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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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.