Периферический вазодилататор с преимущественным влиянием на... Инструкция
Показания к применению
профилактика приступов стенокардии у больных ИБС, в т.ч. после перенесенного инфаркта миокарда; - лечение хронической сердечной недостаточности (в составе комбинированной терапии).
Противопоказания
острые нарушения кровообращения (шок, сосудистый коллапс); - острый инфаркт миокарда с выраженной артериальной гипотензией; - кардиогенный шок, если не обеспечивается достаточно высокое конечное диастолическое давление в левом желудочке путем применения внутриаортальной контрпульсации или за счет введения средств, оказывающих положительное инотропное действие; - токсический отек легких; - анемия (тяжелая форма); - выраженная артериальная гипотензия (систолическое АД менее 90 мм рт.ст., диастолическое АД менее 60 мм рт.ст.); - одновременный прием ингибиторов фосфодиэстеразы, в т.ч. силденафила, варденафила, тадалафила, поскольку они потенцируют антигипертензивное действие нитратов; - наследственная непереносимость галактозы, дефицит лактазы или синдром мальабсорбции глюкозы и галактозы; - детский и подростковый возраст до 18 лет (эффективность и безопасность не установлены); - повышенная чувствительность к нитратам или другим компонентам препарата. С осторожностью- гипертрофическая обструктивная кардиомиопатия, констриктивный перикардит, тампонада перикарда; - низкое давление наполнения при остром инфаркте миокарда, левожелудочковая недостаточность. Не следует допускать снижения систолического АД ниже 90 мм рт.ст.
Периферический вазодилататор с преимущественным влиянием на венозные сосуды. Оказывает сосудорасширяющее и антиангинальное действие. Снижает преднагрузку (за счет расширения периферических вен) и постнагрузку (вследствие снижения общего периферического сосудистого сопротивления), уменьшает потребность миокарда в кислороде, расширяет коронарные артерии и улучшает коронарный кровоток, способствует его перераспределению в ишемизированные области, уменьшает конечный диастолический объем левого желудочка и снижает систолическое напряжение его стенок. Повышает толерантность к физической нагрузке больных с ИБС, снижает давление в малом круге кровообращения. Изосорбида мононитрат вызывает релаксацию мускулатуры бронхов, мочевыводящих путей, мышц желчного пузыря, желчевыводящих путей и пищевода, а также тонкой и толстой кишки, включая сфинктеры. На молекулярном уровне нитраты действуют посредством образования окиси азота (NО) и циклического гуанозилмонофосфата (cGMP), который считается медиатором релаксации. При приеме внутрь изосорбида-5-мононитрата антиангинальный эффект проявляется уже через 30 минут и продолжается 2-6 ч.
Показания к применению
профилактика приступов стенокардии у больных ИБС, в т.ч. после перенесенного инфаркта миокарда; - лечение хронической сердечной недостаточности (в составе комбинированной терапии).
Противопоказания
острые нарушения кровообращения (шок, сосудистый коллапс); - острый инфаркт миокарда с выраженной артериальной гипотензией; - кардиогенный шок, если не обеспечивается достаточно высокое конечное диастолическое давление в левом желудочке путем применения внутриаортальной контрпульсации или за счет введения средств, оказывающих положительное инотропное действие; - токсический отек легких; - анемия (тяжелая форма); - выраженная артериальная гипотензия (систолическое АД менее 90 мм рт.ст., диастолическое АД менее 60 мм рт.ст.); - одновременный прием ингибиторов фосфодиэстеразы, в т.ч. силденафила, варденафила, тадалафила, поскольку они потенцируют антигипертензивное действие нитратов; - наследственная непереносимость галактозы, дефицит лактазы или синдром мальабсорбции глюкозы и галактозы; - детский и подростковый возраст до 18 лет (эффективность и безопасность не установлены); - повышенная чувствительность к нитратам или другим компонентам препарата. С осторожностью- гипертрофическая обструктивная кардиомиопатия, констриктивный перикардит, тампонада перикарда; - низкое давление наполнения при остром инфаркте миокарда, левожелудочковая недостаточность. Не следует допускать снижения систолического АД ниже 90 мм рт.ст.
