спазмы гладкой мускулатуры, связанные с заболеваниями желчевыводящих путей (холецистолитиаз, холангиолитиаз, холецистит, перихолецистит, холангит, папиллит);
Вспомогательные вещества: натрия метабисульфит 2,0 мг, этанол 96% 132,0 мг, вода для инъекций до 2,0 мл.
Фармакологические свойства
Дротаверин представляет собой производное изохинолина, которое проявляет мощное спазмолитическое действие на гладкую мускулатуру за счет ингибирования фермента фосфодиэстеразы (ФДЭ). Фермент ФДЭ необходим для гидролиза цАМФ до АМФ. Ингибирование ФДЭ приводит к повышению концентрации цАМФ, которое запускает следующую каскадную реакцию: высокие концентрации цАМФ активируют цАМФ-зависимое фосфорилирование киназы легких цепей миозина (КЛЦМ). Фосфорилирование КЛЦМ приводит к снижению ее аффинности к кальций (Са2+)-кальмодулиновому комплексу, в результате чего инактивированная форма КЛЦМ поддерживает мышечное расслабление. цАМФ, кроме этого, влияет на цитозольную концентрацию Са2+, благодаря стимулированию транспорта Са2+ в экстрацеллюлярное пространство и саркоплазматический ретикулум. Этот понижающий концентрацию Са2+ эффект дротаверина через цАМФ объясняет антагонистический эффект дротаверина по отношению к Са2+.
In vitro дротаверин ингибирует фермент ФДЭ4, без ингибирования ферментов ФДЭ3 и ФДЭ5. Поэтому эффективность дротаверина зависит от концентраций ФДЭ4 в тканях, содержание которой в разных тканях различается. ФДЭ4 наиболее важна для подавления сократительной активности гладкой мускулатуры, в связи с чем селективное ингибирование ФДЭ4 может быть полезным для лечения гиперкинетических дискинезий и различных заболеваний, сопровождающихся спастическим состоянием ЖКТ.
Гидролиз цАМФ в миокарде и гладкой мускулатуре сосудов происходит главным образом с помощью фермента ФДЭ3, чем объясняется тот факт, что при высокой спазмолитической активности у дротаверина отсутствуют серьезные побочные эффекты со стороны сердца и сосудов и выраженные эффекты в отношении сердечно-сосудистой системы.
Дротаверин эффективен при спазмах гладкой мускулатуры как нейрогенного, так и мышечного происхождения. Независимо от типа вегетативной иннервации, дротаверин расслабляюще действует на гладкую мускулатуру ЖКТ, желчевыводящих путей, мочеполовой системы.
Фармакокинетика
Распределение
In vitro дротаверин имеет высокую связь с белками плазмы (95-97%), особенно с альбумином, γ- и β-глобуминами, а также α-ЛПВП.
Дротаверин и/или его метаболиты могут незначительно проникать через плацентарный барьер.
Метаболизм
У человека дротаверин почти полностью метаболизируется путем O-дезэтилирования. Его метаболиты быстро конъюгируют с глюкуроновой кислотой. Главным метаболитом является 4'-дезэтилдротаверин, кроме которого были идентифицированы 6-дезэтилдротаверин и 4'-дезэтилдротавералдин.
Выведение
У человека для оценки показателей фармакокинетики дротаверина использовалась двухкамерная математическая модель. Конечный Т1/2 плазменной радиоактивности составлял 16 ч.
Т1/2 составляет 8-10 ч. За 72 ч практически полностью выводится из организма, более 50% через почки (преимущественно в виде метаболитов) и около 30% через кишечник. Неизмененный дротаверин в моче не обнаруживается.
Показания к применению
спазмы гладкой мускулатуры, связанные с заболеваниями желчевыводящих путей (холецистолитиаз, холангиолитиаз, холецистит, перихолецистит, холангит, папиллит);
В качестве вспомогательной терапии (когда форма таблеток не может быть применена):
при спазмах гладкой мускулатуры желудочно-кишечного происхождения (язвенная болезнь желудка и двенадцатиперстной кишки, гастрит, спазмы кардии и привратника, энтерит, колит);
при гинекологических заболеваниях (дисменорея).
