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(4:1)",{"amount":54,"unit":33,"perVolumeMl":34},250,[16],[57],{"source":38,"section":39},{"amoxicillin":59,"clavulanate":61},{"name":60,"amount":54,"unit":33},{"fa":43,"en":44},{"name":62,"amount":63,"unit":33},{"fa":47,"en":48},62.5,{"id":65,"form":28,"route":29,"label":66,"concentration":67,"markets":69,"refs":70,"components":72},"susp-200-28","200\u002F28.5 mg per 5 mL (7:1)",{"amount":68,"unit":33,"perVolumeMl":34},200,[16],[71],{"source":38,"section":39},{"amoxicillin":73,"clavulanate":75},{"name":74,"amount":68,"unit":33},{"fa":43,"en":44},{"name":76,"amount":77,"unit":33},{"fa":47,"en":48},28.5,{"id":79,"form":28,"route":29,"label":80,"concentration":81,"markets":83,"refs":84,"components":86},"susp-400-57","400\u002F57 mg per 5 mL (7:1)",{"amount":82,"unit":33,"perVolumeMl":34},400,[16],[85],{"source":38,"section":39},{"amoxicillin":87,"clavulanate":89},{"name":88,"amount":82,"unit":33},{"fa":43,"en":44},{"name":90,"amount":91,"unit":33},{"fa":47,"en":48},57,{"id":93,"form":28,"route":29,"label":94,"concentration":95,"markets":97,"refs":98,"components":101},"susp-es-600","ES-600: 600\u002F42.9 mg per 5 mL (14:1)",{"amount":96,"unit":33,"perVolumeMl":34},600,[16],[99],{"source":100,"section":39},"fda-augmentin-es600",{"amoxicillin":102,"clavulanate":104},{"name":103,"amount":96,"unit":33},{"fa":43,"en":44},{"name":105,"amount":106,"unit":33},{"fa":47,"en":48},42.9,{"id":108,"form":109,"route":29,"label":110,"concentration":111,"markets":114,"refs":115,"components":117},"tab-500-125","tablet","500\u002F125 mg 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h",{"minAge":144,"maxWeightKg":147},{"value":145,"unit":146},12,"week",40,"weightBased",{"perKgPerDay":150,"dividedDoses":151},45,2,[153],{"source":38,"section":154},"2.2, Table 1","amoxicillin",[65,79],[158,165,172],{"text":159,"refs":162},{"fa":160,"en":161},"دوز بر اساس جزء آموکسی‌سیلین محاسبه می‌شود.","Dose is calculated on the amoxicillin component.",[163],{"source":38,"section":164},"2.2",{"text":166,"refs":169},{"fa":167,"en":168},"مدت درمان مطالعه‌شده و توصیه‌شده برای اوتیت مدیای حاد ۱۰ روز است.","Duration studied and recommended for acute otitis media is 10 days.",[170],{"source":38,"section":171},"2.2, Table 1, footnote b",{"text":173,"refs":176},{"fa":174,"en":175},"رژیم هر ۱۲ ساعت به علت اسهال کمتر ترجیح دارد. فرآورده‌های ۲۰۰ و ۴۰۰ حاوی آسپارتام‌اند (فنیل‌کتونوری).","The every-12-hour regimen is recommended (significantly less diarrhea). 