ИНСТРУКЦИЯ
по медицинскому применению препарата
Регистрационный номер:
Торговое название препарата: Химотрипсин
Международное непатентованное название:
Лекарственная форма:
Состав:
Описание: Лиофилизированная пористая масса в виде таблетки, комочков или блестящих чешуек белого цвета.
Фармакотерапевтическая группа:
Код ATX: D03BA
Фармакологические свойства.
Химотрипсин — ферментный препарат протеолитического действия, получаемый из поджелудочной железы крупного рогатого скота. Гидролизует белки и пептоны с образованием относительно низкомолекулярных пептидов, расщепляет связи, образованные остатками ароматических аминокислот (тирозин, триптофан, фенилаланин, метионин).
В медицинской практике применение химотрипсина основано на специфической особенности расщеплять некротизированные ткани и фибринозные образования, разжижать вязкие секреты и экссудаты, а при внутримышечном введении оказывать противовоспалительное действие.
Показания к применению.
Нагноительные заболевания органов дыхания (трахеиты, бронхиты, бронхоэктатическая болезнь, пневмония, абсцессы легких, ателектаз, экссудативный плеврит, бронхиальная астма).
При лечении ожогов, пролежней, гнойных ран, тромбофлебитов.
В офтальмологии — при свежих обширных тромбозах центральной вены сетчатки, острой непроходимости центральной артерии сетчатки, помутнениях стекловидного тела травматического и воспалительного происхождения, экстракции катаракты.
В отоларингологии — при гнойных синуситах, подострых ларинго-трахеитах, после трахеостомии для облегчения удаления густого вязкого экссудата, при острых, подострых, гнойных, хронических средних отитах и евстахиитах с вязким экссудатом.
Противопоказания
Повышенная чувствительность к химотрипсину, злокачественные новообразования, туберкулез легких (открытая форма), хроническая сердечная недостаточность II — III степени, дистрофия и цирроз печени, вирусный гепатит, панкреатит, геморрагический диатез, эмфизема легких с дыхательной недостаточностью.
Нельзя вводить в кровоточащие полости, наносить на изъязвленные поверхности злокачественных опухолей во избежание распространения злокачественного процесса.
С осторожностью.
Эмпиема плевры туберкулезной этиологии (рассасывание экссудата может в некоторых случаях способствовать развитию бронхоплевральной фистулы).
Применение при беременности и в период кормления грудью
Данных о применении препарата при беременности и в период кормления грудью нет.
Способ применения и дозы.
Для внутримышечного введения растворяют непосредственно перед применением 0,005 г препарата в 1 -2 мл стерильного 0,9 % раствора натрия хлорида или 0,5-2 % раствора прокаина. Курс лечения — 6-15 инъекций.
При заболеваниях органов дыхания препарат применяют внутримышечно в дозах по 5-10 мг в день в течение 10-12 дней, возможно сочетание с применением химотрипсина аэрозольно в 5% водном растворе в количестве 3-4мл. Через 7-10 дней курс лечения может быть повторен.
При лечении ожогов и пролежней химотрипсин в дозе 20 мг растворяют в 20 мл 0,25% раствора прокаина и тонкой иглой несколькими уколами вводится под струп. На гнойные раневые поверхности накладывают на 8 часов стерильные салфетки, смоченные раствором 0,025-0,05 г химотрипсина в 10-50 мл 0,25 % раствора прокаина. Для лечения гнойных ран внутримышечные введения препарата сочетают с местным лечением раны тампонами, смоченными 5% водным раствором химотрипсина.
При тромбофлебитах препарат назначается внутримышечно по 5-10 мг ежедневно в течение 7-10 дней.
При экстракции катаракты химотрипсин в разведении 1:5000 вводится в заднюю камеру глаза с последующим промыванием передней камеры глаза 0,9 % раствором натрия хлорида через 4 минуты после введения препарата.
При лечении тромбозов центральной вены сетчатки, острой непроходимости центральной артерии сетчатки химотрипсин вводится субконъюктивально по 0,2 мл 5% раствора, приготовленного на 1% растворе прокаина, 1-2 раза в неделю.
При синуситах препарат вводится в соответствующую полость в количестве 5-10 мг в 3-5 мл 0,9 % раствора натрия хлорида после пункции и промывания полости.
При отитах закапывают в ухо по 0,5-1 мл 0,1% раствора химотрипсина на 0,9 % растворе натрия хлорида. При микрооперациях на ухе для размягчения фибринозных образований в среднем ухе во время операции вводят в полость 0,1% раствор химотрипсина. Одновременно химотрипсин следует вводить внутримышечно по 2,5-5 мг 1-2 раза в день. Препарат разводится в 1-2 мл 0,25-0,5% раствора новокаина или 0,9 % раствора натрия хлорида.