Противопоказания
гиперчувствительность к действующему веществу или к любому из вспомогательных веществ препарата;
гиперчувствительность к натрия дисульфиту;
тяжелая печеночная или почечная недостаточность;
тяжелая хроническая сердечная недостаточность;
детский возраст (применение дротаверина у детей в клинических исследованиях не изучалось);
период кормления грудью.
С осторожностью
при артериальной гипотензии (опасность коллапса, см. раздел "Особые указания");
у беременных женщин (см. раздел "Беременность и лактация").
Применение при беременности и в период грудного вскармливания
Как показали исследования по репродуктивной токсичности у животных и ретроспективные исследования клинических данных, применение дротаверина в период беременности не оказывало ни тератогенного, ни эмбриотоксического действия. Несмотря на это, при назначении дротаверина беременным женщинам следует соблюдать осторожность и применять его только в тех случаях, когда потенциальная польза для матери превышает потенциальный риск для плода, при этом следует избегать назначения инъекционной лекарственной формы препарата Но-шпа® у беременных женщин.
Препарат не следует применять во время родов (потенциальный риск развития послеродовых атонических кровотечений).
В связи с отсутствием необходимых клинических данных в период лактации назначать препарат не рекомендуется.
Способ применения и дозы
Взрослые
Суточная средняя доза составляет 40-240 мг дротаверина гидрохлорида (разделенная на 1-3 дозы/сут) в/м.
При острых коликах (почечной или желчнокаменной) - 40-80 мг в/в медленно (продолжительность введения приблизительно 30 сек).
Побочное действие
Ниже представлены неблагоприятные реакции, наблюдавшиеся в клинических исследованиях, разделенные по системам органов с указанием частоты их возникновения в соответствии со следующими градациями: очень часто (≥10%), часто (≥1% и <10%); нечасто (≥0.1% и <1%); редко (≥0.01% и <0.1%), очень редко, включая отдельные сообщения (<0.01%), неизвестная частота (по имеющимся данным частоту определить нельзя).
Со стороны сердечно-сосудистой системы: редко - учащение сердцебиения, снижение АД.
Со стороны нервной системы: редко - головная боль, вертиго, бессонница; частота неизвестна - головокружение.
Со стороны ЖКТ: редко - тошнота, запор.
Со стороны иммунной системы: редко - аллергические реакции (ангионевротический отек, крапивница, сыпь, зуд); частота неизвестна - при применении препарата сообщалось о развитии анафилактического шока со смертельным исходом и без смертельного исхода.
Местные реакции: редко - реакции в месте введения.
Передозировка
Симптомы: передозировка дротаверина ассоциировалась с нарушениями сердечного ритма и проводимости, включая полную блокаду ножек пучка Гиса и остановку сердца, которая может быть фатальной.
Лечение: в случае передозировки пациенты должны находиться под тщательным медицинским наблюдением; проводят симптоматическую терапию и лечение, направленное на поддержание основных функций организма.
Взаимодействие с другими лекарственными средствами
Ингибиторы ФДЭ, подобные папаверину, ослабляют противопаркинсонический эффект леводопы. При назначении дротаверина одновременно с леводопой возможно усиление ригидности и тремора.
Дротаверин усиливает спазмолитическое действие папаверина, бендазола и других спазмолитиков, включая м-холиноблокаторы.
Усиливает гипотензию, вызываемую трициклическими антидепрессантами, хинидином и прокаинамидом.
Снижает спазмогенную активность морфина.
Фенобарбитал усиливает спазмолитическое действие дротаверина.
Особые указания
Препарат содержит дисульфит, который может вызывать реакции аллергического типа, включая анафилактические симптомы и бронхоспазм у чувствительных лиц, особенно у лиц с астмой или аллергическими заболеваниями в анамнезе. В случае повышенной чувствительности к дисульфиту парентерального применения препарата следует избегать.
При в/в введении дротаверина пациенты с пониженным АД должны находиться в горизонтальном положении в связи с риском развития коллапса.