Применение при беременности и в период грудного вскармливания
По соображениям безопасности Моночинкве может применяться при беременности и в период лактации только строго по назначению врача, после тщательной оценки пользы и возможного риска, поскольку к настоящему моменту недостаточно данных о последствиях его применения у беременных и кормящих матерей. Если кормящая мать все же принимает Моночинкве, необходимо установить наблюдение за ребенком на предмет развития возможных эффектов от препарата.
Способ применения и дозы
Внутрь, после еды запивая водой, не разжевывая. Частота приема и длительность лечения устанавливаются индивидуально. Начинать терапию целесоообразно с дозы 20 мг (1/2 таб.) 2 раза/сут. Затем постепенно повышать дозу до терапевтической - 40 мг (1 таб.) на прием 2-3 раза/сут с интервалом 7-8 ч. Максимальная суточная доза составляет 120 мг.
Побочное действие
При приеме препарата в терапевтических дозах каких-либо значимых побочных эффектов, как правило, не развивается. Очень часто (≥10%): нитратная головная боль может возникать в начале лечения, и при продолжении терапии обычно проходит в течение нескольких дней. Часто (≥1% - меньше10%): после первого приема или после увеличения дозы препарата может произойти снижение АД и/или развитие ортостатической гипотензии, что может сопровождаться тахикардией, головокружением, а также слабостью. Со стороны нервной системы: скованность, сонливость, нечеткость зрения, снижение способности к быстрым психическим и двигательным реакциям (особенно в начале лечения). Редко (≥0.1% - меньше1%): могут отмечаться тошнота, рвота, возможно ощущение легкого жжения языка, сухость во рту, покраснение лица и кожные аллергические реакции. Выраженное снижение АД, сопровождающееся утяжелением симптомов стенокардии (парадоксальная реакция на нитраты). Отмечались случаи коллаптоидных состояний, иногда с брадиаритмией и обмороком. Отдельные случаи (меньше 0.01%): эксфолиативный дерматит.
Передозировка
Симптомы: снижение АД с ортостатической дисрегуляцией, рефлекторная тахикардия и головная боль. Может появиться слабость, головокружение, приливы жара, тошнота, рвота и диарея. В высоких дозах (более 20 мг/кг массы тела) следует ожидать появления метгемоглобинемии, цианоза, диспноэ и тахипноэ из-за образования нитрит-ионов вследствие метаболизма изосорбида мононитрата. Очень высокие дозы могут приводить к повышению внутричерепного давления с возникновением церебральных симптомов. При хронической передозировке возможно повышение уровня метгемоглобина. хотя клиническое значение этого еще окончательно не установлено. Лечение: промывание желудка, пациента следует уложить в горизонтальное положение с приподнятыми ногами. Следует контролировать основные показатели жизненных функций и при необходимости корректировать. Больным с выраженной артериальной гипотензией и/или в состоянии шока следует вводить жидкость; в исключительных случаях для улучшения кровообращения можно проводить инфузии норадреналина (норэпинефрина) и/или допамина. Введение эпинефрина (адреналина) и родственных соединений противопоказано. В зависимости от степени тяжести, в случаях метгемоглобинемии применяются следующие антидоты: 1. витамин С: 1 г внутрь или в форме натриевой соли в/в.2. метиленовый синий: до 50 мл 1% раствора метиленового синего в/в3. толуидин синий: сначала 2-4 мг/кг массы тела в/в; затем, при необходимости возможны повторные введения по 2 мг/кг массы тела с интервалом между введениями в 1 ч. Проводят также оксигенотерапию, гемодиализ, обменное переливание крови.