200 and 400 mg\u002F5 mL products contain aspartame (phenylketonurics).",[177],{"source":38,"section":164},{"id":179,"disease":139,"label":180,"population":183,"type":148,"unit":33,"dose":185,"refs":187,"doseComponent":155,"allowedFormulations":189,"notes":190},"aom-q8",{"fa":181,"en":182},"اوتیت مدیا — هر ۸ ساعت","Otitis media — every 8 h",{"minAge":184,"maxWeightKg":147},{"value":145,"unit":146},{"perKgPerDay":147,"dividedDoses":186},3,[188],{"source":38,"section":154},[27,51],[191,195],{"text":192,"refs":193},{"fa":160,"en":161},[194],{"source":38,"section":164},{"text":196,"refs":197},{"fa":167,"en":168},[198],{"source":38,"section":171},{"id":200,"disease":201,"label":202,"population":205,"type":148,"unit":33,"dose":207,"refs":208,"doseComponent":155,"allowedFormulations":210,"notes":211},"sinusitis-q12","acute-bacterial-sinusitis",{"fa":203,"en":204},"سینوزیت — هر ۱۲ ساعت","Sinusitis — every 12 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زیر ۳ ماه","Neonates and infants \u003C3 months",{"maxAge":318},{"value":145,"unit":146},{"perKgPerDay":320,"dividedDoses":151},30,[322],{"source":38,"section":164},[27],[325],{"text":326,"refs":329},{"fa":327,"en":328},"در این سن تجربه با فرآورده ۲۰۰ محدود است؛ فرآورده ۱۲۵ mg\u002F5 mL توصیه می‌شود.","Experience with the 200 mg\u002F5 mL formulation is limited in this age group; 125 mg\u002F5 mL is recommended.",[330],{"source":38,"section":164},{"id":332,"disease":139,"label":333,"population":336,"type":148,"unit":33,"dose":342,"refs":344,"doseComponent":155,"durationDays":348,"allowedFormulations":350,"notes":351},"es600-aom",{"fa":334,"en":335},"ES-600 — اوتیت مدیا، ۹۰ mg\u002Fkg\u002Fday هر ۱۲ ساعت","ES-600 — otitis media, 90 mg\u002Fkg\u002Fday every 12 h",{"minAge":337,"maxAge":339,"maxWeightKg":147},{"value":186,"unit":338},"month",{"value":340,"unit":341},13,"year",{"perKgPerDay":343,"dividedDoses":151},90,[345,346],{"source":100,"section":154},{"source":100,"section":347},"8.4",{"min":349,"max":349},10,[93],[352,360],{"text":353,"refs":356},{"fa":354,"en":355},"این دوز ۶٫۴ mg\u002Fkg\u002Fday کلاوولانیک اسید می‌دهد. فقط با فرآورده ES-600 (۱۴:۱)؛ فرآورده‌های دیگر جایگزین نیستند.","Provides 6.4 mg\u002Fkg\u002Fday of clavulanic acid. ES-600 (14:1) only; other formulations are not interchangeable.",[357,358],{"source":100,"section":164},{"source":100,"section":359},"2.6",{"text":361,"refs":364},{"fa":362,"en":363},"بی‌خطری و اثربخشی در کودکان ۳ ماه تا ۱۲ سال با وزن بیش از ۴۰ کیلوگرم و زیر ۳ ماه ثابت نشده است.","Safety and effectiveness not established under 3 months, or at 3 months–12 years weighing more than 40 kg.",[365],{"source":100,"section":347},{"id":367,"disease":201,"label":368,"population":371,"type":148,"unit":33,"dose":374,"refs":375,"doseComponent":155,"durationDays":378,"allowedFormulations":379},"es600-sinusitis",{"fa":369,"en":370},"ES-600 — سینوزیت حاد باکتریایی","ES-600 — acute bacterial 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کیلوگرم به بالا — کم‌شدت ۵۰۰ mg هر ۱۲ ساعت","Adults and ≥40 kg — less severe 500 mg every 12 h",{"minWeightKg":147},{"perDose":112,"dosesPerDay":151},[404,405],{"source":38,"section":390},{"source":38,"section":164,"note":406},{"fa":393,"en":394},[108],[409,420],{"id":410,"severity":411,"text":412,"refs":415},"beta-lactam-hypersensitivity","block",{"fa":413,"en":414},"سابقه