User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 500)
Drupal\Core\Render\Renderer->doRender() (Line: 253)
Drupal\Core\Render\Renderer->doRenderRoot() (Line: 143)
Drupal\Core\Render\Renderer->{closure:Drupal\Core\Render\Renderer::renderInIsolation():142}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 142)
Drupal\Core\Render\Renderer->renderInIsolation() (Line: 169)
Drupal\Core\Render\Renderer->doRenderPlaceholder() (Line: 206)
Drupal\Core\Render\Renderer->renderPlaceholder() (Line: 797)
Drupal\Core\Render\Renderer->replacePlaceholders() (Line: 265)
Drupal\Core\Render\Renderer->doRenderRoot() (Line: 143)
Drupal\Core\Render\Renderer->{closure:Drupal\Core\Render\Renderer::renderInIsolation():142}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 142)
Drupal\Core\Render\Renderer->renderInIsolation() (Line: 113)
Drupal\Core\Render\Renderer->renderRoot() (Line: 253)
Drupal\Core\Render\HtmlResponseAttachmentsProcessor->renderPlaceholders() (Line: 74)
Drupal\big_pipe\Render\BigPipeResponseAttachmentsProcessor->processAttachments() (Line: 106)
Drupal\canvas\Render\ImportMapResponseAttachmentsProcessor->processAttachments() (Line: 45)
Drupal\Core\EventSubscriber\HtmlResponseSubscriber->onRespond() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 216)
Symfony\Component\HttpKernel\HttpKernel->filterResponse() (Line: 204)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 169)
Drupal\Core\EventSubscriber\DefaultExceptionHtmlSubscriber->makeSubrequest() (Line: 119)
Drupal\Core\EventSubscriber\CustomPageExceptionHtmlSubscriber->makeSubrequestToCustomPath() (Line: 71)
Drupal\Core\EventSubscriber\CustomPageExceptionHtmlSubscriber->on403() (Line: 109)
Drupal\Core\EventSubscriber\HttpExceptionSubscriberBase->onException() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 241)
Symfony\Component\HttpKernel\HttpKernel->handleThrowable() (Line: 91)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 203)
Drupal\page_cache\StackMiddleware\PageCache->fetch() (Line: 140)
Drupal\page_cache\StackMiddleware\PageCache->lookup() (Line: 89)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 500)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 242)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::prepare():235}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 235)
Drupal\Core\Render\MainContent\HtmlRenderer->prepare() (Line: 131)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 556)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 242)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::prepare():235}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 235)
Drupal\Core\Render\MainContent\HtmlRenderer->prepare() (Line: 131)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 500)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 501)
Drupal\Core\Template\TwigExtension->escapeFilter() (Line: 73)
__TwigTemplate_903f906915f560ffb5a631ed1395e98b->doDisplay() (Line: 402)
Twig\Template->yield() (Line: 386)
Twig\Template->render() (Line: 51)
Twig\TemplateWrapper->render() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 556)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 242)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::prepare():235}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 235)
Drupal\Core\Render\MainContent\HtmlRenderer->prepare() (Line: 131)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 556)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 242)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::prepare():235}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 235)
Drupal\Core\Render\MainContent\HtmlRenderer->prepare() (Line: 131)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 500)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 242)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::prepare():235}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 235)
Drupal\Core\Render\MainContent\HtmlRenderer->prepare() (Line: 131)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 500)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 513)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 242)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::prepare():235}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 235)
Drupal\Core\Render\MainContent\HtmlRenderer->prepare() (Line: 131)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 556)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 242)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::prepare():235}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 235)
Drupal\Core\Render\MainContent\HtmlRenderer->prepare() (Line: 131)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
Drupal\Core\StackMiddleware\Session->handle() (Line: 48)
Drupal\Core\StackMiddleware\KernelPreHandle->handle() (Line: 28)
Drupal\Core\StackMiddleware\ContentLength->handle() (Line: 32)
Drupal\big_pipe\StackMiddleware\ContentLength->handle() (Line: 118)
Drupal\page_cache\StackMiddleware\PageCache->pass() (Line: 92)
Drupal\page_cache\StackMiddleware\PageCache->handle() (Line: 48)
Drupal\Core\StackMiddleware\ReverseProxyMiddleware->handle() (Line: 51)
Drupal\Core\StackMiddleware\NegotiationMiddleware->handle() (Line: 53)
Drupal\Core\StackMiddleware\AjaxPageState->handle() (Line: 54)
Drupal\Core\StackMiddleware\StackedHttpKernel->handle() (Line: 745)
Drupal\Core\DrupalKernel->handle() (Line: 19)

User warning: mkdir(): Permission Denied in Drupal\Component\PhpStorage\FileStorage->createDirectory() (line 125 of core/lib/Drupal/Component/PhpStorage/FileStorage.php).

