Лечение и профилактика рецидивов различных аутоиммунных заболеваний как в виде монотерапии, так и в составе комплексной терапии у взрослых и детей в возрасте 2 лет и старше:
аутоиммунные заболевания соединительной ткани, в т.ч. ревматоидный артрит, вторичный ревматоидный синдром на фоне лимфатических и других опухолей;
гематологические заболевания: аутоиммунная гемолитическая анемия, идиопатическая тромбоцитопеническая пурпура, двух- и трехростковые цитопении, в т.ч. вторичные на фоне лимфоцитарных лимфом и хронического лимфолейкоза.
Действующие вещества: гамма-D-глутамил-D-триптофан натрия 1 мг (в 1 мл).
Вспомогательные вещества: натрия хлорид - 9 мг, натрия гидроксид 1 М - до рН 6,0-8,5, вода д/и - до 1 мл.
Фармакологические свойства
Фармакодинамика
Иммунодепрессант. Синтетический пептид, состоящий из D-аминокислот (глутаминовой кислоты и триптофана), соединенных γ-пептидной связью. Ингибирует реакции гуморального и клеточного иммунитета. Обратимо снижает общее количество лимфоцитов в периферической крови, вызывает пропорциональное снижение, как хелперов, так и супрессоров. Подавляет колониеобразование и вступление стволовых клеток – предшественников кроветворения в S-фазу.
Уменьшает количество маркеров активации на лимфоцитах, подавляет пролиферацию Т-клеток.
Тимодепрессин® угнетает спонтанную выработку фактора некроза опухолей α (ФНОα), усиливает выработку интерлейкина 7, не влияет на выработку интерлейкина 1.
Тимодепрессин® снижает острую реакцию "трансплантат против хозяина" (РТПХ), и на 90% снижает хроническую РТПХ при введении Тимодепрессина донору и реципиенту, способствует более быстрому и кооперативному выходу здоровых клеток-предшественников в пролиферативную фазу и восстановлению лейкопоэза.
Тимодепрессин® нетоксичен, эффективен в низких дозах и характеризуется широким терапевтическим диапазоном доз.
Фармакокинетика
Всасывание
При парентеральном введении в системный кровоток попадает около 90% препарата. Сmax в системном кровотоке достигается через 5 мин после его парентерального введения.
Распределение
Сmax в органах и тканях достигается через 15 мин после введения препарата. В костном мозге и печени Сmax превышает таковую в крови в 9,5 и 3,45 раза соответственно. В плазме концентрация Тимодепрессина выше в 1,5 раза, то есть препарат преимущественно накапливается в плазме, а не в форменных элементах крови.
Метаболизм и выведение
Препарат метаболизируется на 70% в печени.
Выводится с мочой (55-59%), а также с калом (13–19%). Т1/2 составляет около 14 ч. Препарат полностью выводится в течении 24 ч и не накапливается в организме.
Показания к применению
Лечение и профилактика рецидивов различных аутоиммунных заболеваний как в виде монотерапии, так и в составе комплексной терапии у взрослых и детей в возрасте 2 лет и старше:
аутоиммунные заболевания соединительной ткани, в т.ч. ревматоидный артрит, вторичный ревматоидный синдром на фоне лимфатических и других опухолей;
гематологические заболевания: аутоиммунная гемолитическая анемия, идиопатическая тромбоцитопеническая пурпура, двух- и трехростковые цитопении, в т.ч. вторичные на фоне лимфоцитарных лимфом и хронического лимфолейкоза.
Другие показания:
при цитостатической химио- и лучевой терапии для защиты и сохранения стволовых клеток и ускорения выхода из гранулоцитопении;
для профилактики отторжения трансплантата при пересадке органов и тканей;
для профилактики отторжения трансплантата при пересадке костного мозга.
Противопоказания
Повышенная чувствительность к компонентам препарата;
неконтролируемая артериальная гипертензия;
инфекционные (в т.ч. вирусные) заболевания в остром периоде;
беременность и период лактации (грудного вскармливания).
