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HIGHLIGHTS OF PRESCRIBING INFORMATION ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use STIOLTO RESPIMAT safely and effectively. See full PRESCRIBING INFORMATION for STIOLTO RESPIMAT. STIOLTO RESPIMAT (tiotropium bromide and olodaterol) inhalation spray, for oral inhalation use Initial Approval: 2015 WARNING: ASTHMA-RELATED DEATH See full PRESCRIBING INFORMATION for complete boxed warning. Long-acting beta2-adrenergic agonists (LABA) such as olodaterol, one of the active ingredients in STIOLTO RESPIMAT, increase the risk of asthma-related death. ( ) A placebo-controlled study with another long-acting beta2-adrenergic agonist (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. ( ) This finding of an increased risk of asthma-related death with salmeterol is considered a class effect of LABA, including olodaterol, one of the active ingredients in STIOLTO RESPIMAT. The safety and efficacy of STIOLTO RESPIMAT in patients with asthma have not been established.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STIOLTO RESPIMAT safely and effectively.
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