Drupal\Component\PhpStorage\FileStorage->createDirectory() (Line: 73)
Drupal\Component\PhpStorage\FileStorage->ensureDirectory() (Line: 66)
Drupal\Component\PhpStorage\MTimeProtectedFastFileStorage->save() (Line: 116)
Drupal\Core\Template\TwigPhpStorageCache->write() (Line: 410)
Twig\Environment->loadTemplate() (Line: 370)
Twig\Environment->load() (Line: 35)
Drupal\Core\Template\TwigThemeEngine->renderTemplate() (Line: 428)
Drupal\Core\Theme\ThemeManager->render() (Line: 500)
Drupal\Core\Render\Renderer->doRender() (Line: 230)
Drupal\Core\Render\Renderer->render() (Line: 162)
Drupal\Core\Render\MainContent\HtmlRenderer->{closure:Drupal\Core\Render\MainContent\HtmlRenderer::renderResponse():157}() (Line: 634)
Drupal\Core\Render\Renderer::{closure:Drupal\Core\Render\Renderer::executeInRenderContext():634}()
Fiber->start() (Line: 635)
Drupal\Core\Render\Renderer->executeInRenderContext() (Line: 157)
Drupal\Core\Render\MainContent\HtmlRenderer->renderResponse() (Line: 90)
Drupal\Core\EventSubscriber\MainContentViewSubscriber->onViewRenderArray() (Line: 246)
Symfony\Component\EventDispatcher\EventDispatcher::{closure:Symfony\Component\EventDispatcher\EventDispatcher::optimizeListeners():241}() (Line: 206)
Symfony\Component\EventDispatcher\EventDispatcher->callListeners() (Line: 56)
Symfony\Component\EventDispatcher\EventDispatcher->dispatch() (Line: 188)
Symfony\Component\HttpKernel\HttpKernel->handleRaw() (Line: 76)
Symfony\Component\HttpKernel\HttpKernel->handle() (Line: 53)
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Nursing Drug Reference & Checker

🔍

Drug Reference Lookup

FDA label · Alerts · Nursing considerations · Beers · NIOSH

Patient Age

Used for Beers Criteria (65+) across both panels.

Drug Name (Brand or Generic)

Type 2+ letters for RxNorm autocomplete suggestions.

💊 FLUTICASONE PROPIONATE AND SALMETEROL

Generic: FLUTICASONE PROPIONATE AND SALMETEROL

RESPIRATORY (INHALATION) FDA Label

Quick reference

RouteRESPIRATORY (INHALATION)

ManufacturerBryant Ranch Prepack

SourceFDA Label

✅ Indications & Usage ›

1 INDICATIONS AND USAGE Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). Limitations of Use : Fluticasone Propionate/Salmeterol MDPI is not indicated for the relief of acute bronchospasm. Fluticasone Propionate/Salmeterol Multi-Dose Dry Powder Inhaler (MDPI) is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol inhalation powder should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). ( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm. ( 1 )

💉 Dosage & Administration ›

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) 1 inhalation of Fluticasone Propionate/Salmeterol 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg twice daily. ( 2.2 ) Do not use with a spacer or volume holding chamber. ( 2.2 )

2.1 Administration Instructions Fluticasone Propionate/Salmeterol MDPI is for oral inhalation and does not require priming. Do not use Fluticasone Propionate/Salmeterol MDPI with a spacer or volume holding chamber. Do not use more than two times every 24 hours. More frequent administration or a greater number of daily inhalations (more than one inhalation twice daily) is not recommended as some patients are more likely to experience adverse reactions with higher salmeterol dosages. Avoid the concomitant use of other long acting beta 2 -adrenergic agonist (LABAs) [see Warnings and Precautions ( 5.3 , 5.11 )]. If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief.

2.2 Recommended Dosage Administer 1 inhalation of Fluticasone Propionate/Salmeterol MDPI twice daily by oral inhalation (approximately 12 hours apart at the same time every day). Rinse the mouth with water without swallowing after each inhalation. Dosage Selection The recommended starting dosage for Fluticasone Propionate/Salmeterol MDPI is based on asthma severity and current inhaled corticosteroid use and strength. Patients not taking inhaled corticosteroids (ICS) (with less severe asthma): 1 inhalation of 55 mcg/14 mcg Fluticasone Propionate/Salmeterol MDPI dose strength (55 mcg of fluticasone propionate and 14 mcg of salmeterol), twice daily by oral inhalation. Patients with greater asthma severity, use the higher dose strengths: 1 inhalation of 113 mcg/14 mcg Fluticasone Propionate/Salmeterol MDPI (113 mcg of fluticasone propionate and 14 mcg of salmeterol) twice daily; or 1 inhalation of 232 mcg/14 mcg Fluticas... [See full FDA label]