Особые указания
Моночинкве не следует применять для купирования острых приступов стенокардии и острого инфаркта миокарда. В период терапии необходим контроль АД и ЧСС. Следует избегать резкой отмены препарата (дозу снижать постепенно). Возможно развитие толерантности к Моночинкве или перекрестной толерантности к другим нитросоединениям (снижение эффективности лекарственного средства вследствие предшествующего применения других нитросоединений). Для предотвращения развития толерантности к действию Моночинкве следует избегать его непрерывного приема в высоких дозах. У пациентов с лабильностью кровообращения могут развиться симптомы острой недостаточности кровообращения уже при первом приеме препарата. Нитратные головные боли можно в значительной степени предотвратить, если в начале терапии принимать по 1/2 таб. Моночинкве утром и вечером. В период лечения препаратом следует исключить употребление этанола. Влияние на способность к вождению автотранспорта и управлению механизмамиВо время лечения не рекомендуется управлять транспортными средствами и заниматься другими потенциально опасными видами деятельности, требующими быстрой психомоторной реакции.
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Вспомогательные вещества: лактозы моногидрат - 160 мг, целлюлоза микрокристаллическая - 82.5 мг, крахмал кукурузный - 10 мг, тальк - 5 мг, магния стеарат - 2.5 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Периферический вазодилататор с преимущественным влиянием на венозные сосуды. Оказывает сосудорасширяющее и антиангинальное действие. Снижает преднагрузку (за счет расширения периферических вен) и постнагрузку (вследствие снижения общего периферического сосудистого сопротивления), уменьшает потребность миокарда в кислороде, расширяет коронарные артерии и улучшает коронарный кровоток, способствует его перераспределению в ишемизированные области, уменьшает конечный диастолический объем левого желудочка и снижает систолическое напряжение его стенок. Повышает толерантность к физической нагрузке больных с ИБС, снижает давление в малом круге кровообращения. Изосорбида мононитрат вызывает релаксацию мускулатуры бронхов, мочевыводящих путей, мышц желчного пузыря, желчевыводящих путей и пищевода, а также тонкой и толстой кишки, включая сфинктеры. На молекулярном уровне нитраты действуют посредством образования окиси азота (NО) и циклического гуанозилмонофосфата (cGMP), который считается медиатором релаксации. При приеме внутрь изосорбида-5-мононитрата антиангинальный эффект проявляется уже через 30 минут и продолжается 2-6 ч."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["профилактика приступов стенокардии у больных ИБС, в т.ч. после перенесенного инфаркта миокарда; - лечение хронической сердечной недостаточности (в составе комбинированной терапии)."]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["острые нарушения кровообращения (шок, сосудистый коллапс); - острый инфаркт миокарда с выраженной артериальной гипотензией; - кардиогенный шок, если не обеспечивается достаточно высокое конечное диастолическое давление в левом желудочке путем применения внутриаортальной контрпульсации или за счет введения средств, оказывающих положительное инотропное действие; - токсический отек легких; - анемия (тяжелая форма); - выраженная артериальная гипотензия (систолическое АД менее 90 мм рт.ст., диастолическое АД менее 60 мм рт.ст.); - одновременный прием ингибиторов фосфодиэстеразы, в т.ч. силденафила, варденафила, тадалафила, поскольку они потенцируют антигипертензивное действие нитратов; - наследственная непереносимость галактозы, дефицит лактазы или синдром мальабсорбции глюкозы и галактозы; - детский и подростковый возраст до 18 лет (эффективность и безопасность не установлены); - повышенная чувствительность к нитратам или другим компонентам препарата. С осторожностью- гипертрофическая обструктивная кардиомиопатия, констриктивный перикардит, тампонада перикарда; - низкое давление наполнения при остром инфаркте миокарда, левожелудочковая недостаточность. Не следует допускать снижения систолического АД ниже 90 мм рт.ст."]}},{"type":"list","data":{"style":"unordered","items":["аортальный и/или митральный стеноз; - тенденция к ортостатическим нарушениям сосудистой регуляции; - глаукома (риск повышения внутриглазного давления); - тяжелая почечная недостаточность; - печеночная недостаточность (риск развития метгемоглобинемии); - геморрагический инсульт; - тиреотоксикоз; - заболевания, сопровождающиеся повышенным внутричерепным давлением; - недавно перенесенная черепно-мозровая травма."]