Побочное действие
Возможно появление аллергических реакций, повышение температуры тела до субфебриальной, тахикардии.
После ингаляционного введения: изредка наблюдается раздражение слизистых оболочек верхних дыхательных путей, охриплость голоса.
При субконъюнктивальном введении возможны раздражение и отечность конъюнктивы; в таких случаях рекомендуется уменьшать концентрацию применяемого раствора.
После внутримышечного введения могут возникнуть болезненность и гиперемия на месте инъекций.
Взаимодействие с другими лекарственными средствами.
Не описано.
Форма выпуска
Лиофилизат для приготовления раствора для инъекций и местного применения 10 мг (флаконы 5 мл). 10 флаконов вместе с инструкцией по применению в картонной пачке.
Условия хранения
В сухом, защищенном от света месте при температуре не выше +10°С. Растворы химотрипсина неустойчивы: могут храниться в течение суток при температуре 2-5°С.
Хранить в недоступном от детей месте.
Срок годности
3 года. Данное лекарство нельзя использовать после даты, указанной на упаковке.
Условия отпуска из аптек:
Название и адрес изготовителя
Изготовитель: Россия, 196158, Санкт-Петербург, Московское шоссе, 13 ООО "Самсон-Мед"
Показания к применению
Тромбофлебит, пародонтоз (воспалительно-дистрофические формы), остеомиелит, гайморит, отит, ирит, иридоциклит, интракапсулярная экстракция катаракты, кровоизлияние в переднюю камеру глаза, отек периорбитальной области после операций и травм; трахеит, бронхит; эмпиема плевры, экссудативный плеврит; ожоги, гнойные раны, пролежни (применяют местно).
Возможные аналоги (заменители)
Действующее вещество, группа
Лекарственная форма
лиофилизат для приготовления раствора для местного и наружного применения
Противопоказания
Гиперчувствительность, злокачественные новообразования, декомпенсированные формы туберкулеза легких, ХСН II-III ст., дистрофия и цирроз печени, инфекционный гепатит, панкреатит, геморрагический диатез, эмфизема легких с дыхательной недостаточностью.
Нельзя вводить в кровоточащие полости, наносить на изъязвленные поверхности злокачественных опухолей.C осторожностью. Эмпиема плевры туберкулезной этиологии (рассасывание экссудата может способствовать развитию бронхоплевральной фистулы).
Как применять: дозировка и курс лечения
Местно. На гнойные раневые поверхности накладывают на 8 ч стерильные салфетки, смоченные раствором 25-50 мг препарата в 10-50 мл 0.25% раствора прокаина.
В/м, взрослым — по 2.5 мг 1 раз в день; растворяют непосредственно перед применением 5 мг в 1-2 мл стерильного 0.9% раствора NaCl или 0.5-2% раствора прокаина. Курс лечения препаратом — 6-15 инъекций.
Фармакологическое действие
Протеолитическое средство белковой природы. Получают из поджелудочной железы крупного рогатого скота. При в/м введении оказывает противовоспалительное действие; при местном применении расщепляет некротизированные ткани и фибринозные образования; разжижает вязкий секрет, экссудат, сгустки крови. Гидролизует белки и пептоны с образованием низкомолекулярных пептидов, расщепляет связи образованные остатками ароматических аминокислот (тирозин, троптофан, фенилаланин, метионин).
Побочные действия
Аллергические реакции, повышение температуры тела до субфебрильной, тахикардия.
После ингаляционного введения: раздражение слизистой оболочки верхних дыхательных путей, охриплость голоса.
При субконъюнктивальном введении препарата: раздражение и отечность конъюнктивы (в этом случае рекомендуется уменьшить концентрацию применяемого раствора).
При в/м введении препарата: болезненность и гиперемия в месте введения.
Особые указания
Особые указания при приеме препарата отсутствуют.
Взаимодействие
Лекарственного взаимодействия при лечении Химотрипсином совместно с другими препаратами не выявлено.
Инструкция по применению:
Цены в интернет-аптеках:
Химотрипсин – протеолитическое средство.
Форма выпуска и состав
Форма выпуска – лиофилизат для приготовления раствора для местного, наружного применения, а также для инъекций: в виде порошка, таблетки, комочков, пластинок или белых блестящих чешуек (10 мг во флаконе из стекла, под резиновой пробкой и алюминиевым колпачком, 10 флаконов в картонной коробке).
В состав лиофилизата входит химотрипсин – получаемый из поджелудочной железы крупного рогатого скота ферментный препарат протеолитического действия.
