Рибавирин - синтетический аналог нуклеозидов с выраженным противовирусным действием. Обладает широким спектром активности против различных ДНК- и РНК-содержащих вирусов.; Рибавирин легко проникает в пораженные вирусом клетки и быстро фосфорилируется внутриклеточной аденозинкиназой до моно-, ди- и трифосфатного метаболитов. Эти метаболиты, особенно рибавиринтрифосфат, обладают выраженной противовирусной активностью.; Механизм действия рибавирина выяснен недостаточно. Однако известно, что рибавирин ингибирует инозинмонофосфат-дегидрогеназу (ИМФ), этот эффект приводит к выраженному снижению уровня внутриклеточного гуанозинтрифосфата (ГТФ), что, в свою очередь, сопровождается подавлением синтеза вирусной РНК и вирус-специфических белков. Рибавирин ингибирует репликацию новых вирионов, что обеспечивает снижение вирусной нагрузки. Рибавирин селективно ингибирует синтез вирусной РНК, не подавляя синтез РНК в нормально функционирующих клетках.; Рибавирин эффективен в отношении многих ДНК- и РНК-содержащих вирусов. Наиболее чувствительными к рибавирину ДНК-вирусами являются: вирусы Нerpes simplex, поксовирусы, вирус болезни Марека. Нечувствительными к рибавирину ДНК-вирусами являются: Varicella zoster, вирус псевдобешенства, вирус коровьей оспы. Наиболее чувствительными к рибавирину РНК-вирусами являются: вирусы гриппа А, В, парамиксовирусы (парагриппа, эпидемического паротита, болезни Ньюкасла), реовирусы, онкогенные РНК-вирусы. Нечувствительными к рибавирину РНК-вирусами являются: энтеровирусы, риновирусы, вирус энцефалита леса Семлики.; Рибавирин обладает активностью против вируса гепатита С (ВГС). Механизм действия рибавирина против ВГС полностью не выяснен. Предполагается, что накапливающийся по мере фосфорилирования рибавиринтрифосфат конкурентно подавляет образование гуанозинтрифосфата, тем самым снижая синтез вирусных РНК. Считается также, что механизм синергического действия рибавирина и интерферона альфа против ВГС обусловлен усилением фосфорилирования рибавирина интерфероном.
Показания к применению
Хронический вирусный гепатит С (в комбинации с интерфероном альфа-2b или пегинтерфероном альфа-2b):
У первичных больных, ранее не лечившихся интерфероном альфа-2b или пегинтерфероном альфа-2b
При обострении после курса монотерапии интерфероном альфа-2b или пегинтерфероном альфа-2b
У больных, невосприимчивых к монотерапии интерфероном альфа-2b или пегинтерфероном альфа-2b
Противопоказания
— хроническая сердечная недостаточность IIб-III ст.
Инфаркт миокарда
Почечная недостаточность (КК менее 50 мл/мин)
Печеночная недостаточность
Цирроз печени в стадии декомпенсации
Тяжелая анемия
Аутоиммунные заболевания (в т.ч. аутоиммунный гепатит)
Не поддающиеся лечению заболевания щитовидной железы
Тяжелая депрессия с суицидальными намерениями
Детский и подростковый возраст до 18 лет
Беременность
Период лактации
Гиперчувствительность
С осторожностью следует назначать препарат при декомпенсированном сахарном диабете (с приступами кетоацидоза); хронической обструктивной болезни легких; тромбоэмболии легочной артерии; хронической сердечной недостаточности; заболеваниях щитовидной железы (в т.ч. тиреотоксикозе); нарушениях свертываемости крови; тромбофлебите; миелодепрессии; гемоглобинопатии (в т.ч. талассемии, серповидно-клеточной анемии); депрессии, склонности к суициду (в т.ч. в анамнезе); женщинам репродуктивного возраста (наступление беременности нежелательно); пациентам пожилого возраста.
Применение при беременности и в период грудного вскармливания
Применение препарата противопоказано при беременности и в период лактации.
