Olodaterol and tiotropium

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use more than two inhalations every 24 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

-2 inhalations orally once a day, at the same time
Maximum dose: 2 inhalations every 24 hours

Use: Long-term treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

-2 inhalations orally once a day, at the same time
Maximum dose: 2 inhalations every 24 hours

Use: Long-term treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

Mild renal dysfunction: No adjustment recommended.
Moderate to Severe renal dysfunction (CrCl less than 60 mL/min): Use with caution; monitor closely for anticholinergic side effects

US BOXED WARNING:
Asthma-Related Death:
- Long-acting beta2-adrenergic agonists (LABA) such as olodaterol, one of the active ingredients in this drug, 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 with salmeterol is considered a class effect of all LABA, including olodaterol, one of the active ingredients in this drug.
-The safety and efficacy of this drug in patients with asthma have not been established. This drug is not indicated for the treatment of asthma.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.