а Вы в курсе что в России ни арипипразол, ни кветиапин, ни зипрасидон не зарегистрированы в качестве препаратов для лечения детей
В курсе. Кстати, клозапин забыли - можно применять официально. Еще я в курсе того, что общего у жирафа и РФ - до обоих доходит слишком долго. Еще я не вижу никаких реальных препятствий найти врача, который будет лечить сообразно здравому смыслу, опираясь на мировые данные, а не на всякие артефакты на кириллице. Еще я в курсе последних движений МЗиСР, которые еще более в ближайшее время усугубят отставание в области любой фармакотерапии в РФ (в т.ч. ПФТ).
Ок. по пунктам.
РУС: Оланзапин Ограничения к применению: … возраст до 18 лет (безопасность и эффективность не установлены)
а) не противопоказания, ограничения. это две большие разницы. б) безопасность и эффективность установлены уже по ряду позиций, информация устаревшая, то, что производитель не смог актуализировать в этой стране данные в русской редакции - проблема производителя и МЗиСР.
ZYPREXA®
(olanzapine) is an atypical antipsychotic indicated:
As oral formulation for the:
• Treatment of schizophrenia. (1.1)
• Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)
• Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)
• Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)
• Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)
• Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)
• Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)
• Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)
• Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As ZYPREXA IntraMuscular for the:
• Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4)
• Efficacy was established in three 1-day trials in adults. (14.3) As ZYPREXA and Fluoxetine in Combination for the:
• Treatment of depressive episodes associated with bipolar I disorder. (1.5)
• Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.
• Treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different
antidepressants of adequate dose and duration in the current episode). (1.6)
• Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.
официальный pkg inst Zyprexa
РУС: Абилифай Противопоказания: возраст до 18 лет.
Вот тут уже противопоказания указаны - формально сложнее.
Оригинальный pkg inst
ABILIFY is an atypical antipsychotic indicated as oral formulations for the:
Treatment of schizophrenia (1.1)
- Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1)
• Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1)
Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate (1.2) - Adults: Efficacy was established in four 3-week monotherapy trials and one 6-week adjunctive trial in patients with manic or mixed episodes (14.2)
- Pediatric Patients (ages 10-17): Efficacy was established in one 4-week monotherapy trial in patients with manic or mixed episodes (14.2)
Maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate (1.2) - Adults: Efficacy was established in one maintenance monotherapy trial and in one maintenance adjunctive trial (14.2)
Adjunctive treatment of major depressive disorder (MDD) (1.3) - Adults: Efficacy was established in two 6-week trials in patients with MDD who had an inadequate response to antidepressant therapy during the current episode (14.3) Treatment of irritability associated with autistic disorder (1.4)
- Pediatric Patients (ages 6-17 years): Efficacy was established in two 8-week trials in patients with autistic disorder (14.4)
as an injection for the: Acute treatment of agitation associated with schizophrenia or bipolar I disorder (1.5) - Adults: Efficacy was established in three 24-hour trials in agitated patients with schizophrenia or manic/mixed episodes of bipolar I disorder (14.5)
официальный pkg inst Abilify
Зелдокс, официальный pkg inst - пока пусто.
РУС Кветиапин Безопасность и эффективность Сероквеля у детей и подростков не исследовалась. - информация устаревшая.
SEROQUEL is an atypical antipsychotic indicated for the:
Treatment of schizophrenia (1.1)
• Adults: Efficacy was established in three 6-week clinical trials in patients with schizophrenia (14.1)
• Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1)
Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex (1.2)
• Adults: Efficacy was established in two 12-week monotherapy trials and in one 3-week adjunctive trial
in patients with manic episodes associated with bipolar I disorder (14.2)
• Children and Adolescents (ages 10-17): Efficacy was established in one 3-week monotherapy trial in patients with manic episodes associated with bipolar I disorder (14.2)
Acute treatment of depressive episodes associated with bipolar disorder (1.2)
• Adults: Efficacy was established in two 8-week trials in patients with bipolar I or II disorder (14.2)
Maintenance treatment of bipolar disorder as an adjunct to lithium or divalproex (1.2)
• Adults: Efficacy was established in two maintenance trials in adults (14.2)
официальный pkg inst Seroquel
ни один врач не вправе их выписать ребенку
Даже формально это не совсем так, нет прямого запрета опираться врачам РФ на мировые данные. По факту это не так, многие врачи плевать хотели на местные особенности и давно и успешно назначают атипики подросткам и детям.
А если никакой, то и не надо ругать лечение.
Не нужно ругать что? По 2-3 НЛ одновременно в назначениях ребенку, да еще как на подбор самые старые? А что прикажете делать? Похвалить этот мрак??