Способ применения и дозы
Препарат принимают внутрь, вместе с приемом пищи. Капсулы проглатывают целиком, не разжевывая и запивая водой.; Рекомендуемая доза - по 0.8-1.2 г/сут в 2 приема (утром и вечером).; Одновременно назначают интерферон альфа-2b - п/к по 3 млн. ME 3 раза в неделю или пегинтерферон альфа 2b - п/к 1.5 мкг/кг 1 раз в неделю. При комбинации с интерфероном альфа-2b при массе тела пациента до 75 кг доза рибавирина составляет 1 г/сут (0.4 г утром и 0.6 г вечером); выше 75 кг - 1.2 г/сут (0.6 г утром и 0.6 г вечером). При комбинации с пегинтерфероном альфа-2b при массе тела пациента меньше 65 кг доза рибавирина составляет 0.8 г/сут (0.4 г утром и 0.4 г вечером), при массе тела 65-85 кг - 1 г/сут (0.4 г утром и 0.6 г вечером), более 85 кг - 1.2 г/сут (0.6 г утром и 0.6 г вечером).; Длительность лечения - 24 - 48 недель; при этом для ранее не лечившихся пациентов - не менее 24 недель, у пациентов с вирусом генотипа 1 - 48 недель. У пациентов, невосприимчивых к монотерапии интерфероном альфа, а также при рецидиве - не менее 6 мес-1 года (в зависимости от клинического течения заболевания и ответа на проводимую терапию).
Побочное действие
Со стороны нервной системы: головная боль, головокружение, бессонница, депрессия, раздражительность, беспокойство, эмоциональная лабильность, нервозность, возбуждение, агрессивное поведение, спутанное сознание; редко - суицидальная наклонность, повышение тонуса гладких мышц, тремор, парестезии, гиперестезия, гипестезия, обморок.; Со стороны органа зрения: поражение слезной железы, конъюнктивит, нарушение зрения.; Со стороны органа слуха: нарушение/потеря слуха, шум в ушах.; Со стороны сердечно-сосудистой системы: снижение или повышение АД, брадикардия или тахикардия, ощущение сердцебиения, остановка сердца.; Со стороны системы кроветворения: гемолитическая анемия, лейкопения, нейтропения, гранулоцитопения, тромбоцитопения; крайне редко - апластическая анемия.; Со стороны дыхательной системы: диспноэ, кашель, фарингит, одышка, бронхит, средний отит, синусит, ринит.; Со стороны пищеварительной системы: сухость во рту, снижение аппетита, тошнота, рвота, диарея, абдоминальная боль, запор, извращение вкуса, панкреатит, метеоризм, стоматит, глоссит, кровотечение из десен, гипербилирубинемия.; Со стороны репродуктивной системы: снижение либидо, дисменорея, аменорея, меноррагия, простатит.; Со стороны костно-мышечной системы: артралгия, миалгия.; Аллергические реакции: кожная сыпь, эритема, крапивница, гипертермия, ангионевротический отек, бронхоспазм, анафилаксия, фотосенсибилизация, многоформная эритема, синдром Стивенса-Джонсона, токсический эпидермальный некролиз.; Прочие: общая слабость, недомогание, астения, выпадение волос, конъюнктивит, алопеция, нарушение структуры волос, сухость кожи, гипотиреоз, боль в грудной клетке, жажда, грибковая инфекция, вирусная инфекция, гриппоподобный синдром, потливость, лимфаденопатия, приливы.
Передозировка
Симптомы: возможно усиление выраженности побочного действия.; Лечение: отмена препарата, проведение симптоматической терапии.
Особые указания
Следует учитывать тератогенность препарата. Мужчины и женщины репродуктивного возраста во время лечения и в течение 7 мес после окончания терапии должны использовать эффективные контрацептивные средства.; Лабораторные исследования (клинический анализ крови с подсчетом лейкоцитарной формулы и числа тромбоцитов, определение электролитов, содержания креатинина, функциональных проб печени) необходимо проводить перед началом терапии, на 2 и 4 нед, и далее регулярно.; В процессе лечения рибавирином максимальное снижение содержания гемоглобина в большинстве случаев отмечается после 4-8 недель от начала лечения. При снижении гемоглобина ниже 110 мг/мл следует временно уменьшить дозу рибавирина на 400 мг/сут, при снижении гемоглобина ниже 100 мг/мл следует сократить дозу до 50% от исходной. В большинстве случаев рекомендуемые изменения дозы обеспечивают восстановление уровня гемоглобина. При снижении гемоглобина ниже 85 мг/мл прием препарата следует прекратить.; При остром проявлении гиперчувсвительности (крапивница, ангионевротический отек, бронхоспазм, анафилаксия) применение препарата следует немедленно прекратить. Транзиторные высыпания не являются основанием для прерывания лечения.; В связи с возможным ухудшением функции почек у пациентов пожилого возраста, перед применением препарата необходимо провести исследование функции почек, в частности КК.; Влияние на способность к вождению автотранспорта и управлению механизмами; В период лечения пациентам, испытывающим усталость, сонливость или дезориентацию, необходимо воздерживаться от вождения автотранспорта и занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Капсулы.
Условия хранения
В защищенном от света месте, при температуре не выше 20 °C.
Срок годности
2 года. Не использовать после истечения срока годности.
