ВалацикловирЛатинское названиеДействующее веществоАТХ:Фармакологическая группаПоказанияПротивопоказанияПрименение при беременности и кормлении грудьюПобочные действияМеры предосторожностиУсловия хранения препарата ВалацикловирСрок годности препарата Валацикловир таблетки, покрытые пленочной оболочкой 500 мг; упаковка контурная ячейковая 10, пачка картонная 1; № ЛП-000666, 2011-09-28 от НИЖФАРМ (Россия); производитель: Hetero Drugs (Индия); упаковщик: МАКИЗ-ФАРМА (Россия) Valacyclovir Валацикловир*(Valacyclovirum) J05AB11 Валацикловир Противовирусные (за исключением ВИЧ) средства Опоясывающий лишай; инфекции кожи и слизистых оболочек, вызванные вирусом простого герпеса (в т.ч. генитальный герпес); профилактика рецидивов заболеваний, вызванных вирусом простого герпеса. Гиперчувствительность (в т.ч. к ацикловиру), трансплантация костного мозга, трансплантация почки (см. «Меры предосторожности»).
Беременность.
Данные об исходе беременности у женщин, принимавших ацикловир системного действия в I триместре беременности (ацикловир является активным метаболитом валацикловира), не показали увеличения числа врожденных пороков у детей по сравнению с общей популяцией. Поскольку в наблюдение было включено небольшое количество женщин, достоверных и определенных выводов о безопасности валацикловира при беременности сделать нельзя.
Кормление грудью.
В таблице 1 представлены побочные эффекты, часто наблюдавшиеся при лечении валацикловиром (1 г 3 раза в день) у иммунокомпетентных пациентов с опоясывающим лишаем в период проведения рандомизированных двойных слепых клинических испытаний.Побочный эффектПроцент пациентовВалацикловир (n=967)Плацебо (n=195)Тошнота158Головная боль1412Рвота63Головокружение32Абдоминальная боль32Побочный эффектПроцент пациентовЛечение генитального герпесаСупрессивная терапия генитального герпесаВалацикловир 1 г 2 раза в день (n=1194)Валацикловир 500 мг 2 раза в день (n=1159)Плацебо (n=439)Валацикловир 1 г 4 раза в день (n=269)Валацикловир 500 мг 4 раза в день (n=266)Плацебо (n=134)Тошнота65811118Головная боль161514353834Рвота1<1<1332Головокружение323421Абдоминальная боль2131196Дисменорея<1<11854Артралгия<1<1<1654Депрессия10<1755 Таблица 1 Побочные явления, наблюдавшиеся при проведении клинических испытаний у пациентов с опоясывающим лишаем В таблице 2 представлены побочные эффекты, наблюдавшиеся при лечении валацикловиром у пациентов с генитальным герпесом в период проведения клинических испытаний. Таблица 2 Побочные явления, наблюдавшиеся при проведении клинических испытаний у пациентов с генитальным герпесом При супрессивной (профилактической, превентивной) терапии для предотвращения рецидивов генитального герпеса у ВИЧ-инфицированных пациентов, принимавших валацикловир в дозе 500 мг 2 раза в день (n=194) и плацебо (n=99), часто отмечались такие побочные эффекты, как головная боль (13 и 8% соответственно), повышенная утомляемость (8/5%), сыпь (8/1%). У пациентов, принимавших валацикловир, отмечались также отклонения лабораторных показателей (в сравнении с плацебо): повышение уровней ЩФ (4/2%), АЛТ (14/10%), АСТ (16/11%), снижение числа нейтрофилов (18/10%) и тромбоцитов (3/0%). С большой осторожностью назначают при любых состояниях, сопровождающихся иммунодефицитом, особенно у ВИЧ-инфицированных пациентов. В период проведения клинических испытаний при приеме валацикловира в высоких дозах (8 г/сут) в течение продолжительного времени регистрировали тромбоцитопеническую пурпуру и/или гемолитический уремический синдром, в редких случаях с летальным исходом, у пациентов с клинически выраженными формами ВИЧ-инфекции, после трансплантации костного мозга или почки (см. «Противопоказания» и «Ограничения к применению»). Не установлены эффективность и безопасность применения валацикловира у иммунокомпрометированных пациентов (за исключением супрессивной терапии генитального герпеса у ВИЧ-инфицированных больных), для супрессивной терапии рецидивирующего генитального герпеса у пациентов с клинически выраженными формами ВИЧ-инфекции (число CD4 клеток <100 клеток/мм3), для лечения генитального герпеса у ВИЧ-инфицированных пациентов, для лечения генерализованного опоясывающего герпеса, для снижения возможности инфицирования генитальным герпесом здорового партнера. С осторожностью применяют при нарушении функции почек (удлиняется Т1/2 ацикловира), необходима коррекция режима дозирования в зависимости от степени нарушения их функции. У пациентов с заболеваниями почек, получавших высокие дозы валацикловира, наблюдались случаи развития острой почечной недостаточности и нарушений со стороны ЦНС. Пожилым пациентам во время лечения рекомендуется увеличить объем потребляемой жидкости. Во время лечения генитального герпеса следует избегать половых контактов (препарат не предохраняет от передачи инфекции). При температуре не выше 25 °C.
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2 года. Не применять по истечении срока годности, указанного на упаковке. 2000-2015. Регистр лекарственных средств РоссииБаза данных предназначена для специалистов сферы здравоохранения.Не разрешается коммерческое использование материалов.
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