Влияние на способность к управлению транспортными средствами и механизмами
В период лечения необходимо воздерживаться от управления транспортными средствами и занятий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Условия хранения
Препарат следует хранить в оригинальной упаковке в недоступном для детей месте при температуре не выше 25°С.
Срок годности
3 года. Не применять после истечения срока годности, указанного на упаковке.
Условия отпуска
Препарат отпускается по рецепту.
Для описания товара использована информация от партнера 36.6
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ампула."}},{"type":"paragraph","data":{"text":"Вспомогательные вещества: натрия метабисульфит 2,0 мг, этанол 96% 132,0 мг, вода для инъекций до 2,0 мл."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Дротаверин представляет собой производное изохинолина, которое проявляет мощное спазмолитическое действие на гладкую мускулатуру за счет ингибирования фермента фосфодиэстеразы (ФДЭ). Фермент ФДЭ необходим для гидролиза цАМФ до АМФ. Ингибирование ФДЭ приводит к повышению концентрации цАМФ, которое запускает следующую каскадную реакцию: высокие концентрации цАМФ активируют цАМФ-зависимое фосфорилирование киназы легких цепей миозина (КЛЦМ). Фосфорилирование КЛЦМ приводит к снижению ее аффинности к кальций (Са\u003csup\u003e2+\u003c/sup\u003e)-кальмодулиновому комплексу, в результате чего инактивированная форма КЛЦМ поддерживает мышечное расслабление. цАМФ, кроме этого, влияет на цитозольную концентрацию Са\u003csup\u003e2+\u003c/sup\u003e, благодаря стимулированию транспорта Са\u003csup\u003e2+\u003c/sup\u003e в экстрацеллюлярное пространство и саркоплазматический ретикулум. Этот понижающий концентрацию Са\u003csup\u003e2+\u003c/sup\u003e эффект дротаверина через цАМФ объясняет антагонистический эффект дротаверина по отношению к Са\u003csup\u003e2+\u003c/sup\u003e."}},{"type":"paragraph","data":{"text":"In vitro дротаверин ингибирует фермент ФДЭ4, без ингибирования ферментов ФДЭ3 и ФДЭ5. Поэтому эффективность дротаверина зависит от концентраций ФДЭ4 в тканях, содержание которой в разных тканях различается. ФДЭ4 наиболее важна для подавления сократительной активности гладкой мускулатуры, в связи с чем селективное ингибирование ФДЭ4 может быть полезным для лечения гиперкинетических дискинезий и различных заболеваний, сопровождающихся спастическим состоянием ЖКТ."}},{"type":"paragraph","data":{"text":"Гидролиз цАМФ в миокарде и гладкой мускулатуре сосудов происходит главным образом с помощью фермента ФДЭ3, чем объясняется тот факт, что при высокой спазмолитической активности у дротаверина отсутствуют серьезные побочные эффекты со стороны сердца и сосудов и выраженные эффекты в отношении сердечно-сосудистой системы."}},{"type":"paragraph","data":{"text":"Дротаверин эффективен при спазмах гладкой мускулатуры как нейрогенного, так и мышечного происхождения. Независимо от типа вегетативной иннервации, дротаверин расслабляюще действует на гладкую мускулатуру ЖКТ, желчевыводящих путей, мочеполовой системы."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"In vitro дротаверин имеет высокую связь с белками плазмы (95-97%), особенно с альбумином, γ- и β-глобуминами, а также α-ЛПВП."}},{"type":"paragraph","data":{"text":"Дротаверин и/или его метаболиты могут незначительно проникать через плацентарный барьер."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"У человека дротаверин почти полностью метаболизируется путем O-дезэтилирования. Его метаболиты быстро конъюгируют с глюкуроновой кислотой. Главным метаболитом является 4'-дезэтилдротаверин, кроме которого были идентифицированы 6-дезэтилдротаверин и 4'-дезэтилдротавералдин."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"У человека для оценки показателей фармакокинетики дротаверина использовалась двухкамерная математическая модель. Конечный Т\u003csub\u003e1/2\u003c/sub\u003e плазменной радиоактивности составлял 16 ч."}},{"type":"paragraph","data":{"text":"Т\u003csub\u003e1/2\u003c/sub\u003e составляет 8-10 ч. За 72 ч практически полностью выводится из организма, более 50% через почки (преимущественно в виде метаболитов) и около 30% через кишечник. Неизмененный дротаверин в моче не обнаруживается."