Применение при беременности и в период грудного вскармливания
Тимодепрессин противопоказан к применению при беременности и в период лактации (грудного вскармливания).
Способ применения и дозы
Псориаз
Тимодепрессин вводят в/м по 1-2 мл раствора ежедневно в течение 7-10 дней, затем следует 2-дневный перерыв, далее вновь проводят 7-10-дневный цикл введения. В зависимости от клинической ситуации можно проводить от 3 до 5 циклов. Повторные циклы можно проводить до 5 раз. При генерализованной псориатической эритродермии Тимодепрессин® назначают в/м по 2 мл раствора ежедневно в течение 14 дней.
Атопический дерматит
Тимодепрессин вводят в/м по 1-2 мл раствора ежедневно в течение 7-14 дней, курс лечения может быть продлен после 2-дневного перерыва. Длительность курсов и их количество определяется клинико-морфологическими особенностями заболевания.
Экзема
Тимодепрессин вводят в/м по 1-2 мл раствора ежедневно в течение 10 дней с последующим перерывом в течение 2-5 дней, далее вновь проводят 10-дневный курс.
Т-клеточные лимфомы кожи
Препарат вводят в/м по 2 мл раствора ежедневно тремя 7-дневными курсами с 5-дневными перерывами на фоне ГКС в средних дозах (30-40 мг преднизолона).
Пузырчатка
Препарат применяют при различных разновидностях пузырчатки в комплексном лечении с ГКС. Тимодепрессин назначают в/м по 1 мл раствора ежедневно в течение 2 недель в комбинации с преднизолоном (60-80 мг/сутки). Через 7-10 дней после начала лечения суточную дозу преднизолона уменьшают на 1/3 с последующим плавным снижением дозы преднизолона (на 5 мг каждые 4-5 дней). При необходимости сохраняют поддерживающую дозу преднизолона (5 мг/сутки).
Ревматоидный артрит
Тимодепрессин вводят в/м по 1-3 мл раствора ежедневно в течение 7-14 дней, затем 2 раза в неделю. Курс лечения составляет 16 недель.
Применение после цитостатической терапии
Для уменьшения миелотоксического действия цитостатической терапии Тимодепрессин® вводят в/м по 1-2 мл раствора ежедневно в течение 5-7 дней. Введение препарата начинают за 24-48 ч до первого курса цитостатической химиотерапии - 1-е и 2-е введение; 3-е введение производят за 12 ч до начала полихимиотерапии. Далее, в зависимости от длительности курса химиотерапии, препарат продолжают вводить ежедневно в/м по 1-2 мл раствора 1 раз/сутки. Основной показатель эффективности - количество лейкоцитов и гранулоцитов за 3 дня до начала очередного курса цитостатической терапии.
Тимодепрессин показан для применения перед курсами полихимиотерапии, имеющих длительность не более 2 недель и перерывы не менее 2 недель. При длительных непрерывных схемах введения цитостатиков его применение нецелесообразно.
При рецидивирующем течении первичных и вторичных аутоиммунных цитопений Тимодепрессин рекомендуется применять в виде инъекций первые 2 курса, затем при положительном эффекте возможен переход на курсовое применение препарата интраназально в течение нескольких месяцев для стабилизации процесса.
При недостаточном эффекте от первых курсов применения препарата рекомендуется увеличить суточную дозу в 2-3 раза и сократить перерыв между курсами до 7 дней. После достижения эффекта необходимо проводить поддерживающее курсовое лечение, в течение которого дозу препарата можно уменьшить, а перерыв между курсами увеличить.
При тяжелом рецидивирующем течении Тимодепрессин назначают в сочетании с цитостатическими иммунодепрессантами, доза которых уменьшается в 2 раза, а при достижении эффекта цитостатические иммунодепрессанты отменяются.