🚫 Contraindications ›

4 CONTRAINDICATIONS Fluticasone Propionate/Salmeterol MDPI is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see Warnings and Precautions ( 5.10 ) and Description ( 11 )] . Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 ) Severe hypersensitivity to milk proteins or any ingredients of Fluticasone Propionate/Salmeterol MDPI. ( 4 )

⚠️ Warnings & Precautions ›

5 WARNINGS AND PRECAUTIONS LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 ) Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) Do not use in combination with an additional medicine containing LABA because of risk of overdose. ( 5.3 ) Localized infections: Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.4 ) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infection, or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.5 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Fluticasone Propionate/Salmeterol. ( 5.6 ) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone Propionate/Salmeterol slowly. ( 5.7 ) Paradoxical bronchospasm: Discontinue Fluticasone Propionate/Salmeterol and institute alternative therapy if paradoxical bronchospasm occurs. ( 5.9 ) Use with caution in patients with cardiovascular or central nervous system disorders because of beta adrenergic stimulation. ( 5.11 ) Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. ( 5.12 ) Monitor growth of pediatric patients. ( 5.13 ) Close monitoring for glaucoma and cataracts is warranted. ( 5.14 ) Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. ( 5.15 , 5.17 ) Use with caution in pa... [See full FDA label]

🔴 Adverse Reactions ›

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious asthma-related events • hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] Oropharyngeal candidiasis [see Warnings and Precautions ( 5.4 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.5 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.11 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.12 )] Growth effects in pediatrics [see Warnings and Precautions ( 5.13 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (greater than or equal to 3%): nasopharyngitis, oral candidiasis, headache, cough and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience in Asthma Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two placebo-controlled, 12-week, clinical studies (Trials 1 and 2) [see Clinical Studies ( 14 )] , a total of 1,364 adolescent and adult patients with persistent symptomatic asthma despite ICS or ICS/LABA therapy were treated twice daily with either placebo; fluticasone propionate MDPI 55 mcg, 113 mcg, 232 mcg; or fluticasone propionate/salmeterol MDPI 55 mcg/14 mcg, 113 mcg/14 mcg, 232 mcg/14 mcg. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 to 84 days in the fluticasone propionate MDPI and fluticasone propionate/salmeterol MDPI treatment groups compared with 75 days in the placebo group. Table 2 displa... [See full FDA label]

💊 Drug Interactions ›

7 DRUG INTERACTIONS Fluticasone Propionate/Salmeterol MDPI has been used concomitantly with other drugs, including short‑acting beta 2 ‑agonists, and intranasal corticosteroids, commonly used in patients with asthma without adverse drug reactions [see Clinical Pharmacology ( 12.2 )] . No formal drug interaction trials have been performed with Fluticasone Propionate/Salmeterol MDPI. Avoid strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): May increase risk of systemic corticosteroid and cardiovascular effects. ( 7.1 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. ( 7.2 ) Beta‑blockers: Use with caution. May block bronchodilatory effects of beta‑agonists and produce severe bronchospasm. ( 7.3 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non‑potassium‑sparing diuretics may worsen with concomitant beta‑agonists. ( 7.4 )

7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate and salmeterol, the individual components of this product, are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Fluticasone Propionate/Salmeterol MDPI is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. Ritonavir : Fluticasone Propionate: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3)] . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resultin... [See full FDA label]

🤰 Pregnancy ›

8.1 Pregnancy Risk Summary There are no randomized clinical studies of fluticasone propionate/salmeterol MDPI or individual monoproducts, fluticasone propionate and salmeterol, in pregnant women. There are clinical considerations with the use of Fluticasone Propionate/Salmeterol MDPI in pregnant women [see Clinical Considerations] . Animal reproduction studies are available with the combination of fluticasone propionate and salmeterol as well as individual components. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis [see Data] . However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis [see Data] . Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 700 times the MRHDID on a mcg/m 2 basis. These adverse effects generally occurred at large multiples of the MRHDID when salmeterol was administered by the oral route to achieve high systemic exposures. No such effects occurred at an oral salmeterol dose approximately 420 times the MRHDID [see Data] . The estimated risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease‑Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controll... [See full FDA label]