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["спазмы гладкой мускулатуры, связанные с заболеваниями желчевыводящих путей (холецистолитиаз, холангиолитиаз, холецистит, перихолецистит, холангит, папиллит);","спазмы гладкой мускулатуры мочевыводящих путей (нефролитиаз, уретролитиаз, пиелит, цистит, тенезмы мочевого пузыря)."]}},{"type":"paragraph","data":{"text":"В качестве вспомогательной терапии (когда форма таблеток не может быть применена):"}},{"type":"list","data":{"style":"ordered","items":["при спазмах гладкой мускулатуры желудочно-кишечного происхождения (язвенная болезнь желудка и двенадцатиперстной кишки, гастрит, спазмы кардии и привратника, энтерит, колит);","при гинекологических заболеваниях (дисменорея)."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["гиперчувствительность к действующему веществу или к любому из вспомогательных веществ препарата;","гиперчувствительность к натрия дисульфиту;","тяжелая печеночная или почечная недостаточность;","тяжелая хроническая сердечная недостаточность;","детский возраст (применение дротаверина у детей в клинических исследованиях не изучалось);","период кормления грудью."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"list","data":{"style":"ordered","items":["при артериальной гипотензии (опасность коллапса, см. раздел \"Особые указания\");","у беременных женщин (см. раздел \"Беременность и лактация\")."]}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Как показали исследования по репродуктивной токсичности у животных и ретроспективные исследования клинических данных, применение дротаверина в период беременности не оказывало ни тератогенного, ни эмбриотоксического действия. Несмотря на это, при назначении дротаверина беременным женщинам следует соблюдать осторожность и применять его только в тех случаях, когда потенциальная польза для матери превышает потенциальный риск для плода, при этом следует избегать назначения инъекционной лекарственной формы препарата Но-шпа\u003csup\u003e®\u003c/sup\u003e у беременных женщин."}},{"type":"paragraph","data":{"text":"Препарат не следует применять во время родов (потенциальный риск развития послеродовых атонических кровотечений)."}},{"type":"paragraph","data":{"text":"В связи с отсутствием необходимых клинических данных в период лактации назначать препарат не рекомендуется."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eВзрослые\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Суточная средняя доза составляет 40-240 мг дротаверина гидрохлорида (разделенная на 1-3 дозы/сут) в/м."}},{"type":"paragraph","data":{"text":"При \u003ci\u003eострых коликах (почечной или желчнокаменной)\u003c/i\u003e - 40-80 мг в/в медленно (продолжительность введения приблизительно 30 сек)."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Ниже представлены неблагоприятные реакции, наблюдавшиеся в клинических исследованиях, разделенные по системам органов с указанием частоты их возникновения в соответствии со следующими градациями: очень часто (≥10%), часто (≥1% и <10%); нечасто (≥0.1% и <1%); редко (≥0.01% и <0.1%), очень редко, включая отдельные сообщения (<0.01%), неизвестная частота (по имеющимся данным частоту определить нельзя)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e редко - учащение сердцебиения, снижение АД."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы:\u003c/i\u003e редко - головная боль, вертиго, бессонница; частота неизвестна - головокружение."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЖКТ:\u003c/i\u003e редко - тошнота, запор."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны иммунной системы:\u003c/i\u003e редко - аллергические реакции (ангионевротический отек, крапивница, сыпь, зуд); частота неизвестна - при применении препарата сообщалось о развитии анафилактического шока со смертельным исходом и без смертельного исхода."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМестные реакции:\u003c/i\u003e редко - реакции в месте введения."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы:\u003c/i\u003e передозировка дротаверина ассоциировалась с нарушениями сердечного ритма и проводимости, включая полную блокаду ножек пучка Гиса и остановку сердца, которая может быть фатальной."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e в случае передозировки пациенты должны находиться под тщательным медицинским наблюдением; проводят симптоматическую терапию и лечение, направленное на поддержание основных функций организма."