Детям в возрасте от 2 до 12 лет: Тимодепрессин назначают в/м по 0,5-1 мл раствора для в/м введения 1 раз/сутки в течение 7-10 дней, затем делают перерыв 2 дня и, при необходимости, повторяют курс. Возможно проведение от 1 до 5 курсов.
Детям старше 12 лет: Тимодепрессин назначают в/м по 1-2 мл раствора для в/м введения 1 раз/сутки в течение 7-10 дней, затем делают перерыв 2 дня и далее проводят еще 1-2 курса по 7-10 дней.
Побочное действие
Со стороны системы кроветворения: после второго курса лечения Тимодепрессином возможно транзиторное снижение количества лейкоцитов с сохранением лейкоцитарной формулы периферической крови.
Взаимодействие с другими лекарственными средствами
При совместном применении Тимодепрессин не уменьшает противоопухолевое действие цитостатиков.
Особые указания
Применение Тимодепрессина, как и других иммунодепрессантов, предрасполагает к обострению латентных бактериальных, грибковых, паразитарных и вирусных инфекций. При первых клинических проявлениях инфекционного процесса необходимо назначить соответствующую патогенетическую терапию.
Не рекомендуется назначать Тимодепрессин одновременно с препаратами, оказывающими иммуностимулирующее действие.
При проявлении непредвиденного действия препарата пациент должен обратиться к врачу.
Условия хранения
Хранить в недоступном для детей, защищенном от света месте, при температуре от 2° до 15°С.
Срок годности
3 года.
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Синтетический пептид, состоящий из D-аминокислот (глутаминовой кислоты и триптофана), соединенных γ-пептидной связью. Ингибирует реакции гуморального и клеточного иммунитета. Обратимо снижает общее количество лимфоцитов в периферической крови, вызывает пропорциональное снижение, как хелперов, так и супрессоров. Подавляет колониеобразование и вступление стволовых клеток – предшественников кроветворения в S-фазу."}},{"type":"paragraph","data":{"text":"Уменьшает количество маркеров активации на лимфоцитах, подавляет пролиферацию Т-клеток."}},{"type":"paragraph","data":{"text":"Тимодепрессин® угнетает спонтанную выработку фактора некроза опухолей α (ФНОα), усиливает выработку интерлейкина 7, не влияет на выработку интерлейкина 1."}},{"type":"paragraph","data":{"text":"Тимодепрессин® снижает острую реакцию \"трансплантат против хозяина\" (РТПХ), и на 90% снижает хроническую РТПХ при введении Тимодепрессина донору и реципиенту, способствует более быстрому и кооперативному выходу здоровых клеток-предшественников в пролиферативную фазу и восстановлению лейкопоэза."}},{"type":"paragraph","data":{"text":"Тимодепрессин® нетоксичен, эффективен в низких дозах и характеризуется широким терапевтическим диапазоном доз."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Всасывание"}},{"type":"paragraph","data":{"text":"При парентеральном введении в системный кровоток попадает около 90% препарата. С\u003csub\u003emax\u003c/sub\u003e в системном кровотоке достигается через 5 мин после его парентерального введения."}},{"type":"paragraph","data":{"text":"Распределение"}},{"type":"paragraph","data":{"text":"С\u003csub\u003emax\u003c/sub\u003e в органах и тканях достигается через 15 мин после введения препарата. В костном мозге и печени С\u003csub\u003emax\u003c/sub\u003e превышает таковую в крови в 9,5 и 3,45 раза соответственно. В плазме концентрация Тимодепрессина выше в 1,5 раза, то есть препарат преимущественно накапливается в плазме, а не в форменных элементах крови."}},{"type":"paragraph","data":{"text":"Метаболизм и выведение"}},{"type":"paragraph","data":{"text":"Препарат метаболизируется на 70% в печени."}},{"type":"paragraph","data":{"text":"Выводится с мочой (55-59%), а также с калом (13–19%). Т\u003csub\u003e1/2\u003c/sub\u003e составляет около 14 ч. Препарат полностью выводится в течении 24 ч и не накапливается в организме."