واکنش حساسیتی جدی به آموکسی‌سیلین\u002Fکلاوولانات یا سایر بتالاکتام‌ها.","History of serious hypersensitivity to amoxicillin\u002Fclavulanate or other beta-lactams.",[416,418],{"source":100,"section":417},"4.1",{"source":38,"section":419},"4",{"id":421,"severity":411,"text":422,"refs":425},"cholestatic-jaundice",{"fa":423,"en":424},"سابقه یرقان کلستاتیک\u002Fاختلال کبدی مرتبط با آموکسی‌سیلین\u002Fکلاوولانات.","History of cholestatic jaundice\u002Fhepatic dysfunction associated with amoxicillin\u002Fclavulanate.",[426,428],{"source":100,"section":427},"4.2",{"source":38,"section":419},[430,437,444,451,458,465],{"text":431,"refs":434},{"fa":432,"en":433},"واکنش‌های حساسیتی","Hypersensitivity reactions",[435],{"source":38,"section":436},"5.1",{"text":438,"refs":441},{"fa":439,"en":440},"اختلال عملکرد کبد","Hepatic dysfunction",[442],{"source":38,"section":443},"5.2",{"text":445,"refs":448},{"fa":446,"en":447},"اسهال مرتبط با کلستریدیوم دیفیسیل","Clostridium difficile-associated diarrhea",[449],{"source":38,"section":450},"5.3",{"text":452,"refs":455},{"fa":453,"en":454},"بثورات در مونونوکلئوز","Skin rash in patients with mononucleosis",[456],{"source":38,"section":457},"5.4",{"text":459,"refs":462},{"fa":460,"en":461},"فنیل‌کتونوری: برخی فرآورده‌ها آسپارتام دارند","Phenylketonurics: some products contain aspartame",[463],{"source":38,"section":464},"5.6",{"text":466,"refs":469},{"fa":467,"en":468},"قرص ۲۵۰\u002F۱۲۵ با قرص جویدنی ۲۵۰\u002F۶۲٫۵ جایگزین نیست؛ تا وزن ۴۰ کیلوگرم استفاده نشود.","250\u002F125 mg tablet is not interchangeable with 250\u002F62.5 mg chewable; do not use until the child weighs at least 40 kg.",[470],{"source":38,"section":164},[472],{"egfrBelow":320,"severity":473,"text":474,"refs":477},"warn",{"fa":475,"en":476},"GFR کمتر از ۳۰: دوز ۸۷۵ mg تجویز نشود؛ تنظیم طبق برچسب.","GFR \u003C30 mL\u002Fmin: do not give the 875 mg dose; adjust per label.",[478],{"source":38,"section":479},"2.3",[],[],{"status":483,"reviewer":484,"date":484},"unverified",null,[486,491,496,500,506,511,515,519,523,528,534,539,543,549,553],{"regimen":138,"formulation":79,"input":487,"expect":488},{"ageYears":151,"weightKg":145},{"perDose":489,"mlPerDose":490},270,3.38,{"regimen":179,"formulation":51,"input":492,"expect":493},{"ageYears":151,"weightKg":145},{"perDose":494,"mlPerDose":495},160,3.2,{"regimen":138,"formulation":27,"input":497,"expect":498},{"ageYears":151,"weightKg":145},{"status":499},"blocked",{"regimen":200,"formulation":79,"input":501,"expect":502},{"ageYears":34,"weightKg":303},{"perDose":503,"mlPerDose":504,"mlPerDoseRounded":505},450,5.63,5.6,{"regimen":221,"formulation":51,"input":507,"expect":508},{"ageYears":34,"weightKg":303},{"perDose":509,"mlPerDose":510},266.67,5.33,{"regimen":237,"formulation":65,"input":512,"expect":513},{"ageYears":186,"weightKg":349},{"perDose":514,"mlPerDose":504},225,{"regimen":258,"formulation":27,"input":516,"expect":517},{"ageYears":186