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Ингибиторы ФДЭ, подобные папаверину, ослабляют противопаркинсонический эффект леводопы. При назначении дротаверина одновременно с леводопой возможно усиление ригидности и тремора."}},{"type":"paragraph","data":{"text":"Дротаверин усиливает спазмолитическое действие папаверина, бендазола и других спазмолитиков, включая м-холиноблокаторы."}},{"type":"paragraph","data":{"text":"Усиливает гипотензию, вызываемую трициклическими антидепрессантами, хинидином и прокаинамидом."}},{"type":"paragraph","data":{"text":"Снижает спазмогенную активность морфина."}},{"type":"paragraph","data":{"text":"Фенобарбитал усиливает спазмолитическое действие дротаверина."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат содержит дисульфит, который может вызывать реакции аллергического типа, включая анафилактические симптомы и бронхоспазм у чувствительных лиц, особенно у лиц с астмой или аллергическими заболеваниями в анамнезе. В случае повышенной чувствительности к дисульфиту парентерального применения препарата следует избегать."}},{"type":"paragraph","data":{"text":"При в/в введении дротаверина пациенты с пониженным АД должны находиться в горизонтальном положении в связи с риском развития коллапса."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"В период лечения необходимо воздерживаться от управления транспортными средствами и занятий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Препарат следует хранить в оригинальной упаковке в недоступном для детей месте при температуре не выше 25°С."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. Не применять после истечения срока годности, указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Препарат отпускается по рецепту."}}]}],"source":null},"description_toggle":false,"short_description":"Дротаверин представляет собой производное изохинолина, которое проявляет мощное спазмолитическое действие на гладкую мускулатуру за счет ингибирования фермента фосфодиэстеразы (ФДЭ). Фермент ФДЭ необходим для гидролиза цАМФ до АМФ. Ингибирование ФДЭ приводит к повышению концентрации цАМФ, которое запускает следующую каскадную реакцию: высокие концентрации цАМФ активируют цАМФ-зависимое фосфорилирование киназы легких цепей миозина (КЛЦМ). Фосфорилирование КЛЦМ приводит к снижению ее аффинности к кальций (Са2+)-кальмодулиновому комплексу, в результате чего инактивированная форма КЛЦМ поддерживает мышечное расслабление. цАМФ, кроме этого, влияет на цитозольную концентрацию Са2+, благодаря стимулированию транспорта Са2+в экстрацеллюлярное пространство и саркоплазматический ретикулум. Этот понижающий концентрацию Са2+эффект дротаверина через цАМФ объясняет антагонистический эффект дротаверина по отношению к Са2+. In vitro дротаверин ингибирует фермент ФДЭ4, без ингибирования ферментов ФДЭ3 и ФДЭ5. Поэтому эффективность дротаверина зависит от концентраций ФДЭ4 в тканях, содержание которой в разных тканях различается. ФДЭ4 наиболее важна для подавления сократительной активности гладкой мускулатуры, в связи с чем селективное ингибирование ФДЭ4 может быть полезным для лечения гиперкинетических дискинезий и различных заболеваний, сопровождающихся спастическим состоянием ЖКТ. Гидролиз цАМФ в миокарде и гладкой мускулатуре сосудов происходит главным образом с помощью фермента ФДЭ3, чем объясняется тот факт, что при высокой спазмолитической активности у дротаверина отсутствуют серьезные побочные эффекты со стороны сердца и сосудов и выраженные эффекты в отношении сердечно-сосудистой системы. Дротаверин эффективен при спазмах гладкой мускулатуры как нейрогенного, так и мышечного происхождения. Независимо от типа вегетативной иннервации, дротаверин расслабляюще действует на гладкую мускулатуру ЖКТ, желчевыводящих путей, мочеполовой системы.РаспределениеIn vitro дротаверин имеет высокую связь с белками плазмы (95-97%), особенно с альбумином, γ- и β-глобуминами, а также α-ЛПВП. Дротаверин и/или его метаболиты могут незначительно проникать через плацентарный барьер.МетаболизмУ человека дротаверин почти полностью метаболизируется путем O-дезэтилирования. Его метаболиты быстро конъюгируют с глюкуроновой кислотой. 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