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Лечение и профилактика рецидивов различных аутоиммунных заболеваний как в виде монотерапии, так и в составе комплексной терапии у взрослых и детей в возрасте 2 лет и старше:"}},{"type":"list","data":{"style":"ordered","items":["хронические рецидивирующие дерматозы: псориаз, пузырчатка, атопический дерматит, экзема, симптоматическое лечение Т-клеточных лимфом кожи;","аутоиммунные заболевания соединительной ткани, в т.ч. ревматоидный артрит, вторичный ревматоидный синдром на фоне лимфатических и других опухолей;","гематологические заболевания: аутоиммунная гемолитическая анемия, идиопатическая тромбоцитопеническая пурпура, двух- и трехростковые цитопении, в т.ч. вторичные на фоне лимфоцитарных лимфом и хронического лимфолейкоза."]}},{"type":"paragraph","data":{"text":"Другие показания:"}},{"type":"list","data":{"style":"ordered","items":["при цитостатической химио- и лучевой терапии для защиты и сохранения стволовых клеток и ускорения выхода из гранулоцитопении;","для профилактики отторжения трансплантата при пересадке органов и тканей;","для профилактики отторжения трансплантата при пересадке костного мозга."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["Повышенная чувствительность к компонентам препарата;","неконтролируемая артериальная гипертензия;","инфекционные (в т.ч. вирусные) заболевания в остром периоде;","беременность и период лактации (грудного вскармливания)."]}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Тимодепрессин противопоказан к применению при беременности и в период лактации (грудного вскармливания)."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Псориаз"}},{"type":"paragraph","data":{"text":"Тимодепрессин вводят в/м по 1-2 мл раствора ежедневно в течение 7-10 дней, затем следует 2-дневный перерыв, далее вновь проводят 7-10-дневный цикл введения. В зависимости от клинической ситуации можно проводить от 3 до 5 циклов. Повторные циклы можно проводить до 5 раз. При генерализованной псориатической эритродермии Тимодепрессин® назначают в/м по 2 мл раствора ежедневно в течение 14 дней."}},{"type":"paragraph","data":{"text":"Атопический дерматит"}},{"type":"paragraph","data":{"text":"Тимодепрессин вводят в/м по 1-2 мл раствора ежедневно в течение 7-14 дней, курс лечения может быть продлен после 2-дневного перерыва. Длительность курсов и их количество определяется клинико-морфологическими особенностями заболевания."}},{"type":"paragraph","data":{"text":"Экзема"}},{"type":"paragraph","data":{"text":"Тимодепрессин вводят в/м по 1-2 мл раствора ежедневно в течение 10 дней с последующим перерывом в течение 2-5 дней, далее вновь проводят 10-дневный курс."}},{"type":"paragraph","data":{"text":"Т-клеточные лимфомы кожи"}},{"type":"paragraph","data":{"text":"Препарат вводят в/м по 2 мл раствора ежедневно тремя 7-дневными курсами с 5-дневными перерывами на фоне ГКС в средних дозах (30-40 мг преднизолона)."}},{"type":"paragraph","data":{"text":"Пузырчатка"}},{"type":"paragraph","data":{"text":"Препарат применяют при различных разновидностях пузырчатки в комплексном лечении с ГКС. Тимодепрессин назначают в/м по 1 мл раствора ежедневно в течение 2 недель в комбинации с преднизолоном (60-80 мг/сутки). Через 7-10 дней после начала лечения суточную дозу преднизолона уменьшают на 1/3 с последующим плавным снижением дозы преднизолона (на 5 мг каждые 4-5 дней). При необходимости сохраняют поддерживающую дозу преднизолона (5 мг/сутки)."}},{"type":"paragraph","data":{"text":"Ревматоидный артрит"}},{"type":"paragraph","data":{"text":"Тимодепрессин вводят в/м по 1-3 мл раствора ежедневно в течение 7-14 дней, затем 2 раза в неделю. Курс лечения составляет 16 недель."