The recommended dose for adults is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat reusable inhaler once daily at the same time of the day (see Instructions for Use under Patient Counselling Information).
SPECIAL POPULATIONS: Elderly: Elderly patients can use Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) at the recommended dose.
Hepatic impairment and renal impairment: Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.
Hepatic impairment: Patients with mild and moderate hepatic impairment can use Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) at the recommended dose.
There are no data available for use of olodaterol in patients with severe hepatic impairment.
Renal impairment: Renally impaired patients can use Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) at the recommended dose. Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) contains tiotropium, which is a predominantly renally excreted drug. Therefore, Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) use should be monitored closely in patients with moderate to severe renal impairment.
Paediatric population: There is no relevant use of Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) in the paediatric population in COPD. The safety and effectiveness of Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) in the paediatric population have not been established.