В качестве монотерапии у пациентов с неадекватным контролем гликемии только на фоне диеты и физических упражнений, при непереносимости метформина или при противопоказании к его применению вследствие почечной недостаточности,
В качестве двухкомпонентной комбинированной терапии с метформином, производными сульфонилмочевины или тиазолидиндионом в случае неэффективности диетотерапии, физических упражнений и монотерапии этими препаратами,
В качестве трехкомпонентной комбинированной терапии с метформином и производными сульфонилмочевины в случае неэффективности диетотерапии, физических упражнений и комбинированной терапии этими препаратами,
Таблетки Тражента - пероральный гипогликемический препарат. Применяется при лечении сахарного диабета 2 типа.
Показания к применению
Сахарный диабет 2 типа:
В качестве монотерапии у пациентов с неадекватным контролем гликемии только на фоне диеты и физических упражнений, при непереносимости метформина или при противопоказании к его применению вследствие почечной недостаточности,
В качестве двухкомпонентной комбинированной терапии с метформином, производными сульфонилмочевины или тиазолидиндионом в случае неэффективности диетотерапии, физических упражнений и монотерапии этими препаратами,
В качестве трехкомпонентной комбинированной терапии с метформином и производными сульфонилмочевины в случае неэффективности диетотерапии, физических упражнений и комбинированной терапии этими препаратами,
В качестве двухкомпонентной комбинированной терапии с инсулином или многокомпонентной терапии с инсулином, метформином и/или пиоглитазоном и/или производными сульфонилмочевины в случае неэффективности диетотерапии, физических упражнений и комбинированной терапии этими препаратами
Применение при беременности и в период грудного вскармливания
Применение линаглиптина при беременности и в период грудного вскармливания противопоказано. Данные, полученные в доклинических исследованиях у животных, свидетельствуют о выделении линаглиптина и его метаболита с грудным молоком. Не исключается риск воздействия на новорожденных и детей при грудном вскармливании. При необходимости применения линаглиптина в период лактации кормление грудью следует прекратить.
Способ применения и дозы
Препарат принимают внутрь, в любое время дня, независимо от приема пищи. Рекомендуемая доза составляет 5 мг (1 таб.) 1 раз/сут. При пропуске очередного приема пациенту следует принять препарат, как только он об этом вспомнит. Не следует принимать двойную дозу в один день. Коррекция дозы при применении препарата у пациентов с нарушением функции почек, печени и у пациентов пожилого возраста не требуется.
Побочное действие
Частота побочных эффектов при применении линаглиптина в дозе 5 мг была аналогичной частоте побочных эффектов при применении плацебо. Прекращение терапии из-за нежелательных явлений было выше в группе пациентов, получавших плацебо (4.4%), чем в группе, получавших линаглиптин в дозе 5 мг (3.5%). При монотерапии линаглиптином наблюдались следующие побочные эффекты: Со стороны иммунной системы: реакции гиперчувствительности. Со стороны дыхательной системы: кашель. Со стороны пищеварительной системы: панкреатит. Инфекционные заболевания: назофарингит. При применении линаглиптина с метформином: Со стороны иммунной системы: реакции гиперчувствительности. Со стороны дыхательной системы: кашель. Со стороны пищеварительной системы: панкреатит. Инфекционные заболевания: назофарингит. При применении линаглиптина с производными сульфонилмочевины: Со стороны иммунной системы: реакции гиперчувствительности. Метаболические нарушения: гипертриглицеридемия. Со стороны дыхательной системы: кашель. Со стороны пищеварительной системы: панкреатит. Инфекционные заболевания: назофарингит. При применении линаглиптина с пиоглитазоном: Со стороны иммунной системы: реакции гиперчувствительности. Метаболические нарушения: гиперлипидемия. Со стороны дыхательной системы: кашель. Со стороны пищеварительной системы: панкреатит. Инфекционные заболевания: назофарингит. Прочие: увеличение массы тела. При применении линаглиптина с инсулином: Со стороны иммунной системы: реакции гиперчувствительности. Со стороны дыхательной системы: кашель. Со стороны пищеварительной системы: панкреатит, запор. Инфекционные заболевания: назофарингит. При применении линаглиптина с метформином и производными сульфонилмочевины: Со стороны иммунной системы: гиперчувствительность. Метаболические нарушения: гипогликемия. Со стороны дыхательной системы: кашель. Со стороны пищеварительной системы: панкреатит. Инфекционные заболевания: назофарингит. При применении линаглиптина с метформином и пиоглитазоном: Со стороны иммунной системы: реакции гиперчувствительности. Метаболические нарушения: гиперлипидемия. Со стороны дыхательной системы: кашель. Со стороны пищеварительной системы: панкреатит. Инфекционные заболевания: назофарингит. Прочие: увеличение массы тела. Постмаркетинговый опыт примененияСо стороны иммунной системы: ангионевротический отек, крапивница. Со стороны пищеварительной системы: изъязвление слизистой оболочки полости рта. Со стороны кожных покровов: сыпь.
Передозировка
Во время проведения контролируемых клинических исследований у здоровых добровольцев однократный прием линаглиптина в дозе, достигавшей 600 мг (в 120 раз превышавшей рекомендуемую дозу) переносился хорошо. Опыта применения линаглиптина в дозе, превышающей 600 мг, нет. Лечение: в случае передозировки рекомендуется использовать обычные меры поддерживающего характера, например, удаление неабсорбированного препарата из ЖКТ, осуществление клинического контроля и проведение симптоматической терапии.
Особые указания
Противопоказания к применению— сахарный диабет 1 типа,— диабетический кетоацидоз,— беременность,— период лактации (грудного вскармливания),— детский и подростковый возраст до 18 лет,— повышенная чувствительность к любому компоненту препарата.
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