15,"market":16},"Zocor","US",[18,19,7,20,11],"zocor","زوکور","statin",[22,36,44,52,60],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-5","tablet","oral","5 mg tablet",{"amount":28,"unit":29,"perUnit":24,"scored":30},5,"mg",false,[16],[33],{"source":34,"section":35},"fda-simvastatin","3",{"id":37,"form":24,"route":25,"label":38,"concentration":39,"markets":41,"refs":42},"tab-10","10 mg tablet",{"amount":40,"unit":29,"perUnit":24,"scored":30},10,[16],[43],{"source":34,"section":35},{"id":45,"form":24,"route":25,"label":46,"concentration":47,"markets":49,"refs":50},"tab-20","20 mg tablet",{"amount":48,"unit":29,"perUnit":24,"scored":30},20,[16],[51],{"source":34,"section":35},{"id":53,"form":24,"route":25,"label":54,"concentration":55,"markets":57,"refs":58},"tab-40","40 mg tablet",{"amount":56,"unit":29,"perUnit":24,"scored":30},40,[16],[59],{"source":34,"section":35},{"id":61,"form":24,"route":25,"label":62,"concentration":63,"markets":65,"refs":66},"tab-80","80 mg tablet",{"amount":64,"unit":29,"perUnit":24,"scored":30},80,[16],[67],{"source":34,"section":35},[69,99],{"id":70,"disease":71,"label":72,"population":75,"type":79,"unit":29,"dose":80,"refs":81,"limits":84,"notes":88},"adult","hyperlipidemia",{"fa":73,"en":74},"چربی خون — بزرگسال: ۲۰ تا ۴۰ mg عصر","Hyperlipidemia — adults: 20–40 mg in the evening",{"minAge":76},{"value":77,"unit":78},18,"year","fixed",{"perDose":48,"perDoseMax":56,"dosesPerDay":5},[82],{"source":34,"section":83},"2.2",{"maxPerDay":56,"refs":85},[86],{"source":34,"section":87},"2.1",[89],{"text":90,"refs":93},{"fa":91,"en":92},"حداکثر توصیه‌شده ۴۰ mg؛ ۸۰ mg فقط برای کسانی که ≥۱۲ ماه بدون مشکل عضلانی ۸۰ mg مصرف کرده‌اند. با آمیودارون، آملودیپین یا رانولازین حداکثر ۲۰ mg. نارسایی کلیه شدید: شروع ۵ mg.","Max recommended 40 mg; 80 mg only for patients on 80 mg ≥12 months without muscle toxicity. With amiodarone, amlodipine or ranolazine max 20 mg. Severe renal impairment: start 5 mg.",[94,95,97],{"source":34,"section":87},{"source":34,"section":96},"2.5",{"source":34,"section":98},"2.4",{"id":100,"disease":71,"label":101,"population":104,"type":79,"unit":29,"dose":107,"refs":108},"hefh",{"fa":102,"en":103},"هیپرکلسترولمی خانوادگی هتروزیگوت — ۱۰ سال به بالا: ۱۰ تا ۴۰ mg","Heterozygous FH — ≥10 y: 10–40 mg",{"minAge":105,"maxAge":106},{"value":40,"unit":78},{"value":77,"unit":78},{"perDose":40,"perDoseMax":56,"dosesPerDay":5},[109,111],{"source":34,"section":110},"2.3",{"source":34,"section":112},"8.4",[114,123],{"id":115,"severity":116,"text":117,"refs":120},"ci","block",{"fa":118,"en":119},"همراه مهارکننده‌های قوی CYP3A4 (آزول‌ها، ماکرولیدها، ضدویروس‌ها، نفازودون)، سیکلوسپورین، دانازول یا جم‌فیبروزیل (و سایر موارد بخش ۴).","With strong CYP3A4 inhibitors (azoles, macrolides, antivirals, nefazodone), cyclosporine, danazol or gemfibrozil (and other items in section 4).",[121],{"source":34,"section":122},"4",{"id":124,"severity":116,"rule":125,"text":127,"refs":130},"under-10",{"maxAge":126},{"value":40,"unit":78},{"fa":128,"en":129},"زیر ۱۰ سال ثابت نشده.","Not established under 10 years.",[131],{"source":34,"section":112},[],[],[],[],{"status":137,"reviewer":138,"date":138},"unverified",null,[140,144],{"regimen":70,"formulation":45,"input":141,"expect":143},{"ageYears":142,"weightKg":64},55,{"perDose":48,"upperPerDose":56},{"regimen":100,"formulation":37,"input":145,"expect":147},{"ageYears":146,"weightKg":56},12,{"perDose":40},[149],"C10AA01",{"status":151,"forms":152,"refs":161},"registered",[153,157],{"code":154,"en":155,"fa":156},"02458","SIMVASTATIN 10MG TAB","قرص سیمواستاتین ۱۰ میلی‌گرم",{"code":158,"en":159,"fa":160},"01673","SIMVASTATIN 20MG TAB","قرص سیمواستاتین ۲۰ میلی‌گرم",[162],{"source":163,"section":164,"url":165},"darooyab-generic","G-1882\u002FSimvastatin","https:\u002F\u002Fwww.darooyab.ir\u002FG-1882\u002FSimvastatin",[167,171,175,178,181],{"kind":168,"url":169,"label":170},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=078103","ANDA078103",{"kind":172,"url":173,"label":174},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=3f6fad0b-0278-433f-86db-761b673a5803","FDA Simvastatin",{"kind":176,"url":177,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa692030.html",{"kind":179,"url":180,"label":149},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C10AA01",{"kind":182,"url":165,"label":8},"darooyab",{"pregnancy":184,"lactation":193,"pediatric":201,"geriatric":209},{"level":185,"text":186,"quote":189,"refs":190},"avoid",{"fa":187,"en":188},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Simvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, simvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see CLINICAL PHARMACOLOGY ( 12.1 )] .",[191],{"source":34,"section":192},"8.1",{"level":185,"text":194,"quote":197,"refs":198},{"fa":195,"en":196},"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 for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with simvastatin [see USE IN SPECIFIC POPULATIONS (8.1), CLINICAL PHARMACOLOGY ( 12.1 )].",[199],{"source":34,"section":200},"8.2",{"level":202,"text":203,"quote":206,"refs":207},"caution",{"fa":204,"en":205},"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.","The safety and effectiveness of simvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH.",[208],{"source":34,"section":112},{"level":202,"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.","In a clinical study of patients treated with simvastatin 80 mg daily, patients ≥65 years of age had an increased risk of myopathy, including rhabdomyolysis, compared to patients \u003C65 years of age.",[215],{"source":34,"section":216},"8.5",{"kind":218,"refs":219,"id":170},"ANDA",[220],{"source":34,"section":221},"SPL approval \u002F marketing category",1792191870287]