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"По соображениям безопасности Моночинкве может применяться при беременности и в период лактации только строго по назначению врача, после тщательной оценки пользы и возможного риска, поскольку к настоящему моменту недостаточно данных о последствиях его применения у беременных и кормящих матерей. Если кормящая мать все же принимает Моночинкве, необходимо установить наблюдение за ребенком на предмет развития возможных эффектов от препарата."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, после еды запивая водой, не разжевывая. Частота приема и длительность лечения устанавливаются индивидуально. Начинать терапию целесоообразно с дозы 20 мг (1/2 таб.) 2 раза/сут. Затем постепенно повышать дозу до терапевтической - 40 мг (1 таб.) на прием 2-3 раза/сут с интервалом 7-8 ч. Максимальная суточная доза составляет 120 мг."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При приеме препарата в терапевтических дозах каких-либо значимых побочных эффектов, как правило, не развивается. Очень часто (≥10%): нитратная головная боль может возникать в начале лечения, и при продолжении терапии обычно проходит в течение нескольких дней. Часто (≥1% - меньше10%): после первого приема или после увеличения дозы препарата может произойти снижение АД и/или развитие ортостатической гипотензии, что может сопровождаться тахикардией, головокружением, а также слабостью. Со стороны нервной системы: скованность, сонливость, нечеткость зрения, снижение способности к быстрым психическим и двигательным реакциям (особенно в начале лечения). Редко (≥0.1% - меньше1%): могут отмечаться тошнота, рвота, возможно ощущение легкого жжения языка, сухость во рту, покраснение лица и кожные аллергические реакции. Выраженное снижение АД, сопровождающееся утяжелением симптомов стенокардии (парадоксальная реакция на нитраты). Отмечались случаи коллаптоидных состояний, иногда с брадиаритмией и обмороком. Отдельные случаи (меньше 0.01%): эксфолиативный дерматит."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: снижение АД с ортостатической дисрегуляцией, рефлекторная тахикардия и головная боль. Может появиться слабость, головокружение, приливы жара, тошнота, рвота и диарея. В высоких дозах (более 20 мг/кг массы тела) следует ожидать появления метгемоглобинемии, цианоза, диспноэ и тахипноэ из-за образования нитрит-ионов вследствие метаболизма изосорбида мононитрата. Очень высокие дозы могут приводить к повышению внутричерепного давления с возникновением церебральных симптомов. При хронической передозировке возможно повышение уровня метгемоглобина. хотя клиническое значение этого еще окончательно не установлено. Лечение: промывание желудка, пациента следует уложить в горизонтальное положение с приподнятыми ногами. Следует контролировать основные показатели жизненных функций и при необходимости корректировать. Больным с выраженной артериальной гипотензией и/или в состоянии шока следует вводить жидкость; в исключительных случаях для улучшения кровообращения можно проводить инфузии норадреналина (норэпинефрина) и/или допамина. Введение эпинефрина (адреналина) и родственных соединений противопоказано. В зависимости от степени тяжести, в случаях метгемоглобинемии применяются следующие антидоты: 1. витамин С: 1 г внутрь или в форме натриевой соли в/в.2. метиленовый синий: до 50 мл 1% раствора метиленового синего в/в3. толуидин синий: сначала 2-4 мг/кг массы тела в/в; затем, при необходимости возможны повторные введения по 2 мг/кг массы тела с интервалом между введениями в 1 ч. Проводят также оксигенотерапию, гемодиализ, обменное переливание крови."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Моночинкве не следует применять для купирования острых приступов стенокардии и острого инфаркта миокарда. В период терапии необходим контроль АД и ЧСС. Следует избегать резкой отмены препарата (дозу снижать постепенно). Возможно развитие толерантности к Моночинкве или перекрестной толерантности к другим нитросоединениям (снижение эффективности лекарственного средства вследствие предшествующего применения других нитросоединений). Для предотвращения развития толерантности к действию Моночинкве следует избегать его непрерывного приема в высоких дозах. У пациентов с лабильностью кровообращения могут развиться симптомы острой недостаточности кровообращения уже при первом приеме препарата. Нитратные головные боли можно в значительной степени предотвратить, если в начале терапии принимать по 1/2 таб. Моночинкве утром и вечером. В период лечения препаратом следует исключить употребление этанола. 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