Показания к применению
- офтальмология: острая непроходимость центральной вены сетчатки, свежие обширные тромбозы центральной вены сетчатки, вызванное травмой или воспалительным заболеванием помутнение стекловидного тела, экстракция катаракты;
- отоларингология: подострый ларинготрахеит, гнойный синусит, острые, подострые, гнойные, хронические средние отиты, евстахииты с вязким экссудатом; также применяется после трахеотомии (для облегчения удаления вязкого экссудата);
- пародонтоз в воспалительно-дистрофических формах, тромбофлебит;
- нагноительные заболевания органов дыхания: пневмония, бронхоэктатическая болезнь, экссудативный плеврит, абсцесс легких, ателектаз, эмпиема плевры, бронхит;
- гнойные раны, ожоги, пролежни.
Противопоказания
- повышенная сенситивность к химотрипсину;
- открытая форма туберкулеза легких;
- эмфизема легких, осложненная дыхательной недостаточностью;
- хроническая сердечная недостаточность II–III степени;
- дистрофия, цирроз печени;
- панкреатит;
- вирусный гепатит;
- злокачественные новообразования;
- геморрагический диатез.
Противопоказано нанесение на изъязвленные поверхности и кровоточащие полости злокачественных опухолей в связи с риском распространения злокачественного процесса.
С осторожностью следует применять препарат при эмпиеме плевры, вызванной туберкулезом, из-за риска развития бронхоплевральной фистулы по причине рассасывания экссудата.
Способ применения и дозировка
При внутримышечном введении приготовление раствора должно происходить непосредственно перед применением. Растворяют 5 мг лиофилизата в 1-2 мл 0,9% раствора хлорида натрия, либо в 0,5–2% растворе прокаина, курс лечения – 6–15 дней.
- заболевания органов дыхания: доза препарата составляет 5–10 мг в сутки. Курс лечения 10–12 дней. Возможно применение в составе комплексной терапии с Химотрипсином аэрозольно (3–4 мл препарата в 5% водном растворе). Курс применения возможно повторить через 7–10 дней;
- тромбофлебит: внутримышечно, суточная доза – 5–10 мг, курс лечения – 7–10 дней;
- ожоги и пролежни: 20 мг препарата растворяют в 20 мл 0,25% раствора прокаина, вводят в струп при помощи тонкой иглы;
- гнойные раневые поверхности: 25–50 мг препарата растворяют в 10–50 мл 0,25% растворе прокаина, стерильную салфетку, смоченную указанным раствором, накладывают на гнойные раневые поверхности на 8 ч;
- гнойные раны: применяют как внутримышечное, так и местное лечение раны тампонами, смоченными 5% водным раствором Химотрипсина;
- экстракция катаракты: вводится в заднюю камеру глаза в разведении 1:5000 (с последующим промыванием передней камеры глаза 0,9% раствором хлорида натрия через 4 мин после введения Химотрипсина);
- острая непроходимость центральной артерии сетчатки, тромбоз центральной вены сетчатки: 0,2 мл 5% раствора Химотрипсина, приготовленного на 1% растворе прокаина, водится субконъюнктивально 1-2 раза в неделю;
- синуситы: 5–10 мг Химотрипсина растворяют в 3–5 мл 0,9% раствора хлорида натрия, после пункции и промывания вводят в соответствующую полость;
- отиты: 0,5–1 мл 0,1% раствора препарата, приготовленного на 0,9% растворе хлорида натрия, закапывают в ухо;
- при микрооперациях на ухе: требуется одновременно внутримышечное и местное применение Химотрипсина. Внутримышечно препарат вводят в дозе 2,5–5 мг 1-2 раза в день (раствор готовится на 0,9% растворе хлорида натрия для инъекций или 0,25–0,5% растворе прокаина). В полость во время операции вводится 0,1% раствор Химотрипсина для размягчения фиброзных образований в среднем ухе.
Побочные действия
- тахикардия, повышение температуры тела до субфебрильной, аллергические реакции;
- субконъюнктивальное введение: отечность и раздражение конъюнктивы (при проявлении следует снизить концентрацию применяемого раствора Химотрипсина);
- ингаляционное введение: охриплость голоса, раздражение слизистых оболочек верхних дыхательных путей;
- внутримышечное введение: гиперемия и болезненность в месте инъекции.
Особые указания
Перед применением необходима консультация врача.
Данные об использовании препарата во время беременности и кормления грудью отсутствуют.
Лекарственное взаимодействие
Данные о лекарственном взаимодействии Химотрипсина с иными лекарственными средствами не описаны.
Аналоги
Аналогами Химотрипсина являются Коллализин, Химопсин, Дальцекс-трипсин, Лизоамидаза, Коллитин, Пакс-трипсин.
Сроки и условия хранения
Хранить вне доступа детей, вдали от света, при температуре не выше 20 °С.
Срок хранения – 3 года.
Условия отпуска из аптек
Отпускается по рецепту.
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