,"weightKg":349},{"perDose":518,"mlPerDose":510},133.33,{"regimen":274,"formulation":65,"input":520,"expect":521},{"ageYears":186,"weightKg":349},{"perDose":32,"mlPerDose":522},3.13,{"regimen":296,"formulation":27,"input":524,"expect":525},{"ageYears":186,"weightKg":349},{"perDose":526,"mlPerDose":527},66.67,2.67,{"regimen":313,"formulation":27,"input":529,"expect":531},{"ageMonths":5,"weightKg":530},4,{"perDose":532,"mlPerDose":533},60,2.4,{"regimen":332,"formulation":93,"input":535,"expect":536},{"ageYears":151,"weightKg":145},{"perDose":537,"mlPerDose":538},540,4.5,{"regimen":332,"formulation":93,"input":540,"expect":542},{"ageYears":541,"weightKg":150},11,{"status":499},{"regimen":367,"formulation":93,"input":544,"expect":546},{"ageYears":545,"weightKg":303},6,{"perDose":547,"mlPerDose":548},900,7.5,{"regimen":381,"formulation":123,"input":550,"expect":552},{"ageYears":320,"weightKg":551},70,{"tabletsPerDoseRounded":5},{"regimen":397,"formulation":108,"input":554,"expect":555},{"ageYears":320,"weightKg":551},{"tabletsPerDoseRounded":5},[557],"J01CR02",{"status":559,"forms":560,"refs":625},"registered",[561,565,569,573,577,581,585,589,593,597,601,605,609,613,617,621],{"code":562,"en":563,"fa":564},"00335","CO-AMOXICLAV 156 (125\u002F31) POW SUSP","پودر برای تهیه سوسپانسیون خوراکی کو–آموکسی‌کلاو ۱۵۶ (۱۲۵ \u002F ۳۱)",{"code":566,"en":567,"fa":568},"01754","CO-AMOXICLAV 156 (125\u002F31) SACHET","ساشه کو–آموکسی‌کلاو ۱۵۶ (۱۲۵ \u002F ۳۱)",{"code":570,"en":571,"fa":572},"02205","CO-AMOXICLAV 228 (200\u002F28.5)\u002F5ML POW SUSP","پودر برای تهیه سوسپانسیون خوراکی کو–آموکسی‌کلاو ۲۲۸ (۲۰۰ \u002F ۲۸٫۵) \u002F ۵ میلی‌لیتر",{"code":574,"en":575,"fa":576},"01440","CO-AMOXICLAV 312 (250\u002F62.5) POW SUSP","پودر برای تهیه سوسپانسیون خوراکی کو–آموکسی‌کلاو ۳۱۲ (۲۵۰ \u002F ۶۲٫۵)",{"code":578,"en":579,"fa":580},"00336","CO-AMOXICLAV 312 (250\u002F62.5) SACHET","ساشه کو–آموکسی‌کلاو ۳۱۲ (۲۵۰ \u002F ۶۲٫۵)",{"code":582,"en":583,"fa":584},"00337","CO-AMOXICLAV 375 (250\u002F125) TAB","قرص کو–آموکسی‌کلاو ۳۷۵ (۲۵۰ \u002F ۱۲۵)",{"code":586,"en":587,"fa":588},"02206","CO-AMOXICLAV 457 (400\u002F57)\u002F5ML POW SUSP","پودر برای تهیه سوسپانسیون خوراکی کو–آموکسی‌کلاو ۴۵۷ (۴۰۰ \u002F ۵۷) \u002F ۵ میلی‌لیتر",{"code":590,"en":591,"fa":592},"13313","CO-AMOXICLAV 625 (500\u002F125) DISPERSIBLE TAB","قرص پراکنده‌شونده کو–آموکسی‌کلاو ۶۲۵ (۵۰۰ \u002F ۱۲۵)",{"code":594,"en":595,"fa":596},"00338","CO-AMOXICLAV 625 (500\u002F125) TAB","قرص کو–آموکسی‌کلاو ۶۲۵ (۵۰۰ \u002F ۱۲۵)",{"code":598,"en":599,"fa":600},"20307","CO-AMOXICLAV 643 (600\u002F42.9)\u002F5ML FOR SUSP","سوسپانسیون کو–آموکسی‌کلاو ۶۴۳ (۶۰۰ \u002F ۴۲٫۹) \u002F ۵ میلی‌لیتر",{"code":602,"en":603,"fa":604},"52802","CO-AMOXICLAV 1000(875\u002F125) TAB","قرص کو–آموکسی‌کلاو ۱۰۰۰ (۸۷۵ \u002F ۱۲۵)",{"code":606,"en":607,"fa":608},"52224","CO-AMOXICLAV POWDER, FOR SUSPENSION ORAL 250 mg\u002F62.5 mg","سوسپانسیون خوراکی کو–آموکسی‌کلاو ۲۵۰ میلی‌گرم \u002F ۶۲٫۵ میلی‌گرم",{"code":610,"en":611,"fa":612},"51302","CO-AMOXICLAV INJECTION, POWDER, FOR SOLUTION PARENTERAL 1000 mg\u002F200 mg","پودر برای تهیه محلول تزریقی کو–آموکسی‌کلاو ۱۰۰۰ میلی‌گرم \u002F ۲۰۰ میلی‌گرم",{"code":614,"en":615,"fa":616},"52270","CO-AMOXICLAV POWDER, FOR SUSPENSION ORAL 600 mg\u002F42.9 mg\u002F5mL 100 mL","سوسپانسیون خوراکی کو–آموکسی‌کلاو ۶۰۰ میلی‌گرم \u002F ۴۲٫۹ میلی‌گرم \u002F ۵ میلی‌لیتر ۱۰۰ میلی‌لیتر",{"code":618,"en":619,"fa":620},"53057","CO-AMOXICLAV POWDER, FOR SUSPENSION ORAL 200 mg\u002F28.5 mg\u002F5 mL 30 mL","سوسپانسیون خوراکی کو–آموکسی‌کلاو ۲۰۰ میلی‌گرم \u002F ۲۸٫۵ میلی‌گرم \u002F ۵ میلی‌لیتر ۳۰ میلی‌لیتر",{"code":622,"en":623,"fa":624},"53056","CO-AMOXICLAV POWDER, FOR SUSPENSION ORAL 400 mg\u002F57 mg\u002F5 mL 30 mL","سوسپانسیون خوراکی کو–آموکسی‌کلاو ۴۰۰ میلی‌گرم \u002F ۵۷ میلی‌گرم \u002F ۵ میلی‌لیتر ۳۰ میلی‌لیتر",[626],{"source":627,"section":628,"url":629},"darooyab-generic","G-4514\u002FAmoxicillin-Clavulanic-acid","https:\u002F\u002Fwww.darooyab.ir\u002FG-4514\u002FAmoxicillin-Clavulanic-acid",[631,635,639,642,646,649],{"kind":632,"url":633,"label":634},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=050564","NDA050564",{"kind":636,"url":637,"label":638},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db","FDA Augmentin",{"kind":636,"url":640,"label":641},"https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=59979859-8c9b-4173-a5e3-2e6312fd9d79","FDA Augmentin ES-600",{"kind":643,"url":644,"label":645},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa685024.html","Amoxicillin and Clavulanic Acid",{"kind":647,"url":648,"label":557},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J01CR02",{"kind":650,"url":629,"label":651},"darooyab","Amoxicillin-Clavulanic-acid",{"pregnancy":653,"lactation":662,"pediatric":670,"geriatric":677},{"level":654,"text":655,"quote":658,"refs":659},"caution",{"fa":656,"en":657},"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.","Teratogenic Effects :Pregnancy Category B.",[660],{"source":38,"section":661},"8.1",{"level":654,"text":663,"quote":666,"refs":667},{"fa":664,"en":665},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Caution should be exercised when amoxicillin\u002Fclavulanate potassium is administered to a nursing woman.",[668],{"source":38,"section":669},"8.3",{"level":654,"text":671,"quote":674,"refs":675},{"fa":672,"en":673},"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 AUGMENTIN Powder for Oral Suspension and Chewable Tablets have been established in pediatric patients.",[676],{"source":38,"section":347},{"level":654,"text":678,"quote":681,"refs":682},{"fa":679,"en":680},"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.","Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.",[683],{"source":38,"section":684},"8.5",{"kind":686,"refs":687,"id":634},"NDA",[688],{"source":38,"section":689},"SPL approval \u002F marketing category",1792191872077]