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200 мг; Вспомогательные вещества: лактозы моногидрат (сахар молочный) - 96 мг, кремния диоксид коллоидный (аэросил) - 2 мг, магния стеарат - 2 мг.; Состав корпуса капсулы: титана диоксид, желатин.; Состав крышечки капсулы: титана диоксид, желатин."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Рибавирин - синтетический аналог нуклеозидов с выраженным противовирусным действием. Обладает широким спектром активности против различных ДНК- и РНК-содержащих вирусов.; Рибавирин легко проникает в пораженные вирусом клетки и быстро фосфорилируется внутриклеточной аденозинкиназой до моно-, ди- и трифосфатного метаболитов. Эти метаболиты, особенно рибавиринтрифосфат, обладают выраженной противовирусной активностью.; Механизм действия рибавирина выяснен недостаточно. Однако известно, что рибавирин ингибирует инозинмонофосфат-дегидрогеназу (ИМФ), этот эффект приводит к выраженному снижению уровня внутриклеточного гуанозинтрифосфата (ГТФ), что, в свою очередь, сопровождается подавлением синтеза вирусной РНК и вирус-специфических белков. Рибавирин ингибирует репликацию новых вирионов, что обеспечивает снижение вирусной нагрузки. Рибавирин селективно ингибирует синтез вирусной РНК, не подавляя синтез РНК в нормально функционирующих клетках.; Рибавирин эффективен в отношении многих ДНК- и РНК-содержащих вирусов. Наиболее чувствительными к рибавирину ДНК-вирусами являются: вирусы Нerpes simplex, поксовирусы, вирус болезни Марека. Нечувствительными к рибавирину ДНК-вирусами являются: Varicella zoster, вирус псевдобешенства, вирус коровьей оспы. Наиболее чувствительными к рибавирину РНК-вирусами являются: вирусы гриппа А, В, парамиксовирусы (парагриппа, эпидемического паротита, болезни Ньюкасла), реовирусы, онкогенные РНК-вирусы. Нечувствительными к рибавирину РНК-вирусами являются: энтеровирусы, риновирусы, вирус энцефалита леса Семлики.; Рибавирин обладает активностью против вируса гепатита С (ВГС). Механизм действия рибавирина против ВГС полностью не выяснен. Предполагается, что накапливающийся по мере фосфорилирования рибавиринтрифосфат конкурентно подавляет образование гуанозинтрифосфата, тем самым снижая синтез вирусных РНК. Считается также, что механизм синергического действия рибавирина и интерферона альфа против ВГС обусловлен усилением фосфорилирования рибавирина интерфероном."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Хронический вирусный гепатит С (в комбинации с интерфероном альфа-2b или пегинтерфероном альфа-2b):"}},{"type":"list","data":{"style":"unordered","items":["У первичных больных, ранее не лечившихся интерфероном альфа-2b или пегинтерфероном альфа-2b","При обострении после курса монотерапии интерфероном альфа-2b или пегинтерфероном альфа-2b","У больных, невосприимчивых к монотерапии интерфероном альфа-2b или пегинтерфероном альфа-2b"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"— хроническая сердечная недостаточность IIб-III ст."}},{"type":"list","data":{"style":"unordered","items":["Инфаркт миокарда","Почечная недостаточность (КК менее 50 мл/мин)","Печеночная недостаточность","Цирроз печени в стадии декомпенсации","Тяжелая анемия","Аутоиммунные заболевания (в т.ч. аутоиммунный гепатит)","Не поддающиеся лечению заболевания щитовидной железы","Тяжелая депрессия с суицидальными намерениями","Детский и подростковый возраст до 18 лет","Беременность","Период лактации","Гиперчувствительность"]}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать препарат при декомпенсированном сахарном диабете (с приступами кетоацидоза); хронической обструктивной болезни легких; тромбоэмболии легочной артерии; хронической сердечной недостаточности; заболеваниях щитовидной железы (в т.ч. тиреотоксикозе); нарушениях свертываемости крови; тромбофлебите; миелодепрессии; гемоглобинопатии (в т.ч. талассемии, серповидно-клеточной анемии); депрессии, склонности к суициду (в т.ч. в анамнезе); женщинам репродуктивного возраста (наступление беременности нежелательно); пациентам пожилого возраста."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Применение препарата противопоказано при беременности и в период лактации."