👶 Pediatric Use ›

8.4 Pediatric Use The safety and effectiveness of Fluticasone Propionate/Salmeterol MDPI have been established for the treatment of asthma in pediatric patients aged 12 years and older whose asthma (1) is inadequately controlled on a long term asthma control medication or (2) warrants initiation of treatment with both an ICS and a LABA. Use of Fluticasone Propionate/Salmeterol MDPI in pediatric patients aged 12 to 17 years for this indication is supported by evidence from two adequate and well-controlled trials in pediatric patients 12 years old and older with persistent symptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2) [see Clinical Studies ( 14 )]. In these trials, 58 adolescents received Fluticasone Propionate/Salmeterol MDPI one inhalation twice daily. The safety and effectiveness of Fluticasone Propionate/Salmeterol MDPI have not been established in pediatric patients younger than 12 years of age for the treatment of asthma. Effectiveness was not demonstrated in one adequate and well-controlled study conducted in 211 patients aged 4 to 11 years with persistent asthma on a stable asthma regimen who were treated with Fluticasone Propionate/Salmeterol MDPI 55 mcg/14 mcg one inhalation twice daily. Effect on Growth Inhaled corticosteroids, including fluticasone propionate, a component of this product, may cause a reduction in growth velocity in adolescents [see Warning and Precautions ( 5.13 )] . The growth of pediatric patients receiving ICS, including Fluticasone Propionate/Salmeterol MDPI, should be monitored. If an adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered. In such patients, the potential growth effects of prolonged ICS treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of ICS, including Fluticasone Propionate/Salmeterol MDPI, each patient should be titrated to... [See full FDA label]

👴 Geriatric Use ›

8.5 Geriatric Use No overall differences in safety or effectiveness were observed in data collected in 54 subjects aged 65 years and older versus younger subjects who were treated with Fluticasone Propionate/Salmeterol MDPI in placebo-controlled Phase 2 and 3 asthma studies.

🔬 Mechanism of Action ›

12.1 Mechanism of Action This product contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to this combination product. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical, physiologic, and inflammatory indices. Fluticasone Propionate : Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in humans are consistent with these results. The clinical significance of these findings is unknown. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in the treatment of asthma. Salmeterol : Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 ‑adrenoceptors than albuterol. Although beta 2 ‑adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 ‑adrenoceptors are the predominant receptors in the heart, there are also beta 2 ‑adrenoceptors in the human heart comprising 10% to 50% of the total beta‑adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta 2 ‑agonists may have ca... [See full FDA label]

📊 Pharmacokinetics ›

12.3 Pharmacokinetics Absorption Fluticasone Propionate: Fluticasone Propionate/Salmeterol MDPI acts locally in the lung; therefore, plasma levels may not predict therapeutic effect. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate was negligible (<1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver. In contrast, the majority of the fluticasone propionate delivered to the lung was systemically absorbed. After administration of 232 mcg/14 mcg Fluticasone Propionate/Salmeterol MDPI to patients aged 12 years and older with persistent asthma in a clinical trial, the mean C max value of fluticasone propionate was 66 pg/mL with a median t max value of approximately 2 hours. Salmeterol: After administration of 232 mcg/14 mcg Fluticasone Propionate/Salmeterol MDPI to patients aged 12 years and older with persistent asthma, the mean C max values of salmeterol was 60 pg/mL. The median t max was 5 minutes. Distribution Fluticasone Propionate: Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. The volume of distribution averaged

4.2 L/kg. The percentage of fluticasone propionate bound to human plasma proteins averages 99%. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin. Salmeterol: Volume of distribution data are not available for salmeterol. The percentage of salmeterol bound to human plasma proteins averages 96% in vitro over the concentration range of 8 to 7,722 ng of salmeterol base per milliliter, much higher concentrations than those achieved following therapeutic doses of salmeterol. Elimination Fluticasone Propionate: Following intravenous dosing, fluticasone propionate showed polyexponential kinetics and had a terminal elimination half-life of approxi... [See full FDA label]

☠️ Overdosage ›

10 OVERDOSAGE This product contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to Fluticasone Propionate/Salmeterol MDPI. Treatment of overdosage consists of discontinuation of Fluticasone Propionate/Salmeterol MDPI together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta‑receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage. Fluticasone propionate Chronic overdosage of fluticasone propionate may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.7 )] . Salmeterol The expected signs and symptoms with overdosage of salmeterol are those of excessive beta‑adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta‑adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). Overdosage with salmeterol can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias. As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of salmeterol.

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💊 FLUTICASONE PROPIONATE AND SALMETEROL

8.5 Geriatric Use No overall differences in safety or effectiveness were observed in data collected in 54 subjects aged 65 years and older versus younger subjects who were treated with Fluticasone Propionate/Salmeterol MDPI in placebo-controlled Phase 2 and 3 asthma studies.