}},{"type":"paragraph","data":{"text":"Применение после цитостатической терапии"}},{"type":"paragraph","data":{"text":"Для уменьшения миелотоксического действия цитостатической терапии Тимодепрессин® вводят в/м по 1-2 мл раствора ежедневно в течение 5-7 дней. Введение препарата начинают за 24-48 ч до первого курса цитостатической химиотерапии - 1-е и 2-е введение; 3-е введение производят за 12 ч до начала полихимиотерапии. Далее, в зависимости от длительности курса химиотерапии, препарат продолжают вводить ежедневно в/м по 1-2 мл раствора 1 раз/сутки. Основной показатель эффективности - количество лейкоцитов и гранулоцитов за 3 дня до начала очередного курса цитостатической терапии."}},{"type":"paragraph","data":{"text":"Тимодепрессин показан для применения перед курсами полихимиотерапии, имеющих длительность не более 2 недель и перерывы не менее 2 недель. При длительных непрерывных схемах введения цитостатиков его применение нецелесообразно."}},{"type":"paragraph","data":{"text":"При рецидивирующем течении первичных и вторичных аутоиммунных цитопений Тимодепрессин рекомендуется применять в виде инъекций первые 2 курса, затем при положительном эффекте возможен переход на курсовое применение препарата интраназально в течение нескольких месяцев для стабилизации процесса."}},{"type":"paragraph","data":{"text":"При недостаточном эффекте от первых курсов применения препарата рекомендуется увеличить суточную дозу в 2-3 раза и сократить перерыв между курсами до 7 дней. После достижения эффекта необходимо проводить поддерживающее курсовое лечение, в течение которого дозу препарата можно уменьшить, а перерыв между курсами увеличить."}},{"type":"paragraph","data":{"text":"При тяжелом рецидивирующем течении Тимодепрессин назначают в сочетании с цитостатическими иммунодепрессантами, доза которых уменьшается в 2 раза, а при достижении эффекта цитостатические иммунодепрессанты отменяются."}},{"type":"paragraph","data":{"text":"Детям в возрасте от 2 до 12 лет: Тимодепрессин назначают в/м по 0,5-1 мл раствора для в/м введения 1 раз/сутки в течение 7-10 дней, затем делают перерыв 2 дня и, при необходимости, повторяют курс. Возможно проведение от 1 до 5 курсов."}},{"type":"paragraph","data":{"text":"Детям старше 12 лет: Тимодепрессин назначают в/м по 1-2 мл раствора для в/м введения 1 раз/сутки в течение 7-10 дней, затем делают перерыв 2 дня и далее проводят еще 1-2 курса по 7-10 дней."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: после второго курса лечения Тимодепрессином возможно транзиторное снижение количества лейкоцитов с сохранением лейкоцитарной формулы периферической крови."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При совместном применении Тимодепрессин не уменьшает противоопухолевое действие цитостатиков."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Применение Тимодепрессина, как и других иммунодепрессантов, предрасполагает к обострению латентных бактериальных, грибковых, паразитарных и вирусных инфекций. При первых клинических проявлениях инфекционного процесса необходимо назначить соответствующую патогенетическую терапию."}},{"type":"paragraph","data":{"text":"Не рекомендуется назначать Тимодепрессин одновременно с препаратами, оказывающими иммуностимулирующее действие."}},{"type":"paragraph","data":{"text":"При проявлении непредвиденного действия препарата пациент должен обратиться к врачу."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в недоступном для детей, защищенном от света месте, при температуре от 2° до 15°С."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}}]}],"source":null},"description_toggle":false,"short_description":"Фармакодинамика Иммунодепрессант. Синтетический пептид, состоящий из D-аминокислот (глутаминовой кислоты и триптофана), соединенных γ-пептидной связью. Ингибирует реакции гуморального и клеточного иммунитета. 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