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь, вместе с приемом пищи. Капсулы проглатывают целиком, не разжевывая и запивая водой.; Рекомендуемая доза - по 0.8-1.2 г/сут в 2 приема (утром и вечером).; Одновременно назначают интерферон альфа-2b - п/к по 3 млн. ME 3 раза в неделю или пегинтерферон альфа 2b - п/к 1.5 мкг/кг 1 раз в неделю. При комбинации с интерфероном альфа-2b при массе тела пациента до 75 кг доза рибавирина составляет 1 г/сут (0.4 г утром и 0.6 г вечером); выше 75 кг - 1.2 г/сут (0.6 г утром и 0.6 г вечером). При комбинации с пегинтерфероном альфа-2b при массе тела пациента меньше 65 кг доза рибавирина составляет 0.8 г/сут (0.4 г утром и 0.4 г вечером), при массе тела 65-85 кг - 1 г/сут (0.4 г утром и 0.6 г вечером), более 85 кг - 1.2 г/сут (0.6 г утром и 0.6 г вечером).; Длительность лечения - 24 - 48 недель; при этом для ранее не лечившихся пациентов - не менее 24 недель, у пациентов с вирусом генотипа 1 - 48 недель. У пациентов, невосприимчивых к монотерапии интерфероном альфа, а также при рецидиве - не менее 6 мес-1 года (в зависимости от клинического течения заболевания и ответа на проводимую терапию)."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны нервной системы: головная боль, головокружение, бессонница, депрессия, раздражительность, беспокойство, эмоциональная лабильность, нервозность, возбуждение, агрессивное поведение, спутанное сознание; редко - суицидальная наклонность, повышение тонуса гладких мышц, тремор, парестезии, гиперестезия, гипестезия, обморок.; Со стороны органа зрения: поражение слезной железы, конъюнктивит, нарушение зрения.; Со стороны органа слуха: нарушение/потеря слуха, шум в ушах.; Со стороны сердечно-сосудистой системы: снижение или повышение АД, брадикардия или тахикардия, ощущение сердцебиения, остановка сердца.; Со стороны системы кроветворения: гемолитическая анемия, лейкопения, нейтропения, гранулоцитопения, тромбоцитопения; крайне редко - апластическая анемия.; Со стороны дыхательной системы: диспноэ, кашель, фарингит, одышка, бронхит, средний отит, синусит, ринит.; Со стороны пищеварительной системы: сухость во рту, снижение аппетита, тошнота, рвота, диарея, абдоминальная боль, запор, извращение вкуса, панкреатит, метеоризм, стоматит, глоссит, кровотечение из десен, гипербилирубинемия.; Со стороны репродуктивной системы: снижение либидо, дисменорея, аменорея, меноррагия, простатит.; Со стороны костно-мышечной системы: артралгия, миалгия.; Аллергические реакции: кожная сыпь, эритема, крапивница, гипертермия, ангионевротический отек, бронхоспазм, анафилаксия, фотосенсибилизация, многоформная эритема, синдром Стивенса-Джонсона, токсический эпидермальный некролиз.; Прочие: общая слабость, недомогание, астения, выпадение волос, конъюнктивит, алопеция, нарушение структуры волос, сухость кожи, гипотиреоз, боль в грудной клетке, жажда, грибковая инфекция, вирусная инфекция, гриппоподобный синдром, потливость, лимфаденопатия, приливы."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: возможно усиление выраженности побочного действия.; Лечение: отмена препарата, проведение симптоматической терапии."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Следует учитывать тератогенность препарата. Мужчины и женщины репродуктивного возраста во время лечения и в течение 7 мес после окончания терапии должны использовать эффективные контрацептивные средства.; Лабораторные исследования (клинический анализ крови с подсчетом лейкоцитарной формулы и числа тромбоцитов, определение электролитов, содержания креатинина, функциональных проб печени) необходимо проводить перед началом терапии, на 2 и 4 нед, и далее регулярно.; В процессе лечения рибавирином максимальное снижение содержания гемоглобина в большинстве случаев отмечается после 4-8 недель от начала лечения. При снижении гемоглобина ниже 110 мг/мл следует временно уменьшить дозу рибавирина на 400 мг/сут, при снижении гемоглобина ниже 100 мг/мл следует сократить дозу до 50% от исходной. В большинстве случаев рекомендуемые изменения дозы обеспечивают восстановление уровня гемоглобина. При снижении гемоглобина ниже 85 мг/мл прием препарата следует прекратить.; При остром проявлении гиперчувсвительности (крапивница, ангионевротический отек, бронхоспазм, анафилаксия) применение препарата следует немедленно прекратить. Транзиторные высыпания не являются основанием для прерывания лечения.; В связи с возможным ухудшением функции почек у пациентов пожилого возраста, перед применением препарата необходимо провести исследование функции почек, в частности КК.; Влияние на способность к вождению автотранспорта и управлению механизмами; В период лечения пациентам, испытывающим усталость, сонливость или дезориентацию, необходимо воздерживаться от вождения автотранспорта и занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте, при температуре не выше 20 °C. "}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года. 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