Posted from: Monday, October 05, 2015 - 03:59 PM - Present

New Indication for Spiriva Respimat in the Treatment of Asthma

September 17, 2015 – The U.S. Food and Drug Administration approved a new indication for Spiriva Respimat (tiotopium bromide) Inhalation Spray for the long-term, once-daily, maintenance treatment of asthma in patients 12 years of age and older. This new indication is based on data from 12 trials that showed that the addition of Spiriva Respimat to maintenance therapy significantly improved asthma symptoms, reduced risk of severe asthma exacerbations, and had safety similar to placebo. As a long-acting muscarinic antagonist, Spiriva Respimat was previously approved in the U.S. for the maintenance treatment of chronic obstructive pulmonary disease (COPD) at a once-daily dose of 5mcg (two puffs of 2.5mcg each). The recommended dose for asthma maintenance is 2.5mcg (two puffs of 1.25mcg each) once daily. Note that, Spiriva Respimat should not be used to treat the sudden symptoms of asthma or COPD.

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Last Updated Friday, October 18, 2019 - 03:08 AM.