Катрен Стиль
Амлодипин разрешили применять детям с шести лет
Министерство здравоохранения обращается ко всем производителям лекарственных препаратов с действующим веществом амлодипином с просьбой внести изменения в инструкции по применению, добавив в них возможность использования этого ЛС в педиатрической практике. Информационное письмо об этом опубликовано в Государственном реестре лекарственных средств 26 октября.
Минздрав предлагает унифицировать все инструкции ЛС с амлодипином следующим образом:
- В раздел «Показания к применению» добавить новое показание: «Артериальная гипертензия у детей в возрасте 6–17 лет».
- В разделе «Фармакокинетика» необходимо указать информацию о клинических исследованиях амлодипина на пациентах детского возраста, которые показали снижение артериального давления.
- В разделе «Противопоказания» необходимо указать «детский возраст до 6 лет».
-
Раздел «Способ применения и дозы» дополнить следующей информацией:
«Дети и подростки от 6 до 17 лет с артериальной гипертензией
Рекомендуемая антигипертензивная пероральная доза у пациентов детского возраста от 6 до 17 лет составляет 2,5 мг один раз в сутки в качестве начальной дозы с повышением до 5 мг один раз в сутки, если целевое артериальное давление не достигается через 4 недели. Применение у детей доз, превышающих 5 мг в сутки, не изучалось».
Дополнительно для лекарственных препаратов с амлодипином, выпускаемых в дозировке только 10 мг или в таблетках по 5 мг без разделительной риски, в конце раздела «Способ применения и дозы» необходимо добавить следующее указание:
«Для обеспечения указанного выше режима дозирования при необходимости применения амлодипина в дозе 2,5 мг следует назначать препараты других производителей в лекарственной форме “таблетки 2,5 мг” или “таблетки 5 мг” с разделительной риской».
Ранее Министерство здравоохранения рекомендовало производителям всех лекарственных средств с амоксициллином добавить в инструкцию новое побочное действие.
27 октября 2022
Фото: © AndreyPopov / Фотобанк Фотодженика
Выпуск: №226, октябрь 2022864 просмотров
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