Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Stiolto Respimat for COPD

Combination of anticholinergic tiotropium and LABA olodaterol

Indications: Tiotropium bromide and olodaterol (Stiolto Respimat) combines an anticholinergic and long-acting beta2-adrenergic agonist (LABA) for the long-term, once-daily treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Dosing: Each actuation from the mouthpiece contains the equivalent of 2.5 mcg each tiotropium and olodaterol. The standard dose is two actuations and inhalations once daily at the same time each day.

Pharmacokinetics: The pharmacokinetic parameters for tiotropium and olodaterol combined are similar to each drug administered separately. Following inhalation of tiotropium, maximum plasma concentrations occur within 5 to 7 minutes. It is metabolized via the CYP450 pathway and eliminated through urine. Olodaterol reaches a steady state of plasma concentration after 8 days of daily dosing, reaching pack concentration within 10 to 20 minutes. It is metabolized though glucuronidation and by O-demethylation, and eliminated primarily through feces.

Side Effects/Risks: LABAs such as olodaterol may increase the risk of asthma-related death, and worsening of narrow-angle glaucoma may occur. The most commonly reported adverse reactions include nasopharyngitis, cough, and back pain.

Citation : Highlights of prescribing information: Stiolto Respimat. FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf. Revised May 2015. Accessed May 27, 2015.