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If a dose is missed, take the next at the usual time; never two doses together.",[99],{"source":34,"section":100},"2.1",{"text":102,"refs":105},{"fa":103,"en":104},"۱۲ تا ۲۳ ماه فقط گرانول ۴ mg.","12–23 months: 4 mg oral granules only.",[106],{"source":34,"section":92},{"id":108,"disease":108,"label":109,"population":112,"type":71,"unit":29,"dose":114,"refs":124,"notes":127},"allergic-rhinitis",{"fa":110,"en":111},"رینیت آلرژیک فصلی","Seasonal allergic rhinitis",{"minAge":113},{"value":77,"unit":78},{"bands":115},[116,119,122],{"minAge":117,"maxAge":118,"perDose":28,"dosesPerDay":5},{"value":77,"unit":78},{"value":82,"unit":78},{"minAge":120,"maxAge":121,"perDose":49,"dosesPerDay":5},{"value":82,"unit":78},{"value":86,"unit":78},{"minAge":123,"maxAge":89,"perDose":57,"dosesPerDay":5},{"value":86,"unit":78},[125],{"source":34,"section":126},"2.3, Table 3",[128],{"text":129,"refs":132},{"fa":130,"en":131},"فقط برای بیمارانی که به درمان‌های دیگر پاسخ کافی ندارند یا آن را تحمل نمی‌کنند (هشدار جعبه‌ای).","Reserve for patients with inadequate response or intolerance to alternative therapies (boxed warning).",[133],{"source":34,"section":134},"WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS",{"id":136,"disease":137,"label":138,"population":141,"type":71,"unit":29,"dose":143,"refs":150,"notes":153},"eib","exercise-bronchospasm",{"fa":139,"en":140},"پیشگیری از برونکواسپاسم ورزشی — ۲ ساعت قبل از ورزش","Exercise-induced bronchoconstriction — 2 h before exercise",{"minAge":142},{"value":82,"unit":78},{"bands":144},[145,148],{"minAge":146,"maxAge":147,"perDose":49,"dosesPerDay":5},{"value":82,"unit":78},{"value":86,"unit":78},{"minAge":149,"maxAge":89,"perDose":57,"dosesPerDay":5},{"value":86,"unit":78},[151],{"source":34,"section":152},"2.2, Table 2",[154],{"text":155,"refs":158},{"fa":156,"en":157},"تک‌دوز حداقل ۲ ساعت قبل از ورزش؛ تا ۲۴ ساعت دوز دیگری نه.","Single dose at least 2 h before exercise; no additional dose within 24 h.",[159],{"source":34,"section":160},"2.2",[162],{"id":163,"severity":164,"text":165,"refs":168},"hypersensitivity","block",{"fa":166,"en":167},"حساسیت به اجزای مونته‌لوکاست.","Hypersensitivity to any component.",[169],{"source":34,"section":170},"4",[172],{"text":173,"refs":176},{"fa":174,"en":175},"هشدار جعبه‌ای: رویدادهای جدی عصبی‌روانی (بی‌قراری، پرخاشگری، افسردگی، اختلال خواب، افکار خودکشی).","Boxed warning: serious neuropsychiatric events (agitation, aggression, depression, sleep disturbance, suicidal thoughts).",[177,178],{"source":34,"section":134},{"source":34,"section":179},"5.1",[],[],[],{"status":184,"reviewer":89,"date":89},"unverified",[186,191,196,201,206],{"regimen":63,"formulation":23,"input":187,"expect":190},{"ageMonths":188,"weightKg":189},18,11,{"perDose":28,"tabletsPerDoseRounded":5},{"regimen":63,"formulation":46,"input":192,"expect":195},{"ageYears":193,"weightKg":194},8,25,{"perDose":49},{"regimen":63,"formulation":54,"input":197,"expect":200},{"ageYears":198,"weightKg":199},20,65,{"perDose":57},{"regimen":108,"formulation":37,"input":202,"expect":205},{"ageYears":203,"weightKg":204},3,14,{"perDose":28},{"regimen":136,"formulation":46,"input":207,"expect":209},{"ageYears":57,"weightKg":208},30,{"perDose":49},[211],"R03DC03",{"status":213,"forms":214,"refs":227},"registered",[215,219,223],{"code":216,"en":217,"fa":218},"09448","MONTELUCAST 4MG GRANULE SACHET ORAL","ساشه مونتلوکاست ۴ میلی‌گرم",{"code":220,"en":221,"fa":222},"06043","MONTELUKAST SODIUM 10MG TAB","قرص مونته‌لوکاست سدیم ۱۰ میلی‌گرم",{"code":224,"en":225,"fa":226},"01895","MONTELUKAST SODIUM 5MG CHEWABLE TAB","قرص جویدنی مونته‌لوکاست سدیم ۵ میلی‌گرم",[228],{"source":229,"section":230,"url":231},"darooyab-generic","G-1474\u002FMontelukast","https:\u002F\u002Fwww.darooyab.ir\u002FG-1474\u002FMontelukast",[233,237,241,244,247],{"kind":234,"url":235,"label":236},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=090984","ANDA090984",{"kind":238,"url":239,"label":240},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=da038cf6-cfad-43a4-ab8e-d81d028d6087","FDA Montelukast",{"kind":242,"url":243,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa600014.html",{"kind":245,"url":246,"label":211},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=R03DC03",{"kind":248,"url":231,"label":8},"darooyab",{"pregnancy":250,"lactation":259,"pediatric":267,"geriatric":275},{"level":251,"text":252,"quote":255,"refs":256},"caution",{"fa":253,"en":254},"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 prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data] .",[257],{"source":34,"section":258},"8.1",{"level":251,"text":260,"quote":263,"refs":264},{"fa":261,"en":262},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary A published clinical lactation study reports the presence of montelukast in human milk.",[265],{"source":34,"section":266},"8.2",{"level":251,"text":268,"quote":271,"refs":272},{"fa":269,"en":270},"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.","Safety and effectiveness of montelukast sodium for asthma have been established in pediatric patients with asthma 6 to 14 years of age.",[273],{"source":34,"section":274},"8.4",{"level":276,"text":277,"quote":280,"refs":281},"ok",{"fa":278,"en":279},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No dosage adjustment in the elderly is required.",[282],{"source":34,"section":283},"8.5",{"kind":285,"refs":286,"id":236},"ANDA",[287],{"source":34,"section":288},"SPL approval \u002F marketing category",1792444716427]